PAXTINE paroxetine 20mg (as hydrochloride) tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

paroxetine hydrochloride, Quantity: 22.21 mg (Equivalent: paroxetine, Qty 20 mg)

Tilgængelig fra:

Alphapharm Pty Ltd

INN (International Name):

paroxetine hydrochloride

Lægemiddelform:

Tablet, film coated

Sammensætning:

Excipient Ingredients: calcium hydrogen phosphate; sodium starch glycollate; colloidal anhydrous silica; magnesium stearate; purified talc; titanium dioxide; methacrylic acid copolymer

Indgivelsesvej:

Oral

Enheder i pakken:

30 tablets

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Major depression and prevention of relapse of depressive symptoms. Obsessive compulsive disorder (OCD) and prevention of relapse of OCD. Panic disorder and prevention of relapse of panic disorder. Social anxiety disorder/social phobia.

Produkt oversigt:

Visual Identification: White, round film-coated tablet marked P/2 and G; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Licence status A

Autorisation dato:

2014-10-24

Indlægsseddel

PAXTINE
_paroxetine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PAXTINE. It does
not contain all 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 risks of you taking PAXTINE
against the benefits they expect it
will 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 PAXTINE IS USED
FOR
This medicine contains the active
ingredient paroxetine.
This medicine belongs to a group of
medicines called selective serotonin
reuptake inhibitors (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 your usual
activities, be unable to enjoy life,
have a poor appetite or over eat, have
disturbed sleep, often waking up
early, low energy and feel guilty over
nothing.
PAXTINE may be used to treat
irrational fears or obsessional
behaviour. These can also be due to
chemical imbalance in parts of the
brain.
PAXTINE may be used to help
prevent panic attacks.
PAXTINE may be used to treat
patients who may avoid and/or are
fearful of social situations.
Your doctor may decide that you
should continue to use PAXTINE for
some time, even when you have
overcome your problem. This should
prevent the problem from returning.
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.
BEFORE YOU TAKE
PAXTINE
ANTIDEPRESSANTS CAN INCREASE
SUICIDAL THOUGHTS AND ACTIONS IN
SOME

Produktets egenskaber

AUSTRALIAN PRODUCT INFORMATION
PAXTINE
_paroxetine hydrochloride film coated tablet _
1
NAME OF THE MEDICINE
Paroxetine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PAXTINE tablet contains 20 mg of paroxetine (as hydrochloride) as
the active ingredient.
Excipients of known effect: sulfites.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
PAXTINE 20 mg white film coated tablets are convex, debossed “P

2” on one side and “G” on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PAXTINE is indicated for the treatment of:
•
Major depression and prevention of relapse of depressive symptoms
•
Obsessive Compulsive Disorder (OCD) and prevention of relapse of OCD
•
Panic Disorder and prevention of relapse of Panic Disorder
•
Social Anxiety Disorder/Social Phobia
4.2
DOSE 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 paroxetine is 20 mg (1 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 or 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 answer the question of how long
the patient treated with paroxetine should remain on it. It is
generally agreed that acute episodes of depression
require several months or longer of sustained drug therapy. Whether
the dose of an antidepressant needed to
induce remission is identical to the dose needed to ma