VIMPAT. 200 mg. 56 tablets
VIMPAT. 200 mg. 56 tablets
What Vimpat is and what it is used ?
Lacosamide (Vimpat) is used to treat some forms of epilepsy ( see below ) in patients over 16 years of age . Vimpat is used in addition to other antiepileptic drugs.
Epilepsy is a condition in which patients have recurrent seizures ( fits) . Vimpat is used to treat a form of epilepsy which originally affect only one side of the brain , as later as possible , and the coverage of larger portions of the two parts of the brain ( partial onset seizures with or without secondary generalization) . Vimpat is prescribed by your doctor to reduce the number of seizures .
2 . What you should know before taking Vimpat?
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 unsure whether you are allergic , please discuss this with your doctor
• if you suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular block)
Warnings and Precautions
Small number of people being treated with antiepileptics such as lacosamide have had thoughts of harming or killing themselves . If you ever have these thoughts , immediately contact your doctor.
Talk to your doctor before taking Vimpat, if you suffer from a disease that is associated with damage to the electrical conductivity of the heart (AV block, atrial fibrillation and atrial flutter ) or severe cardiac disease such as heart failure or heart attack . Symptoms of AV block are slow or irregular heartbeat , dizziness and fainting. In the case of atrial flutter and fibrillation may experience palpitations , rapid or irregular heartbeat and shortness of breath .
Vimpat may cause dizziness , which could increase the risk of accidental injury or falls. Therefore you should be careful until you get used to the effects that this drug may have.
Children and adolescents
Vimpat is not recommended for children under the age of 16 years . Safety and efficacy are not yet known in this age group.
Other medicines and Vimpat
Tell your doctor or pharmacist if you are taking , have recently taken or might take other medicines. This is especially important if you are taking :
• medicines used to treat heart problems or are taking any medicine which can cause an abnormality on the ECG ( electrocardiogram) , known as prolongation of the PR- interval , such as carbamazepine , lamotrigine, pregabalin (medicines used to treat epilepsy ) and drugs used in certain types of irregular heartbeat or heart failure. If you are not sure if the medicines you are taking could have this effect, discuss this with your doctor.
• drugs , such as fluconazole , itraconazole, ketoconazole ( medicines used to treat fungal infections , ritonavir ( a drug used to treat HIV infection ) , clarithromycin, rifampicin ( drugs used to treat bacterial infections) and St John's wort ( drug used for the treatment of mild anxiety) may affect the manner in which the liver breaks lacosamide.
As a precaution, do not take Vimpat with alcohol.
Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.
Not recommended the use of Vimpat, if you are pregnant , as the effects of Vimpat on pregnancy and not been established. Tell your doctor if you are pregnant or planning to become pregnant , your doctor will decide whether 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 breast milk . If you are nursing , please tell your doctor , your doctor will decide whether you should take Vimpat.
Research has shown an increased risk of birth defects in children of women taking antiepileptic drugs. On the other hand , an effective antiepileptic treatment should not be interrupted, since the aggravation of the disease is harmful to both the mother and the unborn child.
Driving and using machines
Vimpat may cause dizziness or blurred vision . This can affect your ability to drive or operate any tools or machines. You should not drive or operate machinery until you know whether this medication affects your ability to perform these activities.
3 . How to take Vimpat?
Always take this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. Loading dose has not been studied in patients with status epilepticus .
Vimpat should be taken twice a day, once in the morning and once in the evening , at the same time each day. Vimpat is used for prolonged treatment.
The usual starting dose of Vimpat 100 mg per day - taken twice daily - 50 mg in the morning and 50 mg in the evening . Your doctor may increase your daily dose every week by 100 mg, until you reach a so called maintenance dose is between 200 mg and 400 mg taken twice daily. You will take this maintenance dose for long-term treatment . Your doctor may decide to start treatment with Vimpat single loading dose of 200 mg, followed approximately 12 hours later by the shift to the supportive care. Loading dose should be administered under medical supervision.
Your doctor may prescribe a different dose if you have kidney problems .
How to take tablets Vimpat?
You should swallow the Vimpat tablets with a glass of water . You can take Vimpat with or without food.
Duration of treatment with Vimpat
Vimpat is used for prolonged treatment. You need to keep taking Vimpat, unless your doctor tells you to stop .
If you take more than the dose of Vimpat
If you take more than the amount of Vimpat, tell your doctor.
After doses of 1200 mg per day ( 3 times the recommended daily dose) in clinical trials, there were dizziness and nausea , which were overcome by dose adjustment.
If you forget to take Vimpat
If you miss a few hours of a dose, take it as soon as you remember. If it is almost time (less than 6 hours) for your next dose, take the missed dose . Just take the next Vimpat at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Vimpat
Do not stop taking Vimpat, without discussing it with your doctor, as your symptoms may recur or worsen.
If your doctor decides to stop your treatment with Vimpat, he / she will instruct you how to gradually reduce the dose .
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 .
Adverse reactions of the nervous system such as dizziness may be more after the loading dose.
Very common: may affect more than 1 in 10 patients
• Dizziness, headache
• Nausea ( feeling sick)
• Double vision ( diplopia )
Common : may affect 1 to 10 users in 100
• Problems in keeping your balance, difficulties in motor coordination , memory problems , drowsiness , shaking ( tremor) , trouble thinking or finding words, rapid and involuntary eye movements ( nystagmus )
• Blurred vision
• A feeling of " spinning" ( vertigo)
• Nausea , constipation, excessive gas in the stomach and intestines
• Fall Skin
• Fatigue , difficulty walking, unusual tiredness and weakness (asthenia )
• Decreased feeling or sensitivity , trouble saying words , disturbance in attention
• Tinnitus as buzzing , ringing or whistling
• indigestion, dry mouth
• Muscle spasms
• Sleep problems
Uncommon : may affect 1 to 10 of 1000 patients
• Slow heart rate
• Violation of conduction of the heart
• exaggerated feeling of well-being
• Allergic reaction to drug intake
• Abnormal test results of liver function
• Attempted suicide
• Thoughts of suicide or self-harm
• Palpitations and / or fast or irregular heartbeat
• Disturbances in thinking and / or loss of contact with reality
• Severe allergic reaction causing swelling of the face , throat, hand , feet, ankles or lower legs
• Hallucinations (seeing and / or hearing things that are not real)
Not known from the available data can not be estimated frequency
• Very low levels of certain white blood cells ( agranulocytosis)
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet . You can also report side effects directly through the national system of notification referred to in Annex V. As reported side effects , you can do your bit to get more information on the safety of this medicine.
5 . How to store Vimpat?
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after " EXP" . Expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions .
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does Vimpat?
Active substance 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.
Other ingredients are:
Tablet core : microcrystalline cellulose , hydroxypropylcellulose (low substituted) , colloidal anhydrous silica , crospovidone ( Polyplasdone XL- 10 pharmaceutical grade ) , Magnesium Stearate
Film coating : polyvinyl alcohol , polyethylene glycol, talc , titanium dioxide (E171), coloring agents **
50 mg tablets: iron oxide red (E172), black iron oxide (E172), indigo carmine aluminum lake (E132)
100 mg tablets: iron oxide yellow (E172)
150 mg tablets: iron oxide yellow (E172), red iron oxide (E172), black iron oxide (E172)
200 mg tablets: indigo carmine aluminum lake (E132) Vimpat looks like and contents of pack
Vimpat 50 mg are pink, oval film-coated tablets debossed with 'SP' on one side and '50 'on the other side.
Vimpat 100 mg are dark yellow , oval film-coated tablets debossed with 'SP' on one side and '100 'on the other side.
Vimpat 150 mg are salmon , oval film-coated tablets debossed with 'SP' on one side and '150 'on the other side.
Vimpat 200 mg are blue, oval film-coated tablets debossed with 'SP' on one side and '200 'on the other side.
Vimpat is available in packs of 14, 56 and 56 x 1 film-coated tablets and in multipacks comprising 3 packs, each containing 56 tablets. Pack of 56 x 1 film-coated tablets are available in perforated unit dose PVC / PVDC blister sealed with aluminum foil , all packages are available in standard PVC / PVDC blister sealed with aluminum foil. Not all pack sizes may be marketed.
Marketing Authorisation Holder
UCB Pharma SA,
UCB Pharma SA