BLOOMS THE CHEMIST PAROXETINE paroxetine (as hydrochloride) 20mg tablet blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

paroxetine hydrochloride, Quantity: 22.2 mg

Հասանելի է:

Sandoz Pty Ltd

Դեղագործական ձեւ:

Tablet, film coated

Կազմը:

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

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

30 tablets

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

Paroxetine 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.

Ապրանքի ամփոփագիր:

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

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2022-10-21

Տեղեկատվական թերթիկ

Blooms The Chemist Paroxetine
1
BLOOMS THE CHEMIST PAROXETINE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BLOOMS THE CHEMIST PAROXETINE?
Blooms The Chemist Paroxetine contains the active ingredient
paroxetine hydrochloride. Blooms The Chemist Paroxetine is used
to treat depression, or social anxiety disorder/social phobia, general
irrational fears, obsessional behaviour, post-traumatic
stress disorder and prevent panic attacks.
For more information, see Section 1. Why am I using Blooms The Chemist
Paroxetine?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BLOOMS THE CHEMIST PAROXETINE?
Do not use if you have ever had an allergic reaction to Blooms The
Chemist Paroxetine or any of the ingredients listed at the end
of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Blooms The Chemist Paroxetine?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Blooms The Chemist Paroxetine and
affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE BLOOMS THE CHEMIST PAROXETINE?
•
The usual dose for depression or social anxiety disorder/social phobia
is one Blooms The Chemist Paroxetine tablet
(paroxetine 20 mg) per day.
•
To treat obsessions and compulsions or panic attacks, the usual dose
of Blooms The Chemist Paroxetine is two 20 mg tablets
per day.
•
Your doctor may increase the dose slowly over several weeks. This may
require you to break the tablet in half.
More instructions can be found in Section 4. How do I use Blooms The
Chemist Paroxetine?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BLOOMS THE CHEMIST PAROXETINE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dent

Ապրանքի հատկությունները

221021-bloomsthechemist-paroxetine-pi
Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
BLOOMS THE CHEMIST PAROXETINE (PAROXETINE HYDROCHLORIDE)
FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Paroxetine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Blooms The Chemist Paroxetine 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
Blooms The Chemist Paroxetine 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
Blooms The Chemist Paroxetine 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.
221021-bloomsthechemist-paroxetine-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 se