Escitotab 20 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Escitalopram oxalate

Available from:

Genthon B.V.

ATC code:

N06AB; N06AB10

INN (International Name):

Escitalopram oxalate

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Selective serotonin reuptake inhibitors; escitalopram

Authorization status:

Not marketed

Authorization date:

2010-10-15

Patient Information leaflet

Date: 13-08-2019
Pg 1 of 10
M13.1_03.ECM.hox.tab.003.03.IE.198.02
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITOTAB 10 MG FILM-COATED TABLETS
ESCITOTAB 15 MG FILM-COATED TABLETS
ESCITOTAB 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 Escitotab is and what it is used for
2.
What you need to know
before you take Escitotab
3.
How to take Escitotab
4.
Possible side effects
5.
How to store Escitotab
6.
Contents of the package and other information
1.
WHAT ESCITOTAB IS AND WHAT IT IS USED FOR
Escitotab 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.
Disturbances in the serotonin-system are considered an important
factor in the
development of depression and related diseases.
Escitotab 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 compulsions that interfere with normal life functioning
for example,
repeatedly was

Summary of Product characteristics

Health Products Regulatory Authority
06 April 2020
CRN009PR8
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitotab 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 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 '20' (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 daily.
Social anxiety disorder is a disease with a chronic course