Patient leaflet - Lacosamide Fresenius Kabi 10 mg/ml solution for infusion
1. What Lacosamide Fresenius Kabi is and what it is used for What Lacosamide Fresenius Kabi is
Lacosamide Fresenius Kabi 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 Lacosamide Fresenius Kabi is used for
Lacosamide Fresenius Kabi is used:
on its own and in association with other antiepileptic medicines in adults,
adolescents and children aged 2 years and older 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 in adults, adolescents and
children aged 4 years and older 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 Lacosamide Fresenius Kabi
Do not use Lacosamide Fresenius Kabi
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 Lacosamide Fresenius Kabi if any of the above applies to you. If you are not
sure, talk to your doctor or pharmacist before using this medicine.
Lacosamide Fresenius Kabi 10 mg/ml
Mockup / GBR
Lacosamide Fresenius
Kabi 10 mg/ml
Mockup / GBR
Warnings and precautions
Talk to your doctor before using Lacosamide Fresenius Kabi 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
particularly 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. Lacosamide Fresenius Kabi 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 Lacosamide Fresenius Kabi.
If you are taking Lacosamide Fresenius Kabi, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.
If you are taking lacosamide 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
Lacosamide is not recommended for children aged under 2 years with epilepsy characterised by the occurrence of partial-onset seizure and not recommended for children aged under 4 years with primary generalised tonic-clonic seizures. 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 Lacosamide Fresenius Kabi
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 lacosamide 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 Lacosamide Fresenius Kabi.
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 lacosamide on your body:
- medicines for fungal infections such as fluconazole, itraconazole or ketoconazole;
- a medicine for HIV such as ritonavir;
- medicines for bacterial infections such as 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 Lacosamide Fresenius Kabi.
Lacosamide Fresenius Kabi with alcohol
As a safety precaution do not use Lacosamide Fresenius Kabi with alcohol.
Pregnancy and breast-feeding
Fertile women should discuss the use of contraceptives with the doctor.
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 Lacosamide Fresenius Kabi if you are pregnant or breast feeding, as the effects of lacosamide on pregnancy and the unborn baby or the new-born child are not known. Also, it is not known whether lacosamide 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 Lacosamide Fresenius Kabi 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 Lacosamide Fresenius Kabi may make you feel dizzy or cause blurred vision.
Lacosamide Fresenius Kabi 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 Lacosamide Fresenius Kabi
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 Lacosamide Fresenius Kabi
Lacosamide 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 lacosamide for up to 5 days. For longer term treatment lacosamide 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 lacosamide twice each day (approximately 12 hours apart).
- Try to use it at about the same time each day.
How much to use
Listed below are the normal recommended doses of lacosamide 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 lacosamide on its own
- The usual starting dose of lacosamide is 50 mg twice a day.
- The treatment with lacosamide may also start with a dose of 100 mg of lacosamide 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 lacosamide with other antiepileptic medicines
- The usual starting dose of lacosamide 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 lacosamide 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
- In the treatment of partial-onset seizure: Observe that lacosamide is not recommended for children under 2 years of age.
- In the treatment of primary generalised tonic-clonic seizures: Observe that lacosamide is not recommended for children under 4 years of age.
When you use lacosamide on its own
- Your doctor will decide the dose of lacosamide 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. - Dosing charts including the maximum recommended dose are provided below.
This is for information only. Your doctor will work out the right dose for you.
To be used twice daily for children from 2 years of age weighing from 10 kg to less than 40 kg
| Weight | Week 1 Starting dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 0.4 ml/kg | Week 5 0.5 ml/kg | Week 6 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 weighing from 40 kg to less than 50 kg:
| Weight | Week 1 Starting dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 0.4 ml/kg | Week 5 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 lacosamide with other antiepileptic medicines
Your doctor will decide the dose of lacosamide based on your body weight. - For children and adolescents weighing from 10 kg to less than 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. - Dosing charts including the maximum recommended dose are provided below.
This is for information only. Your doctor will work out the right dose for you.
To be used twice daily for children from 2 years of age weighing from 10 kg to less than 20 kg
| Weight | Week 1 Starting dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 0.4 ml/kg | Week 5 0.5 ml/kg | Week 6 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 |
To be used twice daily for children and adolescents weighing from 20 kg to less than 30 kg
| Weight | Week 1 Starting dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 0.4 ml/kg | Week 5 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 |
To be used twice daily for children and adolescents weighing from 30 kg to less than 50 kg
| Weight | Week 1 Starting dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 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 Lacosamide Fresenius Kabi
If your doctor decides to stop your treatment with Lacosamide Fresenius Kabi, 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
The additional side effects in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behaviour, not acting like themselves (abnormal behavior) and lacking in energy (lethargy). Feeling sleepy (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lacosamide Fresenius Kabi
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 Lacosamide Fresenius Kabi 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 Lacosamide Fresenius Kabi contains
The active substance is lacosamide.
1 ml solution for infusion contains 10 mg lacosamide.
1 vial contains 20 ml solution for infusion equivalent to 200 mg lacosamide.
The other ingredients are sodium chloride, hydrochloric acid 0.86%, water for
injections.
What Lacosamide Fresenius Kabi looks like and contents of the pack
Lacosamide Fresenius Kabi 10 mg/ml solution for infusion is a clear, colourless solution.
Lacosamide Fresenius Kabi is available in packs of 1, 5 and 10 vials. Each vial contains 20 ml solution for infusion.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
61352 Bad Homburg v.d.Höhe Germany
Manufacturer
Fresenius Kabi Deutschland GmbH Pfingstweide 53
61169 Friedberg
Germany
Or
Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo, Santiago de Besteiros, 3465-157, Portugal