Fypalan

Package leaflet: Information for the patient

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
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Fypalan is and what it is 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 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 in the treatment of epilepsy, a condition in which patients have recurrent seizures (epileptic fits). Your doctor has prescribed this medicine to help reduce the number of seizures.

Fypalan is used in combination with other antiepileptic medicines for the treatment of certain types of epilepsy:

In adults, adolescents (from 12 years of age), and children (aged 4 to 11 years):

• It is used to treat seizures affecting part of the brain (called partial seizures).
• These partial seizures may or may not progress to seizures affecting the entire brain (called secondarily generalized seizures).

In adults and adolescents (from 12 years of age) and children (aged 7 to 11 years):

• It is also used to treat seizures affecting the entire brain from the onset (called generalized seizures), which may cause convulsions or loss of consciousness.

2. Important information before using Fypalan

When not to take Fypalan:

• if the patient has ever developed a severe skin rash, skin peeling, skin blisters, and/or mouth ulcers 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 function disorders or moderate to severe kidney function disorders, this should be discussed with a doctor or pharmacist before starting treatment with Fypalan.
Fypalan should not be taken if the patient has severe liver function disorders or moderate to severe kidney function disorders.
Before taking this medicine, inform your doctor about any history of alcohol-related illness or drug dependence.
In some patients taking Fypalan in combination with other antiepileptic medicines, increased levels of liver enzymes have been reported.

• Fypalan may cause dizziness or drowsiness in patients, especially at the beginning of treatment.
• Fypalan may increase the risk of falls, particularly in elderly patients; this may be due to the patient's underlying condition.
• Fypalan may cause aggression, anger, or hostility. It may also cause unusual or extreme changes in behaviour and mood, disturbances in thinking, and/or loss of contact with reality. If the patient, their family, and/or friends notice any of these symptoms, contact a doctor or pharmacist immediately.

Suicidal thoughts or self-harm ideation have occurred in a small number of patients treated with antiepileptic medicines. If such thoughts occur at any time during treatment, seek immediate medical advice.
Serious skin reactions have been reported with the use of perampanel, including drug reaction with eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson syndrome.

• DRESS typically, although not exclusively, presents with flu-like symptoms, skin rash, high fever, 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 red or target-shaped spots or circular lesions (often with blisters in the centre) on the trunk. Additionally, mouth, throat, nose, genital, and eye ulcers may occur (eyes may be red and swollen). These severe skin reactions are often preceded by fever and/or flu-like symptoms. Skin rashes may progress to extensive skin peeling over large areas of the body and may lead to life-threatening complications, including death.

If any of the above symptoms occur after taking Fypalan (or if the patient is unsure), medical advice should be sought immediately from a doctor or pharmacist.

Children
Fypalan is not recommended for use in children under 4 years of age. The safety and efficacy of Fypalan have not yet been established in children under 4 years of age with partial seizures, or in children under 7 years of age with generalized seizures.

Fypalan with other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use, including over-the-counter and herbal medicines. Taking Fypalan with certain other medicines may cause side effects or affect their effectiveness. Do not start or stop taking any other medicines without consulting your doctor or pharmacist.

• Other antiepileptic medicines such as carbamazepine, oxcarbazepine, and phenytoin, used to treat seizures, may affect the action of Fypalan. Inform 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 action of Fypalan. Inform your doctor if you 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 (sudden) seizures, as a sedative, and for sleep problems). Inform your doctor if you are taking midazolam, as dose adjustment may be necessary.
• Some other medicines, such as rifampicin (used to treat bacterial infections), St John’s wort (used to treat mild anxiety states), and ketoconazole (used to treat fungal infections), may affect the action of Fypalan. Inform 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). Inform your doctor about any hormonal contraceptives you are using. Fypalan may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. During treatment with Fypalan, use other reliable and effective contraceptive methods (such as condoms or intrauterine devices). Continue using alternative methods for one month after stopping treatment. Discuss with your doctor which contraceptive method is best suited for you.

Alcohol and Fypalan
Talk to your doctor before drinking alcohol. Exercise caution when consuming alcohol with antiepileptic medicines, including Fypalan.

• Drinking alcohol while taking Fypalan may reduce alertness and negatively affect the ability to drive, use tools, or operate machinery.
• Drinking alcohol while taking Fypalan may worsen feelings of anger, confusion, or sadness.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine. Do not stop treatment without first discussing it with your doctor.

• Fypalan is not recommended during pregnancy.
• Effective contraception must be used during treatment with Fypalan to avoid becoming pregnant. Continue using contraception for one month after stopping treatment. Inform your doctor if you are using hormonal contraception. Fypalan may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. During treatment with Fypalan, use other reliable and effective contraceptive methods (such as condoms or intrauterine devices). Continue using alternative methods for one month after stopping treatment. Discuss with your doctor which contraceptive method is best suited for you. It is unknown whether the components of Fypalan pass into human milk. Your doctor will weigh the benefits and risks to the child of using Fypalan during breastfeeding.

Driving and operating machinery
Do not drive or operate machinery until the effect of Fypalan on the patient has been determined.
Discuss with your treating doctor the impact of epilepsy on your ability to drive and operate machinery.

• Fypalan may cause dizziness or drowsiness, especially at the beginning of treatment. If these symptoms occur, do not drive, use tools, or operate machinery.
• Drinking alcohol while taking Fypalan may worsen these symptoms.

Fypalan contains lactose
Fypalan contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

3. How to take Fypalan

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
What dose should be taken
Treatment of partial and generalized seizures in adults and adolescents (aged 12 years and older):
The usual starting dose of the medicine is 2 mg once daily before bedtime.

• Your treating doctor may gradually increase the dose by 2 mg, until reaching a maintenance dose between 4 mg and 12 mg – depending on the 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.
• Do not take a higher dose of Fypalan than prescribed by your treating doctor. Determining the appropriate dose of Fypalan for a patient may take several weeks.

The table below summarizes the recommended doses for 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 body weight of 30 kg and above:
The usual initial dose is 2 mg once daily at night.

• The prescribing physician 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 individual clinical response and tolerability, 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.
• Do not take a higher dose of Fypalan than prescribed by the prescribing physician. Adjusting the appropriate dose of Fypalan for the patient may take several weeks.

Treatment of partial seizures in children (aged 4 to 11 years) with body weight from 20 kg to less than 30 kg:
The usual initial dose is 1 mg once daily at night.

• The prescribing physician 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 individual clinical response and tolerability, 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.
• Do not take a higher dose of Fypalan than prescribed by the prescribing physician. Adjusting the appropriate dose of Fypalan for the patient may take several weeks.

Treatment of partial seizures in children (aged 4 to 11 years) with body weight below 20 kg:
The usual initial dose is 1 mg once daily at night.

• The prescribing physician 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 individual clinical response and tolerability, 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.
• Do not take a higher dose of Fypalan than prescribed by the prescribing physician. Adjusting the appropriate dose of Fypalan for the patient may take several weeks.

Treatment of generalized seizures in children (aged 7 to 11 years) with body weight of 30 kg and above:
The usual initial dose is 2 mg once daily at night.

• The prescribing physician 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 individual clinical response and tolerability, 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.
• Do not take a higher dose of Fypalan than prescribed by the prescribing physician. Adjusting the appropriate dose of Fypalan for the patient may take several weeks.

Treatment of generalized seizures in children (aged 7 to 11 years) with body weight from 20 kg to less than 30 kg:
The usual initial dose is 1 mg once daily at night.

• The prescribing physician 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 individual clinical response and tolerability, 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.
• Do not take a higher dose of Fypalan than prescribed by the prescribing physician. Adjusting the appropriate dose of Fypalan for the patient may take several weeks.

Treatment of generalized seizures in children (aged 7 to 11 years) with body weight below 20 kg:
The usual initial dose is 1 mg once daily at night.

• The prescribing physician 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 individual clinical response and tolerability, 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.
• Do not take a higher dose of Fypalan than prescribed by the prescribing physician. Adjusting the appropriate 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 may be taken independently of meals. Tablets should not be chewed, crushed, or divided.

Taking more than the recommended dose of Fypalan
If more than the recommended dose of Fypalan has been taken, contact a physician immediately. The patient may experience confusion, anxiety, aggressive behavior, and decreased level of consciousness.

Missed dose of Fypalan

• If a dose is missed, wait until the next scheduled dose and continue treatment according to the prescribed regimen.
• Do not take a double dose to make up for a missed dose.
• If treatment with Fypalan has been interrupted for less than 7 days, resume daily dosing according to the physician's instructions.
• If treatment with Fypalan has been interrupted for more than 7 days, contact the physician immediately.

Discontinuation of Fypalan
Fypalan should be taken for as long as prescribed by the physician. Do not discontinue treatment unless instructed by the physician. The physician may slowly and gradually reduce the dose taken by the patient to prevent recurrence or worsening of seizures.

If you have any further questions regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 in a patient, medical advice should be sought immediately.

Very common (occurring in more than 1 in 10 patients) adverse reactions:

• dizziness
• feeling of sleepiness (somnolence or lethargy)

Common (occurring in more than 1 in 100 patients) adverse reactions:

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

Uncommon (occurring in more than 1 in 1,000 patients) adverse reactions:

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

Frequency not known (frequency of adverse reactions cannot be estimated from available data):

• Drug reaction with eosinophilia and systemic symptoms, otherwise known as DRESS, or drug hypersensitivity syndrome: widespread rash, high fever, elevated liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement and involvement of other organs.
• Stevens-Johnson syndrome (SJS). This severe skin rash may present as red target-like spots or circular patches (often with blisters in the center) appearing on the trunk, skin peeling, mouth ulcers, and lesions in the throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms.

If any of these symptoms occur, perampanel should be discontinued immediately and medical advice should be sought or medical help obtained. See also section 2.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the 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 blister and carton after:
"EXP". The expiry date refers to the last day of the specified month.
No special storage instructions apply to this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help
protect the environment.

6. Contents of the packaging 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.

Other ingredients are:
Tablet core:
Monohydrate lactose, low-substituted hydroxypropylcellulose, Povidone K30, microcrystalline cellulose silicon dioxide, magnesium stearate

Coating:
2 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets:
Partially hydrolyzed polyvinyl alcohol, talc, Macrogol 3350, titanium dioxide (E171)
4 mg tablets:
Partially hydrolyzed polyvinyl alcohol, talc, Macrogol 3350

*Additionally:
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
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: Light 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 pack sizes of: 7, 10, 28, 30, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer
G.L. Pharma GmbH
Industriestrasse 1
8502 Lannach
Austria

For further information about this medicine, contact the representative of the Marketing Authorisation 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
[email protected]