Escitalopram Aurovitas Tablet, film coated 5mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ESCITALOPRAM

Available from:

Aurovitas Unipessoal Lda Avenida do Forte, Nº 3, Parque Suécia, Edifício IV, 2º, Carnaxide, 2794-038, Portugal

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:

Withdrawn

Authorization date:

2016-07-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM AUROVITAS 5 MG FILM-COATED TABLETS
ESCITALOPRAM AUROVITAS 10 MG FILM-COATED TABLETS
ESCITALOPRAM AUROVITAS 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 Aurovitas is and what it is used for
2.
What you need to know before you take Escitalopram Aurovitas
3.
How to take Escitalopram Aurovitas
4.
Possible side effects
5.
How to store Escitalopram Aurovitas
6.
Contents of the pack and other information
1.
WHAT ESCITALOPRAM AUROVITAS IS AND WHAT IT IS USED FOR
Escitalopram Aurovitas contains the active substance escitalopram.
Escitalopram Aurovitas 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 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 Escitalopram Aurovitas,
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 AUR

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Escitalopram Aurovitas 5 mg film-coated tablets
Escitalopram Aurovitas 10 mg film-coated tablets
Escitalopram Aurovitas 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 20 mg escitalopram (as oxalate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Escitalopram Aurovitas 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 Aurovitas 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 Aurovitas 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 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.
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