Patient leaflet - Vimpat 10 mg/ml solution for infusion
1. What Vimpat is and what it is used for
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).
2. What you need to know before you use Vimpat
Do not use 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 pr third-degree AV block.
Do not use Vimpat if any of the above appli sure, talk to your doctor or pharmacist befo
Warnings and precautions
Talk to your doctor before using Vimpat if:
- you have thoughts of harming or killing y of people being treated with antiepile such as lacosamide have had thought themselves. If you have any of these th your doctor straight away.
- you have a heart problem that affects th you often have a particulary slow, fast (such as AV block, atrial fibrillation and a
- you have severe heart disease such as h a heart attack.
- you are often dizzy or fall over. Vi dizzy - this could increase the risk of accid means that you should take care until yo of this medicine.
If any of the above apply to you (or you ar doctor or pharmacist before using Vimpat. If you are taking Vimpat, talk to your doctor a new type of seizure or worsening of existi If you are taking Vimpat and you are exp abnormal heartbeat (such as slow, rapid palpitations, shortness of breath, feeling ligh medical advice immediately (see section 4).
oblem called second- or es to you. If you are not re using this medicine.
ourself. A small number ptic medicinal products s of harming or killing oughts at any time, tell e beat of your heart and or irregular heart beat trial flutter).
eart failure or have had mpat may make you ental injury or a fall. This u are used to the effects e not sure), talk to your if you are experiencing ng seizures.
eriencing symptoms of or irregular heartbeat, theaded, fainting), seek
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 using 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;
- a medicine 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 using Vimpat.
Vimpat with alcohol
As a safety precaution do not use 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 using this medicine.
It is not recommended to use 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 the breast milk.
Seek advice immediately from your doctor if you get pregnant or are planning to become pregnant. They will help you decide if you should use 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.
Vimpat contains sodium
This medicine contains 59.8 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 3 % of the recommended maximum daily dietary intake of sodium for an adult.
3. How to use Vim
Always use this medicin told you. Check with yo
Using Vimpat
Vimpat can be starte
- taking the medicin
by being given as a
“IV infusion”) wher doctor or nurse. It
- The IV infusion is usu take the medicine by
Your doctor will decid
There is experience 5 days. For longer te available.
When you change from (or the other way aroun how often you take it st
- Use Vimpat twice ea
- Try to use it at about
How much to use
Listed below are the n different age groups and dose if you have problem Adolescents and childr
When you use Vimpat o
The usual starting do
pat e exactly as your doctor or pharmacist has ur doctor or pharmacist if you are not sure.
d by:
e by mouth or n intravenous infusion (sometimes called an e the medicine is given into your vein by a is given over 15 to 60 minutes.
ally used for a short time when you cannot mouth.
e for how many days you will have infusions. with twice daily infusions of Vimpat for up to rm treatment Vimpat tablets and syrup are the infusion to taking the medicine by mouth
- d) the total amount you take each day and ays the same.
ch day (approximately 12 hours apart). the same time each day.
ormal recommended doses of Vimpat for weights. Your doctor may prescribe a different s with your kidneys or with your liver. en weighing 50 kg or more and adults n its own se of Vimpat is 50 mg twice a day.
- The treatment with Vimpat may also start with a 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 of between 100 mg and 300 mg twice a day.
When you use 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 of 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.
When you use Vimpat on its own
- Your doctor will decide the dose of Vimpat based on your body weight.
- The usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
- Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml), for each kg of your body weight. This will be until you reach a maintenance dose.
Dosing charts including the maximum recommended dose are provided below. This is for information only. Your doctor will work out the right dose for you.
To be used twice daily for children from 2 years of age weighing from 10 kg to less than 40 kg
Weight
Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Starting dose:
0.1 ml/kg 0.2 ml/kg 0.3 ml/kg 0.4 ml/kg 0.5 ml/kg
Maximum recommended dose:
0.6 ml/kg
10 kg 1 ml 2 ml 3 ml 4 ml 5 ml 6 ml
15 kg 1.5 ml 3 ml 4.5 ml 6 ml 7.5 ml 9 ml
20 kg 2 ml 4 ml 6 ml 8 ml 10 ml 12 ml
25 kg 2.5 ml 5 ml 7.5 ml 10 ml 12.5 ml 15 ml
30 kg 3 ml 6 ml 9 ml 12 ml 15 ml 18 ml
35 kg 3.5 ml 7 ml 10.5 ml 14 ml 17.5 ml 21 ml
To be used twice daily for children and adolescents weighing from 40 kg to less than 50 kg
Weight
Week 1 Week 2 Week 3 Week 4 Week 5
Starting dose:
0.1 ml/kg
0.2 ml/kg 0.3 ml/kg 0.4 ml/kg
Maximum recommended dose:
0.5 ml/kg
40 kg 4 ml 8 ml 12 ml 16 ml 20 ml
45 kg 4.5 ml 9 ml 13.5 ml 18 ml 22.5 ml
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pat of the sight and reach of children. e after the expiry date which is stated on the . The expiry date refers to the last day of that
C.
ution for infusion must be used only once solution should be discarded.
from particles and discoloration should be y medicines via wastewater or household acist how to throw away medicines you no ures will help protect the environment.
ack and other information is lacosamide.
for infusion contains 10 mg lacosamide. l Vimpat solution for infusion equivalent to
s are: sodium chloride, hydrochloric acid, and contents of the pack olution for infusion is a clear, colourless
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 Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom.
Manufacturer
Aesica Pharmaceuticals GmbH,
Alfred-Nobel Strasse 10,
D-40789 Monheim am Rhein, Germany.
This leaflet was last revised in June 2022.
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.
When you use Vimpat with other antiepileptic medicines
- Your doctor will decide the dose of Vimpat based on your body weight.
For children and adolescents weighing from 10 kg to less than
50 kg, the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
- Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body weight. This will be until you reach a maintenance dose.
- Dosing charts including the maximum recommended dose are provided below. This is for information only. Your doctor will work out the right dose for you.
To be used twice daily for children from 2 years of age weighing from 10 kg to less than 20 kg
Weight
Week 1 Week 2 Week 3 Week 4 Week 5 Week 6
Starting
dose:
0.1 ml/kg
0.2 ml/kg 0.3 ml/kg 0.4 ml/kg 0.5 ml/kg
Maximum recommended dose:
0.6 ml/kg
10 kg 1 ml 2 ml 3 ml 4 ml 5 ml 6 ml
15 kg 1.5 ml 3 ml 4.5 ml 6 ml 7.5 ml 9 ml
To be used twice daily for children and adolescents weighing from 20 kg to less than 30 kg
Weight
Week 1 Week 2 Week 3 Week 4 Week 5
Starting dose:
0.1 ml/kg
0.2 ml/kg 0.3 ml/kg 0.4 ml/kg
Maximum recommended dose:
0.5 ml/kg
20 kg 2 ml 4 ml 6 ml 8 ml 10 ml
25 kg 2.5 ml 5 ml 7.5 ml 10 ml 12.5 ml
To be used twice daily for children and adolescents weighing from 30 kg to less than 50 kg
Weight
Week 1 Week 2 Week 3 Week 4
Starting dose:
0.1 ml/kg
0.2 ml/kg 0.3 ml/kg
Maximum recommended dose:
0.4 ml/kg
30 kg 3 ml 6 ml 9 ml 12 ml
35 kg 3.5 ml 7 ml 10.5 ml 14 ml
40 kg 4 ml 8 ml 12 ml 16 ml
45 kg 4.5 ml 9 ml 13.5 ml 18 ml
If you stop using Vimpat
If your doctor decides to stop your treatme decrease the dose step by step. This is to pr coming back again or becoming worse. If you have any further questions on the u your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause s everybody gets them.
Nervous system side effects such as dizzin a single “loading” dose.
Talk to your doctor or pharmacist if you g
Very common: may affect more than 1 in 10
- 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 musc
- Difficulties in coordinating your movemen
Problems in keeping your balance, sh
(paresthesia) or muscle spasms, falling e
- Troubles with your memory, thinking or fi
- Rapid and uncontrollable movements o blurred vision;
- A spinning sensation (vertigo), feeling dr
Being sick (vomiting), dry mouth, co excessive gas in the stomach or bowel,
nt with Vimpat, they will event your epilepsy from se of this medicine, ask ide effects, although not ess may be higher after et any of the following:
people les (myoclonic seizures); ts or walking;
aking (tremor), tingling asily and getting bruises; nding words, confusion; f the eyes (nystagmus), unk;
nstipation, indigestion, 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:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects the safety of this medici
5. How to store Vim
Keep this medicine out Do not use this medicin carton and vial after EXP month.
Do not store above 25° Each vial of Vimpat sol (single use). Any unused Only clear solution free used.
Do not throw away an waste. Ask your pharm longer use. These meas
6. Contents of the p
What Vimpat contains
The active substance 1 ml Vimpat solution 1 vial contains 20 m
200 mg lacosamide.
- The other ingredient water for injections.
What Vimpat looks like
- Vimpat 10 mg/ml s solution.