Cipralex 5mg film coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ESCITALOPRAM

Available from:

H. Lundbeck A.S. 9 Ottiliavej, 2500 Valby, Copenhagen, Denmark

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:

2006-11-21

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPRALEX 5 MG FILM-COATED TABLETS
CIPRALEX 10 MG FILM-COATED TABLETS
CIPRALEX 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 Cipralex is and what it is used for
2.
What you need to know before you take Cipralex
3.
How to take Cipralex
4.
Possible side effects
5.
How to store Cipralex
6.
Contents of the pack and other information
1.
WHAT CIPRALEX IS AND WHAT IT IS USED FOR
_ _
Cipralex contains the active substance escitalopram. Cipralex 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.
Cipralex 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).
It may take a couple of weeks before you start to feel better.
Continue to take Cipralex, 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 CIPRALEX
DO NOT TAKE CIPRALEX
•
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 called MAO
inhibitors, including selegiline (used
in the treatment of Parkinson´s diseas

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
CIPRALEX 5 mg film-coated tablets
CIPRALEX 10 mg film-coated tablets
CIPRALEX 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cipralex 5 mg: Each tablet contains 5 mg escitalopram (as oxalate)
Cipralex 10 mg: Each tablet contains 10 mg escitalopram (as oxalate)
Cipralex 20 mg: Each tablet contains 20 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Cipralex 5 mg: Round, white, film-coated tablet of 6 mm marked with
"EK" on one side.
Cipralex 10 mg: Oval, white, scored, film-coated tablet of 8x5.5 mm
marked with "E” and “L" on
each side of the score on one side of the tablet.
Cipralex 20 mg: Oval, white, scored, film-coated tablet of 11.5x7 mm
marked with "E” and “N" on
each side of the score on one side of the tablet.
The 10, 15 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 episodes _
Usual dosage is 10 mg once daily. Depending on individual patient
response, the dose may be
increased to a maximum of 20 mg daily.
Usually 2-4 weeks are necessary to obtain antidepressant response.
After the symptoms resolve,
treatment for at least 6 months is required for consolidation of the
response.
_Panic disorder with or without agoraphobia _
An initial dose of 5 mg is recommended for the first week before
increasing the dose to 10 mg daily.
The dose may be further increased, up to a maximum of 20 mg daily,
dependent on individual patient
response.
Maximum effectiveness is reached after about 3 months. The treatme