Wakix
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
01-02-2024
Charakterystyka produktu
(SPC)
01-02-2024
Sprawozdanie z oceny publicznego
(PAR)
20-04-2023
Składnik aktywny:
pitolisant
Dostępny od:
Bioprojet Pharma
Kod ATC:
N07XX11
INN (International Nazwa):
pitolisant
Grupa terapeutyczna:
Other nervous system drugs
Dziedzina terapeutyczna:
Narcolepsy
Wskazania:
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).
Podsumowanie produktu:
Revision: 15
Status autoryzacji:
Authorised
Data autoryzacji:
2016-03-31
Ulotka dla pacjenta
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
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Charakterystyka produktu
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
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