Patient leaflet - Vimpat

B. PACKAGE LEAFLET

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Vimpat is and what it is used for
2. What you need to know before you take Vimpat
3. How to take Vimpat
4. Possible side effects
5. How to store Vimpat
6. Contents of the pack and other information

1. What Vimpat is and what it is used for

What Vimpat is

Vimpat contains lacosamide. This belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.

You have been given this medicine to lower the number of fits (seizures) you have.

What Vimpat is used for

Vimpat is used in adults, adolescents and children aged 4 years and older.
It is used:
■ on its own and in association with other antiepileptic medicines to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain;
■ in association with other antiepileptic medicines to treat primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take Vimpat

Do not take Vimpat

if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in section 6). If you are not sure whether you are allergic, please discuss with your doctor.
if you have a certain type of heart beat problem called second- or third-degree AV block.

Do not take Vimpat if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Vimpat if:

you have thoughts of harming or killing yourself. A small number of people being treated with

antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, tell your doctor straight away.

you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter).
you have severe heart disease such as heart failure or have had a heart attack.
you are often dizzy or fall over. Vimpat may make you dizzy – this could increase the risk of

accidental injury or a fall. This means that you should take care until you are used to the effects of this medicine.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

If you are taking Vimpat, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.

If you are taking Vimpat and you are experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek medical advice immediately (see section 4).

Children under 4 years

Vimpat is not recommended for children aged under 4 years. This is because we do not yet know whether it will work and whether it is safe for children in this age group.

Other medicines and Vimpat

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart – this is because Vimpat can also affect your heart:

medicines to treat heart problems;
medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
medicines used to treat certain types of irregular heart beat or heart failure.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

Also tell your doctor or pharmacist if you are taking any of the following medicines – this is because they may increase or decrease the effect of Vimpat on your body:

medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
a medicine for HIV called ritonavir;
medicines used to treat bacterial infections called clarithromycin or rifampicin;
a herbal medicine used to treat mild anxiety and depression called St. John’s wort.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

Vimpat with alcohol

As a safety precaution do not take Vimpat with alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not recommended to take Vimpat if you are pregnant or breast-feeding, as the effects of Vimpat on pregnancy and the unborn baby or the new-born child are not known. Also, it is not known whether Vimpat passes into breast milk. Seek advice immediately from your doctor if you get pregnant or are planning to become pregnant. They will help you decide if you should take Vimpat or not.

Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A worsening of your disease can also harm your baby.

Driving and using machines

Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is because Vimpat may make you feel dizzy or cause blurred vision.

3. How to take Vimpat

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking Vimpat

Take Vimpat twice each day – once in the morning and once in the evening.
Try to take it at about the same time each day.
Swallow the Vimpat tablet with a glass of water.
You may take Vimpat with or without food.

You will usually start by taking a low dose each day and your doctor will slowly increase this over a number of weeks. When you reach the dose that works for you, this is called the “maintenance dose”, you then take the same amount each day. Vimpat is used as a long term treatment. You should continue to take Vimpat until your doctor tells you to stop.

How much to take

Listed below are the normal recommended doses of Vimpat for different age groups and weights.

Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.

Adolescents and children weighing 50 kg or more and adults

When you take Vimpat on its own

The usual starting dose of Vimpat is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of Vimpat twice a day.

Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose between 100 mg and 300 mg twice a day.

When you take Vimpat with other antiepileptic medicines

The usual starting dose of Vimpat is 50 mg twice a day.

Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose between 100 mg and 200 mg twice a day.

If you weigh 50 kg or more, your doctor may decide to start Vimpat treatment with a single “loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.

Children and adolescent weighing less than 50 kg

The dose depends on their body weight. They usually start treatment with the syrup and only change to tablets if they are able to take tablets and get the correct dose with the different tablet strengths. The doctor will prescribe the formulation that is best suited to them.

If you take more Vimpat than you should

If you have taken more Vimpat than you should, contact your doctor immediately. Do not try to drive.

You may experience:

dizziness;
feeling sick (nausea) or being sick (vomiting);
fits (seizures), heart beat problems such a slow, fast or irregular heart beat, coma or a fall in blood pressure with rapid heartbeat and sweating.

If you forget to take Vimpat

If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you

remember.

If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the

missed tablet anymore. Instead take Vimpat at the next time that you would normally take it.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Vimpat

Do not stop taking Vimpat without talking to your doctor, as your epilepsy may come back again or become worse.
If your doctor decides to stop your treatment with Vimpat, they will tell you how to decrease

the dose step by step.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Nervous system side effects such as dizziness may be higher after a single “loading” dose.

Talk to your doctor or pharmacist if you get any of the following:

Very common : may affect more than 1 in 10 people

Headache;
Feeling dizzy or sick (nausea);
Double vision (diplopia).

Common : may affect up to 1 in 10 people

Short jerks of a muscle or group of muscles (myoclonic seizures);
Difficulties in coordinating your movements or walking;
Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Troubles with your memory, thinking or finding words, confusion;
Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
A spinning sensation (vertigo), feeling drunk;
Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention;
Noise in the ear such as buzzing, ringing or whistling;
Irritability, trouble sleeping, depression;
Sleepiness, tiredness or weakness (asthenia);
Itching, rash.

Uncommon : may affect up to 1 in 100 people

Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
Allergic reaction to medicine intake, hives;
Blood tests may show abnormal liver function, liver injury;
Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away;
Feeling angry or agitated;
Abnormal thinking or losing touch with reality;
Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower

legs;

Fainting;
Abnormal involuntary movements (dyskinesia).

Not known : frequency cannot be estimated from available data

Abnormal rapid heartbeat (ventricular tachyarrhythmia);
A sore throat, high temperature and getting more infections than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
Convulsion.

Additional side effects in children

Common: may affect up to 1 in 10 children

Runny nose (nasopharyngitis);
Fever (pyrexia);
Sore throat (pharyngitis);
Eating less than usual.

Uncommon : may affect up to 1 in 100 children

Feeling sleepy or lacking in energy (lethargy).

Not known: frequency cannot be estimated from available data

Changes in behaviour, not acting like themselves.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vimpat

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Vimpat contains

The active substance is lacosamide.

One tablet of Vimpat 50 mg contains 50 mg lacosamide.

One tablet of Vimpat 100 mg contains 100 mg lacosamide.

One tablet of Vimpat 150 mg contains 150 mg lacosamide.

One tablet of Vimpat 200 mg contains 200 mg lacosamide.

The other ingredients are:

Tablet core : microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), colloidal anhydrous silica, crospovidone (polyplasdone XL-10 Pharmaceutical Grade), magnesium stearate.

Film-coat : polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colourants.

The colourants are:

50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132).

100 mg tablet: yellow iron oxide (E172).

150 mg tablet: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

200 mg tablet: indigo carmine aluminium lake (E132).

What Vimpat looks like and contents of the pack

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Vimpat is and what it is used for
2. What you need to know before you take Vimpat
3. How to take Vimpat
4. Possible side effects
5. How to store Vimpat
6. Contents of the pack and other information

1. What Vimpat is and what it is used for

What Vimpat is

Vimpat contains lacosamide. This belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.

You have been given this medicine to lower the number of fits (seizures) you have.

What Vimpat is used for

Vimpat is used in adolescents and children aged 4 years and older weighing 50 kg or more and in adults.
It is used:
■ on its own and in association with other antiepileptic medicines to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain;
■ in association with other antiepileptic medicines to treat primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take Vimpat

Do not take Vimpat

if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in section 6). If you are not sure whether you are allergic, please discuss with your doctor.
if you have a certain type of heart beat problem called second- or third-degree AV block.

Do not take Vimpat if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Vimpat if:

you have thoughts of harming or killing yourself. A small number of people being treated with

antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, tell your doctor straight away.

you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter).
you have severe heart disease such as heart failure or have had a heart attack.
you are often dizzy or fall over. Vimpat may make you dizzy – this could increase the risk of

accidental injury or a fall. This means that you should take care until you are used to the effects of this medicine.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

If you are taking Vimpat, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.

Children under 4 years

Vimpat is not recommended for children aged under 4 years. This is because we do not yet know whether it will work and whether it is safe for children in this age group.

Other medicines and Vimpat

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart – this is because Vimpat can also affect your heart:

medicines to treat heart problems;
medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
medicines used to treat certain types of irregular heart beat or heart failure.

If any of the above apply to you (or you are not sure) talk to your doctor or pharmacist before taking Vimpat.

Also tell your doctor or pharmacist if you are taking any of the following medicines – this is because they may increase or decrease the effect of Vimpat on your body:

medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
a medicine for HIV called ritonavir;
medicines for bacterial infections called clarithromycin or rifampicin;
a herbal medicine used to treat mild anxiety and depression called St. John’s wort.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

Vimpat with alcohol

As a safety precaution do not take Vimpat with alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not recommended to take Vimpat if you are pregnant or breast-feeding, as the effects of Vimpat on pregnancy and the unborn baby or the new-born child are not known. Also, it is not known whether Vimpat passes into the breast milk. Seek advice immediately from your doctor if you get pregnant or are planning to become pregnant. They will help you decide if you should take Vimpat or not.

Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A worsening of your disease can also harm your baby.

Driving and using machines

Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is because Vimpat may make you feel dizzy or cause blurred vision.

3. How to take Vimpat

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking Vimpat

Take Vimpat twice each day – once in the morning and once in the evening.
Try to take it at about the same time each day.
Swallow the Vimpat tablet with a glass of water.
You may take Vimpat with or without food.

How much to take

Listed below are the normal recommended doses of Vimpat for different age groups and weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.

Adolescents and children weighing 50 kg or more and adults only

When you take Vimpat on its own

The usual starting dose of Vimpat is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of Vimpat twice a day.

Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose between 100 mg and 300 mg twice a day.

When you take Vimpat with other antiepileptic medicines

– Start of the treatment (the first 4 weeks)

This pack (treatment initiation pack) is used when you start your treatment with Vimpat.

The pack contains 4 different packages for the first 4 weeks of treatment, one package for each week.

Each package has 14 tablets, corresponding to 2 tablets per day for 7 days.

Each package contains a different dosage strength of Vimpat, so you will increase your dose gradually.

You will start your treatment with a low dose of Vimpat, usually 50 mg twice a day, and increase it week by week. The usual dose that may be taken per day for each of the first 4 weeks of treatment is shown in the following table. Your doctor will tell you whether you need all 4 packages.

Table: Start of the treatment (the first 4 weeks)

Week	Package to be used	First dose (in the morning)	Second dose (in the evening)	TOTAL daily dose
Week 1	Package marked „Week 1“	50 mg (1 tablet Vimpat 50 mg)	50 mg (1 tablet Vimpat 50 mg)	100 mg
Week 2	Package marked „Week 2“	100 mg (1 tablet Vimpat 100 mg)	100 mg (1 tablet Vimpat 100 mg)	200 mg
Week 3	Package marked „Week 3“	150 mg (1 tablet Vimpat 150 mg)	150 mg (1 tablet Vimpat 150 mg)	300 mg
Week 4	Package marked „Week 4“	200 mg (1 tablet Vimpat 200 mg)	200 mg (1 tablet Vimpat 200 mg)	400 mg

– Maintenance treatment (after the first 4 weeks)

After the first 4 weeks of treatment, your doctor may adjust the dose with which you will continue your long term treatment. This dose is called a maintenance dose and will depend on how you respond to Vimpat. For most patients the maintenance dose is between 200 mg and 400 mg per day.

Children and adolescents below 50 kg

The treatment initiation pack is not suitable for children and adolescents weighing less than 50 kg.

If you take more Vimpat than you should

If you have taken more Vimpat than you should, contact your doctor immediately. Do not try to drive.

You may experience:

dizziness;
feeling sick (nausea) or being sick (vomiting);
fits (seizures), heart beat problems such as a slow, fast or irregular heart beat, coma or a fall in blood pressure with rapid heartbeat and sweating.

If you forget to take Vimpat

If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you remember.
If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the missed tablet anymore. Instead take Vimpat at the next time that you would normally take it.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Vimpat

Do not stop taking Vimpat without talking to your doctor, as your epilepsy may come back again or become worse.
If your doctor decides to stop your treatment with Vimpat, they will tell you how to decrease the dose step by step.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Talk to your doctor or pharmacist if you get any of the following:

Very common : may affect more than 1 in 10 people

Headache;
Feeling dizzy or sick (nausea);
Double vision (diplopia).

Common : may affect up to 1 in 10 people

Short jerks of a muscle or group of muscles (myoclonic seizures);
Difficulties in coordinating your movements or walking;
Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Troubles with your memory, thinking or finding words, confusion;
Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
A spinning sensation (vertigo), feeling drunk;
Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention;
Noise in the ear such as buzzing, ringing or whistling;
Irritability, trouble sleeping, depression;
Sleepiness, tiredness, or weakness (asthenia);
Itching, rash.

Uncommon : may affect up to 1 in 100 people

Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
Allergic reaction to medicine intake, hives;
Blood tests may show abnormal liver function, liver injury;
Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away;
Feeling angry or agitated;
Abnormal thinking or losing touch with reality;
Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower legs;
Fainting;
Abnormal involuntary movements (dyskinesia).

Not known : frequency cannot be estimated from available data

Abnormal rapid heartbeat (ventricular tachyarrhythmia);
A sore throat, high temperature and getting more infections than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
Convulsion.

Additional side effects in children

Common: may affect up to 1 in 10 children

Runny nose (nasopharyngitis);
Fever (pyrexia);
Sore throat (pharyngitis);
Eating less than usual.

Uncommon : may affect up to 1 in 100 children

Feeling sleepy or lacking in energy (lethargy).

Not known: frequency cannot be estimated from available data

Changes in behaviour, not acting like themselves.

Reporting of side effects

5. How to store Vimpat

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Vimpat contains

The active substance is lacosamide.

One tablet of Vimpat 50 mg contains 50 mg lacosamide.

One tablet of Vimpat 100 mg contains 100 mg lacosamide.

One tablet of Vimpat 150 mg contains 150 mg lacosamide.

One tablet of Vimpat 200 mg contains 200 mg lacosamide.

The other ingredients are:

Film-coat : polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colourants*. * The colourants are:

50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132).

100 mg tablet: yellow iron oxide (E172).

150 mg tablet: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

200 mg tablet: indigo carmine aluminium lake (E132).

What Vimpat looks like and contents of the pack

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Vimpat is and what it is used for
2. What you need to know before you take Vimpat
3. How to take Vimpat
4. Possible side effects
5. How to store Vimpat
6. Contents of the pack and other information

1. What Vimpat is and what it is used for

What Vimpat is

Vimpat contains lacosamide. This belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.

You have been given this medicine to lower the number of fits (seizures) you have.

What Vimpat is used for

Vimpat is used in adults, adolescents and children aged 4 years and older.
It is used:
■ on its own and in association with other antiepileptic medicines to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain;
■ in association with other antiepileptic medicines to treat primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take Vimpat

Do not take Vimpat

if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in Section 6). If you are not sure whether you are allergic, please discuss with your doctor.
if you have a certain type of heart beat problem called second- or third-degree AV block.

Do not take Vimpat if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Vimpat if:

you have thoughts of harming or killing yourself. A small number of people being treated with

antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, tell your doctor straight away.

you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation or atrial flutter).
you have severe heart disease such as heart failure or have had a heart attack.
you are often dizzy or fall over. Vimpat may make you dizzy – this could increase the risk of

accidental injury or a fall. This means that you should take care until you are used to the effects of this medicine.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

If you are taking Vimpat, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.

Children under 4 years

Vimpat is not recommended for children aged under 4 years. This is because we do not yet know whether it will work and whether it is safe for children in this age group.

Other medicines and Vimpat

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart – this is because Vimpat can also affect your heart:

medicines to treat heart problems;
medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
medicines used to treat certain types of irregular heart beat or heart failure.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

Also tell your doctor or pharmacist if you are taking any of the following medicines – this is because they may increase or decrease the effect of Vimpat on your body:

medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
a medicine for HIV called ritonavir;
medicines for bacterial infections called clarithromycin or rifampicin;
a herbal medicine used to treat mild anxiety and depression called St. John’s wort.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

Vimpat with alcohol

As a safety precaution do not take Vimpat with alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not recommended to take Vimpat if you are pregnant or breast-feeding, as the effects of Vimpat on pregnancy and the unborn baby or the new-born child are not known. Also, it is not known whether Vimpat passes into the breast milk. Seek advice immediately from your doctor if you get pregnant or are planning to become pregnant. They will help you decide if you should take Vimpat or not.

Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A worsening of your disease can also harm your baby.

Driving and using machines

Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is because Vimpat may make you feel dizzy or cause blurred vision.

Vimpat contains sorbitol, sodium, sodium methyl parahydroxybenzoate, aspartame, propylene glycol and potassium

Sorbitol (a type of sugar): This medicine contains 187 mg sorbitol in each ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Sodium (salt): This medicine contains 1.42 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.07 % of the recommended maximum daily dietary intake of sodium for an adult.
Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).
Aspartame (E951): This medicine contains 0.032 mg aspartame in each ml. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Propylene glycol (E1520): This medicine contains 2.14 mg propylene glycol in each ml.
Potassium: This medicine contains potassium, less than 1 mmol (39 mg) per 60 mL, i.e.

essentially ‚potassium-free‘.

3. How to take Vimpat

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking Vimpat

Take Vimpat twice each day – once in the morning and once in the evening.
Try to take it at about the same time each day.
You may take Vimpat with or without food.

How much to take

Listed below are the normal recommended doses of Vimpat for different age groups and weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.

Adolescents and children weighing 50 kg or more and adults

Use the measuring cup provided in the carton box.

When you take Vimpat on its own

The usual starting dose of Vimpat is 50 mg (5 ml) twice a day.

Your doctor may also prescribe a starting dose of 100 mg (10 ml) of Vimpat twice a day.

Your doctor may increase your twice daily dose every week by 50 mg (5 ml). This will be until you reach a maintenance dose of between 100 mg (10 ml) and 300 mg (30 ml) twice a day.

When you take Vimpat with other antiepileptic medicines

The usual starting dose of Vimpat is 50 mg (5 ml) twice a day.

Your doctor may increase your twice daily dose every week by 50 mg (5 ml). This will be until you reach a maintenance dose of between 100 mg (10 ml) and 200 mg (20 ml) twice a day.

If you weigh 50 kg or more, your doctor may decide to start Vimpat treatment with a single “loading” dose of 200 mg (20 ml). You would then start your ongoing maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

Use the oral syringe provided in the carton box.

When you take Vimpat on its own

Your doctor will decide the dose of Vimpat based on your body weight.

The usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml), for each kg of your body weight. This will be until you reach a maintenance dose. The maximum recommended dose is 6 mg (0.6 ml) for each kg of body weight, twice a day, for children weighing under 40 kg. The maximum recommended dose is 5 mg (0.5 ml) for each kg of body weight, twice a day, for children weighing from 40 kg to under 50 kg. Dosing charts are provided below:

Taking Vimpat on its own – This is for information only. Your doctor will work out the right dose for you:

To be taken twice daily for children from 4 years of age weighing less than 40 kg

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	0.5 ml/kg	Maximum recommended dose: 0.6 ml/kg
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml	12 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml	15 ml
30 kg	3 ml	6 ml	9 ml	12 ml	15 ml	18 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml	17.5 ml	21 ml

To be taken twice daily for children and adolescents from 4 years of age weighing 40 kg to under 50 kg :

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	Maximum recommended dose: 0.5 ml/kg
40 kg	4 ml	8 ml	12 ml	16 ml	20 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml	22.5 ml

When you take Vimpat with other antiepileptic medicines

Your doctor will decide the dose of Vimpat based on your body weight.

In children from 4 years of age with a body weight of under 20 kg:

the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body weight. This will be until you reach a maintenance dose. The maximum recommended dose is 6 mg (0.6 ml), for each kg of body weight, twice a day. A dosing chart is provided below.

Taking Vimpat with other antiepileptic medicines – Children above 4 years of age weighing less than 20 kg - This is for information only. Your doctor will work out the right dose for you:

To be taken twice daily for children from 4 years of age weighing less than 20 kg

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	0.5 ml/kg	Maximum recommended dose: 0.6 ml/kg
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml

In children from 4 years of age with a body weight of 20 to under 30 kg:

the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body weight. This will be until you reach a maintenance dose. The maximum recommended dose is 5 mg (0.5 ml), for each kg of body weight, twice a day. A dosing chart is provided below.

Taking Vimpat with other antiepileptic medicines – Children and adolescents with a body weight of 20 kg to under 30 kg - This is for information only. Your doctor will work out the right dose for you:

To be taken twice daily for children and adolescents from 4 years of age weighing 20 kg to under 30 kg :

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	Maximum recommended dose: 0.5 ml/kg
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml

In children from 4 years of age with a body weight of 30 to under 50 kg:

the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body weight. This will be until you reach a maintenance dose. The maximum recommended dose is 4 mg (0.4 ml), for each kg of body weight, twice a day. A dosing chart is provided below.

Taking Vimpat with other antiepileptic medicines – Children and adolescents with a body weight of 30 kg to under 50 kg - This is for information only. Your doctor will work out the right dose for you:

To be taken twice daily for children and adolescents from 4 years of age weighing 30 kg to under 50 kg :

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	Maximum recommended dose: 0.4 ml/kg
30 kg	3 ml	6 ml	9 ml	12 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml
40 kg	4 ml	8 ml	12 ml	16 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml

Instructions for use: measuring cup

Adolescents and children weighing 50 kg or more and adults

Use the measuring cup provided in this pack.
1. Shake the bottle well before use.
2. Fill the measuring cup to the millilitre (ml) dose marker prescribed by your doctor.
3. Swallow the dose of syrup.
4. Then drink some water.

Instructions for use: oral syringe

Your doctor will show you how to use the oral syringe, before you use it for the first time. If you have any questions, please go back to your doctor or pharmacist.

Children and adolescents weighing less than 50 kg

Use the oral syringe and the adaptor provided in this pack.

Shake the bottle well before use.

Open the bottle by pressing the cap while turning it anti-clockwise (figure 1).

Follow these steps the first time you take Vimpat:

Take off the adaptor from the oral syringe (figure 2).
Put the adaptor into the top of the bottle (figure 3). Make sure it is fixed well in place. You do not need to remove the adaptor after use.

Follow these steps each time you take Vimpat:

Put the oral syringe into the adaptor opening (figure 4).
Turn the bottle upside down (figure 5).
Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.
Pull the piston down to fill the oral syringe with a small amount of solution (figure 6).
Push the piston up to get rid of any bubbles (figure 7).
Pull the piston down to the millilitre (ml) dose marker prescribed by your doctor (figure 8).
Turn the bottle the right way up (figure 9).
Take the oral syringe out of the adaptor (figure 10).

There are two ways in which you can choose to drink the medicine:

empty the contents of the oral syringe into a little water by pushing the piston to the bottom of the oral syringe (figure 11) – you will then need to drink all of the water (add just enough to make it easy to drink) or
drink the solution directly from the oral syringe without water (figure 12) – drink the whole contents of the oral syringe.
Close the bottle with the plastic screw cap (you do not need to remove the adaptor).
Wash the oral syringe with water only (figure 13).

If you take more Vimpat than you should

If you have taken more Vimpat than you should, contact your doctor immediately. Do not try to drive. You may experience:

dizziness;
feeling sick (nausea) or being sick (vomiting);
fits (seizures), heart beat problems such as a slow, fast or irregular heart beat, coma or a fall in blood pressure with rapid heartbeat and sweating.

If you forget to take Vimpat

If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you

remember.

If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the

missed syrup anymore. Instead take Vimpat at the next time that you would normally take it.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Vimpat

Do not stop taking Vimpat without talking to your doctor, as your epilepsy may come back again or become worse.
If your doctor decides to stop your treatment with Vimpat, they will tell you how to decrease the dose step by step.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Nervous system side effects such as dizziness may be higher after a single “loading” dose.

Talk to your doctor or pharmacist if you get any of the following:

Very common : may affect more than 1 in 10 people

Headache;
Feeling dizzy or sick (nausea);
Double vision (diplopia).

Common : may affect up to 1 in 10 people

Short jerks of a muscle or group of muscles (myoclonic seizures);
Difficulties in coordinating your movements or walking;
Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Trouble with your memory, thinking or finding words, confusion;
Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
A spinning sensation (vertigo), feeling drunk;
Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention;
Noise in the ear such as buzzing, ringing or whistling;
Irritability, trouble sleeping, depression;
Sleepiness, tiredness or weakness (asthenia);
Itching, rash.

Uncommon : may affect up to 1 in 100 people

Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
Allergic reaction to medicine intake, hives;
Blood tests may show abnormal liver function, liver injury;
Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away;
Feeling angry or agitated;
Abnormal thinking or losing of touch with reality;
Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower legs;
Fainting;
Abnormal involuntary movements (dyskinesia).

Not known : frequency cannot be estimated from available data

Abnormal rapid heartbeat (ventricular tachyarrhythmia);
A sore throat, high temperature and getting more infections than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
Convulsion.

Additional side effects in children

Common: may affect up to 1 in 10 children

Runny nose (nasopharyngitis);
Fever (pyrexia);
Sore throat (pharyngitis);
Eating less than usual.

Uncommon : may affect up to 1 in 100 children

Feeling sleepy or lacking in energy (lethargy).

Not known: frequency cannot be estimated from available data

Changes in behaviour, not acting like themselves.

Reporting of side effects

5. How to store Vimpat

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.

Do not refrigerate.

Once you have opened the syrup bottle, do not use beyond 2 months.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Vimpat contains

The active substance is lacosamide. 1 ml Vimpat syrup contains 10 mg lacosamide.
The other ingredients are glycerol (E422), carmellose sodium, sorbitol liquid (crystallizing) (E420), polyethylene glycol 4000, sodium chloride, citric acid anhydrous, acesulfame potassium (E950), sodium methyl parahydroxybenzoate (E219), strawberry flavour (contains propylene glycol, maltol), masking flavour (contains propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionised water), purified water.

What Vimpat looks like and contents of the pack

Vimpat 10 mg/ml syrup is a slightly viscous clear, colourless to yellow-brown liquid.
Vimpat is available in a bottle of 200 ml.

The carton boxes of Vimpat syrup contain a 30 ml measuring cup with graduation marks and a 10 ml oral syringe.

The measuring cup is suitable for adults, adolescents and children weighing 50 kg and above. Each graduation mark (5 ml) of the measuring cup corresponds to 50 mg of lacosamide (for example 2 graduation marks correspond to 100 mg).
The oral syringe is suitable for children and adolescents below 50 kg. One full 10 ml oral syringe corresponds to 100 mg of lacosamide. The minimum extractable volume is 1 ml, which is 10 mg of lacosamide. After this, each graduation mark (0.25 ml) corresponds to 2.5 mg of lacosamide (for example 4 graduation marks corresponds to 10 mg).

Marketing Authorisation Holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.

Manufacturer

Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany or

UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.

For any information about this medicine, please Authorisation Holder.

Belgie/Belgique/Belgien

UCB Pharma SA/NV

Tél/Tel: + 32 / (0)2 559 92 00

Efcnrapua

TO CH EH Etnrapua EOOfl

Ten.: + 359 (0) 2 962 30 49

Česká republika

UCB s.r.o.

Tel: + 420 221 773 411

Danmark

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Deutschland

UCB Pharma GmbH

Tel: + 49 /(0) 2173 48 4848

Eesti

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Soome)

EXXáSa

UCB A.E.

Tql: + 30 /2109974000

España

UCB Pharma, S.A.

Tel: + 34 / 91 570 34 44

France

UCB Pharma S.A.

Tél: + 33 / (0)1 47 29 44 35

Hrvatska

Medis Adria d.o.o.

Tel: +385 (0) 1 230 34 46

Ireland

UCB (Pharma) Ireland Ltd.

Tel: + 353 / (0)1–46 37 395

Ísland

Vistor hf.

Simi: + 354 535 7000

contact the local representative of the Marketing

Lietuva

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Suomija)

Luxembourg/Luxemburg

UCB Pharma SA/NV

Tél/Tel: + 32 / (0)2 559 92 00

Magyarország

UCB Magyarország Kft.

Tel.: + 36-(1) 391 0060

Malta

Pharmasud Ltd.

Tel: + 356 / 21 37 64 36

Nederland

UCB Pharma B.V.

Tel.: + 31 / (0)76–573 11 40

Norge

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Österreich

UCB Pharma GmbH

Tel: + 43 (0)1 291 80 00

Polska

UCB Pharma Sp. z o.o.

Tel: + 48 22 696 99 20

Portugal

Bial – Portela & Ca, S.A.

Tel: + 351 22 986 6100

Romania

UCB Pharma Romania S.R.L.

Tel: + 40 21 300 29 04

Slovenija

Medis, d.o.o.

Tel: + 386 1 589 69 00

Slovenská republika

UCB s.r.o., organizačná zložka

Tel: + 421 (0) 2 5920 2020

Italia

UCB Pharma S.p.A.

Tel: + 39 / 02 300 791

Suomi/Finland

UCB Pharma Oy Finland

Puh/Tel: + 358 9 2514 4221

Kûnpoç

Lifepharma (Z.A.M.) Ltd

Tql: + 357 22 05 63 00

Sverige

UCB Nordic A/S

Tel: + 46 / (0) 40 29 49 00

Latvija

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Somija)

United Kingdom (Northern Ireland)

UCB (Pharma) Ireland Ltd

Tel: + 353 / (0)1–46 37 395

This leaflet was last revised in {month/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Vimpat 10 mg/ml solution for infusion lacosamide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Vimpat is and what it is used for
2. What you need to know before you use Vimpat
3. How to use Vimpat
4. Possible side effects
5. How to store Vimpat
6. Contents of the pack and other information

1. What Vimpat is and what it is used for

What Vimpat is

Vimpat contains lacosamide. This belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.

You have been given this medicine to lower the number of fits (seizures) you have.

What Vimpat is used for

Vimpat is used in adults, adolescents and children aged 4 years and older.
It is used:
■ on its own and in association with other antiepileptic medicines to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain;
■ in association with other antiepileptic medicines to treat primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you use Vimpat

Do not use Vimpat

if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in section 6). If you are not sure whether you are allergic, please discuss with your doctor.
if you have a certain type of heart beat problem called second- or third-degree AV block.

Do not use Vimpat if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.

Warnings and precautions

Talk to your doctor before using Vimpat if:

you have thoughts of harming or killing yourself. A small number of people being treated with antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, tell your doctor straight away.
you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter).
you have severe heart disease such as heart failure or have had a heart attack.
you are often dizzy or fall over. Vimpat may make you dizzy – this could increase the risk of

accidental injury or a fall. This means that you should take care until you are used to the effects of this medicine.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Vimpat.

If you are taking Vimpat, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.

Children under 4 years

Vimpat is not recommended for children aged under 4 years. This is because we do not yet know whether it will work and whether it is safe for children in this age group.

Other medicines and Vimpat

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart – this is because Vimpat can also affect your heart:

medicines to treat heart problems;
medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
medicines used to treat certain types of irregular heart beat or heart failure.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Vimpat.

Also tell your doctor or pharmacist if you are taking any of the following medicines – this is because they may increase or decrease the effect of Vimpat on your body:

medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
a medicine for HIV called ritonavir;
medicines for bacterial infections called clarithromycin or rifampicin;
a herbal medicine used to treat mild anxiety and depression called St. John’s wort.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Vimpat.

Vimpat with alcohol

As a safety precaution do not use Vimpat with alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

It is not recommended to use Vimpat if you are pregnant or breast feeding, as the effects of Vimpat on pregnancy and the unborn baby or the new-born child are not known. Also, it is not known whether Vimpat passes into breast milk. Seek advice immediately from your doctor if you get pregnant or are planning to become pregnant. They will help you decide if you should use Vimpat or not.

Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A worsening of your disease can also harm your baby.

Driving and using machines

Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is because Vimpat may make you feel dizzy or cause blurred vision.

Vimpat contains sodium

This medicine contains 59.8 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 3 % of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use Vimpat

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Using Vimpat

Vimpat can be started by:
– taking the medicine by mouth or
– by being given as an intravenous infusion (sometimes called an “IV infusion”) where the medicine is given into your vein by a doctor or nurse. It is given over 15 to 60 minutes.

The IV infusion is usually used for a short time when you cannot take the medicine by mouth.
Your doctor will decide for how many days you will have infusions. There is experience with twice daily infusions of Vimpat for up to 5 days. For longer term treatment Vimpat tablets and syrup are available.

When you change from the infusion to taking the medicine by mouth (or the other way around) the total amount you take each day and how often you take it stays the same.

Use Vimpat twice each day – once in the morning and once in the evening.
Try to use it at about the same time each day.

How much to use

Listed below are the normal recommended doses of Vimpat for different age groups and weights.

Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.

Adolescents and children weighing 50 kg or more and adults

When you use Vimpat on its own

The usual starting dose of Vimpat is 50 mg twice a day.

The treatment with Vimpat may also start with a dose of 100 mg of Vimpat twice a day.

Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose of between 100 mg and 300 mg twice a day.

When you use Vimpat with other antiepileptic medicines

The usual starting dose of Vimpat is 50 mg twice a day.

Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose of between 100 mg and 200 mg twice a day.

If you weigh 50 kg or more, your doctor may decide to start Vimpat treatment with a single “loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

When you use Vimpat on its own

Your doctor will decide the dose of Vimpat based on your body weight.

The usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml), for each kg of your body weight. This will be until you reach a maintenance dose. The maximum recommended dose is

6 mg (0.6 ml) for each kg of body weight, twice a day, for children weighing under 40 kg. The maximum maintenance dose is 5 mg (0.5 ml) for each kg of body weight, twice a day, for children weighing from 40 kg to under 50 kg. Dosing charts are provided below:

Using Vimpat on its own – This is for information only. Your doctor will work out the right dose for you:

To be used twice daily for children from 4 years of age weighing less than 40 kg

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	0.5 ml/kg	Maximum recommended dose: 0.6 ml/kg
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml	12 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml	15 ml
30 kg	3 ml	6 ml	9 ml	12 ml	15 ml	18 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml	17.5 ml	21 ml

To be used twice daily for children and adolescents from 4 years of age weighing 40 kg to under

50 kg :

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	Maximum recommended dose: 0.5 ml/kg
40 kg	4 ml	8 ml	12 ml	16 ml	20 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml	22.5 ml

When you use Vimpat with other antiepileptic medicines

Your doctor will decide the dose of Vimpat based on your body weight.

In children from 4 years of age with a body weight of under 20 kg:

the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Using Vimpat with other antiepileptic medicines – Children above 4 years of age weighing less than 20 kg – This is for information only. Your doctor will work out the right dose for you:

To be used twice daily for children from 4 years of age weighing less than 20 kg

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	0.5 ml/kg	Maximum recommended dose: 0.6 ml/kg
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml

In children from 4 years of age with a body weight of 20 kg to under 30 kg:

the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may increase your twice daily dose every week by 1 mg (0.1 ml), for each kg of body weight. This will be until you reach a maintenance dose. The maximum recommended dose is 5 mg (0.5 ml), for each kg of body weight, twice a day. A dosing chart is provided below.

Using Vimpat with other antiepileptic medicines – Children and adolescents with a body weight of 20 to under 30 kg – This is for information only. Your doctor will work out the right dose for you:

To be used twice daily for children and adolescents from 4 years of age weighing 20 kg to under 30 kg :

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	Maximum recommended dose: 0.5 ml/kg
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml

In children from 4 years of age with a body weight of 30 to under 50 kg:

the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body weight. This will be until you reach a maintenance dose. The maximum recommended dose is 4 mg (0.4 ml), for each kg of body weight, twice a day. A dosing chart is provided below.

Using Vimpat with other antiepileptic medicines – Children and adolescents with a body weight of 30 kg to under 50 kg - This is for information only. Your doctor will work out the right dose for you:

To be used twice daily for children and adolescents from 4 years of age weighing 30 kg to under 50 kg :

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	Maximum recommended dose: 0.4 ml/kg
30 kg	3 ml	6 ml	9 ml	12 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml
40 kg	4 ml	8 ml	12 ml	16 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml

If you stop using Vimpat

If your doctor decides to stop your treatment with Vimpat, they will decrease the dose step by step. This is to prevent your epilepsy from coming back again or becoming worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Nervous system side effects such as dizziness may be higher after a single “loading” dose.

Talk to your doctor or pharmacist if you get any of the following:

Very common : may affect more than 1 in 10 people

Headache;
Feeling dizzy or sick (nausea);
Double vision (diplopia).

Common : may affect up to 1 in 10 people

Short jerks of a muscle or group of muscles (myoclonic seizures);
Difficulties in coordinating your movements or walking;
Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Troubles with your memory, thinking or finding words, confusion;
Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
A spinning sensation (vertigo), feeling drunk;
Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention;
Noise in the ear such as buzzing, ringing or whistling;
Irritability, trouble sleeping, depression;
Sleepiness, tiredness or weakness (asthenia);
Itching, rash.

Uncommon : may affect up to 1 in 100 people

Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
Allergic reaction to medicine intake, hives;
Blood tests may show abnormal liver function, liver injury;
Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away;
Feeling angry or agitated;
Abnormal thinking or losing touch with reality;
Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower legs;
Fainting;
Abnormal involuntary movements (dyskinesia).

Not known : frequency cannot be estimated from available data

Abnormal rapid heartbeat (ventricular tachyarrhythmia);
A sore throat, high temperature and getting more infections than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
Convulsion.

Additional side effects when given as an intravenous infusion There may be local side effects.

Common : may affect up to 1 in 10 people

Injection site pain or discomfort or irritation.

Uncommon : may affect up to 1 in 100 people

Injection site redness.

Additional side effects in children

Common: may affect up to 1 in 10 children

Runny nose (nasopharyngitis);
Fever (pyrexia);
Sore throat (pharyngitis);
Eating less than usual.

Uncommon : may affect up to 1 in 100 children

Feeling sleepy or lacking in energy (lethargy).

Not known: frequency cannot be estimated from available data

Changes in behaviour, not acting like themselves.

Reporting of side effects

5. How to store Vimpat

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Each vial of Vimpat solution for infusion must be used only once (single use). Any unused solution should be discarded.

Only clear solution free from particles and discoloration should be used.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Vimpat contains

The active substance is lacosamide.
1 ml Vimpat solution for infusion contains 10 mg lacosamide.
1 vial contains 20 ml Vimpat solution for infusion equivalent to 200 mg lacosamide.

The other ingredients are: sodium chloride, hydrochloric acid, water for injections.

What Vimpat looks like and contents of the pack

Vimpat 50 mg are pinkish, oval film-coated tablets of approximately 10.4 mm x 4.9 mm with a debossed ‘SP’ on one side and ‘50’ on the other side.
Vimpat 100 mg are dark yellow, oval film-coated tablets of approximately 13.2 mm x 6.1 mm with a debossed ‘SP’ on one side and ‘100’ on the other side.
Vimpat 150 mg are salmon, oval film-coated tablets of approximately 15.1 mm x 7.0 mm with a debossed ‘SP’ on one side and ‘150’ on the other side.
Vimpat 200 mg are blue, oval film-coated tablets of approximately 16.6 mm x 7.8 mm with a debossed ‘SP’ on one side and ‘200’ on the other side.

Vimpat is available in packs of 14, 28, 56, 60, 14 × 1 and 56 × 1 film-coated tablets.

Vimpat 50 mg and Vimpat 100 mg are available in packs of 168 film-coated tablets and Vimpat 150 mg and Vimpat 200 mg are available in multipacks comprising 3 cartons, each containing 56 tablets. The 14 × 1 and 56 × 1 film-coated tablets packs are available as perforated unit dose PVC/PVDC blisters sealed with an aluminium foil, the 14, 28, 56 and 168 packs are available with standard PVC/PVDC blisters sealed with an aluminium foil, the 60 packs are available in HDPE bottles with a child-resistant closure. Not all pack sizes may be marketed.

Marketing Authorisation Holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.

Manufacturer

UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.

Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

UCB Pharma SA/NV

Tél/Tel: + 32 / (0)2 559 92 00

Efc^rapufl

TO CH EH Etarapua EOOfl

Tea.: + 359 (0) 2 962 30 49

Česká republika

UCB s.r.o.

Tel: + 420 221 773 411

Lietuva

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Suomija)

Luxembourg/Luxemburg

UCB Pharma SA/NV

Tél/Tel: + 32 / (0)2 559 92 00

Magyarország

UCB Magyarország Kft.

Tel.: + 36-(1) 391 0060

Danmark

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Deutschland

UCB Pharma GmbH

Tel: + 49 /(0) 2173 48 4848

Eesti

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Soome)

EXXáSa

UCB A.E.

Tql: + 30 /2109974000

España

UCB Pharma, S.A.

Tel: + 34 / 91 570 34 44

France

UCB Pharma S.A.

Tél: + 33 / (0)1 47 29 44 35

Hrvatska

Medis Adria d.o.o.

Tel: +385 (0) 1 230 34 46

Ireland

UCB (Pharma) Ireland Ltd.

Tel: + 353 / (0)1–46 37 395

Ísland

Vistor hf.

Simi: + 354 535 7000

Italia

UCB Pharma S.p.A.

Tel: + 39 / 02 300 791

Kúnpog

Lifepharma (Z.A.M.) Ltd

Tql: + 357 22 05 63 00

Latvija

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Somija)

Malta

Pharmasud Ltd.

Tel: + 356 / 21 37 64 36

Nederland

UCB Pharma B.V.

Tel.: + 31 / (0)76–573 11 40

Norge

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Österreich

UCB Pharma GmbH

Tel: + 43 (0)1 291 80 00

Polska

UCB Pharma Sp. z o.o.

Tel: + 48 22 696 99 20

Portugal

Bial – Portela & Ca, S.A.

Tel: + 351 22 986 6100

Romania

UCB Pharma Romania S.R.L.

Tel: + 40 21 300 29 04

Slovenija

Medis, d.o.o.

Tel: + 386 1 589 69 00

Slovenská republika

UCB s.r.o., organizačná zložka

Tel: + 421 (0) 2 5920 2020

Suomi/Finland

UCB Pharma Oy Finland

Puh/Tel: + 358 9 2514 4221

Sverige

UCB Nordic A/S

Tel: + 46 / (0) 40 29 49 00

United Kingdom (Northern Ireland)

UCB (Pharma) Ireland Ltd

Tel: + 353 / (0)1–46 37 395

This leaflet was last revised in {month/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Vimpat 50 mg film-coated tablets

Vimpat 100 mg film-coated tablets

Vimpat 150 mg film-coated tablets

Vimpat 200 mg film-coated tablets lacosamide

The treatment initiation pack is only suitable in adolescents and children weighing 50 kg or more and in adults.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Vimpat is and what it is used for
2. What you need to know before you take Vimpat
3. How to take Vimpat
4. Possible side effects
5. How to store Vimpat
6. Contents of the pack and other information

1. What Vimpat is and what it is used for

What Vimpat is

Vimpat contains lacosamide. This belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.

You have been given this medicine to lower the number of fits (seizures) you have.

What Vimpat is used for

Vimpat is used in adolescents and children aged 4 years and older weighing 50 kg or more and in adults.
It is used:
■ on its own and in association with other antiepileptic medicines to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain;
■ in association with other antiepileptic medicines to treat primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take Vimpat

Do not take Vimpat

if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in section 6). If you are not sure whether you are allergic, please discuss with your doctor.
if you have a certain type of heart beat problem called second- or third-degree AV block.

Do not take Vimpat if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Vimpat if:

you have thoughts of harming or killing yourself. A small number of people being treated with

antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, tell your doctor straight away.

you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter).
you have severe heart disease such as heart failure or have had a heart attack.
you are often dizzy or fall over. Vimpat may make you dizzy – this could increase the risk of

accidental injury or a fall. This means that you should take care until you are used to the effects of this medicine.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

If you are taking Vimpat, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.

Children under 4 years

Vimpat is not recommended for children aged under 4 years. This is because we do not yet know whether it will work and whether it is safe for children in this age group.

Other medicines and Vimpat

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart – this is because Vimpat can also affect your heart:

medicines to treat heart problems;
medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
medicines used to treat certain types of irregular heart beat or heart failure.

If any of the above apply to you (or you are not sure) talk to your doctor or pharmacist before taking Vimpat.

Also tell your doctor or pharmacist if you are taking any of the following medicines – this is because they may increase or decrease the effect of Vimpat on your body:

medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
a medicine for HIV called ritonavir;
medicines for bacterial infections called clarithromycin or rifampicin;
a herbal medicine used to treat mild anxiety and depression called St. John’s wort.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

Vimpat with alcohol

As a safety precaution do not take Vimpat with alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not recommended to take Vimpat if you are pregnant or breast-feeding, as the effects of Vimpat on pregnancy and the unborn baby or the new-born child are not known. Also, it is not known whether Vimpat passes into the breast milk. Seek advice immediately from your doctor if you get pregnant or are planning to become pregnant. They will help you decide if you should take Vimpat or not.

Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A worsening of your disease can also harm your baby.

Driving and using machines

Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is because Vimpat may make you feel dizzy or cause blurred vision.

3. How to take Vimpat

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking Vimpat

Take Vimpat twice each day – once in the morning and once in the evening.
Try to take it at about the same time each day.
Swallow the Vimpat tablet with a glass of water.
You may take Vimpat with or without food.

How much to take

Listed below are the normal recommended doses of Vimpat for different age groups and weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.

Adolescents and children weighing 50 kg or more and adults only

When you take Vimpat on its own

The usual starting dose of Vimpat is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of Vimpat twice a day.

Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose between 100 mg and 300 mg twice a day.

When you take Vimpat with other antiepileptic medicines

– Start of the treatment (the first 4 weeks)

This pack (treatment initiation pack) is used when you start your treatment with Vimpat.

The pack contains 4 different packages for the first 4 weeks of treatment, one package for each week.

Each package has 14 tablets, corresponding to 2 tablets per day for 7 days.

Each package contains a different dosage strength of Vimpat, so you will increase your dose gradually.

Table: Start of the treatment (the first 4 weeks)

Week	Package to be used	First dose (in the morning)	Second dose (in the evening)	TOTAL daily dose
Week 1	Package marked „Week 1“	50 mg (1 tablet Vimpat 50 mg)	50 mg (1 tablet Vimpat 50 mg)	100 mg
Week 2	Package marked „Week 2“	100 mg (1 tablet Vimpat 100 mg)	100 mg (1 tablet Vimpat 100 mg)	200 mg
Week 3	Package marked „Week 3“	150 mg (1 tablet Vimpat 150 mg)	150 mg (1 tablet Vimpat 150 mg)	300 mg
Week 4	Package marked „Week 4“	200 mg (1 tablet Vimpat 200 mg)	200 mg (1 tablet Vimpat 200 mg)	400 mg

– Maintenance treatment (after the first 4 weeks)

Children and adolescents below 50 kg

The treatment initiation pack is not suitable for children and adolescents weighing less than 50 kg.

If you take more Vimpat than you should

If you have taken more Vimpat than you should, contact your doctor immediately. Do not try to drive.

You may experience:

dizziness;
feeling sick (nausea) or being sick (vomiting);
fits (seizures), heart beat problems such as a slow, fast or irregular heart beat, coma or a fall in blood pressure with rapid heartbeat and sweating.

If you forget to take Vimpat

If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you remember.
If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the missed tablet anymore. Instead take Vimpat at the next time that you would normally take it.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Vimpat

Do not stop taking Vimpat without talking to your doctor, as your epilepsy may come back again or become worse.
If your doctor decides to stop your treatment with Vimpat, they will tell you how to decrease the dose step by step.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Talk to your doctor or pharmacist if you get any of the following:

Very common : may affect more than 1 in 10 people

Headache;
Feeling dizzy or sick (nausea);
Double vision (diplopia).

Common : may affect up to 1 in 10 people

Short jerks of a muscle or group of muscles (myoclonic seizures);
Difficulties in coordinating your movements or walking;
Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Troubles with your memory, thinking or finding words, confusion;
Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
A spinning sensation (vertigo), feeling drunk;
Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention;
Noise in the ear such as buzzing, ringing or whistling;
Irritability, trouble sleeping, depression;
Sleepiness, tiredness, or weakness (asthenia);
Itching, rash.

Uncommon : may affect up to 1 in 100 people

Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
Allergic reaction to medicine intake, hives;
Blood tests may show abnormal liver function, liver injury;
Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away;
Feeling angry or agitated;
Abnormal thinking or losing touch with reality;
Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower legs;
Fainting;
Abnormal involuntary movements (dyskinesia).

Not known : frequency cannot be estimated from available data

Abnormal rapid heartbeat (ventricular tachyarrhythmia);
A sore throat, high temperature and getting more infections than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
Convulsion.

Additional side effects in children

Common: may affect up to 1 in 10 children

Runny nose (nasopharyngitis);
Fever (pyrexia);
Sore throat (pharyngitis);
Eating less than usual.

Uncommon : may affect up to 1 in 100 children

Feeling sleepy or lacking in energy (lethargy).

Not known: frequency cannot be estimated from available data

Changes in behaviour, not acting like themselves.

Reporting of side effects

5. How to store Vimpat

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Vimpat contains

The active substance is lacosamide.

One tablet of Vimpat 50 mg contains 50 mg lacosamide.

One tablet of Vimpat 100 mg contains 100 mg lacosamide.

One tablet of Vimpat 150 mg contains 150 mg lacosamide.

One tablet of Vimpat 200 mg contains 200 mg lacosamide.

The other ingredients are:

Film-coat : polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colourants*. * The colourants are:

50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132).

100 mg tablet: yellow iron oxide (E172).

150 mg tablet: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

200 mg tablet: indigo carmine aluminium lake (E132).

What Vimpat looks like and contents of the pack

Vimpat 50 mg are pinkish, oval film-coated tablets of approximately 10.4 mm x 4.9 mm with a debossed ‘SP’ on one side and ‘50’ on the other side.
Vimpat 100 mg are dark yellow, oval film-coated tablets of approximately 13.2 mm x 6.1 mm with a debossed ‘SP’ on one side and ‘100’ on the other side.
Vimpat 150 mg are salmon, oval film-coated tablets of approximately 15.1 mm x 7.0 mm with a debossed ‘SP’ on one side and ‘150’ on the other side.
Vimpat 200 mg are blue, oval film-coated tablets of approximately 16.6 mm x 7.8 mm with a debossed ‘SP’ on one side and ‘200’ on the other side.

The treatment initiation pack contains 56 film-coated tablets in 4 packages:

the package marked ‘Week 1’contains 14 tablets of 50 mg,
the package marked ‘Week 2’ contains 14 tablets of 100 mg,
the package marked ‘Week 3’ contains 14 tablets of 150 mg,
the package marked ‘Week 4’ contains 14 tablets of 200 mg.

Marketing Authorisation Holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.

Manufacturer

UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.

Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany.

For any information about this medicine, please Authorisation Holder.

Belgie/Belgique/Belgien

UCB Pharma SA/NV

Tél/Tel: + 32 / (0)2 559 92 00

Efc^rapufl

TO CH EH Etarapua EOOfl

Tea.: + 359 (0) 2 962 30 49

Česká republika

UCB s.r.o.

Tel: + 420 221 773 411

Danmark

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Deutschland

UCB Pharma GmbH

Tel: + 49 /(0) 2173 48 4848

Eesti

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Soome)

EXXáSa

UCB A.E.

Tql: + 30 /2109974000

España

UCB Pharma, S.A.

Tel: + 34 / 91 570 34 44

France

UCB Pharma S.A.

Tél: + 33 / (0)1 47 29 44 35

Hrvatska

Medis Adria d.o.o.

Tel: +385 (0) 1 230 34 46

Ireland

UCB (Pharma) Ireland Ltd.

Tel: + 353 / (0)1–46 37 395

contact the local representative of the Marketing

Lietuva

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Suomija)

Luxembourg/Luxemburg

UCB Pharma SA/NV

Tel/Tel: + 32 / (0)2 559 92 00

Magyarorszag

UCB Magyarorszag Kft.

Tel.: + 36-(1) 391 0060

Malta

Pharmasud Ltd.

Tel: + 356 / 21 37 64 36

Nederland

UCB Pharma B.V.

Tel.: + 31 / (0)76–573 11 40

Norge

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Österreich

UCB Pharma GmbH

Tel: + 43 (0)1 291 80 00

Polska

UCB Pharma Sp. z o.o.

Tel: + 48 22 696 99 20

Portugal

Bial – Portela & Ca, S.A.

Tel: + 351 22 986 6100

Romania

UCB Pharma Romania S.R.L.

Tel: + 40 21 300 29 04

Slovenija

Medis, d.o.o.

Tel: + 386 1 589 69 00

Island

Vistor hf.

Simi: + 354 535 7000

Italia

UCB Pharma S.p.A.

Tel: + 39 / 02 300 791

Knnpog

Lifepharma (Z.A.M.) Ltd

Tql: + 357 22 05 63 00

Latvija

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Somija)

Slovenská republika

UCB s.r.o., organizačná zložka

Tel: + 421 (0) 2 5920 2020

Suomi/Finland

UCB Pharma Oy Finland

Puh/Tel: + 358 9 2514 4221

Sverige

UCB Nordic A/S

Tel: + 46 / (0) 40 29 49 00

United Kingdom (Northern Ireland)

UCB (Pharma) Ireland Ltd

Tel: + 353 / (0)1–46 37 395

This leaflet was last revised in {month/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Vimpat 10 mg/ml syrup lacosamide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Vimpat is and what it is used for
2. What you need to know before you take Vimpat
3. How to take Vimpat
4. Possible side effects
5. How to store Vimpat
6. Contents of the pack and other information

1. What Vimpat is and what it is used for

What Vimpat is

Vimpat contains lacosamide. This belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.

You have been given this medicine to lower the number of fits (seizures) you have.

What Vimpat is used for

Vimpat is used in adults, adolescents and children aged 4 years and older.
It is used:
■ on its own and in association with other antiepileptic medicines to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain;
■ in association with other antiepileptic medicines to treat primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take Vimpat

Do not take Vimpat

if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in Section 6). If you are not sure whether you are allergic, please discuss with your doctor.
if you have a certain type of heart beat problem called second- or third-degree AV block.

Do not take Vimpat if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Vimpat if:

you have thoughts of harming or killing yourself. A small number of people being treated with

antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, tell your doctor straight away.

you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation or atrial flutter).
you have severe heart disease such as heart failure or have had a heart attack.
you are often dizzy or fall over. Vimpat may make you dizzy – this could increase the risk of

accidental injury or a fall. This means that you should take care until you are used to the effects of this medicine.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

If you are taking Vimpat, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.

Children under 4 years

Vimpat is not recommended for children aged under 4 years. This is because we do not yet know whether it will work and whether it is safe for children in this age group.

Other medicines and Vimpat

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart – this is because Vimpat can also affect your heart:

medicines to treat heart problems;
medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
medicines used to treat certain types of irregular heart beat or heart failure.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

Also tell your doctor or pharmacist if you are taking any of the following medicines – this is because they may increase or decrease the effect of Vimpat on your body:

medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
a medicine for HIV called ritonavir;
medicines for bacterial infections called clarithromycin or rifampicin;
a herbal medicine used to treat mild anxiety and depression called St. John’s wort.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.

Vimpat with alcohol

As a safety precaution do not take Vimpat with alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not recommended to take Vimpat if you are pregnant or breast-feeding, as the effects of Vimpat on pregnancy and the unborn baby or the new-born child are not known. Also, it is not known whether Vimpat passes into the breast milk. Seek advice immediately from your doctor if you get pregnant or are planning to become pregnant. They will help you decide if you should take Vimpat or not.

Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A worsening of your disease can also harm your baby.

Driving and using machines

Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is because Vimpat may make you feel dizzy or cause blurred vision.

Vimpat contains sorbitol, sodium, sodium methyl parahydroxybenzoate, aspartame, propylene glycol and potassium

Sorbitol (a type of sugar): This medicine contains 187 mg sorbitol in each ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Sodium (salt): This medicine contains 1.42 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.07 % of the recommended maximum daily dietary intake of sodium for an adult.
Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).
Aspartame (E951): This medicine contains 0.032 mg aspartame in each ml. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Propylene glycol (E1520): This medicine contains 2.14 mg propylene glycol in each ml.
Potassium: This medicine contains potassium, less than 1 mmol (39 mg) per 60 mL, i.e.

essentially ‚potassium-free‘.

3. How to take Vimpat

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking Vimpat

Take Vimpat twice each day – once in the morning and once in the evening.
Try to take it at about the same time each day.
You may take Vimpat with or without food.

How much to take

Listed below are the normal recommended doses of Vimpat for different age groups and weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.

Adolescents and children weighing 50 kg or more and adults

Use the measuring cup provided in the carton box.

When you take Vimpat on its own

The usual starting dose of Vimpat is 50 mg (5 ml) twice a day.

Your doctor may also prescribe a starting dose of 100 mg (10 ml) of Vimpat twice a day.

Your doctor may increase your twice daily dose every week by 50 mg (5 ml). This will be until you reach a maintenance dose of between 100 mg (10 ml) and 300 mg (30 ml) twice a day.

When you take Vimpat with other antiepileptic medicines

The usual starting dose of Vimpat is 50 mg (5 ml) twice a day.

Your doctor may increase your twice daily dose every week by 50 mg (5 ml). This will be until you reach a maintenance dose of between 100 mg (10 ml) and 200 mg (20 ml) twice a day.

If you weigh 50 kg or more, your doctor may decide to start Vimpat treatment with a single “loading” dose of 200 mg (20 ml). You would then start your ongoing maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

Use the oral syringe provided in the carton box.

When you take Vimpat on its own

Your doctor will decide the dose of Vimpat based on your body weight.

The usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Taking Vimpat on its own – This is for information only. Your doctor will work out the right dose for you:

To be taken twice daily for children from 4 years of age weighing less than 40 kg

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	0.5 ml/kg	Maximum recommended dose: 0.6 ml/kg
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml	12 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml	15 ml
30 kg	3 ml	6 ml	9 ml	12 ml	15 ml	18 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml	17.5 ml	21 ml

To be taken twice daily for children and adolescents from 4 years of age weighing 40 kg to under 50 kg :

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	Maximum recommended dose: 0.5 ml/kg
40 kg	4 ml	8 ml	12 ml	16 ml	20 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml	22.5 ml

When you take Vimpat with other antiepileptic medicines

Your doctor will decide the dose of Vimpat based on your body weight.

In children from 4 years of age with a body weight of under 20 kg:

the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Taking Vimpat with other antiepileptic medicines – Children above 4 years of age weighing less than 20 kg - This is for information only. Your doctor will work out the right dose for you:

To be taken twice daily for children from 4 years of age weighing less than 20 kg

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	0.5 ml/kg	Maximum recommended dose: 0.6 ml/kg
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml

In children from 4 years of age with a body weight of 20 to under 30 kg:

the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body weight. This will be until you reach a maintenance dose. The maximum recommended dose is 5 mg (0.5 ml), for each kg of body weight, twice a day. A dosing chart is provided below.

To be taken twice daily for children and adolescents from 4 years of age weighing 20 kg to under 30 kg :

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	Maximum recommended dose: 0.5 ml/kg
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml

In children from 4 years of age with a body weight of 30 to under 50 kg:

the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body weight. This will be until you reach a maintenance dose. The maximum recommended dose is 4 mg (0.4 ml), for each kg of body weight, twice a day. A dosing chart is provided below.

To be taken twice daily for children and adolescents from 4 years of age weighing 30 kg to under 50 kg :

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	Maximum recommended dose: 0.4 ml/kg
30 kg	3 ml	6 ml	9 ml	12 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml
40 kg	4 ml	8 ml	12 ml	16 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml

Instructions for use: measuring cup

Adolescents and children weighing 50 kg or more and adults

Use the measuring cup provided in this pack.
1. Shake the bottle well before use.
2. Fill the measuring cup to the millilitre (ml) dose marker prescribed by your doctor.
3. Swallow the dose of syrup.
4. Then drink some water.

Instructions for use: oral syringe

Your doctor will show you how to use the oral syringe, before you use it for the first time. If you have any questions, please go back to your doctor or pharmacist.

Children and adolescents weighing less than 50 kg

Use the oral syringe and the adaptor provided in this pack.

Shake the bottle well before use.

Open the bottle by pressing the cap while turning it anti-clockwise (figure 1).

Follow these steps the first time you take Vimpat:

Take off the adaptor from the oral syringe (figure 2).
Put the adaptor into the top of the bottle (figure 3). Make sure it is fixed well in place. You do not need to remove the adaptor after use.

Follow these steps each time you take Vimpat:

Put the oral syringe into the adaptor opening (figure 4).
Turn the bottle upside down (figure 5).
Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.
Pull the piston down to fill the oral syringe with a small amount of solution (figure 6).
Push the piston up to get rid of any bubbles (figure 7).
Pull the piston down to the millilitre (ml) dose marker prescribed by your doctor (figure 8).
Turn the bottle the right way up (figure 9).
Take the oral syringe out of the adaptor (figure 10).

There are two ways in which you can choose to drink the medicine:

empty the contents of the oral syringe into a little water by pushing the piston to the bottom of the oral syringe (figure 11) – you will then need to drink all of the water (add just enough to make it easy to drink) or
drink the solution directly from the oral syringe without water (figure 12) – drink the whole contents of the oral syringe.
Close the bottle with the plastic screw cap (you do not need to remove the adaptor).
Wash the oral syringe with water only (figure 13).

If you take more Vimpat than you should

If you have taken more Vimpat than you should, contact your doctor immediately. Do not try to drive. You may experience:

dizziness;
feeling sick (nausea) or being sick (vomiting);
fits (seizures), heart beat problems such as a slow, fast or irregular heart beat, coma or a fall in blood pressure with rapid heartbeat and sweating.

If you forget to take Vimpat

If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you

remember.

If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the

missed syrup anymore. Instead take Vimpat at the next time that you would normally take it.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Vimpat

Do not stop taking Vimpat without talking to your doctor, as your epilepsy may come back again or become worse.
If your doctor decides to stop your treatment with Vimpat, they will tell you how to decrease the dose step by step.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Nervous system side effects such as dizziness may be higher after a single “loading” dose.

Talk to your doctor or pharmacist if you get any of the following:

Very common : may affect more than 1 in 10 people

Headache;
Feeling dizzy or sick (nausea);
Double vision (diplopia).

Common : may affect up to 1 in 10 people

Short jerks of a muscle or group of muscles (myoclonic seizures);
Difficulties in coordinating your movements or walking;
Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Trouble with your memory, thinking or finding words, confusion;
Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
A spinning sensation (vertigo), feeling drunk;
Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention;
Noise in the ear such as buzzing, ringing or whistling;
Irritability, trouble sleeping, depression;
Sleepiness, tiredness or weakness (asthenia);
Itching, rash.

Uncommon : may affect up to 1 in 100 people

Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
Allergic reaction to medicine intake, hives;
Blood tests may show abnormal liver function, liver injury;
Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away;
Feeling angry or agitated;
Abnormal thinking or losing of touch with reality;
Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower legs;
Fainting;
Abnormal involuntary movements (dyskinesia).

Not known : frequency cannot be estimated from available data

Abnormal rapid heartbeat (ventricular tachyarrhythmia);
A sore throat, high temperature and getting more infections than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
Convulsion.

Additional side effects in children

Common: may affect up to 1 in 10 children

Runny nose (nasopharyngitis);
Fever (pyrexia);
Sore throat (pharyngitis);
Eating less than usual.

Uncommon : may affect up to 1 in 100 children

Feeling sleepy or lacking in energy (lethargy).

Not known: frequency cannot be estimated from available data

Changes in behaviour, not acting like themselves.

Reporting of side effects

5. How to store Vimpat

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.

Do not refrigerate.

Once you have opened the syrup bottle, do not use beyond 2 months.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Vimpat contains

The active substance is lacosamide. 1 ml Vimpat syrup contains 10 mg lacosamide.
The other ingredients are glycerol (E422), carmellose sodium, sorbitol liquid (crystallizing) (E420), polyethylene glycol 4000, sodium chloride, citric acid anhydrous, acesulfame potassium (E950), sodium methyl parahydroxybenzoate (E219), strawberry flavour (contains propylene glycol, maltol), masking flavour (contains propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionised water), purified water.

What Vimpat looks like and contents of the pack

Vimpat 10 mg/ml syrup is a slightly viscous clear, colourless to yellow-brown liquid.
Vimpat is available in a bottle of 200 ml.

The carton boxes of Vimpat syrup contain a 30 ml measuring cup with graduation marks and a 10 ml oral syringe.

The measuring cup is suitable for adults, adolescents and children weighing 50 kg and above. Each graduation mark (5 ml) of the measuring cup corresponds to 50 mg of lacosamide (for example 2 graduation marks correspond to 100 mg).
The oral syringe is suitable for children and adolescents below 50 kg. One full 10 ml oral syringe corresponds to 100 mg of lacosamide. The minimum extractable volume is 1 ml, which is 10 mg of lacosamide. After this, each graduation mark (0.25 ml) corresponds to 2.5 mg of lacosamide (for example 4 graduation marks corresponds to 10 mg).

Marketing Authorisation Holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.

Manufacturer

Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany or

UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.

For any information about this medicine, please Authorisation Holder.

Belgie/Belgique/Belgien

UCB Pharma SA/NV

Tél/Tel: + 32 / (0)2 559 92 00

Efcnrapua

TO CH EH Etnrapua EOOfl

Ten.: + 359 (0) 2 962 30 49

Česká republika

UCB s.r.o.

Tel: + 420 221 773 411

Danmark

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Deutschland

UCB Pharma GmbH

Tel: + 49 /(0) 2173 48 4848

Eesti

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Soome)

EXXáSa

UCB A.E.

Tql: + 30 /2109974000

España

UCB Pharma, S.A.

Tel: + 34 / 91 570 34 44

France

UCB Pharma S.A.

Tél: + 33 / (0)1 47 29 44 35

Hrvatska

Medis Adria d.o.o.

Tel: +385 (0) 1 230 34 46

Ireland

UCB (Pharma) Ireland Ltd.

Tel: + 353 / (0)1–46 37 395

Ísland

Vistor hf.

Simi: + 354 535 7000

contact the local representative of the Marketing

Lietuva

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Suomija)

Luxembourg/Luxemburg

UCB Pharma SA/NV

Tél/Tel: + 32 / (0)2 559 92 00

Magyarország

UCB Magyarország Kft.

Tel.: + 36-(1) 391 0060

Malta

Pharmasud Ltd.

Tel: + 356 / 21 37 64 36

Nederland

UCB Pharma B.V.

Tel.: + 31 / (0)76–573 11 40

Norge

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Österreich

UCB Pharma GmbH

Tel: + 43 (0)1 291 80 00

Polska

UCB Pharma Sp. z o.o.

Tel: + 48 22 696 99 20

Portugal

Bial – Portela & Ca, S.A.

Tel: + 351 22 986 6100

Romania

UCB Pharma Romania S.R.L.

Tel: + 40 21 300 29 04

Slovenija

Medis, d.o.o.

Tel: + 386 1 589 69 00

Slovenská republika

UCB s.r.o., organizačná zložka

Tel: + 421 (0) 2 5920 2020

Italia

UCB Pharma S.p.A.

Tel: + 39 / 02 300 791

Suomi/Finland

UCB Pharma Oy Finland

Puh/Tel: + 358 9 2514 4221

Kûnpoç

Lifepharma (Z.A.M.) Ltd

Tql: + 357 22 05 63 00

Sverige

UCB Nordic A/S

Tel: + 46 / (0) 40 29 49 00

Latvija

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Somija)

United Kingdom (Northern Ireland)

UCB (Pharma) Ireland Ltd

Tel: + 353 / (0)1–46 37 395

This leaflet was last revised in {month/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Vimpat 10 mg/ml solution for infusion lacosamide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Vimpat is and what it is used for
2. What you need to know before you use Vimpat
3. How to use Vimpat
4. Possible side effects
5. How to store Vimpat
6. Contents of the pack and other information

1. What Vimpat is and what it is used for

What Vimpat is

Vimpat contains lacosamide. This belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.

You have been given this medicine to lower the number of fits (seizures) you have.

What Vimpat is used for

Vimpat is used in adults, adolescents and children aged 4 years and older.
It is used:
■ on its own and in association with other antiepileptic medicines to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain;
■ in association with other antiepileptic medicines to treat primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you use Vimpat

Do not use Vimpat

if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in section 6). If you are not sure whether you are allergic, please discuss with your doctor.
if you have a certain type of heart beat problem called second- or third-degree AV block.

Do not use Vimpat if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.

Warnings and precautions

Talk to your doctor before using Vimpat if:

you have thoughts of harming or killing yourself. A small number of people being treated with antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, tell your doctor straight away.
you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter).
you have severe heart disease such as heart failure or have had a heart attack.
you are often dizzy or fall over. Vimpat may make you dizzy – this could increase the risk of

accidental injury or a fall. This means that you should take care until you are used to the effects of this medicine.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Vimpat.

If you are taking Vimpat, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.

Children under 4 years

Vimpat is not recommended for children aged under 4 years. This is because we do not yet know whether it will work and whether it is safe for children in this age group.

Other medicines and Vimpat

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart – this is because Vimpat can also affect your heart:

medicines to treat heart problems;
medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
medicines used to treat certain types of irregular heart beat or heart failure.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Vimpat.

Also tell your doctor or pharmacist if you are taking any of the following medicines – this is because they may increase or decrease the effect of Vimpat on your body:

medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
a medicine for HIV called ritonavir;
medicines for bacterial infections called clarithromycin or rifampicin;
a herbal medicine used to treat mild anxiety and depression called St. John’s wort.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Vimpat.

Vimpat with alcohol

As a safety precaution do not use Vimpat with alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A worsening of your disease can also harm your baby.

Driving and using machines

Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is because Vimpat may make you feel dizzy or cause blurred vision.

Vimpat contains sodium

This medicine contains 59.8 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 3 % of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use Vimpat

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Using Vimpat

Vimpat can be started by:
– taking the medicine by mouth or
– by being given as an intravenous infusion (sometimes called an “IV infusion”) where the medicine is given into your vein by a doctor or nurse. It is given over 15 to 60 minutes.

The IV infusion is usually used for a short time when you cannot take the medicine by mouth.
Your doctor will decide for how many days you will have infusions. There is experience with twice daily infusions of Vimpat for up to 5 days. For longer term treatment Vimpat tablets and syrup are available.

When you change from the infusion to taking the medicine by mouth (or the other way around) the total amount you take each day and how often you take it stays the same.

Use Vimpat twice each day – once in the morning and once in the evening.
Try to use it at about the same time each day.

How much to use

Listed below are the normal recommended doses of Vimpat for different age groups and weights.

Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.

Adolescents and children weighing 50 kg or more and adults

When you use Vimpat on its own

The usual starting dose of Vimpat is 50 mg twice a day.

The treatment with Vimpat may also start with a dose of 100 mg of Vimpat twice a day.

Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose of between 100 mg and 300 mg twice a day.

When you use Vimpat with other antiepileptic medicines

The usual starting dose of Vimpat is 50 mg twice a day.

Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose of between 100 mg and 200 mg twice a day.

If you weigh 50 kg or more, your doctor may decide to start Vimpat treatment with a single “loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

When you use Vimpat on its own

Your doctor will decide the dose of Vimpat based on your body weight.

The usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml), for each kg of your body weight. This will be until you reach a maintenance dose. The maximum recommended dose is

6 mg (0.6 ml) for each kg of body weight, twice a day, for children weighing under 40 kg. The maximum maintenance dose is 5 mg (0.5 ml) for each kg of body weight, twice a day, for children weighing from 40 kg to under 50 kg. Dosing charts are provided below:

Using Vimpat on its own – This is for information only. Your doctor will work out the right dose for you:

To be used twice daily for children from 4 years of age weighing less than 40 kg

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	0.5 ml/kg	Maximum recommended dose: 0.6 ml/kg
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml	12 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml	15 ml
30 kg	3 ml	6 ml	9 ml	12 ml	15 ml	18 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml	17.5 ml	21 ml

To be used twice daily for children and adolescents from 4 years of age weighing 40 kg to under

50 kg :

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	Maximum recommended dose: 0.5 ml/kg
40 kg	4 ml	8 ml	12 ml	16 ml	20 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml	22.5 ml

When you use Vimpat with other antiepileptic medicines

Your doctor will decide the dose of Vimpat based on your body weight.

In children from 4 years of age with a body weight of under 20 kg:

the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Using Vimpat with other antiepileptic medicines – Children above 4 years of age weighing less than 20 kg – This is for information only. Your doctor will work out the right dose for you:

To be used twice daily for children from 4 years of age weighing less than 20 kg

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	0.5 ml/kg	Maximum recommended dose: 0.6 ml/kg
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml

In children from 4 years of age with a body weight of 20 kg to under 30 kg:

the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

To be used twice daily for children and adolescents from 4 years of age weighing 20 kg to under 30 kg :

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	0.4 ml/kg	Maximum recommended dose: 0.5 ml/kg
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml

In children from 4 years of age with a body weight of 30 to under 50 kg:

the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body weight. This will be until you reach a maintenance dose. The maximum recommended dose is 4 mg (0.4 ml), for each kg of body weight, twice a day. A dosing chart is provided below.

To be used twice daily for children and adolescents from 4 years of age weighing 30 kg to under 50 kg :

Weight	Starting dose: 0.1 ml/kg	0.2 ml/kg	0.3 ml/kg	Maximum recommended dose: 0.4 ml/kg
30 kg	3 ml	6 ml	9 ml	12 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml
40 kg	4 ml	8 ml	12 ml	16 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml

If you stop using Vimpat

If your doctor decides to stop your treatment with Vimpat, they will decrease the dose step by step. This is to prevent your epilepsy from coming back again or becoming worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Nervous system side effects such as dizziness may be higher after a single “loading” dose.

Talk to your doctor or pharmacist if you get any of the following:

Very common : may affect more than 1 in 10 people

Headache;
Feeling dizzy or sick (nausea);
Double vision (diplopia).

Common : may affect up to 1 in 10 people

Short jerks of a muscle or group of muscles (myoclonic seizures);
Difficulties in coordinating your movements or walking;
Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Troubles with your memory, thinking or finding words, confusion;
Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
A spinning sensation (vertigo), feeling drunk;
Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention;
Noise in the ear such as buzzing, ringing or whistling;
Irritability, trouble sleeping, depression;
Sleepiness, tiredness or weakness (asthenia);
Itching, rash.

Uncommon : may affect up to 1 in 100 people

Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
Allergic reaction to medicine intake, hives;
Blood tests may show abnormal liver function, liver injury;
Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away;
Feeling angry or agitated;
Abnormal thinking or losing touch with reality;
Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower legs;
Fainting;
Abnormal involuntary movements (dyskinesia).

Not known : frequency cannot be estimated from available data

Abnormal rapid heartbeat (ventricular tachyarrhythmia);
A sore throat, high temperature and getting more infections than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
Convulsion.

Additional side effects when given as an intravenous infusion There may be local side effects.

Common : may affect up to 1 in 10 people

Injection site pain or discomfort or irritation.

Uncommon : may affect up to 1 in 100 people

Injection site redness.

Additional side effects in children

Common: may affect up to 1 in 10 children

Runny nose (nasopharyngitis);
Fever (pyrexia);
Sore throat (pharyngitis);
Eating less than usual.

Uncommon : may affect up to 1 in 100 children

Feeling sleepy or lacking in energy (lethargy).

Not known: frequency cannot be estimated from available data

Changes in behaviour, not acting like themselves.

Reporting of side effects

5. How to store Vimpat

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Each vial of Vimpat solution for infusion must be used only once (single use). Any unused solution should be discarded.

Only clear solution free from particles and discoloration should be used.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Vimpat contains

The active substance is lacosamide.
1 ml Vimpat solution for infusion contains 10 mg lacosamide.
1 vial contains 20 ml Vimpat solution for infusion equivalent to 200 mg lacosamide.

The other ingredients are: sodium chloride, hydrochloric acid, water for injections.

What Vimpat looks like and contents of the pack

Vimpat 10 mg/ml solution for infusion is a clear, colourless solution.

Vimpat - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - Vimpat

1. What Vimpat is and what it is used for

2. What you need to know before you take Vimpat

3. How to take Vimpat

4. Possible side effects

5. How to store Vimpat

6. Contents of the pack and other information

1. What Vimpat is and what it is used for

2. What you need to know before you take Vimpat

3. How to take Vimpat

4. Possible side effects

5. How to store Vimpat

6. Contents of the pack and other information

1. What Vimpat is and what it is used for

2. What you need to know before you take Vimpat

3. How to take Vimpat

4. Possible side effects

5. How to store Vimpat

6. Contents of the pack and other information

1. What Vimpat is and what it is used for

2. What you need to know before you use Vimpat

3. How to use Vimpat

4. Possible side effects

5. How to store Vimpat

6. Contents of the pack and other information

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Vimpat is and what it is used for

What Vimpat is used for

2. What you need to know before you take Vimpat

3. How to take Vimpat

4. Possible side effects

5. How to store Vimpat

6. Contents of the pack and other information

What Vimpat looks like and contents of the pack

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Vimpat is and what it is used for

What Vimpat is used for

2. What you need to know before you take Vimpat

3. How to take Vimpat

Instructions for use: measuring cup

Instructions for use: oral syringe

4. Possible side effects

5. How to store Vimpat

6. Contents of the pack and other information

What Vimpat looks like and contents of the pack

1. What Vimpat is and what it is used for

What Vimpat is used for

2. What you need to know before you use Vimpat

3. How to use Vimpat

4. Possible side effects

5. How to store Vimpat

6. Contents of the pack and other information

What Vimpat looks like and contents of the pack