Escitalopram Glenmark 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Escitalopram

Available from:

Glenmark Pharmaceuticals Europe Limited

ATC code:

N06AB; N06AB10

INN (International Name):

Escitalopram

Dosage:

10 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:

2012-02-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Escitalopram Glenmark 5 mg film-coated tablets
Escitalopram Glenmark 10 mg film-coated tablets
Escitalopram Glenmark 15 mg film-coated tablets
Escitalopram Glenmark 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 Glenmark is and what it is used for
2.
What you need to know before you take Escitalopram Glenmark
3.
How to take Escitalopram Glenmark
4.
Possible side effects
5.
How to store Escitalopram Glenmark
6.
Contents of the pack and other information
1.
WHAT ESCITALOPRAM GLENMARK IS AND WHAT IT IS USED FOR
Escitalopram Glenmark
contains escitalopram and is used to treat depression (major
depressive
episodes) and anxiety disorders (such as panic disorder with or
without agoraphobia which is fear of
being in places where help might not be available, social anxiety
disorder, generalised anxiety
disorder and obsessive-compulsive disorder).
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.
It may take a couple of weeks before you start to feel better.
Continue to take Escitalopram, 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.

Summary of Product characteristics

Health Products Regulatory Authority
07 February 2020
CRN008L69
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram Glenmark 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coatedtablet
White to off-white, oval, biconvex, film coated tablets with ‘E
2’debossed on one side and scoreline on the other side.
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
POSOLOGY
The 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 anti depressant 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, and
treatment for 12 weeks is recommended to consolidate response.
Long-term treatment of responders has been stu