STRATTERA 40MG CAPSULE

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ingredients actius:

ATOMOXETINE HYDROCHLORIDE

Disponible des:

ZUELLIG PHARMA SDN BHD

Designació comuna internacional (DCI):

ATOMOXETINE HYDROCHLORIDE

Unidades en paquete:

28 mcg/mL; 28 mcg/mL

Fabricat per:

Lilly del Caribe Inc.,

Informació per a l'usuari

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
STRATTERA CAPSULE
®
Atomoxetine HCl
(10 mg, 18 mg, 25 mg, 40 mg, 60 mg)
________________________________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Strattera is used for
2.
How Strattera works
3.
Before you use Strattera
4.
How to use Strattera
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Strattera
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT STRATTERA IS USED FOR
Strattera contains atomoxetine and is
used to treat attention-deficit and
hyperactivity disorder (ADHD).
ADHD is a behavioural disorder that
causes lack of focus and/or
hyperactivity that is much more
frequent or severe than others who are
close in age or development. Strattera
is used in:
•
children over six years of age
•
young people
•
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 drug
works or is safe in these people.
In adults, Strattera 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 STRATTERA WORKS
Strattera increases the amount of
noradrenaline in the brain. This is a
chemical in the brain that is produced
naturally, which increases attention
and decreases impulsiveness and
hyperactivity in patients with ADHD.
This medicine has been prescribed to
help control the symptoms of ADHD.
This medicine is not a stimulant and is
therefore not addictive.
It may take a few weeks after you start
the medicine for your symptoms to
fully improve.
BEFORE YOU USE STRATTERA
_- When you must not use it _
•
if you are allergic (hypersensitive)
to atomoxetine or any of the other
ingredients of Strattera.
•
if you t

Fitxa tècnica

Strattera Package Insert EU SPC 07 May 2015 and CDS 15 Aug 2014_11 Oct
2016_v1
1
STRATTERA
®
10 MG, 18 MG, 25 MG, 40 MG, OR 60 MG HARD CAPSULES
(ATOMOXETINE HCL)
1.
NAME OF THE MEDICINAL PRODUCT
STRATTERA 10 mg, 18 mg, 25 mg, 40 mg, or 60 mg hard capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is atomoxetine hydrochloride.
Each STRATTERA 10 mg, 18 mg, 25 mg, 40 mg, or 60 mg capsule contains
atomoxetine
hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, or 60 mg of
atomoxetine.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules.
STRATTERA 10 mg capsules are opaque white, are imprinted with “Lilly
3227” on the cap
and “10 mg” on the body in black ink
STRATTERA 18 mg capsules are gold (cap) and opaque white (body),
imprinted with “Lilly
3238” on the cap and “18 mg” on the body in black ink
STRATTERA 25 mg capsules are opaque blue (cap) and opaque white
(body), imprinted with
“Lilly 3228” on the cap and “25 mg” on the body in black ink
STRATTERA 40 mg capsules are opaque blue, imprinted with “Lilly
3229” on the cap and
“40mg” on the body in black ink
STRATTERA 60 mg capsules are opaque blue (cap) and gold (body),
imprinted with “Lilly
3239” on the cap and “60 mg” on the body in black ink
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
STRATTERA is indicated for the treatment
of
Attention-Deficit/Hyperactivity Disorder
(ADHD) in children 6 years of age and older, adolescents and adults
(see 5.1.). Diagnosis
should be made according to DSM-IV criteria or the guidelines in
ICD-10.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use. STRATTERA can be administered as a single daily dose in
the morning.
Patients who experience unwanted effects when taking STRATTERA as a
single daily dose
may benefit from taking it as twice daily evenly divided doses in the
morning and late
afternoon or early evening.
Dosing of Children and Adolescents up to 70 kg Body Weight
Strattera Package Insert EU SPC 07 May 2015 and CDS 15 Aug 2014_11 Oct
201