Perampanel Teva

Patient Information Leaflet

Perampanel Teva 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
Please read all of this leaflet carefully before you start taking 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 they have the same symptoms 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 Perampanel Teva is and what it is used for
2. What you need to know before taking Perampanel Teva
3. How to take Perampanel Teva
4. Possible side effects
5. How to store Perampanel Teva
6. Contents of the pack and other information

1. What Perampanel Teva is and what it is used for

Perampanel Teva contains an active substance called perampanel. It belongs to a group of medicines
called antiepileptics, used to treat epilepsy, a condition characterised by repeated
seizures (epileptic seizures). Your doctor has prescribed it to reduce the number of
epileptic seizures.
Perampanel Teva is used in combination with other antiepileptic medicines to treat 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 affecting the entire brain (called “secondary generalisation”). 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 affect the entire brain from the onset (called “generalised seizures”) and that cause convulsions or absence seizures.

2. What you should know before taking Perampanel Teva

DO NOT TAKE Perampanel Teva:

• if you have ever developed a severe skin rash or 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 Perampanel Teva if you have liver problems or moderate to severe kidney problems.
You must not take Perampanel Teva 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.
Cases of increased liver enzymes have been reported in some patients taking Perampanel Teva in combination with other antiepileptic drugs.

• Perampanel Teva may cause dizziness or drowsiness, especially at the beginning of treatment.
• Perampanel Teva may increase the risk of falls, particularly in elderly people; this may be due to the underlying disease.
• Perampanel Teva may cause aggression, anger or violence. It may also cause unusual or extreme changes in behaviour or mood, abnormal thoughts and/or loss of contact with reality. If you or a family member and/or 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 these thoughts, 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 rash accompanied by high body temperature, elevated liver enzyme levels detected in blood tests, an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes.
• Stevens-Johnson syndrome (SJS) may initially present as red, “target-like” spots or circular patches, often with central blisters, located on the trunk. In addition, ulcers may occur in the mouth, throat, nose, genital area and eyes (red and swollen eyes). These serious skin rashes 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 Perampanel Teva (or if in doubt), consult your doctor or pharmacist.
Children
Perampanel Teva is not recommended in children below 4 years of age. Safety and efficacy have not yet been established in children below 4 years of age for partial seizures and below 7 years of age for generalized seizures.
Other medicines and Perampanel Teva
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 Perampanel Teva 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 Perampanel Teva. 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 Perampanel Teva. 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 Perampanel Teva. 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 Perampanel Teva. 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 taking hormonal contraceptives. Perampanel Teva may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. During treatment with Perampanel Teva, 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 the most suitable contraceptive method for you.
Perampanel Teva and alcohol
Consult your doctor before drinking alcohol. Be cautious about consuming alcohol while taking antiepileptic medicines, including Perampanel Teva.

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

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

• Perampanel Teva is not recommended during pregnancy.
• To avoid becoming pregnant during treatment with Perampanel Teva, you must use a reliable method of contraception and continue using it for one month after stopping treatment. Inform your doctor if you are taking hormonal contraceptives. Perampanel Teva may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. During treatment with Perampanel Teva, 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 the most suitable contraceptive method for you. It is not known whether the active substance of Perampanel Teva passes into breast milk. Your doctor will assess the benefits and risks to the infant if treatment with Perampanel Teva is needed during breastfeeding.

Driving and using machines
Do not drive and do not operate machinery until you are certain how Perampanel Teva affects you. Talk to your doctor about the effects of epilepsy on driving and using machinery.

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

Perampanel Teva contains lactose
Perampanel Teva 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 Perampanel Teva

Take this medicine exactly as your doctor has instructed you. 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 2 mg increments, 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 Perampanel Teva higher than that recommended by your doctor. It may take several weeks to find the perampanel dose that is right 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, for the treatment of partial
seizures:
The usual starting dose is 2 mg once daily before bedtime.

• The doctor may increase this dose in 2 mg increments, up to a maintenance dose of 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 daily and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel Teva higher than that recommended by the doctor. It may take several weeks to find the appropriate perampanel dose for the child.

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

• The doctor may increase this dose in 1 mg increments, up to a maintenance dose of 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 daily and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel Teva higher than that recommended by the doctor. It may take several weeks to find the appropriate perampanel dose for the child.

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

• The doctor may increase this dose in 1 mg increments, up to a maintenance dose of 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 daily and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel Teva higher than that recommended by the doctor. It may take several weeks to find the appropriate perampanel dose for the child.

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

• The doctor may increase this dose in 2 mg increments, up to a maintenance dose of 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 daily and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel Teva higher than that recommended by the doctor. It may take several weeks to find the appropriate perampanel dose for the child.

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

• The doctor may increase this dose in 1 mg increments, up to a maintenance dose of 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 daily and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel Teva higher than that recommended by the doctor. It may take several weeks to find the appropriate perampanel dose for the child.

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

• The doctor may increase this dose in 1 mg increments, up to a maintenance dose of 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 daily and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel Teva higher than that recommended by the doctor. It may take several weeks to find the appropriate perampanel dose for the child.

How to take it
Perampanel Teva is for oral use.
The tablet should be swallowed whole with a glass of water. You may take Perampanel Teva with or without food.
Do not chew, crush, or divide the tablet. The tablets cannot be divided accurately because they do not have a score line.

If you take more Perampanel Teva than you should
If you have taken more Perampanel Teva than you should, contact your doctor immediately. Symptoms such as confusion, agitation, aggressive behaviour, and reduced level of consciousness may occur.

If you forget to take Perampanel Teva

• 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 treatment with Perampanel Teva, continue taking the daily tablet according to your doctor's initial instructions.
• If you have missed more than 7 days of treatment with Perampanel Teva, inform your doctor immediately.

If you stop taking Perampanel Teva
Take Perampanel Teva 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 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 side effects, although not everybody gets them.
A small number of people taking antiepileptic medicines have had thoughts of harming themselves or ending their life. If you experience such thoughts at any time, contact your doctor immediately.
Very common (may affect more than 1 in 10 people):

• dizziness
• feeling sleepy (drowsiness or somnolence)

Common (may affect up to 1 in 10 people):

• reduced or increased appetite, weight gain

• aggression, anger, irritability, anxiety or confusion

• difficulty walking or other balance problems [ataxia (loss of muscular coordination),
  altered gait, disturbance of equilibrium]

• slowness in speaking (dysarthria)

• blurred vision or double vision (diplopia)

• sensation of vertigo

• nausea

• back pain

• feeling very tired (fatigue)

• fall

Uncommon (may affect up to 1 in 100 people):

• thoughts of self-harm or of ending one’s life (suicidal thoughts), attempt to end one’s life (suicide attempt)
• hallucinations (seeing, hearing or sensing things that do not exist)
• abnormal thinking and/or loss of contact with reality (psychotic disorder)

Not known (frequency cannot be estimated from the 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.
• Stevens-Johnson syndrome (SJS). This serious skin rash may appear as red, target-like spots or circular patches, often with central blisters, usually on the trunk, skin peeling, mouth, throat, nose, genital and eye ulcers, and may be preceded by fever and flu-like symptoms.

Stop using perampanel if you develop these symptoms and consult 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, speak to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Perampanel Teva

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 pack. 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 Perampanel Teva contains

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

The other components are:
Tablet core: lactose monohydrate, microcrystalline cellulose, povidone K30, low-substituted hydroxypropylcellulose, crospovidone (type A), magnesium stearate.

Film coating:
Perampanel Teva 2 mg film-coated tablets: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172), red iron oxide (E172).
Perampanel Teva 4 mg film-coated tablets: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol 4000, talc, red iron oxide (E172).
Perampanel Teva 6 mg film-coated tablets: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol 4000, talc, red iron oxide (E172).
Perampanel Teva 8 mg film-coated tablets: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol 4000, talc, indigo carmine aluminium lake (E132), red iron oxide (E172).
Perampanel Teva 10 mg film-coated tablets: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol 4000, talc, indigo carmine aluminium lake (E132), yellow iron oxide (E172).
Perampanel Teva 12 mg film-coated tablets: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol 4000, talc, indigo carmine aluminium lake (E132).

Description of the appearance of Perampanel Teva and pack contents
Perampanel Teva 2 mg film-coated tablets are beige, round, biconvex, film-coated tablets, marked with “TV” on one side and “W2” on the other side. They are available in blisters or divisible unit dose blisters containing 7, 28, 30 and 7x1, 10x1, 28x1, 30x1, 98x1 tablets.
Perampanel Teva 4 mg film-coated tablets are pink, round, biconvex, film-coated tablets, marked with “TV” on one side and “W4” on the other side. They are available in blisters or divisible unit dose blisters containing 28, 30 and 7x1, 28x1, 30x1, 98x1 tablets.
Perampanel Teva 6 mg film-coated tablets are pink, round, biconvex, film-coated tablets, marked with “TV” on one side and “W6” on the other side. They are available in blisters or divisible unit dose blisters containing 28, 30 and 28x1, 30x1, 98x1 tablets.
Perampanel Teva 8 mg film-coated tablets are purple, round, biconvex, film-coated tablets, marked with “TV” on one side and “W8” on the other side. They are available in blisters or divisible unit dose blisters containing 28, 30 and 28x1, 30x1, 98x1 tablets.
Perampanel Teva 10 mg film-coated tablets are green, round, biconvex, film-coated tablets, marked with “TV” on one side and “W0” on the other side. They are available in blisters or divisible unit dose blisters containing 28, 30 and 28x1, 30x1, 98x1 tablets.
Perampanel Teva 12 mg film-coated tablets are light blue, round, biconvex, film-coated tablets, marked with “TV” on one side and “W1” on the other side. They are available in blisters or divisible unit dose blisters containing 28, 30 and 28x1, 30x1, 98x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva Italia S.r.l., Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Manufacturer
PLIVA Croatia Ltd., Prilaz baruna Filipovića 25 - 10000 Zagreb, Croatia