ESCITALOPRAM BIOORGANICS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESCITALOPRAM OXALATE

Available from:

BioOrganics BV

ATC code:

N06AB10

INN (International Name):

ESCITALOPRAM OXALATE

Dosage:

15 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

escitalopram

Authorization status:

Not Marketed

Authorization date:

2010-10-15

Patient Information leaflet

Date: 03-03-14
Pg 1 of 10
M13.1_03.ECM.hox.tab.002.09.IE.201.01
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM BIOORGANICS 10 MG FILM-COATED TABLETS
ESCITALOPRAM BIOORGANICS 15 MG FILM-COATED TABLETS
ESCITALOPRAM BIOORGANICS 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 BioOrganics is and what it is used for
2.
What you need to know before you take Escitalopram BioOrganics
3.
How to take Escitalopram BioOrganics
4.
Possible side effects
5.
How to store Escitalopram BioOrganics
6.
Contents of the package and other information
1.
WHAT ESCITALOPRAM BIOORGANICS IS AND WHAT IT IS USED FOR
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. Disturbances in the serotonin-system
are considered an
important factor in the development of depression and related
diseases.
Escitalopram BioOrganics contains escitalopram and is used to treat
depression
(major depressive episodes) and anxiety disorders such as repeated
panic attacks
(panic disorder) with or without fear of experiencing a panic attack
in a place or
situation from which escape is difficult or embarrassing e.g. in
public or open spaces
(agoraphobia), fear of being judged by others and/or publicly behaving
in a way that
could lead to embarrassment (social anxiety disorder), chronic anxiety
(generalised
anxiety disorder) and obsessions or comp

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram BioOrganics 15 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White, oval, film-coated tablets, debossed with 'E9CM'
on one side and on the other side scored and debossed with
'15'
(one number on each side of the scoring line).
The 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
Safety of daily doses above 20 mg has not been demonstrated.
Escitalopram is administered as a single daily dose and may be taken
with or without food.
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 treatment
lasts several months.
SOCIAL ANXIETY DISORDER
Usual dosage is 10 mg once daily. Usually 2-4 weeks are necessary to
obtain symptom relief. The dose may
subsequently, depending on individual patient response, be decreased
to 5 mg or increased to a maximum of 20 mg
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