Patient leaflet - Perampanel G.L. Pharma 6 mg film-coated tablets
1. What Perampanel G.L. Pharma is and what it is used for
Perampanel G.L. Pharma contains an active substance 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 given to you by your doctor to reduce the number of fits that you have.
Perampanel is used in association with other antiepileptic 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 fits that affect one part of your
brain (called a “partial seizure”).
These partial seizures may or may not then be
followed by a fit affecting all of your brain (called a “secondary generalisation”).
In adults and 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.
2. What you need to know before you take Perampanel G.L. Pharma
Do not take Perampanel G.L. Pharma
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).
Warnings and precautions
Talk to your doctor or pharmacist before taking perampanel if you have liver problems or moderate or severe kidney problems.
You should not take perampanel 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 perampanel in combination with other antiepileptic medicines.
Perampanel may make you feel dizzy or sleepy,
particularly at the beginning of treatment.
Perampanel may make you more likely to fall
over, particularly if you are an older person; this might be due to your illness.
Perampanel 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 Perampanel G.L. Pharma (or are not sure) talk to your doctor or pharmacist.
Children
Perampanel G.L. Pharma 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.
Other medicines and Perampanel G.L. Pharma
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 perampanel 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 perampanel. 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 perampanel. 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 perampanel. 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 perampanel. 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. Perampanel 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 perampanel. You should continue doing this for one month after stopping treatment. Discuss with your doctor what may be appropriate contraception for you.
Perampanel G.L. Pharma with alcohol
Speak to your doctor before drinking alcohol. Be careful about consuming alcohol with epilepsy medicines including perampanel.
- Drinking alcohol while taking perampanel can make you less alert and affect your ability to drive or use tools or machines.
- Drinking alcohol while taking perampanel can also make any feelings of anger, confusion or sadness worse.
Pregnancy and breast-feeding
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.
- Perampanel is not recommended in pregnancy.
- You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with perampanel. You should continue doing this for one month after stopping treatment. Tell your doctor if you are taking hormonal contraceptives. Perampanel 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 perampanel. 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 active substance of perampanel can pass into breast milk.
The doctor will weigh up the benefit and risks to your baby of taking perampanel while you are breast-feeding.
Driving and using machines
Do not drive or use machines until you know how perampanel affects you.
You must talk to your doctor about the effect of your epilepsy on driving and using machines.
- Perampanel 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 perampanel may make these effects worse.
Perampanel G.L. Pharma contains lactose
Perampanel G.L. Pharma 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.
3. How to take Perampanel G.L. Pharma
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
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 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 perampanel than your doctor has recommended. It may take a few weeks to find the right dose of perampanel 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 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 (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.
Package Leaflet: Information for the patient
Perampanel G.L. Pharma 2 mg film-coated tablets Perampanel G.L. Pharma 4 mg film-coated tablets Perampanel G.L. Pharma 6 mg film-coated tablets Perampanel G.L. Pharma 8 mg film-coated tablets Perampanel G.L. Pharma 10 mg film-coated tablets Perampanel G.L. Pharma 12 mg film-coated tablets
GI58450GB, Perampanel G.L. Pharma 2/4/6/8/10/12 mg Fta.
InfoProd-49551 2.0 GI58450GB, Perampanel G.L. Pharma 2/4/6/8/10/12 mg Fta.
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 perampanel than your doctor
has recommended. It may take a few weeks to find the right dose of perampanel 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 perampanel than your doctor
has recommended. It may take a few weeks to find the right dose of perampanel 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 perampanel than your doctor
has recommended. It may take a few weeks to find the right dose of perampanel 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 perampanel than your doctor
has recommended. It may take a few weeks to find the right dose of perampanel 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 perampanel than your doctor
has recommended. It may take a few weeks to find the right dose of perampanel 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 perampanel than your doctor
has recommended. It may take a few weeks to find the right dose of perampanel for you. How to take Perampanel G.L. Pharma
Perampanel G.L. Pharma is for oral use. Swallow the tablet whole with a glass of water. You can take Perampanel G.L. Pharma 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 take more Perampanel G.L. Pharma than you should
If you have taken more perampanel than you should contact your doctor straight away. You may experience confusion, agitation, aggressive behaviour, vomiting and reduced level of consciousness.
If you forget to take Perampanel G.L. Pharma
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 perampanel, continue taking your daily tablet as originally instructed by your doctor.
If you have missed more than 7 days of
treatment with perampanel, talk to your doctor immediately.
If you stop taking Perampanel G.L. Pharma
Take perampanel 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 have any further questions on the use of this medicine, ask 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 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.
Very common (may affect more than 1 user in 10) are:
- feeling dizzy
- feeling sleepy (drowsiness or somnolence) Common (may affect more than 1 user in 100) are:
- increased or decreased appetite, weight gain
feeling aggressive, angry, irritable, anxious or
confused
difficulty with walking or other balance problems
(ataxia, gait disturbance, balance disorder)
- slow speech (dysarthria)
- blurred vision or double vision (diplopia)
- spinning sensation (vertigo)
- feeling sick (nausea)
- back pain
- feeling very tired (fatigue)
- falling down
Uncommon (may affect more than 1 user in 1000) are:
- thoughts about harming yourself or ending your own life (suicidal thoughts), tried to end your own life (attempted suicide)
- hallucinations (seeing, hearing or feeling things that are not there)
- abnormal thinking and/or loss of touch with reality (psychotic disorder)
Not known (the frequency of this side effect cannot be estimated from the available data) are:
Drug Reaction with Eosinophilia and Systemic
Symptoms which is also known as DRESS or drug hypersensitivity syndrome: widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement.
- Stevens-Johnson syndrome, SJS. This serious skin rash can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using perampanel if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2. Reporting of side effects
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 Website: 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.
5. How to store Perampanel G.L. Pharma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of the month. This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Perampanel G.L. Pharma contains
The active substance is perampanel.
Perampanel G.L. Pharma 2 mg film-coated tablets Each film-coated tablet contains
2 mg perampanel.
Perampanel G.L. Pharma 4 mg film-coated tablets Each film-coated tablet contains
4 mg perampanel.
Perampanel G.L. Pharma 6 mg film-coated tablets Each film-coated tablet contains
6 mg perampanel.
Perampanel G.L. Pharma 8 mg film-coated tablets Each film-coated tablet contains
8 mg perampanel.
Perampanel G.L. Pharma 10 mg film-coated tablets Each film-coated tablet contains
10 mg perampanel.
Perampanel G.L. Pharma 12 mg film-coated tablets Each film-coated tablet contains
12 mg perampanel.
The other ingredients are:
Tablet core
Lactose monohydrate, low-substituted hydroxypropylcellulose, povidone K30, silicified microcrystalline cellulose, magnesium stearate Film coating
2 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets Polyvinyl alcohol part. hydrolyzed, talc, macrogol 3350, titanium dioxide (E171) 4 mg tablets
Polyvinyl alcohol part. hydrolyzed, 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 Perampanel G.L. Pharma looks like and contents of the pack
film-coated tablet
2 mg:
yellow coloured, round and biconvex film-coated tablets
4 mg:
red coloured, round and biconvex
film-coated tablets
6 mg:
orange coloured, round and biconvex film-coated tablets
8 mg:
pale pink coloured, round and biconvex film-coated tablets
10 mg:
green coloured, round and biconvex
film-coated tablets
12 mg:
grey to purple coloured, round and biconvex film-coated tablets
Perampanel G.L. Pharma is available in packs of 7, 28, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1, 8502 Lannach, Austria Manufacturer
G.L. Pharma GmbH
Industriestrasse 1, 8502 Lannach, Austria This leaflet was last revised in July 2026.
Präparatename/Stärke:
Perampanel G.L. Pharma 2/4/6/8/10/12 mg Darreichungsform:
Filmtabletten
Art.-Nr.: GI58450GB
Code-Nr.:
Land: Großbritannien / uk
Format: 148 x 480 mm
Packmittelart: Gebrauchsinformation
Produktion: intern
Schrift: Helvetica 8,0 – 18,0 Punkt
Druckfarbe: ♦ Schwarz
Korr.-Version: 1
Datum: 09.07.2026
Uhrzeit: 15:10:21
InfoProd-49551 2.0