Escitalopram-Teva 20mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ESCITALOPRAM

Available from:

Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC code:

N06AB10

INN (International Name):

ESCITALOPRAM 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ESCITALOPRAM 20 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2009-06-17

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM TEVA 5 MG FILM-COATED TABLETS
ESCITALOPRAM TEVA 10 MG FILM-COATED TABLETS
ESCITALOPRAM TEVA 15 MG FILM-COATED TABLETS
ESCITALOPRAM TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Escitalopram Teva
3.
How you take Escitalopram Teva
4.
Possible side effects
5.
How to store Escitalopram Teva
6.
Contents of the pack and other information
1
WHAT ESCITALOPRAM TEVA IS AND WHAT IT IS USED FOR_ _
Escitalopram Teva 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. Disturbances in the serotonin-system are considered
an important factor in the
development of depression and related diseases.
Escitalopram Teva contains escitalopram and is 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).
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESCITALOPRAM TEVA
DO NOT TAKE ESCITALOPRAM TEVA

if you are allergic to escitalopram or any of the other ingredients of
this medicine (listed in
section 6).

if you take other medicines that belongs to a group called MAO
inhibitors, including
selegiline (used in the treatment of Parkinso

Summary of Product characteristics

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Escitalopram Teva 5 mg Film-coated Tablets
Escitalopram Teva 10 mg Film-coated Tablets
Escitalopram Teva 15 mg Film-coated Tablets
Escitalopram Teva 20 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Escitalopram Teva 5 mg: Each film-coated tablet contains 5 mg
escitalopram (as oxalate).
Escitalopram Teva 10 mg: Each film-coated tablet contains 10 mg
escitalopram (as oxalate).
Escitalopram Teva 15 mg: Each film-coated tablet contains 15 mg
escitalopram (as oxalate).
Escitalopram Teva 20 mg: 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 Teva 5 mg: White, round, biconvex film-coated tablet,
debossed with “93” on one
side and “7414” on the other side.
Escitalopram Teva 10 mg: White, round, biconvex film-coated tablet,
scored on one side and
debossed with “9” on the left side of the score and “3” on the
right side of the score. The other side
of the tablet is debossed with “7462”.
The tablet can be divided into equal halves.
Escitalopram Teva 15 mg: White, round, biconvex film-coated tablet,
scored on one side and
debossed with “S” on the left side of the score and “C” on the
right side of the score. The other side
of the tablet is debossed with “15”.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
Escitalopram Teva 20 mg: White, round, biconvex film-coated tablet,
scored on one side and
debossed with “9” on the left side of the score and “3” on the
right side of the score. The other side
of the tablet is debossed with “7463”.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes
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Treatment of panic disorder with or without agoraphobia.
Treatment of social anxiety disorder (social phobia).
Treatment of ge