Patient leaflet - Lacosamide UCB
1. What Lacosamide UCB is and what it is used for
What Lacosamide UCB is
Lacosamide UCB 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 UCB is used for
- Lacosamide UCB 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 Lacosamide UCB
Do not use Lacosamide UCB
- 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 UCB 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 Lacosamide UCB 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. Lacosamide UCB 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 UCB.
If you are taking Lacosamide UCB, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures.
If you are taking Lacosamide UCB 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
Lacosamide UCB 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 Lacosamide UCB
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 UCB 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 UCB.
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 UCB 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 Lacosamide UCB.
Lacosamide UCB with alcohol
As a safety precaution do not use Lacosamide UCB 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 Lacosamide UCB if you are pregnant or breast feeding, as the effects of Lacosamide UCB on pregnancy and the unborn baby or the new-born child are not known. Also, it is not known whether Lacosamide UCB 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 UCB 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 UCB may make you feel dizzy or cause blurred vision.
Lacosamide UCB 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 UCB
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 UCB
- Lacosamide UCB 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 UCB for up to 5 days. For longer term treatment Lacosamide UCB 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 UCB 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 Lacosamide UCB 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 UCB on its own
The usual starting dose of Lacosamide UCB is 50 mg twice a day.
The treatment with Lacosamide UCB may also start with a dose of 100 mg of Lacosamide UCB 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 UCB with other antiepileptic medicines
The usual starting dose of Lacosamide UCB 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 UCB 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 Lacosamide UCB on its own
Your doctor will decide the dose of Lacosamide UCB 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 Lacosamide UCB 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 Lacosamide UCB with other antiepileptic medicines
Your doctor will decide the dose of Lacosamide UCB 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.
Using Lacosamide UCB 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 Lacosamide UCB 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 Lacosamide UCB 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 Lacosamide UCB
If your doctor decides to stop your treatment with Lacosamide UCB, 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
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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lacosamide UCB
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 UCB 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 UCB contains
- The active substance is lacosamide.
1 ml Lacosamide UCB solution for infusion contains 10 mg lacosamide.
1 vial contains 20 ml Lacosamide UCB solution for infusion equivalent to 200 mg lacosamide.
- The other ingredients are: sodium chloride, hydrochloric acid, water for injections.
What Lacosamide UCB looks like and contents of the pack
- Lacosamide UCB 10 mg/ml solution for infusion is a clear, colourless solution.
Lacosamide UCB solution for infusion is available in packages of 1 vial and 5 vials. Each vial contains 20 ml.
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.
or
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany.
For any information about this medicine, please Authorisation Holder.
België/Belgique/Belgien
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00
Efc^rapufl
ro 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)
EÀÀàôa
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.
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
Simi: + 354 535 7000
Italia
UCB Pharma S.p.A.
Tel: + 39 / 02 300 791
Tel: + 421 (0) 2 5920 2020
Suomi/Finland
UCB Pharma Oy Finland
Puh/Tel: + 358 9 2514 4221
Kvnpog
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: http://www.ema.europa.eu/
The following information is intended for medical or healthcare professionals only.
Each vial of Lacosamide UCB solution for infusion must be used only once (single use). Any unused solution should be discarded (see section 3).
Lacosamide UCB solution for infusion can be administered without further dilution, or may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml (5 %) or lactated Ringer’s solution.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C for product mixed with these diluents and stored in glass or PVC bags.
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