Escitalopram 5mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ESCITALOPRAM

Available from:

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

ATC code:

N06AB10

INN (International Name):

ESCITALOPRAM 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ESCITALOPRAM 5 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2013-08-01

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM 5 MG FILM-COATED TABLETS
ESCITALOPRAM 10 MG FILM-COATED TABLETS
ESCITALOPRAM 15 MG FILM-COATED TABLETS
ESCITALOPRAM 20 MG FILM-COATED TABLETS
escitalopram
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 Escitalopram is and what it is used for
2.
What you need to know before you take Escitalopram
3.
How to take Escitalopram
4.
Possible side effects
5.
How to store Escitalopram
6.
Contents of the pack and other information
1.
WHAT ESCITALOPRAM IS AND WHAT IT IS USED FOR
Escitalopram contains the active substance escitalopram. Escitalopram
belongs to a group of
antidepressants called selective serotonin reuptake inhibitors
(SSRIs). These medicines act on the
serotonin-system in the brain by increasing the serotonin level.
Escitalopram used to treat depression (major depressive episodes) and
anxiety disorders (such as
panic disorder with or without agoraphobia, social anxiety disorder,
generalised anxiety disorder and
obsessive-compulsive disorder).
It may take a couple of weeks before you start to feel better.
Continue to take Escitalopram, even if it
takes some time before you feel any improvement in your condition.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESCITALOPRAM
_ _
DO NOT TAKE ESCITALOPRAM:
-
if you are allergic to escitalopram or any of the other ingredients of
this medicine (listed in
section 6).
-
if you take other medicines which belong to a group

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Escitalopram 5 mg film-coated tablets
Escitalopram 10 mg film-coated tablets
Escitalopram 15 mg film-coated tablets
Escitalopram 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg escitalopram (as oxalate).
Each film-coated tablet contains 10 mg escitalopram (as oxalate).
Each film-coated tablet contains 15 mg escitalopram (as oxalate).
Each film-coated tablet contains 20 mg escitalopram (as oxalate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Escitalopram 5 mg:_
White to off – white colored, round shaped [diameter 5.6 mm], film-
coated, biconvex tablets debossed with ‘F’ on one side and
‘53’ on the other side.
_Escitalopram 10 mg:_
White to off – white colored, oval shaped, film-coated, biconvex
tablets
debossed with ‘F’ on one side and ‘54’ on the other side with
a deep scoreline between ‘5’
and ‘4’. The size is 8.1 mm X 5.6 mm.
_Escitalopram 15 mg:_
White to off – white colored, oval shaped, film-coated, biconvex
tablets
debossed with ‘F’ on one side and ‘55’ on the other side with
a deep scoreline between ‘5’
and ‘5’. The size is 9.8 mm X 6.3 mm.
_Escitalopram 20 mg:_
White to off – white colored, oval shaped, film-coated, biconvex
tablets
debossed with ‘F’ on one side and ‘56’ on the other side with
a deep scoreline between ‘5’
and ‘6’. The size is 11.6 mm X 7.1 mm.
The 10 mg, 15 mg and 20 mg tablets
can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
Treatment of panic disorder with or without agoraphobia.
Treatment of social anxiety disorder (social phobia).
Treatment of generalised anxiety disorder.
Treatment of obsessive-compulsive disorder.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Safety of daily doses above 20 mg has not been demonstrated.
Major depressive epi