AROPAX paroxetine 20mg (as hydrochloride) tablet blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

paroxetine hydrochloride hemihydrate, Quantity: 22.88 mg (Equivalent: paroxetine, Qty 20 mg)

Pieejams no:

Aspen Pharmacare Australia Pty Ltd

Zāļu forma:

Tablet, film coated

Kompozīcija:

Excipient Ingredients: sodium starch glycollate; magnesium stearate; calcium hydrogen phosphate dihydrate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400

Ievadīšanas:

Oral

Vienības iepakojumā:

10 tablets (sample pack), 30 tablets

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

AROPAX is indicated for treatment of major depression and for the prevention of relapse of depressive symptoms; Obsessive Compulsive Disorder and for the prevention of relapse of OCD; Panic Disorder and for the prevention of relapse of Panic Disorder; Social Anxiety Disorder/Social Phobia; Generalised Anxiety Disorder; and Posttraumatic Stress Disorder.

Produktu pārskats:

Visual Identification: White film coated oval shaped biconvex tablet debossed with "20" on one side and a break bar on the other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizācija statuss:

Licence status A

Autorizācija datums:

1997-01-15

Lietošanas instrukcija

AROPAX
®
1
AROPAX
®
_paroxetine (as hydrochloride hemihydrate) 20 mg tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AROPAX. It does
not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you taking
AROPAX against the risks this
medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS AROPAX 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.
Depression 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 may also be used to treat
irrational fears or obsessional
behaviour. These can also be due to
chemical imbalance in parts of the
brain.
AROPAX may also be used to help
prevent panic attacks.
AROPAX may also be used to treat
patients who may avoid and/or are
fearful of social situations.
AROPAX may also be used to treat
patients who have excessive anxiety
and worry, and who feel irritable,
restless, and/or tense in the muscles.
AROPAX may also be used to treat
repetitive and distressing
recollections of a past traumatic
event.
Your doctor may decide that you
should continue to use AROPAX for
some time, even when you have

Produkta apraksts

1
AUSTRALIAN PRODUCT INFORMATION
AROPAX (PAROXETINE (AS HYDROCHLORIDE)) TABLETS
1
NAME OF THE MEDICINE
Paroxetine hydrochloride hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AROPAX tablets contain 20 mg paroxetine (as hydrochloride hemihydrate)
as the active
ingredient. They also contain calcium hydrogen phosphate dihydrate,
magnesium stearate,
opadry white YS-1R-7003 (PI) and sodium starch glycollate as
excipients.
3
PHARMACEUTICAL FORM
AROPAX are white, film-coated oval shaped biconvex tablets, debossed
with “20” on one side
and a break bar on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
AROPAX is indicated for the treatment of:
•
major depression and for the prevention of relapse of depressive
symptoms;
•
Obsessive Compulsive Disorder and for the prevention of relapse of
OCD;
•
Panic Disorder and for the prevention of relapse of Panic Disorder;
•
Social Anxiety Disorder/Social Phobia;
•
Generalised Anxiety Disorder; and
•
Post-traumatic Stress Disorder.
4.2
D
OSE AND METHOD OF ADMINISTRATION
It is recommended that paroxetine is administered once daily in the
morning with food. The
tablet should be swallowed rather than chewed.
DEPRESSION
The recommended dose of AROPAX is 20 mg (1 AROPAX tablet) daily. Many
patients will
respond to a 20 mg daily dose. Patients not responding to a 20 mg dose
may benefit from
dose increases in 10 mg/day increments, up to a maximum of 50 mg/day
according to the
patient's response.
As with all antidepressant drugs, dosage should be reviewed and
adjusted if necessary
within 2 to 3 weeks of initiation of therapy and thereafter as judged
clinically appropriate.
Dose changes should occur at intervals of at least 1 week.
It is generally recommended that a course of antidepressant drug
treatment should continue
for a sufficient period, often for several months. There is no body of
evidence available to
2
answer the question of how long the patient treated with paroxetine
should remain on it. It is
generally agreed that acute episodes of depressi