Fycompa 10 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Fycompa 2mg, 4mg, 6mg, 8mg, 10mg and 12mg film-coated tablets
perampanel
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
Contents of the leaflet
- What Fycompa is and what it is used for
- What you need to know before taking Fycompa
- How to take Fycompa
- Possible side effects
- How to store Fycompa
- Contents of the pack and other information
1. What Fycompa is and what it is used for
Fycompa contains a medicine called perampanel. It belongs to a group of medicines called antiepileptics. These medicines are used to treat epilepsy, a condition in which a person has repeated seizures. Your doctor has prescribed it to you to reduce the number of epileptic seizures you experience.
Fycompa is used in combination with other antiepileptic medicines to treat specific forms of epilepsy:
In adults, adolescents (12 years of age and older), and children (4 to 11 years of age)
- It is used to treat epileptic seizures that affect one part of the brain (“partial seizures”).
- These partial seizures may or may not be followed by a seizure affecting the entire brain (“secondary generalization”).
In adults, adolescents (12 years of age and older), and children (7 to 11 years of age)
- It is also used to treat epileptic seizures that affect the entire brain from the onset (“generalized seizures”) and cause convulsions.
2. What you need to know before taking Fycompa
DO NOT TAKE Fycompa:
- if you have ever had a severe skin rash, skin peeling, blisters and/or mouth sores after taking perampanel.
- if you are allergic to perampanel or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Fycompa if you have liver problems or moderate to severe kidney problems.
You must not take Fycompa if you have severe liver problems or moderate to severe kidney problems.
Before starting this medicine, you should tell your doctor if you have a history of alcoholism or drug dependence.
Elevated liver enzymes have been reported in some patients taking Fycompa together with other antiepileptic medicines.
- Fycompa may make you feel dizzy or drowsy, especially at the beginning of treatment.
- Fycompa may make you more likely to fall, especially if you are elderly; this could be due to your condition.
- Fycompa may cause you to become aggressive, angry or violent. It may also cause unusual or extreme changes in your behaviour or mood, abnormal thoughts or loss of contact with reality.
If you, a family member or a friend notice any of these reactions, consult your doctor or pharmacist.
A small number of people taking antiepileptic medicines have had thoughts of harming themselves or of suicide. If at any time you have such thoughts, contact your doctor immediately.
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SJS), have been reported with perampanel treatment.
- DRESS usually, although not exclusively, presents with flu-like symptoms and a rash accompanied by fever, increased liver enzymes and a type of white blood cell (eosinophilia) in blood tests, and swollen lymph nodes.
- Stevens-Johnson syndrome (SJS) may initially appear as red, target-shaped spots or circular patches, often with blisters in the centre, typically located on the trunk. Ulcerations may also occur in the mouth, throat, nose, genitals and eyes (eye swelling and redness). These serious skin rashes are often preceded by fever or flu-like symptoms. The rashes may progress to extensive skin peeling and life-threatening complications, or may be fatal.
If you experience any of the above problems after taking Fycompa (or are unsure), consult your doctor or pharmacist.
Children
Fycompa is not recommended for use in children under 4 years of age. Safety and efficacy have not yet been established in children under 4 years of age for partial seizures, or in children under 7 years of age for generalized seizures.
Other medicines and Fycompa
Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines. This includes medicines obtained without a prescription and herbal medicines. Taking Fycompa with certain other medicines may cause adverse effects or affect how they work. Do not start or stop taking any other medicines without first consulting your doctor or pharmacist.
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Other antiepileptic medicines, such as carbamazepine, oxcarbazepine and phenytoin used to treat seizures, may affect Fycompa. Inform your doctor if you are taking or have recently taken these medicines, as your dose may need to be adjusted.
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Felbamate (a medicine used to treat epilepsy) may also affect Fycompa. Inform your doctor if you are taking or have recently taken this medicine, as your dose may need to be adjusted.
- Midazolam (a medicine used to stop acute [sudden] and prolonged seizures, for sedation and sleep problems) may be affected by Fycompa. Inform your doctor if you are taking midazolam, as your dose may need to be adjusted.
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Other medicines, such as rifampicin (a medicine used to treat bacterial infections), St. John’s wort (a herbal medicine used to treat mild anxiety) and ketoconazole (a medicine used to treat fungal infections) may affect Fycompa. Inform your doctor if you are taking or have recently taken these medicines, as your dose may need to be adjusted.
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Hormonal contraceptives (including oral contraceptives, implants, injections and patches).
Inform your doctor if you are taking hormonal contraceptives. Fycompa may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. You should use other safe and effective contraceptive methods (such as condoms or an intrauterine device) while taking Fycompa. You should continue to do so for one month after stopping treatment. Ask your doctor which contraceptive method is appropriate for you.
Taking Fycompa with alcohol
Talk to your doctor before drinking alcohol. Be cautious about alcohol consumption when taking antiepileptic medicines, including Fycompa.
- Drinking alcohol while taking Fycompa may reduce your level of alertness and affect your ability to drive or operate tools and machinery.
- Drinking alcohol while taking Fycompa may also worsen feelings of anger, confusion or sadness.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine. Do not stop treatment without first talking to your doctor.
- Fycompa is not recommended during pregnancy.
- You should use a reliable method of contraception to prevent pregnancy while being treated with Fycompa. You should continue to do so for one month after stopping treatment. Inform your doctor if you are taking hormonal contraceptives. Fycompa may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. You should use other safe and effective contraceptive methods (such as condoms or an intrauterine device) while taking Fycompa. You should also continue to do so for one month after stopping treatment. Ask your doctor which contraceptive method is appropriate for you.
It is unknown whether the components of Fycompa pass into breast milk.
Your doctor will weigh the benefits of Fycompa treatment for the mother against the potential risks for the breastfed infant during breastfeeding.
Driving and using machines
Do not drive or operate machinery until you know how Fycompa affects you.
You should discuss with your doctor the effects of epilepsy on driving and operating machinery.
- Fycompa may make you feel dizzy or drowsy, especially at the beginning of treatment. If this occurs, do not drive or operate tools or machinery.
- Drinking alcohol while taking Fycompa may worsen these effects.
Fycompa contains lactose
Fycompa contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Fycompa
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
How much to take
Adults and adolescents (12 years of age and older) for the treatment of partial-onset seizures and generalized tonic-clonic seizures:
The recommended starting dose is 2 mg once daily before bedtime.
- Your doctor may increase this dose in 2-mg increments up to a maintenance dose between 4 mg and 12 mg, depending on your response.
- If you have mild or moderate liver (hepatic) problems, your dose should not exceed 8 mg per day, and dose increases should be made at intervals of at least 2 weeks.
- Do not take more Fycompa than recommended by your doctor. It may take several weeks to find the appropriate Fycompa dose for you.
The following table shows a summary of the recommended doses for the treatment of partial-onset seizures in children aged 4 to 11 years and generalized tonic-clonic seizures in children aged 7 to 11 years. For further information, see below the table.
Children weighing: | |||
More than 30 kg | From 20 kg to no more than 30 kg | Less than 20 kg | |
Recommended initial dose | 2 mg/day | 1 mg/day | 1 mg/day |
Recommended maintenance dose | 4-8 mg/day | 4-6 mg/day | 2-4 mg/day |
Maximum recommended dose | 12 mg/day | 8 mg/day | 6 mg/day |
Children (4 to 11 years of age) weighing 30 kg or more in the treatment of partial seizures:
The recommended initial dose is 2 mg once daily before bedtime.
- Your doctor may increase this dose in 2 mg increments up to a maintenance dose between 4 mg and 8 mg, depending on your response. Based on individual clinical response and tolerability, the dose may be increased up to a maximum of 12 mg/day.
- If you have mild or moderate liver (hepatic) problems, your dose should not exceed 4 mg daily, and dose increases should be made at intervals of at least 2 weeks.
- Do not take more Fycompa than prescribed by your doctor. It may take several weeks to find the appropriate Fycompa dose for you.
Children (4 to 11 years of age) weighing 20 kg and less than 30 kg in the treatment of partial seizures:
The recommended initial dose is 1 mg once daily before bedtime.
- Your doctor may increase this dose in 1 mg increments up to a maintenance dose between 4 mg and 6 mg, depending on your response. Based on individual clinical response and tolerability, the dose may be increased up to a maximum of 8 mg/day.
- If you have mild or moderate liver (hepatic) problems, your dose should not exceed 4 mg daily, and dose increases should be made at intervals of at least 2 weeks.
- Do not take more Fycompa than prescribed by your doctor. It may take several weeks to find the appropriate Fycompa dose for you.
Children (4 to 11 years of age) weighing less than 20 kg in the treatment of partial seizures:
The recommended initial dose is 1 mg once daily before bedtime.
- Your doctor may increase this dose in 1 mg increments up to a maintenance dose between 2 mg and 4 mg, depending on your response. Based on individual clinical response and tolerability, the dose may be increased up to a maximum of 6 mg/day.
- If you have mild or moderate liver (hepatic) problems, your dose should not exceed 4 mg daily, and dose increases should be made at intervals of at least 2 weeks.
- Do not take more Fycompa than prescribed by your doctor. It may take several weeks to find the appropriate Fycompa dose for you.
Children (7 to 11 years of age) weighing 30 kg or more in the treatment of generalized seizures:
The recommended initial dose is 2 mg once daily before bedtime.
- Your doctor may increase this dose in 2 mg increments up to a maintenance dose between 4 mg and 8 mg, depending on your response. Based on individual clinical response and tolerability, the dose may be increased up to a maximum of 12 mg/day.
- If you have mild or moderate liver (hepatic) problems, your dose should not exceed 4 mg daily, and dose increases should be made at intervals of at least 2 weeks.
- Do not take more Fycompa than prescribed by your doctor. It may take several weeks to find the appropriate Fycompa dose for you.
Children (7 to 11 years of age) weighing 20 kg and less than 30 kg in the treatment of generalized seizures:
The recommended initial dose is 1 mg once daily before bedtime.
- Your doctor may increase this dose in 1 mg increments up to a maintenance dose between 4 mg and 6 mg, depending on your response. Based on individual clinical response and tolerability, the dose may be increased up to a maximum of 8 mg/day.
- If you have mild or moderate liver (hepatic) problems, your dose should not exceed 4 mg daily, and dose increases should be made at intervals of at least 2 weeks.
- Do not take more Fycompa than prescribed by your doctor. It may take several weeks to find the appropriate Fycompa dose for you.
Children (7 to 11 years of age) weighing less than 20 kg in the treatment of generalized seizures:
The recommended initial dose is 1 mg once daily before bedtime.
- Your doctor may increase this dose in 1 mg increments up to a maintenance dose between 2 mg and 4 mg, depending on your response. Based on individual clinical response and tolerability, the dose may be increased up to a maximum of 6 mg/day.
- If you have mild or moderate liver (hepatic) problems, your dose should not exceed 4 mg daily, and dose increases should be made at intervals of at least 2 weeks.
- Do not take more Fycompa than prescribed by your doctor. It may take several weeks to find the appropriate Fycompa dose for you.
How to take
Swallow the tablet whole with a glass of water. Fycompa can be taken with or without food. Do not chew, crush, or split the tablet. The tablets cannot be split accurately as they do not have a breakline.
If you take more Fycompa than you should
If you have taken more Fycompa than prescribed, contact your doctor immediately. You may experience dizziness, agitation, aggressive behavior, and decreased level of consciousness.
If you forget to take Fycompa
- If you forget to take a dose, wait until it is time for your next dose and then continue as usual.
- Do not take a double dose to make up for missed doses.
- If you have missed less than 7 days of Fycompa treatment, continue taking the daily tablet as originally prescribed by your doctor.
- If you have missed more than 7 days of Fycompa treatment, contact your doctor immediately.
If you stop taking Fycompa
Take Fycompa for the duration recommended by your doctor. Do not discontinue treatment unless advised by your doctor. Your doctor may gradually reduce your dose to prevent seizures (convulsive seizures) from returning or worsening.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
A small number of people taking antiepileptic medicines have had thoughts of harming themselves or of suicide. If you experience such thoughts at any time, consult your doctor immediately.
Very common (may affect more than 1 in 10 users):
- dizziness
- feeling sleepy (drowsiness or somnolence)
Common (may affect up to 1 in 10 users):
- increased or decreased appetite, weight gain
- feelings of aggression, anger, irritability, anxiety, or confusion
- difficulty walking or other balance problems (ataxia, gait disorder, balance disorder)
- slurred speech (dysarthria)
- blurred vision or double vision (diplopia)
- sensation of spinning (vertigo)
- feeling sick (nausea)
- back pain
- feeling very tired (fatigue)
- falls
Uncommon (may affect up to 1 in 100 users):
- thoughts of self-harm or of ending your life (suicidal thoughts), attempting to end your life (suicide attempt)
- hallucinations (seeing, hearing, or feeling things that do not exist)
- abnormal thoughts or loss of contact with reality (psychotic disorder)
Frequency not known (frequency of this adverse effect cannot be estimated from available data):
- Drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome: widespread rash, elevated body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other body organs.
- Stevens-Johnson syndrome (SJS). This serious skin rash may appear as red target-like spots or circular patches, often with blisters in the center, typically on the trunk; skin peeling, mouth, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms.
Stop taking perampanel if any of these symptoms occur and consult your doctor or seek immediate medical attention. See also section 2.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fycompa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer needed. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fycompa
The active substance is perampanel. Each film-coated tablet contains 2 mg, 4 mg, 6 mg, 8 mg, 10 mg or 12 mg of perampanel.
The other components are:
Tablet core (2 mg and 4 mg tablets):
Monohydrate lactose, low-substituted hydroxypropylcellulose, povidone, magnesium stearate (E470b)
Tablet core (6 mg, 8 mg, 10 mg and 12 mg tablets):
Monohydrate lactose, low-substituted hydroxypropylcellulose, povidone, microcrystalline cellulose, magnesium stearate (E470b)
Film coating (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets):
Hypromellose 2910, talc, Macrogol 8000, titanium dioxide (E171), colouring agents*
- The colouring agents are:
2 mg tablet: Iron oxide, Yellow (E172), Iron oxide, Red (E172)
4 mg tablet: Iron oxide, Red (E172)
6 mg tablet: Iron oxide, Red (E172)
8 mg tablet: Iron oxide, Red (E172), Iron oxide, Black (E172)
10 mg tablet: Iron oxide, Yellow (E172), FD&C Blue No. 2 Aluminium Indigo Carmine Lake (E132)
12 mg tablet: FD&C Blue No. 2 Aluminium Indigo Carmine Lake (E132)
Nature and content of the container
All strengths of Fycompa are film-coated, round, biconvex tablets.
2 mg: orange-coloured, with the marking E275 on one side and 2 on the other side
4 mg: red-coloured, with the marking E277 on one side and 4 on the other side
6 mg: pink-coloured, with the marking E294 on one side and 6 on the other side
8 mg: purple-coloured, with the marking E295 on one side and 8 on the other side
10 mg: green-coloured, with the marking E296 on one side and 10 on the other side
12 mg: blue-coloured, with the marking E297 on one side and 12 on the other side
Fycompa is available in the following pack sizes:
2 mg tablet – pack of 7, 28 and 98
4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets – packs of 7, 28, 84 and 98
Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
e-mail: [email protected]
Manufacturer
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Belgium/Belgium/Belgium Eisai SA/NV Tel/Tel: +32 (0)800 158 58 | Lithuania Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Germany) |
Greece Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Germany) | Luxembourg/Luxembourg Eisai SA/NV Tel/Tel: +32 (0)800 158 58 (Belgium/Belgium) |
Czech Republic Eisai GesmbH organisational unit Tel: + 420 242 485 839 | Hungary Eisai GmbH Tel.: + 49 (0) 69 66 58 50 (Germany) |
Denmark Eisai AB Tlf: + 46 (0) 8 501 01 600 (Sweden) | Malta Cherubino LTD Tel: +356 21343270 |
Germany Eisai GmbH Tel: + 49 (0) 69 66 58 50 | Netherlands Eisai B.V. Tel: + 31 (0) 900 575 3340 |
Estonia Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Germany) | Norway Eisai AB Tlf: + 46 (0) 8 501 01 600 (Sweden) |
Greece Arriani Pharmaceutical S.A. Tel: + 30 210 668 3000 | Austria Eisai GesmbH Tel: + 43 (0) 1 535 1980-0 |
Spain Eisai Farmacéutica, S.A. Tel: + (34) 91 455 94 55 | Poland Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Germany) |
France Eisai SAS Tél: + (33) 1 47 67 00 05 | Portugal Eisai Farmacêutica, Unipessoal Lda Tel: + 351 214 875 540 |
Croatia Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Germany) | Romania Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Germany) |
Ireland Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Germany) | Slovenia Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Germany) |
Iceland Eisai AB Tel: + 46 (0)8 501 01 600 (Sweden) | Slovakia Eisai GesmbH organisational unit Tel.: + 420 242 485 839 (Czech Republic) |
Italy Eisai S.r.l. Tel: + 39 02 5181401 | Finland Eisai AB Tel/Tel: + 46 (0) 8 501 01 600 (Sweden) |
Cyprus Arriani Pharmaceuticals S.A. Tel: + 30 210 668 3000 (Greece) | Sweden Eisai AB Tel: + 46 (0) 8 501 01 600 |
Latvia Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Germany) | United Kingdom (Northern Ireland) Eisai GmbH Tel: + 49 (0) 69 66 58 50 (Germany) |
Date of the most recent review of this leaflet:
Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.