Vimpat 10 mg/ml solution for infusion

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).

Vimpat solution for infusion is an alternative form of treatment for a short period of time, when oral (by mouth) administration is not possible.

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").

Using 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.

Important information about some of the ingredients of Vimpat

This medicinal product contains 2.6 mmol (or 59.8 mg) sodium per vial. To be taken into consideration for patients on a controlled sodium diet.

The solution for infusion is an alternative form of treatment for a short period of time, when Vimpat can't be taken by mouth. It will be administered into a vein by a health care professional. It is possible to switch directly from oral administration to infusion and the other way around. Your total daily dose and frequency of administration remain the same.

Dosage

Vimpat must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
The treatment with Vimpat starts usually with a dose of 100 mg daily given half (50 mg) in the morning and half (50 mg) in the evening. The daily maintenance dose is between 200 mg and 400 mg. Your doctor may use a different dose if you have problems with your kidneys.

How Vimpat is given to you

Vimpat is administered as an infusion into a vein (intravenously) by a healthcare professional. It is infused over 15-60 minutes.

Duration of the treatment with Vimpat solution for infusion

Your doctor will decide for how many days you will receive the infusions. There is experience with twice daily infusions of Vimpat up to 5 days. For the long term treatment Vimpat tablets and syrup are available.

If you stop using VimpatIf your doctor decides to stop your treatment with Vimpat, he/she will decrease the dose step by step. This is to prevent your symptoms from coming back again or becoming worse.

If you have any further questions on the use of this medicine, 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

Intravenous administration
Intravenous administration was associated with local side effects such as :
Common: affects 1 to 10 users in 100

• Injection site pain or discomfort,
• Irritation

Uncommon: affects 1 to 10 users in 1,000

• Redness.

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 vial. 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.
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.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 injection.

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 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 Malta

UCB s.r.o. Tel 420 221 773 411 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)

This leaflet was last approved in {MM/YYYY}.

The following information is intended for medical or healthcare professionals only

Vimpat solution for infusion can be administered without further dilution, or may be diluted with the following solutions: 0.9% sodium chloride 9 mg/ml (0.9%), 5% glucose 50 mg/ml or lactated Ringer?s solution. Each vial of Vimpat solution for infusion must be used only once (single use). Any unused solution should be discarded (see section 3).