lacosamide: package leaflet

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:
- 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 year 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).

Do not take 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 take Lacosamide UCB 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 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 taking 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
Lacosamide UCB 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 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 taking 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 such as fluconazole, itraconazole or ketoconazole;
- medicines for HIV such as ritonavir;
- medicines used to treat 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 taking Lacosamide UCB.

Lacosamide UCB with alcohol
As a safety precaution do not take Lacosamide UCB 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 planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not recommended to take Lacosamide UCB if you are pregnant, as the effects of Lacosamide UCB on pregnancy and the unborn baby are not known.
It is not recommended to breast-feed your baby while taking Lacosamide UCB, as 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 take 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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Other form(s) of this medicine may be more suitable for children;
ask your doctor or pharmacist.

Taking Lacosamide UCB
- Take Lacosamide UCB twice each day - approximately 12 hours apart.
- Try to take it at about the same time each day.
- Swallow the Lacosamide UCB tablet with a glass of water.
- You may take Lacosamide UCB 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. Lacosamide UCB is used as a long term treatment. You should continue to take Lacosamide UCB until your doctor tells you to stop.

How much to take
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 take Lacosamide UCB on its own
- The usual starting dose of Lacosamide UCB is 50 mg twice a day.
- Your doctor may also prescribe a starting 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 between 100 mg and 300 mg twice a day.

When you take 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 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
- In the treatment of partial-onset seizure: Observe that Lacosamide UCB is not recommended for children under 2 years of age.
- In the treatment of primary generalised tonic-clonic seizures: Observe that Lacosamide UCB is not recommended for children under 4 years of age.

• 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 Lacosamide UCB than you should
If you have taken more Lacosamide UCB 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 Lacosamide UCB
- 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 Lacosamide UCB 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 Lacosamide UCB
- Do not stop taking Lacosamide UCB without talking to your doctor, as your epilepsy may come back again or become worse.
- If your doctor decides to stop your treatment with Lacosamide UCB, 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.

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

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

What Lacosamide UCB contains
- The active substance is lacosamide.
One tablet of Lacosamide UCB 50 mg contains 50 mg lacosamide.
One tablet of Lacosamide UCB 100 mg contains 100 mg lacosamide.
One tablet of Lacosamide UCB 150 mg contains 150 mg lacosamide.
One tablet of Lacosamide UCB 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 Lacosamide UCB looks like and contents of the pack
- Lacosamide UCB 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.
- Lacosamide UCB 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.
- Lacosamide UCB 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.
- Lacosamide UCB 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.

Lacosamide UCB is available in packs of 14, 28, 56, 14 x 1 and 56 x 1 film-coated tablets.
Lacosamide UCB 50 mg and Lacosamide UCB 100 mg are available in packs of 168 film-coated tablets and Lacosamide UCB 150 mg and Lacosamide UCB 200 mg are available in multipacks comprising 3 cartons, each containing 56 tablets. The 14 x 1 and 56 x 1 film-coated tablets packs are available as perforated unit dose PVC/PVDC blisters sealed with an aluminium foil, all other packs are available with standard PVC/PVDC blisters sealed with an aluminium foil. 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 contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00

Lietuva
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Suomija)

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49
Luxembourg/Luxemburg
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: + 420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: + 36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf.: + 45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: + 356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 40

Eesti
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge
UCB Nordic A/S
Tlf: + 47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: + 43 (0)1 291 80 00
España
UCB Pharma, S.A.
Tel: + 34 / 91 570 34 44

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel.: + 48 22 696 99 20

France
UCB Pharma
Tél: + 33 / (0)1 47 29 44 35
Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: + 351 21 302 5300

Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

România
UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
UCB Nordic A/S
Sími: + 45 / 32 46 24 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

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: + 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)

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:
https://www.ema.europa.eu.

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:
- 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 year 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).

Do not take 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 take Lacosamide UCB 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 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 taking 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
Lacosamide UCB 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 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 taking 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 such as fluconazole, itraconazole or ketoconazole;
- medicines 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 taking Lacosamide UCB.

Lacosamide UCB with alcohol
As a safety precaution do not take Lacosamide UCB 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 taking this medicine.

It is not recommended to take Lacosamide UCB if you are pregnant, as the effects of Lacosamide UCB on pregnancy and the unborn baby are not known.
It is not recommended to breast-feed your baby while taking Lacosamide UCB, as 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 take 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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Other form(s) of this medicine may be more suitable for children;
ask your doctor or pharmacist.

Taking Lacosamide UCB
- Take Lacosamide UCB twice each day - approximately 12 hours apart.
- Try to take it at about the same time each day.
- Swallow the Lacosamide UCB tablet with a glass of water.
- You may take Lacosamide UCB 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. Lacosamide UCB is used as a long term treatment. You should continue to take Lacosamide UCB until your doctor tells you to stop.

How much to take
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 only
When you take Lacosamide UCB on its own
The usual starting dose of Lacosamide UCB is 50 mg twice a day.
Your doctor may also prescribe a starting 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 between 100 mg and 300 mg twice a day.

When you take Lacosamide UCB 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 Lacosamide UCB.
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 Lacosamide UCB, so you will increase your dose gradually.
You will start your treatment with a low dose of Lacosamide UCB, 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 Lacosamide UCB
50 mg)
50 mg
(1 tablet Lacosamide UCB
50 mg)
100 mg
Week 2 Package marked
"Week 2"
100 mg
(1 tablet Lacosamide UCB
100 mg)
100 mg
(1 tablet Lacosamide UCB
100 mg)
200 mg
Week 3
Package marked
"Week 3"
150 mg
(1 tablet Lacosamide UCB
150 mg)
150 mg
(1 tablet Lacosamide UCB
150 mg)
300 mg
Week 4
Package marked
"Week 4"
200 mg
(1 tablet Lacosamide UCB
200 mg)
200 mg
(1 tablet Lacosamide UCB
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 Lacosamide UCB. 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 Lacosamide UCB than you should
If you have taken more Lacosamide UCB 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 Lacosamide UCB
- 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 Lacosamide UCB 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 Lacosamide UCB
- Do not stop taking Lacosamide UCB without talking to your doctor, as your epilepsy may come back again or become worse.
- If your doctor decides to stop your treatment with Lacosamide UCB, 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.

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

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

What Lacosamide UCB contains
- The active substance is lacosamide.
One tablet of Lacosamide UCB 50 mg contains 50 mg lacosamide.
One tablet of Lacosamide UCB 100 mg contains 100 mg lacosamide.
One tablet of Lacosamide UCB 150 mg contains 150 mg lacosamide.
One tablet of Lacosamide UCB 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 Lacosamide UCB looks like and contents of the pack
- Lacosamide UCB 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.
- Lacosamide UCB 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.
- Lacosamide UCB 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.
- Lacosamide UCB 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.
or
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

Lietuva
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Suomija)

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49
Luxembourg/Luxemburg
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: + 420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: + 36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf.: + 45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: + 356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 40

Eesti
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge
UCB Nordic A/S
Tlf: + 47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: + 43 (0)1 291 80 00
España
UCB Pharma, S.A.
Tel: + 34 / 91 570 34 44

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel.: + 48 22 696 99 20

France
UCB Pharma
Tél: + 33 / (0)1 47 29 44 35
Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: + 351 21 302 5300

Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

România
UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
UCB Nordic A/S
Sími: + 45 / 32 46 24 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

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: + 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)

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:
https://www.ema.europa.eu.

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.

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 Lacosamide UCB:
- 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 Lacosamide UCB:
- 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 plunger down to fill the oral syringe with a small amount of solution (figure 6).
- Push the plunger up to get rid of any bubbles (figure 7).
- Pull the plunger down to the millilitre (ml) dose marker prescribed by your doctor (figure 8).
The plunger may rise back up the barrel on the first dosage. Therefore, ensure that the plunger is kept in position until the oral syringe is disconnected from the bottle.

• 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 plunger 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).
• To clean the oral syringe, rinse with cold water only, moving the plunger several times up and down to take up and expel the water, without separating the two components of the syringe (figure 13).

• Keep the bottle, the oral syringe, and the leaflet in the carton.

If you take more Lacosamide UCB than you should
If you have taken more Lacosamide UCB 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 Lacosamide UCB
- 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 Lacosamide UCB 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 Lacosamide UCB
- Do not stop taking Lacosamide UCB without talking to your doctor, as your epilepsy may come back again or become worse.
- If your doctor decides to stop your treatment with Lacosamide UCB, 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

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 6 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.

What Lacosamide UCB contains
- The active substance is lacosamide. 1 ml Lacosamide UCB 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 Lacosamide UCB looks like and contents of the pack
- Lacosamide UCB 10 mg/ml syrup is a slightly viscous clear, colourless to yellow-brown liquid.
- Lacosamide UCB is available in a bottle of 200 ml.

The carton boxes of Lacosamide UCB syrup contain a 30 ml polypropylene measuring cup and a 10 ml polyethylene / polypropylene oral syringe (black graduation marks) with its polyethylene adaptor.
- The measuring cup is suitable for doses above 20 ml. 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 10 ml oral syringe is suitable for doses between 1 ml and 20 ml. 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 contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00

Lietuva
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Suomija)

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49
Luxembourg/Luxemburg
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: + 420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: + 36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf.: + 45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: + 356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 40

Eesti
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge
UCB Nordic A/S
Tlf: + 47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: + 43 (0)1 291 80 00
España
UCB Pharma, S.A.
Tel: + 34 / 91 570 34 44

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel.: + 48 22 696 99 20

France
UCB Pharma
Tél: + 33 / (0)1 47 29 44 35

Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: + 351 21 302 5300
Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

România
UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
UCB Nordic A/S
Sími: + 45 / 32 46 24 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

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: + 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)

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:
https://www.ema.europa.eu.

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

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

7 ml
10.5 ml
14 ml
40 kg
4 ml
8 ml
12 ml
16 ml
45 kg

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

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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 contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00

Lietuva
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Suomija)

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49
Luxembourg/Luxemburg
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: + 420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: + 36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf.: + 45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: + 356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 40

Eesti
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge
UCB Nordic A/S
Tlf: + 47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: + 43 (0)1 291 80 00
España
UCB Pharma, S.A.
Tel: + 34 / 91 570 34 44

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel.: + 48 22 696 99 20

France
UCB Pharma
Tél: + 33 / (0)1 47 29 44 35
Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: + 351 21 302 5300
Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

România
UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
UCB Nordic A/S
Sími: + 45 / 32 46 24 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

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: + 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)

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:
https://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.

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:
- 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).

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
Vimpat 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 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 such as fluconazole, itraconazole or ketoconazole;
- medicines for HIV such as ritonavir;
- medicines used to treat 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 taking Vimpat.

Vimpat with alcohol
As a safety precaution do not take Vimpat 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 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, as the effects of Vimpat on pregnancy and the unborn baby are not known.
It is not recommended to breast-feed your baby while taking Vimpat, as 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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Other form(s) of this medicine may be more suitable for children;
ask your doctor or pharmacist.

Taking Vimpat
- Take Vimpat twice each day - approximately 12 hours apart.
- 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 adolescents weighing less than 50 kg
- In the treatment of partial-onset seizure: Observe that Vimpat is not recommended for children under 2 years of age.
- In the treatment of primary generalised tonic-clonic seizures: Observe that Vimpat is not recommended for children under 4 years of age.

• 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.

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

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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
- 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 x 1 and 56 x 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 x 1 and 56 x 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.
or
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

Lietuva
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Suomija)

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49
Luxembourg/Luxemburg
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: + 420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: + 36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf.: + 45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: + 356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 40

Eesti
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge
UCB Nordic A/S
Tlf: + 47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: + 43 (0)1 291 80 00
España
UCB Pharma, S.A.
Tel: + 34 / 91 570 34 44

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel.: + 48 22 696 99 20

France
UCB Pharma
Tél: + 33 / (0)1 47 29 44 35
Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: + 351 21 302 5300

Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

România
UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
UCB Nordic A/S
Sími: + 45 / 32 46 24 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

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: + 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)

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:
https://www.ema.europa.eu.

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:
- 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).

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
Vimpat 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 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 such as fluconazole, itraconazole or ketoconazole;
- medicines 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 taking Vimpat.

Vimpat with alcohol
As a safety precaution do not take Vimpat 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 taking this medicine.

It is not recommended to take Vimpat if you are pregnant, as the effects of Vimpat on pregnancy and the unborn baby are not known.
It is not recommended to breast-feed your baby while taking Vimpat, as 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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Other form(s) of this medicine may be more suitable for children;
ask your doctor or pharmacist.

Taking Vimpat
- Take Vimpat twice each day - approximately 12 hours apart.
- 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 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.

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

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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
- 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.
or
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

Lietuva
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Suomija)

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49
Luxembourg/Luxemburg
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: + 420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: + 36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf.: + 45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: + 356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 40

Eesti
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge
UCB Nordic A/S
Tlf: + 47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: + 43 (0)1 291 80 00

España
UCB Pharma, S.A.
Tel: + 34 / 91 570 34 44

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel.: + 48 22 696 99 20

France
UCB Pharma
Tél: + 33 / (0)1 47 29 44 35
Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: + 351 21 302 5300

Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

România
UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
UCB Nordic A/S
Sími: + 45 / 32 46 24 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

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: + 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)

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:
https://www.ema.europa.eu.

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.

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 plunger down to fill the oral syringe with a small amount of solution (figure 6).
• Push the plunger up to get rid of any bubbles (figure 7).

- Pull the plunger down to the millilitre (ml) dose marker prescribed by your doctor (figure 8).
The plunger may rise back up the barrel on the first dosage. Therefore, ensure that the plunger is kept in position until the oral syringe is disconnected from the bottle.

• 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 plunger 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).
• To clean the oral syringe, rinse with cold water only, moving the plunger several times up and down to take up and expel the water, without separating the two components of the syringe (figure 13).

• Keep the bottle, the oral syringe, and the leaflet in the carton.

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

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 the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 6 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.

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 polypropylene measuring cup and a 10 ml polyethylene / polypropylene oral syringe (black graduation marks) with its polyethylene adaptor.
- The measuring cup is suitable for doses above 20 ml. 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 10 ml oral syringe is suitable for doses between 1 ml and 20 ml. 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 contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00

Lietuva
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Suomija)

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49
Luxembourg/Luxemburg
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: + 420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: + 36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf.: + 45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: + 356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 40

Eesti
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge
UCB Nordic A/S
Tlf: + 47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: + 43 (0)1 291 80 00
España
UCB Pharma, S.A.
Tel: + 34 / 91 570 34 44

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel.: + 48 22 696 99 20

France
UCB Pharma
Tél: + 33 / (0)1 47 29 44 35
Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: + 351 21 302 5300

Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

România
UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
UCB Nordic A/S
Sími: + 45 / 32 46 24 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

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: + 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)

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:
https://www.ema.europa.eu.

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

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

7 ml
10.5 ml
14 ml
40 kg
4 ml
8 ml
12 ml
16 ml
45 kg

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

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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 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 contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00

Lietuva
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Suomija)

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49
Luxembourg/Luxemburg
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: + 420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: + 36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf.: + 45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: + 356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 40

Eesti
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge
UCB Nordic A/S
Tlf: + 47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: + 43 (0)1 291 80 00
España
UCB Pharma, S.A.
Tel: + 34 / 91 570 34 44

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel.: + 48 22 696 99 20

France
UCB Pharma
Tél: + 33 / (0)1 47 29 44 35
Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: + 351 21 302 5300

Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

România
UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
UCB Nordic A/S
Sími: + 45 / 32 46 24 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

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: + 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)

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:
https://www.ema.europa.eu.

The following information is intended for medical or healthcare professionals only.

Each vial of Vimpat solution for infusion must be used only once (single use). Any unused solution should be discarded (see section 3).

Vimpat 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.