Wakix 4.5mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Pitolisant hydrochloride

Commercializzato da:

Lincoln Medical Ltd

Codice ATC:

N07XX11

INN (Nome Internazionale):

Pitolisant hydrochloride

Dosaggio:

4.5mg

Forma farmaceutica:

Tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04040000; GTIN: 3760254600001

Scheda tecnica

OBJECT 1
WAKIX 4.5 MG / 18MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 30-Sep-2016 | Lincoln
Medical Limited
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 5 mg of pitolisant hydrochloride equivalent to
4.45 mg of pitolisant.
Wakix 18 mg film-coated tablet
Each tablet contains 20 mg of 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
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 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
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.
- 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 do