APX-PAROXETINE paroxetine (as hydrochloride) 20 mg tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

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

Sẵn có từ:

Arrotex Pharmaceuticals Pty Ltd

Dạng dược phẩm:

Tablet, film coated

Thành phần:

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

Tuyến hành chính:

Oral

Các đơn vị trong gói:

30 tablets

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2020-02-21

Tờ rơi thông tin

APX-PAROXETINE- Consumer Medicine Information
Page 1 of 6
APX-PAROXETINE
paroxetine (as hydrochloride)
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APX-PAROXETINE.
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 APX-
PAROXETINE 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 APX-PAROXETINE
IS USED FOR
APX-PAROXETINE 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. APX-PAROXETINE corrects
the chemical imbalance and so
helps relieving the symptoms of
depression.
APX-PAROXETINE 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 recommen

Đặc tính sản phẩm

1
AUSTRALIAN PRODUCT INFORMATION – APX-PAROXETINE
(PAROXETINE (AS HYDROCHLORIDE)) TABLET
1
NAME OF THE MEDICINE
Paroxetine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-PAROXETINE tablets contain 20 mg of paroxetine (as hydrochloride).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
APX-PAROXETINE 20MG Oval, white film-coated tablet with “X

T” on one side and blank on the other
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
APX-PAROXETINE 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 APX-PAROXETINE be administered once daily in
the morning with food. The
tablets should be swallowed rather than chewed.
2
DEPRESSION
The recommended dose of APX-PAROXETINE 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 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