Vimpat 50 mg film-coated tablets

Vimpat is used to treat a certain form of epilepsy (see below) in patients aged 16 years and older. Vimpat is used in addition to other antiepileptic medicines.
Epilepsy is a condition where the patients have repeated fits (seizures). Vimpat is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation).

Do NOT take Vimpat

• if you are allergic (hypersensitive) to lacosamide, or any of the other ingredients of Vimpat (listed in Section 6). If you are not sure whether you are allergic, please discuss with your doctor
• if you suffer from a certain type of heart rhythm disorder (second or third degree AV block)

Take special care with Vimpat

Please inform your doctor about the following:

• if you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval, for example medicines used to treat certain types of irregular heart beat or heart failure. If you are not sure if the medicines you are taking could have this effect, discuss this with your doctor.
• if you suffer from a severe heart disease such as heart rhythm disorder, heart failure or heart attack

Vimpat may cause dizziness, which could increase the risk of accidental injury or a fall. Therefore, you should be careful until you are used to the effects this medicine might have.

A small number of people being treated with anti-epileptics such as lacosamide have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you take medicines to treat heart problems (see also above "Take special care").

Taking Vimpat with food and drink
You may take Vimpat with or without food.
It is not advisable to drink alcohol while you are under treatment with Vimpat, because Vimpat could make you feel tired or dizzy. Drinking alcohol could make these effects worse.

Pregnancy and breast-feeding

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. Tell your doctor immediately if you are pregnant or planning to become pregnant; he/she will decide if you should take Vimpat.

It is not recommended to breast-feed your baby while taking Vimpat, as it is not known if Vimpat passes into the breast milk. If you are breast-feeding, please inform your doctor immediately; he/she will decide if you should take Vimpat.

Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines. On the other hand effective anti-epileptic therapy must not be interrupted since the worsening of the disease is harmful to both the mother and the unborn child.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Vimpat may cause dizziness or blurred vision. This may affect your ability to drive or operate any tools or machinery. You should not drive or use machines until you know whether this medicine affects your ability to perform these activities.

Always take Vimpat exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

Vimpat must be taken twice a day, once in the morning and once in the evening, at about the same time each day. Vimpat is used as a long term treatment.

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 1 100 mg Package marked Week 1 50 mg 1tablet Vimpat 50 mg 50 mg 1 tablet Vimpat 50 mg Week 2 100 mg 100 mg 200 mg Package marked Week 2 1 tablet Vimpat 100 mg 1 tablet Vimpat 100 mg Week 3 300 mg Package marked Week 3 150 mg 1 tablet Vimpat 150 mg 150 mg 1 tablet Vimpat 150 mg Week 4 Package marked 200 mg 200 mg 400 mg Week 4 1 tablet Vimpat 200 mg 1 tablet Vimpat 200 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.

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

How to take the Vimpat tablets

You should swallow the Vimpat tablet with a glass of water. You may take Vimpat with or without food.

Duration of the treatment with Vimpat

Vimpat is used as a long term treatment. You should continue to take Vimpat until your doctor tells you to stop.

If you take more Vimpat than you should If you have taken more Vimpat than you should, contact your doctor.

If you forget to take Vimpat
If you miss a dose by a few hours, take it as soon as you remember. If it is close to your next dose, don't take the missed tablet anymore. Just 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 VimpatDo not stop taking Vimpat without talking to your doctor, as your symptoms may come back again or become worse.
If your doctor decides to stop your treatment with Vimpat, he/she will instruct you about how you should decrease the dose step by step.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data

Very common: affects more than 1 user in 10

• Dizziness, headache
• Nausea (feeling sick)
• Double vision (diplopia)

Common: affects 1 to 10 users in 100

• Problems in keeping your balance, difficulties in coordinating your movements, troubles with your memory, sleepiness, shaking (tremor), trouble thinking or finding words, rapid and uncontrollable movements of the eyes (nystagmus)
• Blurred vision
• A feeling of "spinning" (vertigo)
• Vomiting, constipation, excessive gas in the stomach or bowel
• Itching
• Fall
• Tiredness, difficulties in walking, unusual tiredness and weakness (asthenia)
• Depression
• Confusion
• Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention
• Noise in the ear such as buzzing, ringing or whistling
• Indigestion, dry mouth
• Irritability
• Muscle spasms
• Rash

Uncommon: affects 1 to 10 users in 1000

• Slow heart rate
• Heart conduction disorder
• Exaggerated feeling of wellbeing
• Allergic reaction to drug intake
• Liver function test abnormal

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.
Do not use Vimpat after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to 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, 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 with a debossed ?SP? on one side and ?50? on the other side.
Vimpat 100 mg are dark yellow, oval film-coated tablets with a debossed ?SP? on one side and ?100? on the other side.Vimpat 150 mg are salmon, oval film-coated tablets with a debossed ?SP? on one side and ?150? on the other side.Vimpat 200 mg are blue, oval film-coated tablets 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 and Manufacturer

Marketing Authorisation Holder: UCB Pharma SA, Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Manufacturer: UCB Pharma GmbH, Alfred-Nobel-Str. 10, 40789 Monheim am Rhein, Germany.

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

BelgiëBelgiqueBelgien UCB Pharma SANV TelTél 32 02 559 92 00 LuxembourgLuxemburg UCB Pharma SANV TélTel 32 02 559 92 00

Te. 359 0 2 962 99 20 Magyarország UCB Magyarország Kft. Tel. 36-1 391 0060

eská republika UCB s.r.o. Tel 420 221 773 411 Malta Pharmasud Ltd. Tel 356 21 37 64 36

Danmark UCB Nordic AS Tlf 45 32 46 24 00 Nederland UCB Pharma B.V. Tel. 31 076-573 11 40

Deutschland UCB GmbH Tel 49 0 2173 48 4847 Norge UCB Nordic AS Tlf 45 32 46 24 00

Eesti UCB Pharma Oy Finland Tel 358 10 234 6800 Soome Österreich UCB Pharma GmbH Tel 43 1 291 80 00

UCB .. 30 2109974000 Polska UCB Pharma Sp. z o.o. Tel. 48 022 696 99 20

España UCB Pharma, S.A. Tel 34 91 570 34 44 Portugal UCB Pharma Produtos Farmacêuticos, Lda Tel 351 21 302 5300

France UCB Pharma S.A. Tél 33 01 47 29 44 35 România UCB Pharma Romania S.R.L. Tel 40 21 300 29 04

Ireland UCB Pharma Ireland Ltd. Tel 353 01-46 37 395 Slovenija Medis, d.o.o. Tel 386 1 589 69 00

Ísland Vistor hf. Tel 354 535 7000 Slovenská republika UCB s.r.o., organizaná zloka Tel 421 0 2 5920 2020

Italia UCB Pharma S.p.A. Tel 39 02 300 791 SuomiFinland UCB Pharma Oy Finland PuhTel 358 10 234 6800

Lifepharma Z.A.M. Ltd 357 22 34 74 40 Sverige UCB Nordic AS Tel 46 0 40 29 49 00

Latvija UCB Pharma Oy Finland Tel 358 10 234 6800 Somija United Kingdom UCB Pharma Ltd. Tel 44 01753 534 655

Lietuva
UCB Pharma Oy Finland
Tel: + 358 10 234 6800 (Suomija)

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