PAROXETINE SANDOZ paroxetine (as hydrochloride) 20mg tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

paroxetine hydrochloride, Quantity: 22.2 mg

Sẵn có từ:

Sandoz Pty Ltd

Dạng dược phẩm:

Tablet, film coated

Thành phần:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; mannitol; titanium dioxide; sodium starch glycollate; colloidal anhydrous silica; hypromellose; copovidone; purified talc

Tuyến hành chính:

Oral

Các đơn vị trong gói:

30 tablets

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

Paroxetine Sandoz is indicated for the treatment of : - Major Depression and for the prevention of relapse of depressive symptoms - Obsessive Compulsive Disorder (OCD) and prevention of relapse of OCD - Panic Disorder and for the prevention of relapse of Panic Disorder - Social Anxiety Disorder/Social Phobia - General Anxiety Disorder - Post-traumatic Stress Disorder.

Tóm tắt sản phẩm:

Visual Identification: White, round bi-sected film-coated tablet with a one-sided breaking notch ("Snap-tab") and embossment 'PX 20' on opposite side, intact surface.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2002-05-09

Tờ rơi thông tin

PAROXETINE SANDOZ
®
1
PAROXETINE SANDOZ
®
_paroxetine hydrochloride tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Paroxetine Sandoz.
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 this medicine
against the benefits it is expected to
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 PAROXETINE
SANDOZ IS USED
FOR
The name of your medicine is
Paroxetine Sandoz. It contains the
active ingredient paroxetine
hydrochloride.
Paroxetine hydrochloride belongs to
a group of medicines called selective
serotonin reuptake inhibitors (SSRIs)
antidepressants. They are thought to
work by their action on brain
chemicals called amines which are
involved in controlling mood.
Depression is longer lasting and/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, loss of interest in
usual activities, being unable to enjoy
life, have poor appetite or over eat,
disturbed sleep, often waking up
early, loss of sex drive, low energy
and feeling guilty over nothing.
Paroxetine Sandoz may also be used
to treat irrational fears or obsessional
behaviour. These can also be due to
chemical imbalance in parts of the
brain.
Paroxetine Sandoz may also be used
to help prevent panic attacks.
Paroxetine Sandoz may also be used
to treat patients who may avoid
and/or are fearful of social situations.
Paroxetine Sandoz may also be used
to treat patients who have excessive
anxiety and worry, and who feel
irritable, restless, and/or tense in the
muscles.
Paroxetine Sandoz may also be used
to treat repetitive and

Đặc tính sản phẩm

210604-paroxetine-sandoz-pi
Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
PAROXETINE SANDOZ
® (PAROXETINE HYDROCHLORIDE) FILM-COATED
TABLETS
1.
NAME OF THE MEDICINE
Paroxetine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Paroxetine Sandoz film-coated tablet contains 22.2 mg of
paroxetine hydrochloride
equivalent to 20 mg paroxetine.
_Excipient with known effect: _
Mannitol.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Paroxetine Sandoz tablets are white, round bi-sected film-coated
tablets with a one-sided
breaking notch ("Snap-tab") and embossment 'PX 20' on opposite side,
intact surface.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Paroxetine Sandoz is indicated for the treatment of:
•
Major Depression and for the prevention of relapse of depressive
symptoms
•
Obsessive Compulsive Disorder (OCD) and prevention of relapse of OCD
•
Panic Disorder and for the prevention of relapse of Panic Disorder
•
Social Anxiety Disorder/Social Phobia
•
General Anxiety Disorder
•
Post-traumatic Stress Disorder.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
It is recommended that paroxetine be administered once daily in the
morning with food. The
tablet should be swallowed rather than chewed.
_ADULTS _
_DEPRESSION _
The recommended dose 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.
210604-paroxetine-sandoz-pi
Page 2 of 28
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
th