Fycompa 4 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Fycompa is and what it is used for
2. What you need to know before you take Fycompa
3. How to take Fycompa
4. Possible side effects
5. How to store Fycompa
6. Contents of the pack and other information

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

Talk to your doctor or pharmacist before taking Fycompa if you have liver problems or moderate or severe kidney problems.

You should not take Fycompa if you have serious liver problems or moderate or serious kidney problems.

Before taking this medicine you should tell your doctor if you have a history of alcoholism or drug dependence.

Cases of increased liver enzymes have been reported in some patients taking Fycompa in combination with other antiepileptic drugs.

• Fycompa may make you feel dizzy or sleepy, particularly at the beginning of treatment.
• Fycompa may make you more likely to fall over, particularly if you are an older person; this might be due to your illness.
• Fycompa may make you aggressive, angry or violent. It may also cause you to have unusual or extreme changes in behaviour or mood, abnormal thinking and/or loss of touch with reality.

If you or your family and/or friends notice any of these reactions, talk to your doctor or pharmacist.

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

Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) and Stevens - Johnson Syndrome (SJS) have been reported with the use of perampanel.

• DRESS typically, although not exclusively, appears as flu-like symptoms and a rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
• Stevens - Johnson Syndrome (SJS) can appear initially as reddish target- like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal.

If you experience any of the above after taking Fycompa (or you are not sure) talk to your doctor or pharmacist.

Fycompa is not recommended for children aged under 4. 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.

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal 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.

• Other anti-epileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin that are used to treat fits may affect Fycompa. Tell 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 Fycompa. Tell 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) convulsive seizures, for sedation and sleep problem) may be affected by Fycompa. Tell your doctor if you are taking midazolam as your dose may need to be adjusted.
• Some other medicines such as rifampicin (a medicine used to treat bacterial infections), hypericum (St. John’s Wort) (a medicine used to treat mild anxiety) and ketoconazole (a medicine used to treat fungal infections) may affect Fycompa. Tell 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)

Tell your doctor if you are taking hormonal contraceptives. Fycompa may make certain hormonal contraceptives such as levonorgestrel less effective. You should use other forms of safe and effective contraception (such as a condom or coil) when taking Fycompa. You should continue doing this for one month after stopping treatment. Discuss with your doctor what may be appropriate contraception for you.

Speak to your doctor before drinking alcohol. Be careful about consuming alcohol with epilepsy medicines including Fycompa.

• Drinking alcohol while taking Fycompa can make you less alert and affect your ability to drive or use tools or machines.
• Drinking alcohol while taking Fycompa can also make any feelings of anger, confusion or sadness worse.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not stop treatment without first discussing it with your doctor.

• Fycompa is not recommended in pregnancy.
• You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Fycompa. You should continue doing this for one month after stopping treatment. Tell your doctor if you are taking hormonal contraceptives. Fycompa may make certain hormonal contraceptives such as levonorgestrel less effective. You should use other forms of safe and effective contraception (such as a condom or coil) when taking Fycompa. You should also do this for one month after stopping treatment. Discuss with your doctor what may be appropriate contraception for you.

It is not known whether the ingredients of Fycompa can pass into breast milk.

The doctor will weigh up the benefit and risks to your baby of taking Fycompa while you are breast-feeding.

Do not drive or use machines until you know how Fycompa affects you.

You must talk to your doctor about the effect of your epilepsy on driving and using machines.

• Fycompa may make you feel dizzy or sleepy, particularly at the beginning of treatment. If this happens to you, do not drive or use any tools or machines.
• Drinking alcohol while taking Fycompa may make these effects worse.

Fycompa contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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 in 2 mg steps to a maintenance dose between 4 mg and 12 mg - depending on your response.
• If you have mild or moderate liver problems, your dose should not be more than 8 mg each day and your dose increases should be at least 2 weeks apart.
• Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

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 (from 4 to 11 years of age) weighing 30 kg or more in treating partial seizures:

The usual starting dose is 2 mg once a day before you go to bed.

• Your doctor may increase this in 2 mg steps to a maintenance dose between 4 mg and 8 mg - 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 each day and your dose increases should be at least 2 weeks apart.
• Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

Children (from 4 to 11 years of age) weighing 20 kg and less than 30 kg in treating partial seizures:

The usual starting dose is 1 mg once a day before you go to bed.

• Your doctor may increase this in 1 mg steps to a maintenance dose between 4 mg and 6 mg 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 each day and your dose increases should be at least 2 weeks apart.
• Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

Children (from 4 to 11 years of age) weighing less than 20 kg in treating partial seizures:

The usual starting dose is 1 mg once a day before you go to bed.

• Your doctor may increase this in 1 mg steps to a maintenance dose between 2 mg and 4 mg - 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 each day and your dose increases should be at least 2 weeks apart.
• Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

Children (from 7 to 11 years of age) weighing 30 kg or more in treating generalised seizures:

The usual starting dose is 2 mg once a day before you go to bed.

• Your doctor may increase this in 2 mg steps to a maintenance dose between 4 mg and 8 mg 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 each day and your dose increases should be at least 2 weeks apart.
• Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

Children (from 7 to 11 years of age) weighing 20 kg and less than 30 kg in treating generalised seizures:

The usual starting dose is 1 mg once a day before you go to bed.

• Your doctor may increase this in 1 mg steps to a maintenance dose between 4 mg and 6 mg 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 each day and your dose increases should be at least 2 weeks apart.
• Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

Children (from 7 to 11 years of age) weighing less than 20 kg in treating generalised seizures:

The usual starting dose is 1 mg once a day before you go to bed.

• Your doctor may increase this in 1 mg steps to a maintenance dose between 2 mg and 4 mg - 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 each day and your dose increases should be at least 2 weeks apart.
• Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

Swallow the tablet whole with a glass of water. You can take Fycompa with or without food. Do not chew, crush or split the tablet. The tablets cannot be split accurately as there is no break line.

If you have taken more Fycompa than you should contact your doctor straight away. You may experience confusion, agitation, aggressive behaviour and depressed level of consciousness.

• If you forget to take a tablet, wait until your next dose and then carry on as usual.
• Do not take a double dose to make up for a forgotten dose.
• If you have missed less than 7 days of treatment with Fycompa, continue taking your daily tablet as originally instructed by your doctor.
• If you have missed more than 7 days of treatment with Fycompa, talk to your doctor immediately.

Take Fycompa for as long as your doctor recommends. Do not stop unless your doctor advises you to.

Your doctor may reduce your dose slowly to avoid your fits (seizures) coming back or getting worse.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

The active substance is perampanel. Each film-coated tablet contains 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg perampanel.

The other ingredients are:

Tablet core (2 mg and 4 mg tablets):

Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, magnesium stearate (E470b)

Tablet core (6 mg, 8 mg, 10 mg and 12 mg tablets)

Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate (E470b)

Film coating (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets)

Hypromellose 2910, talc, Macrogol 8000, titanium dioxide (E171), colourants*

*The colourants are:

2 mg tablet: Ferric Oxide, Yellow (E172), Ferric Oxide, Red (E172)

4 mg tablet: Ferric Oxide, Red (E172)

6 mg tablet: Ferric Oxide, Red (E172)

8 mg tablet: Ferric Oxide, Red (E172), Ferric Oxide, Black (E172)

10 mg tablet: Ferric Oxide, Yellow (E172), FD&C Blue #2 Indigo carmine aluminium lake (E132)

12 mg tablet: FD&C Blue #2 Indigo carmine aluminium lake (E132)

All strengths of Fycompa are round, biconvex film-coated tablets

2 mg: orange, marked with E275 on one side and 2 on other side

4 mg: red, marked with E277 on one side and 4 on other side

6 mg: pink, marked with E294 on one side and 6 on other side

8 mg: purple, marked with E295 on one side and 8 on other side

10 mg: green, marked with E296 on one side and 10 on other side

12 mg: blue, marked with E297 on one side and 12 on other side

Fycompa is available in packs of:

2 mg tablet – pack of 7, 28 and 98

4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets – packs of 7, 28, 84 and 98

Not all pack sizes may be marketed