Aropax

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Paroxetine hydrochloride 22.8mg equivalent to 20 mg Paroxetine;  

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Paroxetine hydrochloride 22.8 mg (Equiv to 20 mg Paroxetine)

Dosage:

20 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Paroxetine hydrochloride 22.8mg equivalent to 20 mg Paroxetine   Excipient: Calcium hydrogen phosphate dihydrate Magnesium stearate Opadry white YS-1-7003 Sodium starch glycolate

Units in package:

Blister pack, PVC x Al, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aesica Pharmaceuticals Limited

Therapeutic indications:

AROPAX is indicated for the treatment of major depressive disorder (MDD). AROPAX is indicated for the prevention of relapse and also recurrence of further depressive episodes.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC x Al - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Child resistant PVC/Al/paper - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1990-07-09

Patient Information leaflet

1
AROPAX
_paroxetine tablets, 20 mg _
CONSUMER MEDICINE INFORMATION LEAFLET
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about AROPAX. It
does not contain all the available
information. It does not take the place
of talking to your doctor or
pharmacist.
Please read this leaflet before you start
taking AROPAX. If you are helping
someone else take AROPAX, please
read this leaflet before you give the
first dose.
All medicines have risks and benefits.
Your doctor has weighed the expected
benefits of taking AROPAX against
the possible risks. If you have any
concerns, speak to your doctor.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICATION.
You may want to read it again.
WHAT AROPAX IS USED
FOR
The name of your medicine is
AROPAX; it is also known as
paroxetine.
AROPAX belongs to a group of
medicines called selective serotonin
reuptake inhibitor (SSRI)
antidepressants. They are thought to
work by their action on brain
chemicals called amines, which are
involved in controlling mood.
Major depressive disorder is longer
lasting or more severe than the ‘low
moods’ that everyone has from time to
time. It is thought to be caused by a
chemical imbalance in parts of the
brain. This imbalance affects your
whole body and can cause emotional
and physical symptoms. You may feel
low in spirit, lose interest in usual
activities, be unable to enjoy life, have
poor appetite or over eat, have
disturbed sleep, often waking up early,
low energy and feel guilty over
nothing. AROPAX corrects the
chemical imbalance and so helps
relieve the symptoms of major
depressive disorder.
AROPAX may also be used to treat
irrational fears, general anxiety and
obsessive behaviour. These can also
be due to chemical imbalances in parts
of the brain.
AROPAX may also be used to treat
the symptoms of panic attacks. When
taken regularly it will help prevent the
attacks.
AROPAX may also be used to treat
patients who may avoid and/or are
fearful of social sit

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
AROPAX paroxetine 20 mg film coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 22.8 mg of paroxetine hydrochloride
hemihydrate
equivalent to 20 mg of paroxetine free base.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film coated tablet
White, film coated, oval shaped biconvex tablets de-bossed with
“20” on one side
and a break bar on the other to enable the tablets to be broken in
half if required.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ADULTS AGED 18 YEARS AND OLDER _
Major Depressive Disorder:
AROPAX is indicated for the treatment of major depressive disorder
(MDD).
AROPAX is indicated for the prevention of relapse and also recurrence
of further
depressive episodes (see section 5 Pharmacological Properties).
Obsessive Compulsive Disorder:
AROPAX is indicated for the treatment of Obsessive Compulsive Disorder
(OCD)
(see section 5 Pharmacological Properties).
Panic Disorder:
AROPAX is indicated for the treatment of Panic Disorder with and
without
agoraphobia (see section 5 Pharmacological Properties).
Social Anxiety Disorder/Social Phobia:
AROPAX has been shown to be effective in the treatment of Social
Anxiety
Disorder/Social Phobia.
Generalised Anxiety Disorder:
AROPAX has been shown to be effective in the treatment of Generalised
Anxiety
Disorder (see section 5 Pharmacological Properties).
2
Post-Traumatic Stress Disorder:
AROPAX has been shown to be effective in the treatment of
Post-Traumatic Stress
Disorder.
_CHILDREN AND ADOLESCENTS (<18 YEARS) _
AROPAX is not indicated for use in children or adolescents aged <18
years (see
section 4.4 Special warnings and precautions for use).
Controlled clinical studies in children and adolescents with major
depressive disorder
failed to demonstrate efficacy, and do not support the use of AROPAX
in the
treatment of depression in this population (see section 4.4 Special
warnings and
precautions for use).
The safety and efficacy