FYCOMPA Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Fycompa 2 mg film-coated tablets. Fycompa 4 mg film-coated tablets. Fycompa 6 mg film-coated tablets. Fycompa 8 mg film-coated tablets. Fycompa 10 mg film-coated tablets. Fycompa 12 mg film-coated tablets ...
Qualitative and quantitative composition
Fycompa 2 mg film-coated tablets: Each film-coated tablet contains 2 mg perampanel. Excipient with known effect: Each 2 mg tablet contains 78.5 mg of lactose (as monohydrate). For the full list of excipients, ...
Pharmaceutical form
Film-coated tablet (tablet). Fycompa 2 mg film-coated tablets: Orange, round, biconvex tablet, engraved with E275 on one side and 2 on other side Fycompa 4 mg film-coated tablets: Red, round, biconvex ...
Therapeutic indications
Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy. Fycompa ...
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. Perampanel should be taken orally ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Suicidal ideation Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicinal products in several indications. A meta-analysis of randomised placebo-controlled ...
Interaction with other medicinal products and other forms of interaction
Fycompa is not considered a strong inducer or inhibitor of cytochrome P450 or UGT enzymes (see section 5.2). Hormonal contraceptives In healthy women receiving 12 mg (but not 4 or 8 mg/day) for 21 days ...
Fertility, pregnancy and lactation
Women of childbearing potential and contraception in males and females Fycompa is not recommended in women of childbearing potential not using contraception unless clearly necessary. Fycompa may decrease ...
Effects on ability to drive and use machines
Fycompa has moderate influence on the ability to drive and use machines. Perampanel may cause dizziness and somnolence and, therefore, may influence the ability to drive or use machines. Patients are advised ...
Undesirable effects
Summary of the safety profile In all controlled and uncontrolled trials in patients with partial-onset seizures, 1,639 subjects have received perampanel of whom 1,147 have been treated for 6 months and ...
Overdose
There is limited clinical experience with perampanel overdose in humans. In a report of an intentional overdose that could have resulted in a dose up to 264 mg, the patient experienced events of altered ...
Pharmacodynamic properties
Pharmacotherapeutic group: antiepileptics, other antiepileptics ATC code: N03AX22 Mechanism of action Perampanel is a first-in-class selective, non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic ...
Pharmacokinetic properties
The pharmacokinetics of perampanel have been studied in healthy adult subjects (age range 18 to 79), adults and adolescents with partial-onset seizures and primary generalised tonic-clonic seizures, adults ...
Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: In the fertility ...
List of excipients
Fycompa 2 mg, 4 mg film-coated tablets Core: Lactose monohydrate Low-substituted hydroxypropyl cellulose Povidone K-29/32 Magnesium stearate (E470b) Fycompa 6 mg, 8 mg, 10 mg, 12 mg film-coated tablets ...
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/aluminium blisters. Fycompa 2 mg film-coated tablets: Pack of 7 only for first week of dosing, 28 and 98 Fycompa 4 mg film-coated tablets: 4 mg – packs of 7, 28, 84 and 98 Fycompa 6 mg film-coated ...
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Eisai GmbH, Edmund-Rumpler-Straße 3, 60549, Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net
Marketing authorization number(s)
EU/1/12/776/001-023
Date of first authorization / renewal of the authorization
Date of first authorisation: 23/07/2012 Date of latest renewal: 6 April 2017
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