Fycompa 2 mg/4 mg/6 mg/8 mg/10 mg/12 mg Film-Coated Tablets

Fycompa contains a medicine called perampanel. It belongs to a group of medicines called anti - epileptics. These medicines are used to treat epilepsy - where someone has repeated fits (seizures). It has been prescribed to you by your doctor to reduce the number of fits that you have.

Fycompa is used alone or in association with other anti - epileptic medicines to treat certain forms of epilepsy: In adults, adolescents (aged 12 years and older), and children (from 4 to 11 years)

• It is used to treat seizures that affect one part of the brain (called a “partial seizure ” ).
• These partial seizures may or may not be followed by a seizure affecting all of the brain (called a “secondary generalisation”).

In adults, adolescents (aged 12 years and older), and children (from 7 to 11 years)

• It is also used to treat certain fits that affect all of your brain from the start (called “generalised seizures”) and cause convulsions or staring spells.

Do not take Fycompa:

• if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Fycompa
• if you are allergic (hypersensitive) to perampanel or any of the other ingredients of Fycompa (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Fycompa:

• if you have liver problems; you should not take Fycompa if you have serious liver problems
• if you have moderate or severe kidney problems; you should not take Fycompa if you have serious kidney problems
• if you have a history of alcoholism or drug dependence
• if you are taking any other anti - epileptic medicines (see “Other medicines and Fycompa”); your doctor may need to monitor your liver function and/or adjust your dose of Fycompa

Take special care with Fycompa:

• if you experience any signs of a serious skin reaction such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or Stevens - Johnson Syndrome (SJS); tell you doctor immediately
• if you start having thoughts of harming or killing yourself (suicide); tell you doctor immediately, as some people being treated with anti - epileptics have had thoughts of harming or killing themselves
• Fycompa may make you aggressive, angry or violent, it may also cause you to have unusual or extreme changes in behaviour or mood; your doctor may need to adjust your dose or discontinue Fycompa
• Fycompa may make you feel dizzy or sleepy; tell your doctor if this happens
• Fycompa may make you more likely to fall over, particularly if you are an older person, this might also be due to your illness; tell your doctor if this happens

Children

Fycompa is not recommended for children aged under 4 years. The safety and effectiveness are not yet known in children under 4 years of age for partial seizures and under 7 years of age in generalised seizures.

Other medicines and Fycompa

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.) Taking Fycompa with certain other medicines may cause side effects or affect how they work. Do not start or stop other medicines without talking to your doctor or pharmacist.

Do not share medicines prescribed for you with any other person. Always take Fycompa exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of Fycompa is too strong or too weak, tell your doctor or pharmacist.

How much to take

Adults, adolescents (aged 12 years and older) in treating partial seizures and generalised seizures:

• The usual starting dose is 2 mg once a day before you go to bed.
• Your doctor may increase this dose in 2 mg steps to a maintenance dose of between 4 mg and 12 mg once a day, depending on your response.
• If you have mild or moderate liver problems, your dose should not be more than 8 mg once a day and your dose increases should be at least 2 weeks apart.
• Do not take more Fycompa than your doctor has prescribed. It may take a few weeks to find the right dose of Fycompa for you.

Children in treating partial seizures (children from 4 to 11 years of age) and generalised seizures (children from 7 to 11 years of age):

The following table summarises the recommended doses in treating partial seizures in children 4 to 11 years of age, and generalised seizures in children 7 to 11 years of age. More details are provided below the table.

Children weighing:

• More than 30 kg
• 20 kg to less than 30 kg
• Less than 20 kg

Recommended starting dose

• 2 mg/day
• 1 mg/day
• 1 mg/day

Recommended maintenance dose

• 4 – 8 mg/day
• 4 – 6 mg/day
• 2 – 4 mg/day

Recommended maximum dose

• 12 mg/day
• 8 mg/day
• 6 mg/day

Children weighing 30 kg or more: The usual starting dose is 2 mg once a day before you go to bed.

• Your doctor may increase this dose in 2 mg steps to a maintenance dose of between 4 mg and 8 mg once a day, depending on your response. Depending upon individual clinical response and tolerability, the dose may be increased to a maximum dose of 12 mg/day.
• If you have mild or moderate liver problems, your dose should not be more than 4 mg once a day and your dose increases should be at least 2 weeks apart.
• Do not take more Fycompa than your doctor has prescribed. It may take a few weeks to find the right dose of Fycompa for you.

Children weighing 20 kg and less than 30 kg: The usual starting dose is 1 mg once a day before you go to bed.

• Your doctor may increase this dose in 1 mg steps to a maintenance dose of between 4 mg and 6 mg once a day, depending on your response. Depending upon individual clinical response and tolerability, the dose may be increased to a maximum dose of 8 mg/day.
• If you have mild or moderate liver problems, your dose should not be more than 4 mg once a day and your dose increases should be at least 2 weeks apart.
• Do not take more Fycompa than your doctor has prescribed. It may take a few weeks to find the right dose of Fycompa for you.

Children weighing less than 20 kg: The usual starting dose is 1 mg once a day before you go to bed.

• Your doctor may increase this dose in 1 mg steps to a maintenance dose of between 2 mg and 4 mg once a day, depending on your response. Depending upon individual clinical response and tolerability, the dose may be increased to a maximum dose of 6 mg/day.
• If you have mild or moderate liver problems, your dose should not be more than 4 mg once a day and your dose increases should be at least 2 weeks apart.
• Do not take more Fycompa than your doctor has prescribed. It may take a few weeks to find the right dose of Fycompa for you.

How to take

Swallow the tablet whole with a glass of water. The tablets cannot be split accurately as there is no break line, to ensure that you get the correct dose, do not chew, crush or split the tablet. You can take Fycompa with or without food.

Fycompa can cause side effects. Not all side effects reported for Fycompa are included in this leaflet. Should your general health worsen of if you experience any untoward effects while taking Fycompa, please consult your healthcare provider for advice.

If any of the following happens, stop taking Fycompa and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Signs of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) which is also known as drug hypersensitivity syndrome:
• widespread or maculopapular rash (rash characterised by a flat, red area on the skin that is covered with small confluent bumps)
• high body temperature
• blood abnormalities (eosinophilia)
• liver enzyme elevations
• enlarged lymph nodes and other body organs involvement
• Signs of Stevens - Johnson syndrome (SJS):
• reddish target - like macules or circular patches often with central blisters on the trunk
• skin peeling
• ulcers of mouth, throat, nose, genitals and eyes
• fever and flu - like symptoms

These effects can appear several weeks after starting treatment with Fycompa. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Fycompa. You may need urgent medical attention or hospitalisation.

Some people being treated with anti - epileptics such as Fycompa have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor straight away.

Frequent side effects:

• feeling dizzy, or sleepy (drowsiness or somnolence)
• decreased or increased appetite, weight gain
• feeling aggressive, angry, irritable, anxious or confused
• slow speech (dysarthria)
• difficulty with walking or other balance problems (ataxia, gait disturbance, balance disorder)
• double vision (diplopia), blurred vision
• spinning sensation (vertigo)
• feeling sick (nausea)
• back pain
• feeling very tired (fatigue)
• falling down

Less frequent side effects:

• thoughts about harming yourself or ending your own life (suicidal thoughts), tried to end your own life (attempted suicide)
• seeing, hearing or feeling things that are not there (hallucinations)

Side effects with unknown frequency:

• Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome
• Stevens - Johnson syndrome (SJS) which is a serious skin rash

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Fycompa.

Store all medicines out of reach of children. Do not use Fycompa after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of the month. Store at or below 30 °C. Keep the blisters in the outer carton until required for use. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.