Atofab 60 mg harde capsules

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

ATOMOXETINEHYDROCHLORIDE 68,6 mg/stuk SAMENSTELLING overeenkomend met ; ATOMOXETINE 60 mg/stuk

Available from:

G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)

ATC code:

N06BA09

INN (International Name):

ATOMOXETINEHYDROCHLORIDE 68,6 mg/stuk SAMENSTELLING overeenkomend met ; ATOMOXETINE 60 mg/stuk

Pharmaceutical form:

Capsule, hard

Composition:

AMMONIA (E 527) ; DIMETICON (E 900) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMLAURILSULFAAT (E 487) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,

Administration route:

Oraal gebruik

Therapeutic area:

Atomoxetine

Product summary:

Hulpstoffen: AMMONIA (E 527); DIMETICON (E 900); GELATINE (E 441); IJZEROXIDE GEEL (E 172); IJZEROXIDE ZWART (E 172); INDIGOKARMIJN (E 132); MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMLAURILSULFAAT (E 487); PROPYLEENGLYCOL (E 1520); SCHELLAK GLAZE, GEDEELTELIJK VERESTERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); ZWARTE INKT;

Authorization date:

2018-04-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATOFAB 10 MG HARDE CAPSULES
ATOFAB 18 MG HARDE CAPSULES
ATOFAB 25 MG HARDE CAPSULES
ATOFAB 40 MG HARDE CAPSULES
ATOFAB 60 MG HARDE CAPSULES
ATOFAB 80 MG HARDE CAPSULES
ATOFAB 100 MG HARDE CAPSULES
Atomoxetine
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 Atofab is and what it is used for
2.
What you need to know before you take Atofab
3.
How to take Atofab
4.
Possible side effects
5.
How to store Atofab
6.
Contents of the pack and other information
1.
WHAT ATOFAB IS AND WHAT IT IS USED FOR
WHAT IT IS USED FOR
Atofab contains atomoxetine and is used to treat attention-deficit and
hyperactivity disorder (ADHD).
It is used:
-
in children over six years of age
-
in adolescents
-
in adults
It is used only as a part of the total treatment of the disease which
also requires treatments which do
not involve medicines, such as counselling and behavioural therapy.
It is not for use as a treatment for ADHD in children under 6 years of
age as it is not known if the
medicine works or is safe in these people.
In adults, this medicine is used to treat ADHD when the symptoms are
very troublesome and affect
your work or social life and when you have had symptoms of the disease
as a child.
HOW IT WORKS
This medicine increases the amount of noradrenaline in the brain. This
is a chemical that is produced
naturally, and increases attention and decreases impulsiveness and
hyperactivity in patients with
ADHD. This medicine has been prescribed to help control the symptoms
of

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Atofab 10 mg harde capsules
Atofab 18 mg harde capsules
Atofab 25 mg harde capsules
Atofab 40 mg harde capsules
Atofab 60 mg harde capsules
Atofab 80 mg harde capsules
Atofab 100 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atofab 10 mg harde capsules
Each hard capsule contains 10 mg atomoxetine as 11.43 mg atomoxetine
hydrochloride.
Atofab 18 mg harde capsules
Each hard capsule contains 18 mg atomoxetine as 20.57 mg atomoxetine
hydrochloride.
Atofab 25 mg harde capsules
Each hard capsule contains 25 mg atomoxetine as 28.57 mg atomoxetine
hydrochloride.
Atofab 40 mg harde capsules
Each hard capsule contains 40 mg atomoxetine as 45.71 mg atomoxetine
hydrochloride.
Atofab 60 mg harde capsules
Each hard capsule contains 60 mg atomoxetine as 68.57 mg atomoxetine
hydrochloride.
Atofab 80 mg harde capsules
Each hard capsule contains 80 mg atomoxetine as 91.42 mg atomoxetine
hydrochloride.
Atofab 100 mg harde capsules
Each hard capsule contains 100 mg atomoxetine as 114.28 mg atomoxetine
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Atofab 10 mg harde capsules
White powder in a hard gelatin capsule of size No 3 (length of
15.7±0.4 mm), opaque white cap
imprinted in black ink with ‘10’ and opaque white body imprinted
in black ink with ‘mg’.
Atofab 18 mg harde capsules
White powder in a hard gelatin capsule of size No 3 (length of
15.7±0.4 mm), opaque rich yellow cap
imprinted in black ink with ‘18’ and opaque white body imprinted
in black ink with ‘mg’.
Atofab 25 mg harde capsules
White powder in a hard gelatin capsule of size No 3 (length of
15.7±0.4 mm), opaque blue cap
imprinted in black ink with ‘25’ and opaque white body imprinted
in black ink with ‘mg’.
Atofab 40 mg harde capsules
White powder in a hard gelatin capsule of size No 3 (length of
15.7±0.4 mm), opaque blue cap
imprinted in black ink with ‘40’ and opaque blue body imprinted in
bl