Apo-Atomoxetine

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Atomoxetine hydrochloride 28.5mg equivalent to atomoxetine 25 mg

متاح من:

Arrotex Pharmaceuticals (NZ) Limited

INN (الاسم الدولي):

Atomoxetine hydrochloride 28.5 mg (equivalent to atomoxetine 25 mg)

جرعة:

25 mg

الشكل الصيدلاني:

Capsule

تركيب:

Active: Atomoxetine hydrochloride 28.5mg equivalent to atomoxetine 25 mg Excipient: Gelatin   Indigo carmine Iron oxide yellow Starch TekPrint black SW-9008 TekPrint black SW-9009 Titanium dioxide   Water  

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

Apotex Pharmachem Inc

الخصائص العلاجية:

Indicated for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) as defined by DSM-IV criteria in children 6 years of age and older, adolescents and adults.

ملخص المنتج:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC clear film 10ML 250/60, with aluminium foil - 28 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, 950cc HDPE round, white, opaque bottle. Blue or White polypropylene screw cap 53mm-400mm with liner - 1000 capsules - 24 months from date of manufacture stored at or below 25°C

تاريخ الترخيص:

2013-12-12

نشرة المعلومات

APO-Atomoxetine Capsules - Consumer Medicine Information
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
APO-ATOMOXETINE
CAPSULES
_Contains the active ingredient atomoxetine (as hydrochloride) _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about atomoxetine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet. You may want to
read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Atomoxetine capsules. It contains the
active ingredient atomoxetine (as
hydrochloride).
It is used to treat Attention Deficit
Hyperactivity Disorder (ADHD) in
children 6 years and older,
adolescents and adults. 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.
Atomoxetine works by acting on
brain chemicals called amines which
are involved in controlling
behaviour.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN CHOSEN FOR YOU. YOUR
DOCTOR MAY HAVE GIVEN YOU THIS
MEDICINE FOR ANOTHER REASON.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
THIS MEDICINE
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN THIS
MEDICINE IF:
•
YOU HAVE OR HAV

خصائص المنتج

NEW ZEALAND DATA SHEET
APO-ATOMOXETINE
1. PRODUCT NAME
Atomoxetine (as hydrochloride)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100
mg of atomoxetine
(as hydrochloride), as the active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Atomoxetine hydrochloride is available as capsules for oral
administration. The capsules contain
a white to off-white powder.
APO-ATOMOXETINE 10mg is hard gelatin capsule with white opaque body
and white opaque
cap. Imprinted “APO AM10” in black ink.
APO-ATOMOXETINE 18mg is hard gelatin capsule with white opaque body
and gold opaque
cap. Imprinted “APO AM18” in black ink.
APO-ATOMOXETINE 25mg is hard gelatin capsule with white opaque body
and blue opaque
cap. Imprinted “APO AM25” in black ink.
APO-ATOMOXETINE 40mg is hard gelatin capsule with blue opaque body and
blue opaque
cap. Imprinted “APO AM40” in black ink.
APO-ATOMOXETINE 60mg is hard gelatin capsule with gold opaque body and
blue opaque
cap. Imprinted “APO AM60” in black ink
APO-ATOMOXETINE 80mg is hard gelatin capsule with white opaque body
and orange
opaque cap. Imprinted “APO AM80” in black ink.
APO-ATOMOXETINE 100mg is hard gelatin capsule with orange opaque body
and orange
opaque cap. Imprinted “APO AM100” in black ink.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APO-ATOMOXETINE is indicated for the treatment of
Attention-Deficit/Hyperactivity Disorder
(ADHD) as defined by DSM-IV criteria in children 6 years of age and
older, adolescents and
adults.
4.2 DOSE AND METHOD OF ADMINISTRATION
INSTRUCTIONS FOR USE/HANDLING
APO-ATOMOXETINE capsules are not intended to be opened. Atomoxetine
hydrochloride
is an ocular irritant. In the event of capsule content coming in
contact with the eye, the
affected eye
should
be
flushed
immediately
with
water,
and
medical
advice
obtained.
Hands and any potentially contaminated surfaces should be washed as
soon as possible.
NEW ZEALAND D