Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
pitolisant
Bioprojet Pharma
N07XX11
pitolisant
Other nervous system drugs
Narcolepsy
Wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.1).
Revision: 15
Authorised
2016-03-31
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT WAKIX 4.5 MG FILM-COATED TABLETS WAKIX 18 MG FILM-COATED TABLETS pitolisant This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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. WHAT IS IN THIS LEAFLET? 1. What Wakix is and what it is used for 2. What you need to know before you take Wakix 3. How to take Wakix 4. Possible side effects 5. How to store Wakix 6. Contents of the pack and other information 1. WHAT WAKIX IS AND WHAT IT IS USED FOR Wakix contains the active ingredient pitolisant. It is a medicine used to treat adults, adolescents and children over the age of 6 years with narcolepsy, with or without cataplexy. Narcolepsy is a condition that causes excessive daytime sleepiness and a tendency to suddenly fall asleep in inappropriate situations (sleep attacks). Cataplexy is the onset of sudden muscle weakness or paralysis without losing consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter or surprise. The active substance, pitolisant, attaches to receptors on cells in the brain that are involved in stimulating alertness. This helps to combat daytime sleepiness and cataplexy and promote wakefulness. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE WAKIX _ _ DO NOT TAKE WAKIX IF YOU - Are allergic to pitolisant or any of the other ingredients of this m Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Wakix 4.5 mg film-coated tablets Wakix 18 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Wakix 4.5 mg film-coated tablet Each tablet contains pitolisant hydrochloride equivalent to 4.45 mg of pitolisant. Wakix 18 mg film-coated tablet Each tablet contains pitolisant hydrochloride equivalent to 17.8 mg of pitolisant. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Wakix 4.5 mg film-coated tablet White, round, biconvex film-coated tablet, 3.7 mm diameter, marked with “5” on one side. Wakix 18 mg film-coated tablet White, round, biconvex film-coated tablet, 7.5 mm diameter marked with “20” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by a physician experienced in the treatment of sleep disorders. Posology _Adults _ Wakix should be used at the lowest effective dose, depending on individual patient response and tolerance, according to an up-titration scheme, without exceeding the dose of 36 mg/day: - Week 1: initial dose of 9 mg (two 4.5 mg tablets) per day. - Week 2: the dose may be increased to 18 mg (one 18 mg tablet) per day or decreased to 4.5 mg (one 4.5 mg tablet) per day. 3 - Week 3: the dose may be increased to 36 mg (two 18 mg tablets) per day. At any time the dose can be decreased (down to 4.5 mg per day) or increased (up to 36 mg per day) according to the physician assessment and the patient’s response. The total daily dose should be administered a Pročitajte cijeli dokument