Paroxetine Aurobindo 20 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PAROXETINE HYDROCHLORIDE, HEMIHYDRATE

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

N06AB05

INN (International Name):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2016-10-18

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PAROXETINE AUROBINDO 20 MG FILM-COATED TABLETS
PAROXETINE AUROBINDO 30 MG FILM-COATED TABLETS
Paroxetine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor,or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Paroxetine Aurobindo
is and what it is used for
2.
What you need to know before you take Paroxetine Aurobindo
3.
How to take Paroxetine Aurobindo
4.
Possible side effects
5.
How to store Paroxetine Aurobindo
6.
Contents of the pack and other information
1.
WHAT PAROXETINE AUROBINDO IS AND WHAT IT IS USED FOR
PAROXETINE AUROBINDO IS A TREATMENT FOR ADULTS WITH DEPRESSION AND/OR
ANXIETY DISORDERS.
: The
anxiety disorders that Paroxetine Aurobindo is used to treat are:
obsessive compulsive disorder
(repetitive, obsessive thoughts with uncontrollable behaviour); panic
disorder (panic attacks,
including those caused by agoraphobia, which is a fear of open
spaces); social anxiety disorder (fear
or avoidance of social situations); post-traumatic stress disorder
(anxiety caused by a traumatic event);
and generalised anxiety disorder (generally feeling very anxious or
nervous).
Paroxetine Aurobindo is one of a group of medicines called SSRIs
(selective serotonin reuptake
inhibitors). Everyone has a substance called serotonin in their brain.
People who are depressed or
anxious have lower levels of serotonin than others. It is not fully
understood how Paroxetine
Aurobindo and other SSRIs work but they may help by increasing the
level of serotonin in the brain.
Treating depression or anxiety d

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paroxetine Aurobindo
20 mg film-coated tablets
Paroxetine Aurobindo 30 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg paroxetine (as paroxetine
hydrochloride hemihydrate).
Excipient with known effect: Lactose monohydrate 10 mg /film-coated
tablet.
Each film-coated tablet contains 30 mg paroxetine (as paroxetine
hydrochloride hemihydrate).
Excipient with known effect: Lactose monohydrate 15 mg /film-coated
tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_ _
_20 mg:_
White to off-white colored film-coated modified capsule shaped,
biconvex tablets debossed with ‘56’
on one side and ‘C’ with a deep break line on the other side. The
tablet can be divided into equal
doses.
_30 mg:_
Blue coloured film-coated modified capsule shaped, biconvex tablets
debossed with ‘F’ on one side
and ‘12’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of
- Major depressive episode.
- Obsessive Compulsive Disorder (OCD).
- Panic disorder with and without agoraphobia.
- Social anxiety disorders/social phobia.
- Generalized anxiety disorder.
- Post-traumatic stress disorder
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
POSOLOGY
_MAJOR DEPRESSIVE EPISODES _
_ _
The recommended dose is 20 mg daily. In general, improvement in
patients starts after one week but
may only become evident from the second week of therapy.
As with all antidepressant medicinal products, dosage should be
reviewed and adjusted if necessary
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within 3 to 4 weeks of initiation of therapy and thereafter as judged
clinically appropriate. In some
patients, with insufficient response to 20 mg, the dose may be
increased gradually up to a maximum
of 50 mg a day in 10 mg steps according to the patient’s response.
Patients with depression should be treated for a sufficient period of
at least 6 months to ensure that
they are free