Wakix 4.5mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Pitolisant hydrochloride

Dostępny od:

Lincoln Medical Ltd

Kod ATC:

N07XX11

INN (International Nazwa):

Pitolisant hydrochloride

Dawkowanie:

4.5mg

Forma farmaceutyczna:

Tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04040000; GTIN: 3760254600001

Charakterystyka produktu

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