Fypalan

Package leaflet: Information for the patient

Fypalan 2 mg film-coated tablets, 4 mg film-coated tablets, 6 mg film-coated tablets, 8 mg film-coated tablets, 10 mg film-coated tablets, 12 mg film-coated tablets

perampanel
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Fypalan is and what it is used for
2. What you need to know before taking Fypalan
3. How to take Fypalan
4. Possible side effects
5. How to store Fypalan
6. Contents of the pack and other information

1. What Fypalan is and what it is used for

Fypalan contains an active substance called perampanel. It belongs to a group of medicines known as antiepileptic drugs. These medicines are used to treat epilepsy, a condition in which a person has repeated seizures (epileptic seizures). Your doctor has prescribed it for you to reduce the number of epileptic seizures.
Fypalan is used in combination with other antiepileptic medicines for the treatment of certain types of epilepsy: in adults, adolescents (aged 12 years and older), and children (aged between 4 and 11 years).

• It is used to treat epileptic seizures affecting one part of the brain (called "partial seizures").
• These partial seizures may or may not be followed by a seizure involving the entire brain (called "secondary generalization"). In adults, adolescents (aged 12 years and older), and children (aged between 7 and 11 years).
• It is also used to treat certain epileptic seizures that involve the entire brain from the start (called "generalized seizures") and that cause convulsions or absence seizures.

2. What you need to know before taking Fypalan

Do not take Fypalan

• If you have ever developed a severe skin rash, skin peeling, blistering, and/or mouth ulcers 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 Fypalan if you have liver problems or moderate to severe kidney problems.
You must not take Fypalan if you have severe liver problems or moderate to severe kidney problems.
Before taking this medicine, inform your doctor if you have previously had problems with alcoholism or drug dependence.
Increases in liver enzymes have been reported in some patients taking perampanel in combination with other antiepileptic drugs.

• Fypalan may cause dizziness or drowsiness, especially at the beginning of treatment.
• Fypalan may increase the risk of falls, particularly in elderly people; this may be due to the underlying disease.
• Fypalan may cause aggression, anger, or violence. It may also cause unusual or extreme changes in behaviour or mood, abnormal thinking, and/or loss of contact with reality. If you or a family member or friend notice any of these reactions, consult your doctor or pharmacist.

A small number of people treated with antiepileptic medicines have had thoughts of harming themselves or of suicide.
If you have these thoughts at any time, contact your doctor immediately.
Serious skin reactions have been reported with the use of perampanel, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson Syndrome (SJS).

• DRESS usually presents, although not exclusively, with flu-like symptoms and a skin rash accompanied by high body temperature, increased levels of liver enzymes in blood tests, an increase in a type of white blood cell (eosinophilia), and swollen lymph nodes.
• Stevens-Johnson Syndrome (SJS) may initially appear as red, "target-like" spots or circular patches, often with central blisters, located on the trunk. In addition, ulcers may develop in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These serious skin reactions are often preceded by fever and/or flu-like symptoms. Skin rashes may progress to widespread skin peeling and potentially life-threatening complications, or may be fatal.

If any of the above conditions occur after taking Fypalan (or if you are unsure), consult your doctor or pharmacist.
Children
Fypalan is not recommended 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 and under 7 years of age for generalized seizures.
Other medicines and Fypalan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal medicines.
Taking Fypalan with certain other medicines may cause side effects or affect their action. Do not start or stop treatment with other medicines without consulting your doctor or pharmacist.

• Other antiepileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin, used to treat epileptic seizures, may affect Fypalan. Inform your doctor if you are taking or have recently taken these medicines, as your dose may need to be adjusted.
• Felbamate (a medicine used to treat epilepsy) may also affect Fypalan. 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 prolonged acute (sudden) seizures, for sedation, and for sleep problems) may be affected by Fypalan. Inform your doctor if you are taking midazolam, as your dose may need to be adjusted.
• Other medicines, such as rifampicin (a medicine used to treat bacterial infections), St. John’s wort (a herbal remedy used for mild anxiety), and ketoconazole (a medicine used to treat fungal infections), may affect Fypalan. Inform your doctor if you are taking or have recently taken these medicines, as your dose may need to be adjusted.
• Hormonal contraceptives (including oral contraceptives, implants, injections, and patches). Inform your doctor if you are using hormonal contraceptives. Fypalan may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. During treatment with Fypalan, you must use other effective and reliable contraceptive methods (such as condoms or an intrauterine device) and continue using them for one month after stopping treatment. Discuss with your doctor which contraceptive method is suitable for you.

Fypalan and alcohol
Consult your doctor before drinking alcohol. Be cautious about alcohol consumption when taking antiepileptic medicines, including Fypalan.

• Drinking alcohol during treatment with Fypalan may reduce alertness and affect your ability to drive or operate tools or machinery.
• Drinking alcohol during treatment with Fypalan may also worsen possible feelings of anger, confusion, or sadness.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. Do not stop treatment without first discussing it with your doctor.

• Fypalan is not recommended during pregnancy.
• You must use a reliable method of contraception to avoid becoming pregnant during treatment with Fypalan. You must continue using it for one month after stopping treatment. Inform your doctor if you are taking hormonal contraceptives. Fypalan may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. During treatment with Fypalan, you must use other effective and reliable contraceptive methods (such as condoms or an intrauterine device). You must continue using them for one month after stopping treatment. Discuss with your doctor which contraceptive method is suitable for you. It is not known whether the components of Fypalan pass into breast milk. Your doctor will assess the benefits and risks to the baby if treatment with Fypalan is needed during breastfeeding.

Driving and using machines
Do not drive or operate machinery until you are certain how Fypalan affects you. Talk to your doctor about the effect of epilepsy on driving and using machinery.

• Fypalan may cause dizziness or drowsiness, especially at the beginning of treatment. If this occurs, do not drive or operate tools or machinery.
• Drinking alcohol during treatment with Fypalan may worsen these effects.

Fypalan contains lactose
Fypalan contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Fypalan

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
Adults and adolescents (aged 12 years and older) for the treatment of partial seizures and generalized
seizures:
The usual starting dose is 2 mg once daily before bedtime.

• Your doctor may increase this dose in increments of 2 mg, up to a maintenance dose ranging from 4 mg to 12 mg, depending on your response to treatment.
• If you have mild or moderate liver problems, the dose must not exceed 8 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fypalan higher than that recommended by your doctor. It may take several weeks to find the right dose of Fypalan for you.

The table below summarizes the recommended doses for the treatment of partial seizures in children aged
4 to 11 years and generalized seizures in children aged 7 to 11 years. Further details are provided below the table.

Children (aged between 4 and 11 years) weighing at least 30 kg or more in the treatment of partial
seizures:
The usual initial dose is 2 mg once daily before bedtime.

• The doctor may increase this dose by increments of 2 mg, up to a maintenance dose between 4 mg and 8 mg, depending on response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 12 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fypalan higher than that recommended by the doctor. It may take several weeks to find the correct Fypalan dose for the child.

Children (aged between 4 and 11 years) weighing between 20 kg and less than 30 kg in the treatment of
partial seizures:
The usual initial dose is 1 mg once daily before bedtime.

• The doctor may increase this dose by increments of 1 mg, up to a maintenance dose between 4 mg and 6 mg, depending on response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 8 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fypalan higher than that recommended by the doctor. It may take several weeks to find the correct Fypalan dose for the child.

Children (aged between 4 and 11 years) weighing less than 20 kg in the treatment of partial seizures:
The usual initial dose is 1 mg once daily before bedtime.

• The doctor may increase this dose by increments of 1 mg, up to a maintenance dose between 2 mg and 4 mg, depending on response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 6 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fypalan higher than that recommended by the doctor. It may take several weeks to find the correct Fypalan dose for the child.

Children (aged between 7 and 11 years) weighing at least 30 kg in the treatment of generalized seizures:
The usual initial dose is 2 mg once daily before bedtime.

• The doctor may increase this dose by increments of 2 mg, up to a maintenance dose between 4 mg and 8 mg, depending on response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 12 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fypalan higher than that recommended by the doctor. It may take several weeks to find the correct Fypalan dose for the child.

Children (aged between 7 and 11 years) weighing between 20 kg and less than 30 kg in the treatment of
generalized seizures:
The usual initial dose is 1 mg once daily before bedtime.

• The doctor may increase this dose by increments of 1 mg, up to a maintenance dose between 4 mg and 6 mg, depending on response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 8 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fypalan higher than that recommended by the doctor. It may take several weeks to find the correct Fypalan dose for the child.

Children (aged between 7 and 11 years) weighing less than 20 kg in the treatment of generalized seizures:
The usual initial dose is 1 mg once daily before bedtime.

• The doctor may increase this dose by increments of 1 mg, up to a maintenance dose between 2 mg and 4 mg, depending on response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 6 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fypalan higher than that recommended by the doctor. It may take several weeks to find the correct Fypalan dose for the child.

How to take Fypalan
Fypalan is for oral use. Swallow the tablet whole with a glass of water. You may take Fypalan with or without food. Do not chew, crush, or divide the tablet.
If you take more Fypalan than you should
If you have taken more Fypalan than you should, contact your doctor immediately. Symptoms may include confusion, agitation, aggressive behaviour, and reduced level of consciousness.
If you forget to take Fypalan

• If you forget to take a tablet, wait until the next scheduled dose and then continue as usual.
• Do not take a double dose to make up for the forgotten dose.
• If you have missed less than 7 days of Fypalan treatment, continue taking the daily tablet according to your doctor's original instructions.
• If you have missed more than 7 days of Fypalan treatment, inform your doctor immediately.

If you stop taking Fypalan
Take Fypalan for the entire period recommended by your doctor. Do not stop treatment unless instructed by your doctor. Your doctor may gradually reduce the dose to prevent seizures (epileptic seizures) from recurring or worsening. If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause unwanted side effects, although not everyone experiences them.
A small number of people treated with antiepileptic medicines have had thoughts about harming themselves or taking their own life.
If you experience such thoughts at any time, contact your doctor immediately.

Very common (may affect more than 1 in 10 patients):

• dizziness
• feeling sleepy (lethargy or drowsiness)

Common (may affect more than 1 in 100 patients):

• reduced or increased appetite, weight gain
• aggression, anger, irritability, anxiety, or confusion
• difficulty walking or other balance problems [ataxia (loss of coordination), gait disturbance, balance disorder]
• slowness of speech (dysarthria)
• blurred vision or double vision (diplopia)
• sensation of dizziness (vertigo)
• feeling unwell (nausea)
• back pain
• feeling very tired (fatigue)
• falling

Uncommon (may affect more than 1 in 1,000 patients):

• thoughts of self-harm or of taking your own life (suicidal thoughts), attempt to take your own life (suicide attempt)
• hallucinations (seeing, hearing, or sensing things that are not there)
• abnormal thinking and/or loss of contact with reality (psychotic disorder)

Not known (frequency of this adverse effect cannot be determined from available data):

• Drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome: widespread rash, elevated body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs in the body.
• Stevens-Johnson syndrome (SJS). This serious skin rash may appear as red, target-like spots or circular patches, often with central blisters, typically on the trunk, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes; it may be preceded by fever and flu-like symptoms.

Stop taking perampanel if you develop any of these symptoms and contact your doctor or seek immediate medical attention. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via:
Website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fypalan

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 refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fypalan contains
The active substance is perampanel.
Fypalan 2 mg film-coated tablets
Each film-coated tablet contains 2 mg of perampanel.
Fypalan 4 mg film-coated tablets
Each film-coated tablet contains 4 mg of perampanel.
Fypalan 6 mg film-coated tablets
Each film-coated tablet contains 6 mg of perampanel.
Fypalan 8 mg film-coated tablets
Each film-coated tablet contains 8 mg of perampanel.
Fypalan 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of perampanel.
Fypalan 12 mg film-coated tablets
Each film-coated tablet contains 12 mg of perampanel.

The other components are:
Tablet core
Monohydrate lactose, low-substituted hydroxypropylcellulose, povidone K30, microcrystalline cellulose, silicified
magnesium stearate

Film coating
Tablets of 2 mg, 6 mg, 8 mg, 10 mg and 12 mg
Partially hydrolysed polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E171)

Tablets of 4 mg
Partially hydrolysed polyvinyl alcohol, talc, macrogol 3350

*Additionally:
2 mg tablet: Yellow iron oxide (E172), Red iron oxide (E172)
4 mg tablet: Red iron oxide (E172)
6 mg tablet: Yellow iron oxide (E172), Red iron oxide (E172)
8 mg tablet: Black iron oxide (E172), Red iron oxide (E172)
10 mg tablet: Yellow iron oxide (E172), Black iron oxide (E172)
12 mg tablet: Black iron oxide (E172), Red iron oxide (E172)

Description of the appearance of Fypalan and contents of the pack
Film-coated tablet
2 mg: yellow, round, biconvex film-coated tablets
4 mg: red, round, biconvex film-coated tablets
6 mg: orange, round, biconvex film-coated tablets
8 mg: pale pink, round, biconvex film-coated tablets
10 mg: green, round, biconvex film-coated tablets
12 mg: grey to violet, round, biconvex film-coated tablets

Fypalan is available in packs of 7, 10, 28, 30, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
Manufacturer
G.L. Pharma GmbH, Industriestrasse 1, 8502 Lannach, Austria

Sole distributor:
G.L. Pharma Italy S.r.l., [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Fypalan 2 mg Filmtabletten
Fypalan 4 mg Filmtabletten
Fypalan 6 mg Filmtabletten
Fypalan 8 mg Filmtabletten
Fypalan 10 mg Filmtabletten
Fypalan 12 mg Filmtabletten

Austria Fypalan 2 mg Filmtabletten
Fypalan 4 mg Filmtabletten
Fypalan 6 mg Filmtabletten
Fypalan 8 mg Filmtabletten
Fypalan 10 mg Filmtabletten
Fypalan 12 mg Filmtabletten

Czech Republic Fypalan

Italy Fypalan

Poland Fypalan

Slovakia Fypalan 2 mg filmom obalené tablety
Fypalan 4 mg filmom obalené tablety
Fypalan 6 mg filmom obalené tablety
Fypalan 8 mg filmom obalené tablety