Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Perampanel
EISAI (MALAYSIA) SDN BHD (18039-D)
Perampanel
98 Tablets; 28 Tablets
Eisai Manufacturing Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ FYCOMPA FILM-COATED TABLETS ® Perampanel (2mg, 4mg, 6mg, 8mg, 10mg, 12mg) 1 WHAT IS IN THIS LEAFLET 1. What _Fycompa_ is used for 2. How _Fycompa_ works 3. Before you use _Fycompa_ 4. How to use _Fycompa_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Fycompa_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _FYCOMPA_ IS USED FOR _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 given to you by your doctor to reduce the number of fits that you have. _Fycompa _ is used to treat a certain form _ _ of epilepsy in people aged 12 years and older. - 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”). - 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. HOW _FYCOMPA_ WORKS The active substance in _Fycompa_ , perampanel, is an anti-epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. Although the precise mechanism by which _Fycompa_ works is not fully understood, it is thought to block the action of the neurotransmitter glutamate. Neurotransmitters are naturally- occurring chemicals in the nervous system that allow nerve cells to communicate with each other. Glutamate is the main stimulatory neurotransmitter in nerve cells. Therefore by blocking glutamate’s actions, _Fycompa_ is thought to stop epileptic seizures from occurring. BEFORE YOU USE _FYCOMPA _ - _When you must not use it_ Do not take _Fycompa_ if you are allergic to perampanel or any of the other ingredients of this medicine as listed in Ingredients. _Pregnancy Olvassa el a teljes dokumentumot
FYCOMPA Tablets 2mg, 4mg, 6mg, 8mg, 10mg, 12mg1. NAME OF THE MEDICINAL PRODUCT Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg film-coated tablets 2. QUANTITATIVE COMPOSITION Each film-coated tablet contains 2, 4, 6, 8, 10, or 12 mg perampanel. The complete quantitative composition can be found in Section 6. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet): 2mg tablet: Orange,round, biconvex tablet, debossed with €275 on one side and ‘2’ on the other side 4mg tablet: Red, round, biconvex tablet, debossed with €277 on one side and ‘4’ on the other side 6mg tablet: Pink, round, biconvex tablet, debossed with €294 on one side and ‘6’ on the other side 8mg tablet: Purple, round, biconvex tablet, debossed with €295 on one side and ‘8’ on the other side 10mg tablet: Green, round, biconvex tablet, debossed with €296 on one side and ‘10’ on the other side 12mg tablet: Blue, round, biconvex tablet, debossed with €297 on one side and ‘12’ on the other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents_ Fycompa must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability. Fycompa should be taken orally once daily at bedtime. _Partial-Onset Seizures _ Fycompa at doses of 4 mg/day to 12 mg/day has been shown to be effective therapy in partial- onset seizures. Treatment with Fycompa should be initiated with a dose of 2 mg/day. The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks as per half- Olvassa el a teljes dokumentumot