Ozawade

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

pitolisant

Available from:

Bioprojet Pharma

ATC code:

N07XX11

INN (International Name):

pitolisant

Therapeutic group:

Other nervous system drugs

Therapeutic area:

Sleep Apnea, Obstructive

Therapeutic indications:

Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA)

Product summary:

Revision: 3

Authorization status:

Authorised

Authorization date:

2021-09-01

Patient Information leaflet

27
B.
PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OZAWADE 4.5 MG FILM-COATED TABLETS
OZAWADE 18 MG FILM-COATED TABLETS
pitolisant
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 Ozawade is and what it is used for
2.
What you need to know before you take Ozawade
3.
How to take Ozawade
4.
Possible side effects
5.
How to store Ozawade
6.
Contents of the pack and other information
1.
WHAT OZAWADE IS AND WHAT IT IS USED FOR
Ozawade is a medicine that contains the active substance pitolisant.
Ozawade is used in adults with obstructive sleep apnoea to treat
excessive daytime sleepiness. It is
used when sleepiness occurs despite treatment with continuous positive
airway pressure (CPAP) or in
patients who have not tolerated CPAP.
Obstructive sleep apnoea (OSA) is a condition that causes you to stop
breathing for at least 10 seconds
during sleep. This can lead to excessive daytime sleepiness and a
tendency to suddenly fall asleep in
inappropriate situations (sleep attacks).
The active substance, pitolisant, works on receptors (targets) on
cells in the brain that are involved in
stimulating alertness. This effect helps to reduce daytime sleepiness
and tiredness.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OZAWADE
DO NOT TAKE OZAWADE IF YOU
-
Are allergic to pitolisant or any of the other ingredients of this
medicine (listed in section 6).
-
Have severe liver problems, as pitolisant is normally broken down in
the liver and high levels
may build up in patients whose liver function is severel

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ozawade 4.5 mg film-coated tablets
Ozawade 18 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ozawade 4.5 mg film-coated tablet
Each tablet contains pitolisant hydrochloride equivalent to 4.45 mg of
pitolisant.
Ozawade 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)
Ozawade 4.5 mg film-coated tablet
White, round, biconvex film-coated tablet, 3.7 mm diameter, marked
with “5” on one side.
Ozawade 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
Ozawade is indicated to improve wakefulness and reduce excessive
daytime sleepiness (EDS) in adult
patients with obstructive sleep apnoea (OSA) whose EDS has not been
satisfactorily treated by, or
who have not tolerated, OSA primary therapy, such as continuous
positive airway pressure (CPAP).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by a healthcare professional experienced
in the treatment of OSA and
cardiovascular risk. OSA disease should be annually reassessed.
Ozawade is not a therapy for the underlying airway obstruction in
patients with OSA. Primary OSA
therapy should be maintained or periodically rechallenged in patients
not tolerating primary OSA
therapy.
Posology
Pitolisant 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 18 mg/day:
-
Week 1: initial dose of 4.5 mg (one 4.5 mg tablet) per day.
-
Week 2: the dose may be increased to 9 mg (two 4.5 mg tablets) per
day.
-
Week 3: 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
At any time the dose can be decreased (down to 4.5 mg