Fipalan

Leaflet included in the packaging: patient information

Fypalan, 2 mg, coated tablets

Fypalan, 4 mg, coated tablets

Fypalan, 6 mg, coated tablets

Fypalan, 8 mg, coated tablets

Fypalan, 10 mg, coated tablets

Fypalan, 12 mg, coated tablets

Perampanel
You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed to you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Fypalan and what is it used for

Fypalan contains the active substance perampanel. It belongs to a group of medicines called antiepileptic drugs. These medicines are used to treat epilepsy, in which the patient has recurring seizures (epileptic seizures). It has been prescribed to you by your doctor to reduce the number of seizures.

Fypalan is used in combination with other antiepileptic medicines to treat certain types of epilepsy:

• In adults, adolescents (from 12 years of age), and children (from 4 to 11 years of age)
• Fypalan is used to treat seizures that affect only a part of the brain (called partial seizures).
• After such partial seizures, the patient may or may not experience seizures that affect the entire brain (called secondary generalized seizures).
• In adults and adolescents (from 12 years of age), and children (from 7 to 11 years of age)
• The medicine is also used to treat seizures that affect the entire brain from the start (called primary generalized seizures), which can cause convulsions or loss of consciousness.

2. Important information before taking Fypalan

When not to take Fypalan:

Warnings and precautions

If you have liver or kidney problems, you should discuss this with your doctor or pharmacist before taking Fypalan.

You should not take Fypalan if you have severe liver or kidney problems.

Before taking the medicine, you should inform your doctor about any history of alcoholism or drug addiction.

In some patients taking Fypalan with other antiepileptic medicines, increased liver enzymes have been reported.

• Fypalan may cause dizziness or drowsiness in you, especially at the beginning of treatment.
• Fypalan may increase the risk of falls, especially in elderly patients; this may be due to the patient's condition.
• Fypalan may cause aggression, anger, or violence. It may also cause unusual or extreme changes in behavior and mood, thinking disorders, and (or) loss of contact with reality. If you, your family, or friends notice any of these effects, you should contact your doctor or pharmacist.

In a small number of patients treated with antiepileptic medicines, thoughts of self-harm or suicidal thoughts have occurred. If you experience such thoughts at any time, you should contact your doctor immediately.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson syndrome, have been reported with perampanel.

• DRESS typically presents with flu-like symptoms and a rash with a high temperature, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.
• Stevens-Johnson syndrome (SJS) may initially appear as a red target-like rash or circular patches (often with blisters in the center) on the torso. Additionally, there may be ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes can be preceded by fever and flu-like symptoms. The rashes can progress to peeling of the skin over a large surface area and life-threatening complications, even leading to death.

If you experience any of these symptoms after taking Fypalan (or if you are unsure), you should contact your doctor or pharmacist.

Children

Fypalan is not recommended for use in children under 4 years of age. The safety and efficacy of the medicine in children under 4 years of age with partial seizures or under 7 years of age with primary generalized seizures are not yet known.

Fypalan and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines available without a prescription and herbal medicines. Taking Fypalan with certain other medicines may cause side effects or affect their efficacy. You should not start or stop taking other medicines without consulting your doctor or pharmacist.

• Other antiepileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin, used to treat seizures, may affect the efficacy of Fypalan. You should tell your doctor if you are taking or have recently taken these medicines, as dose adjustment may be necessary.
• Felbamate (a medicine used to treat epilepsy) may also affect the efficacy of Fypalan. You should tell your doctor if you are taking or have recently taken this medicine, as dose adjustment may be necessary. Fypalan may affect the efficacy of midazolam (a medicine used to treat prolonged, acute seizures, as a sedative, and for sleep disorders). You should tell your doctor if you are taking midazolam, as dose adjustment may be necessary.
• Certain other medicines, such as rifampicin (a medicine used to treat bacterial infections), St. John's Wort (a medicine used to treat mild anxiety), and ketoconazole (a medicine used to treat fungal infections), may affect the efficacy of Fypalan. You should tell your doctor if you are taking or have recently taken these medicines, as dose adjustment may be necessary.
• Hormonal contraceptives (including oral contraceptives, implants, injections, and patches). You should tell your doctor about any hormonal contraceptives you are taking. Fypalan may reduce the efficacy of certain hormonal contraceptives, such as levonorgestrel. During treatment with Fypalan, you should use other methods of safe and effective contraception (such as condoms or an intrauterine device). You should continue using other methods for a month after stopping treatment. You should discuss with your doctor which method of contraception is best for you.

Taking Fypalan with alcohol

You should consult your doctor before consuming alcohol. You should be cautious when consuming alcohol with antiepileptic medicines, including Fypalan.

• Consuming alcohol while taking Fypalan may cause decreased alertness in you and negatively affect your ability to drive, use tools, or operate machinery.
• Consuming alcohol while taking Fypalan may exacerbate feelings of anger, confusion, or sadness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine. You should not stop treatment without first discussing it with your doctor.

• Fypalan is not recommended during pregnancy.
• During treatment with Fypalan, you should use effective contraception to avoid becoming pregnant. You should continue using contraception for a month after stopping treatment. You should tell your doctor if you are using hormonal contraception. Fypalan may reduce the efficacy of certain hormonal contraceptives, such as levonorgestrel. During treatment with Fypalan, you should use other methods of safe and effective contraception (such as condoms or an intrauterine device). You should continue using other methods for a month after stopping treatment. You should discuss with your doctor which method of contraception is best for you. It is not known whether the ingredients of Fypalan pass into breast milk. Your doctor will weigh the benefits and risks of taking Fypalan during breastfeeding.

Driving and operating machinery

You should not drive or operate machinery until you know how Fypalan affects you.

You should discuss with your doctor how epilepsy affects your ability to drive or operate machinery.

• Fypalan may cause dizziness or drowsiness in you, especially at the beginning of treatment. If you experience these symptoms, you should not drive, use tools, or operate machinery.
• Consuming alcohol while taking Fypalan may exacerbate these symptoms.

Fypalan contains lactose

Fypalan contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Fypalan

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

What dose to take

Treatment of partial and primary generalized seizures in adults and adolescents (12 years of age and older):

The usual starting dose of Fypalan is 2 mg once daily before bedtime.

• Your doctor may gradually increase the dose by 2 mg, up to a maintenance dose between 4 mg and 12 mg, depending on your response to treatment.
• If you have mild or moderate liver problems, the dose should not exceed 8 mg per day and should not be increased more frequently than every 2 weeks.
• You should not take a higher dose of Fypalan than recommended by your doctor. It may take several weeks to determine the correct dose of Fypalan for you.

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

Treatment of partial seizures in children (aged 4 to 11 years) with a body weight of 30 kg or more:

The usual starting dose of Fypalan is 2 mg once daily before bedtime.

• Your doctor may gradually increase the dose by 2 mg, up to a maintenance dose between 4 mg and 8 mg, depending on your response to treatment. Depending on your individual clinical response and tolerance, the dose may be gradually increased to a maximum dose of 12 mg/day.
• If you have mild or moderate liver problems, the dose should not exceed 4 mg per day and should not be increased more frequently than every 2 weeks.
• You should not take a higher dose of Fypalan than recommended by your doctor. It may take several weeks to determine the correct dose of Fypalan for you.

Treatment of partial seizures in children (aged 4 to 11 years) with a body weight from 20 kg to less than 30 kg:

The usual starting dose of Fypalan is 1 mg once daily before bedtime.

• Your doctor may gradually increase the dose by 1 mg, up to a maintenance dose between 4 mg and 6 mg, depending on your response to treatment. Depending on your individual clinical response and tolerance, the dose may be gradually increased to a maximum dose of 8 mg/day.
• If you have mild or moderate liver problems, the dose should not exceed 4 mg per day and should not be increased more frequently than every 2 weeks.
• You should not take a higher dose of Fypalan than recommended by your doctor. It may take several weeks to determine the correct dose of Fypalan for you.

Treatment of partial seizures in children (aged 4 to 11 years) with a body weight less than 20 kg:

The usual starting dose of Fypalan is 1 mg once daily before bedtime.

• Your doctor may gradually increase the dose by 1 mg, up to a maintenance dose between 2 mg and 4 mg, depending on your response to treatment. Depending on your individual clinical response and tolerance, the dose may be gradually increased to a maximum dose of 6 mg/day.
• If you have mild or moderate liver problems, the dose should not exceed 4 mg per day and should not be increased more frequently than every 2 weeks.
• You should not take a higher dose of Fypalan than recommended by your doctor. It may take several weeks to determine the correct dose of Fypalan for you.

Treatment of primary generalized seizures in children (aged 7 to 11 years) with a body weight of 30 kg or more:

The usual starting dose of Fypalan is 2 mg once daily before bedtime.

• Your doctor may gradually increase the dose by 2 mg, up to a maintenance dose between 4 mg and 8 mg, depending on your response to treatment. Depending on your individual clinical response and tolerance, the dose may be gradually increased to a maximum dose of 12 mg/day.
• If you have mild or moderate liver problems, the dose should not exceed 4 mg per day and should not be increased more frequently than every 2 weeks.
• You should not take a higher dose of Fypalan than recommended by your doctor. It may take several weeks to determine the correct dose of Fypalan for you.

Treatment of primary generalized seizures in children (aged 7 to 11 years) with a body weight from 20 kg to less than 30 kg:

The usual starting dose of Fypalan is 1 mg once daily before bedtime.

• Your doctor may gradually increase the dose by 1 mg, up to a maintenance dose between 4 mg and 6 mg, depending on your response to treatment. Depending on your individual clinical response and tolerance, the dose may be gradually increased to a maximum dose of 8 mg/day.
• If you have mild or moderate liver problems, the dose should not exceed 4 mg per day and should not be increased more frequently than every 2 weeks.
• You should not take a higher dose of Fypalan than recommended by your doctor. It may take several weeks to determine the correct dose of Fypalan for you.

Treatment of primary generalized seizures in children (aged 7 to 11 years) with a body weight less than 20 kg:

The usual starting dose of Fypalan is 1 mg once daily before bedtime.

• Your doctor may gradually increase the dose by 1 mg, up to a maintenance dose between 2 mg and 4 mg, depending on your response to treatment. Depending on your individual clinical response and tolerance, the dose may be gradually increased to a maximum dose of 6 mg/day.
• If you have mild or moderate liver problems, the dose should not exceed 4 mg per day and should not be increased more frequently than every 2 weeks.
• You should not take a higher dose of Fypalan than recommended by your doctor. It may take several weeks to determine the correct dose of Fypalan for you.

How to take it

The tablet should be swallowed whole, with a glass of water. Fypalan can be taken with or without food. The tablets should not be chewed, crushed, or divided.

Taking a higher dose of Fypalan than recommended

If you take a higher dose of Fypalan than recommended, you should contact your doctor immediately. You may experience confusion, anxiety, aggressive behavior, and decreased level of consciousness.

Missing a dose of Fypalan

• If you miss a dose, you should wait until the next scheduled dose and continue treatment as directed.
• You should not take a double dose to make up for the missed dose.
• If you stop taking Fypalan for less than 7 days, you should continue taking the tablet daily as directed by your doctor.
• If you stop taking Fypalan for more than 7 days, you should contact your doctor immediately.

Stopping treatment with Fypalan

You should take Fypalan for as long as your doctor recommends. You should not stop treatment without first discussing it with your doctor. Your doctor may gradually decrease the dose you are taking to prevent seizures from returning or worsening.

If you have any further questions about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fypalan can cause side effects, although not everybody gets them.

In a small number of patients treated with antiepileptic medicines, thoughts of self-harm or suicidal thoughts have occurred. If you experience such thoughts at any time, you should contact your doctor immediately.

Very common(occurring in more than 1 in 10 patients) side effects:

• dizziness
• drowsiness (drowsiness or lethargy)

Common(occurring in more than 1 in 100 patients) side effects:

• increased or decreased appetite, weight gain
• aggression, anger, irritability, anxiety, or disorientation
• walking problems or other balance problems (ataxia, gait disturbances, balance disorders)
• slow speech (dysarthria)
• blurred vision or double vision (diplopia)
• peripheral dizziness
• nausea
• back pain
• feeling very tired
• falls

Uncommon(occurring in more than 1 in 1,000 patients) side effects:

• thoughts of self-harm or suicide, attempted suicide
• hallucinations (seeing, hearing, or feeling things that are not there)
• abnormal thinking and (or) loss of contact with reality (psychotic disorders)

Frequency not known(the frequency of side effects cannot be determined from the available data):

• Drug reaction with eosinophilia and systemic symptoms (DRESS), or hypersensitivity syndrome: widespread rash, high temperature, elevated liver enzymes, blood disorders (eosinophilia), and enlarged lymph nodes, as well as involvement of other organs.
• Stevens-Johnson syndrome (SJS). This severe skin rash may appear as a red target-like rash or circular patches (often with blisters in the center) on the torso, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms.

If you experience any of these symptoms, you should stop taking perampanel and contact your doctor or seek medical attention immediately. See also section 2.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C,
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fypalan

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month.

There are no special precautions for storage of the medicinal product.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fypalan contains

The active substance of Fypalan is perampanel.

Fypalan 2 mg coated tablets
Each coated tablet contains 2 mg of perampanel.

Fypalan 4 mg coated tablets
Each coated tablet contains 4 mg of perampanel.

Fypalan 6 mg coated tablets
Each coated tablet contains 6 mg of perampanel.

Fypalan 8 mg coated tablets
Each coated tablet contains 8 mg of perampanel.

Fypalan 10 mg coated tablets
Each coated tablet contains 10 mg of perampanel.

Fypalan 12 mg coated tablets
Each coated tablet contains 12 mg of perampanel.

Other ingredients are:

Tablet core
Lactose monohydrate, hydroxypropylcellulose, low-substituted, Povidone K30, microcrystalline cellulose, siliconized, magnesium stearate

Coating

2 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets
Polyvinyl alcohol, partially hydrolyzed, talc, Macrogol 3350, titanium dioxide (E171)

4 mg tablets
Polyvinyl alcohol, partially hydrolyzed, talc, Macrogol 3350

In addition:

2 mg tablet: iron oxide, yellow (E172); iron oxide, red (E172)

4 mg tablet: iron oxide, red (E172)

6 mg tablet: iron oxide, yellow (E172); iron oxide, red (E172)

8 mg tablet: iron oxide, black (E172); iron oxide, red (E172)

10 mg tablet: iron oxide, yellow (E172); iron oxide, black (E172)

12 mg tablet: iron oxide, black (E172); iron oxide, red (E172)

What Fypalan looks like and contents of the pack

Coated tablet

2 mg: Yellow, round, biconvex coated tablets

4 mg: Red, round, biconvex coated tablets

6 mg: Orange, round, biconvex coated tablets

8 mg: Pink, round, biconvex coated tablets

10 mg: Green, round, biconvex coated tablets

12 mg: Gray to purple, round, biconvex coated tablets

Fypalan is available in packs of 7, 10, 28, 30, 98, and 100 coated tablets.

Not all pack sizes may be available.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

For more information about this medicine, you should contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet: