PAROXETINE AUROBINDO 30 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
14-03-2017
Summary of Product characteristics
(SPC)
14-03-2017
Active ingredient:
PAROXETINE
Available from:
Aurobindo Pharma Limited
ATC code:
N06AB05
INN (International Name):
PAROXETINE
Dosage:
30 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Selective serotonin reuptake inhibitors
Authorization status:
Authorised
Authorization date:
2008-05-30
Patient Information leaflet
_ _
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. 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
7.
1.
WHAT PAROXETINE AUROBINDO IS AND WHAT IT IS USED FOR
Paroxetine Aurobindo belongs to a group of medicines called Selective
Serotonin Reuptake Inhibitors
(SSRIs), which are antidepressants.
Paroxetine Aurobindo is used in the treatment of:
-
Depression (major depressive episodes).
-
Obsessive Compulsive Disorder (compulsive thoughts and compulsive
actions) (OCD).
-
Panic disorder with and without agoraphobia (e.g. fear of leaving the
house, entering shops, or
fear of public places).
-
Social phobia (overwhelming fear or avoidance of everyday social
situations).
-
Generalized anxiety disorder (more permanent present fear, in which
cronic nervous worring is
prominent).
-
Post-traumatic stress disorder (anxiety caused by a traumatic event).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PAROXETINE AUROBINDO
DO NOT TAKE PAROXETINE AUROBINDO
-
Ff you are allergic to paroxetine or any of the other ingredients of
this medicine (listed in
section 6).
-
If you are taking medicines called monoamine oxidase inhibitors
(MAOIs, including
moclobemide and methylth
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paroxetine Aurobindo 30 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30mg paroxetine (as paroxetine
hydrochloride hemihydrate).
Excipient with known effect: anhydrous lactose 14.25mg /film-coated
tablet.
For
the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Blue coloured film-coated 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.
-
Generalised anxiety disorder.
-
Post-traumatic stress disorder
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
It is recommended that paroxetine is administered once daily in the
morning with food.
The film-coated tablet should be swallowed rather than chewed.
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 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 from
symptoms.
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