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
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 the patient by a 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 generalized seizures), which can cause convulsions or loss of consciousness.

2. Important information before taking Fypalan

When not to take Fypalan:

• if the patient has ever had a severe skin rash, skin peeling, blisters, and/or mouth sores after taking perampanel.
• if the patient is allergic to perampanel or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If the patient has liver or kidney problems, they should discuss this with their doctor or pharmacist before taking Fypalan.

Fypalan should not be taken if the patient has severe liver or kidney problems.

Before taking the medicine, the patient should inform their 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 the patient, especially at the start 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 the patient, their family, or friends notice any of these actions, they should contact their doctor or pharmacist.

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

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 swollen lymph nodes.
• Stevens-Johnson syndrome (SJS) may initially appear as a red target-like rash or round patches (often with blisters in the center) on the torso. Additionally, there may be mouth sores, throat, nose, genital, and eye ulcers (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 any of these symptoms occur in the patient after taking Fypalan (or if the patient is unsure), they should contact their 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 generalized seizures are not yet known.

Fypalan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 action. The patient should not start or stop taking other medicines without consulting their doctor or pharmacist.

• Other antiepileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin, used to treat seizures, may affect the action of Fypalan. The patient should tell their doctor if they 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 action of Fypalan. The patient should tell their doctor if they are taking or have recently taken this medicine, as dose adjustment may be necessary. Fypalan may affect the action of midazolam (a medicine used to treat prolonged, acute seizures, as a sedative, and for sleep problems). The patient should tell their doctor if they 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 action of Fypalan. The patient should tell their doctor if they are taking or have recently taken these medicines, as dose adjustment may be necessary.
• Hormonal contraceptives (including oral contraceptives, implants, injections, and patches). The patient should tell their doctor about any hormonal contraceptives they are taking. Fypalan may reduce the effectiveness of some hormonal contraceptives, such as levonorgestrel. During treatment with Fypalan, the patient should use other methods of safe and effective contraception (such as condoms or an intrauterine device). The use of other methods should be continued for a month after the end of treatment. The patient should discuss with their doctor which method of contraception is best for them.

Taking Fypalan with alcohol

The patient should talk to their doctor before consuming alcohol. The patient should be cautious when consuming alcohol with antiepileptic medicines, including Fypalan.

• Consuming alcohol while taking Fypalan may cause decreased alertness in the patient and negatively affect their 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. The patient should not stop treatment without first talking to their doctor.

• Fypalan is not recommended during pregnancy.
• During treatment with Fypalan, the patient should use effective contraception to avoid becoming pregnant. Contraception should be continued for a month after the end of treatment. The patient should tell their doctor if they are using hormonal contraception. Fypalan may reduce the effectiveness of some hormonal contraceptives, such as levonorgestrel. During treatment with Fypalan, the patient should use other methods of safe and effective contraception (such as condoms or an intrauterine device). The use of other methods should be continued for a month after the end of treatment. The patient should discuss with their doctor which method of contraception is best for them. It is not known whether the ingredients of Fypalan pass into breast milk. The doctor will weigh the benefits and risks of taking Fypalan during breastfeeding.

Driving and operating machinery

The patient should not drive or operate machinery until the effect of Fypalan on them is known.

The patient should talk to their doctor about the impact of epilepsy on their ability to drive and operate machinery.

• Fypalan may cause dizziness or drowsiness in the patient, especially at the start of treatment. If these symptoms occur, the patient 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 the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Fypalan

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

What dose to take

Treatment of partial and 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.

• The doctor may gradually increase the dose by 2 mg, up to a maintenance dose between 4 mg and 12 mg, depending on the patient's response to treatment.
• If the patient has 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.
• The patient should not take a higher dose of Fypalan than recommended by their doctor. Finding the right dose of Fypalan for the patient may take several weeks.

The following table shows 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 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.

• The doctor may gradually increase the dose by 2 mg, up to a maintenance dose between 4 mg and 8 mg, depending on the patient's response to treatment. Depending on the individual clinical response and tolerance, the dose may be gradually increased to a maximum dose of 12 mg/day.
• If the patient has 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.
• The patient should not take a higher dose of Fypalan than recommended by their doctor. Finding the right dose of Fypalan for the patient may take several weeks.

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

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

• The doctor may gradually increase the dose by 1 mg, up to a maintenance dose between 4 mg and 6 mg, depending on the patient's response to treatment. Depending on the individual clinical response and tolerance, the dose may be gradually increased to a maximum dose of 8 mg/day.
• If the patient has 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.
• The patient should not take a higher dose of Fypalan than recommended by their doctor. Finding the right dose of Fypalan for the patient may take several weeks.

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

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

• The doctor may gradually increase the dose by 1 mg, up to a maintenance dose between 2 mg and 4 mg, depending on the patient's response to treatment. Depending on the individual clinical response and tolerance, the dose may be gradually increased to a maximum dose of 6 mg/day.
• If the patient has 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.
• The patient should not take a higher dose of Fypalan than recommended by their doctor. Finding the right dose of Fypalan for the patient may take several weeks.

Treatment of 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.

• The doctor may gradually increase the dose by 2 mg, up to a maintenance dose between 4 mg and 8 mg, depending on the patient's response to treatment. Depending on the individual clinical response and tolerance, the dose may be gradually increased to a maximum dose of 12 mg/day.
• If the patient has 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.
• The patient should not take a higher dose of Fypalan than recommended by their doctor. Finding the right dose of Fypalan for the patient may take several weeks.

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

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

• The doctor may gradually increase the dose by 1 mg, up to a maintenance dose between 4 mg and 6 mg, depending on the patient's response to treatment. Depending on the individual clinical response and tolerance, the dose may be gradually increased to a maximum dose of 8 mg/day.
• If the patient has 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.
• The patient should not take a higher dose of Fypalan than recommended by their doctor. Finding the right dose of Fypalan for the patient may take several weeks.

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

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

• The doctor may gradually increase the dose by 1 mg, up to a maintenance dose between 2 mg and 4 mg, depending on the patient's response to treatment. Depending on the individual clinical response and tolerance, the dose may be gradually increased to a maximum dose of 6 mg/day.
• If the patient has 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.
• The patient should not take a higher dose of Fypalan than recommended by their doctor. Finding the right dose of Fypalan for the patient may take several weeks.

How to take

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 the patient has taken a higher dose of Fypalan than recommended, they should contact their doctor immediately. The patient may experience confusion, anxiety, aggressive behavior, and decreased level of consciousness.

Missing a dose of Fypalan

• If a tablet is missed, the patient should wait until the next scheduled dose and continue treatment as directed.
• The patient should not take a double dose to make up for the missed dose.
• If treatment with Fypalan is interrupted for less than 7 days, the patient should continue taking the tablet daily as directed by their doctor.
• If treatment with Fypalan is interrupted for more than 7 days, the patient should contact their doctor immediately.

Stopping treatment with Fypalan

Fypalan should be taken for as long as the doctor recommends. The patient should not stop treatment without first talking to their doctor. The doctor may gradually reduce the dose taken by the patient to prevent seizures from returning or worsening.

If the patient has any further questions about the use of this medicine, they should contact their 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 such thoughts occur at any time, the patient should immediately contact their doctor.

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
• feeling aggressive, angry, irritable, anxious, or disoriented
• problems with walking 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 estimated 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), swollen lymph nodes, and involvement of other organs.
• Stevens-Johnson syndrome (SJS). This severe skin rash may appear as a red target-like rash or round patches (often with blisters in the center) on the torso, peeling of the skin, mouth sores, throat, nose, genital, and eye ulcers (red and swollen eyes), and may be preceded by fever and flu-like symptoms.

If any of these symptoms occur, the patient should stop taking perampanel and contact their doctor or seek medical help. See also section 2.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported 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.

Reporting side effects will help to gather 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 stated.

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

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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, silicon dioxide, 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 marketed.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

For more information about this medicine, please 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: