EXTINE 20 paroxetine (as hydrochloride) 20 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paroxetine hydrochloride, Quantity: 22.22 mg (Equivalent: paroxetine, Qty 20 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

paroxetine hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium starch glycollate; magnesium stearate; microcrystalline cellulose; mannitol; basic butylated methacrylate copolymer; titanium dioxide; purified talc; polyvinyl alcohol; sodium lauryl sulfate; glyceryl monostearate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression and for the prevention of relapse of depressive symptoms; Treatment of obsessive compulsive disorder and for the prevention of relapse of OCD; Treatment of panic disorder and for the prevention of relapse of panic disorder; Treatment of social anxiety disorder/ social phobia; Treatment of generalised anxiety disorder; and Treatment of post-traumatic stress disorder

Product summary:

Visual Identification: White, film-coated, oval, biconvex tablets with "X" scoreline "T" on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-07-26

Patient Information leaflet

EXTINE- Consumer Medicine Information
Page 1 of 6
EXTINE
paroxetine (as hydrochloride)
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EXTINE.
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 benefits and
risks. Your doctor has weighed the
risks of you taking EXTINE against
the benefits they expect it will have
for you.
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to read
it again.
WHAT EXTINE IS USED FOR
EXTINE is used to:
•
treat depression
•
treat irrational fears or
obsessional behaviour
•
prevent panic attacks
•
treat patients who avoid or are
fearful of social situations
•
treat patients with excessive
anxiety and worry, and who feel
irritable, restless, and/or tense in
the muscles
•
treat repetitive and distressing
recollections of a past traumatic
event.
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 wake up early, have
low energy and feel guilty over
nothing. EXTINE corrects the
chemical imbalance and so helps
relieving the symptoms of
depression.
EXTINE 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.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS
BEEN PRESCRIBED FOR YOU.
It is not recommended to treat
depression in children and
adolescents under 18 (see

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – EXTINE (PAROXETINE (AS
HYDROCHLORIDE)) TABLET
1
NAME OF THE MEDICINE
Paroxetine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EXTINE tablets come in three strengths and contain either 10 mg, 20 mg
or 30 mg of paroxetine (as
hydrochloride).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
EXTINE 10
Oval, yellow film-coated tablet with “PX 10” on one side and “
>
” on the other side.
EXTINE 20
Oval, white film-coated tablet with “X

T” on one side and blank on the other side.
EXTINE 30
Oval, blue film-coated tablet with “PX 30” on one side and “
>
” on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
EXTINE is indicated in 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
•
Posttraumatic Stress Disorder.
4.2
D
OSE AND METHOD OF ADMINISTRATION
It is recommended that EXTINE be administered once daily in the
morning with food. The tablets
should be swallowed rather than chewed.
2
DEPRESSION
The recommended dose of EXTINE is 20 mg 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 two or
three weeks of initiation of therapy and thereafter as judged
clinically appropriate. Dose changes
should occur at intervals of at least one 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 answer the
question of how long the patient tre