Atomoxetine

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Atomoxetine hydrochloride 5.715mg equivalent to atomoxetine 5mg

제공처:

Arrotex Pharmaceuticals (NZ) Limited

INN (International Name):

Atomoxetine hydrochloride 5.715 mg (equiv to atomoxetine 5mg)

복용량:

5 mg

약제 형태:

Capsule

구성:

Active: Atomoxetine hydrochloride 5.715mg equivalent to atomoxetine 5mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Gelatin   Iron oxide yellow   Magnesium stearate Opacode black S-1-277002 Starch Titanium dioxide  

처방전 유형:

Prescription

Manufactured by:

Aurobindo Pharma Limited

치료 징후:

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

제품 요약:

Package - Contents - Shelf Life: Blister pack, PVC/Aclar/Al blister enclosed in a secondary cardboard carton - 7 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Aclar/Al blister enclosed in a secondary cardboard carton - 14 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Aclar/Al blister enclosed in a secondary cardboard carton - 28 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Aclar/Al blister enclosed in a secondary cardboard carton - 56 capsules - 36 months from date of manufacture stored at or below 30°C

승인 날짜:

2016-05-06

환자 정보 전단

_ _
Atomoxetine capsules
_ _
_atomoxetine hydrochloride _
CONSUMER MEDICINE INFORMATION
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 shown on
the final page. More recent
information on this medicine may be
available. Make sure you speak to
your pharmacist or doctor to obtain
the most up to date information on
this medicine.. The updated leaflet
may contain important information
about atomoxetine and its use that
you should be aware of.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking atomoxetine
against the benefits it may have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
WHAT ATOMOXETINE IS
USED FOR
Atomoxetine 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 PRESCRIBED
FOR YOU. YOUR DOCTOR MAY HAVE
PRESCRIBED IT FOR ANOTHER
REASON.
Available evidence suggests that
atomoxetine does not have a
significant potential for abuse.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE
ATOMOXETINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ATOMOXETINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
atomoxetine hydrochloride
(the active ingredient)
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing; swelling of
the face, lips,

제품 특성 요약

NEW ZEALAND DATA SHEET
1.
NAME OF THE MEDICINAL PRODUCT
Atomoxetine (as hydrochloride) 5 mg, 10 mg, 18 mg, 25 mg, 40 mg, 60
mg, 80 mg and 100 mg
capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains atomoxetine as the hydrochloride salt
equivalent to: 5 mg, 10 mg, 18
mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg of atomoxetine.
For full list of excipients, see
SECTION 6.1.
3.
PHARMACEUTICAL FORM
Atomoxetine is available as capsules for oral administration.
5 mg capsules: Yellow capsule body and yellow cap with “5 mg”
printed on the capsule body in
black
10 mg capsules: White capsule body and white cap with “10 mg”
printed on the capsule body in
black
18 mg capsules: White capsule body and yellow cap with “18 mg”
printed on the capsule body in
black
25 mg capsules: White capsule body and blue cap with “25 mg”
printed on the capsule body in
black
40 mg capsules: Blue capsule body and blue cap with “40 mg”
printed on the capsule body in
black
60 mg capsules: Yellow capsule body and blue cap with “60 mg”
printed on the capsule body in
black
80 mg capsules: White capsule body and brown cap with “80 mg”
printed on the capsule body in
black
100 mg capsules: Brown capsule body and brown cap with “100 mg”
printed on the capsule body
in black
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
_INITIAL TREATMENT _
_PAEDIATRIC POPULATION_
_ _
Children and Adolescents up to 70 kg Body Weight
Atomoxetine should be initiated at a total daily dose of approximately
0.5 mg/kg and increased
after a minimum of three days to a target total daily dose of
approximately 1.2 mg/kg
administered either as a single daily dose in the morning or as evenly
divided doses in the
morning and late afternoon/early evening. After an additional two to
four weeks, the total dai