Escitalopram 20 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Escitalopram

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N06AB; N06AB10

INN (International Name):

Escitalopram

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Selective serotonin reuptake inhibitors; escitalopram

Authorization status:

Marketed

Authorization date:

2012-01-13

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM 5 MG FILM-COATED TABLETS
ESCITALOPRAM 10 MG FILM-COATED TABLETS
ESCITALOPRAM 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 or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Escitalopram film-coated tablets is and what it is used for
2.
What you need to know before you take Escitalopram film-coated Tablets
3.
How to take Escitalopram film-coated tablets
4.
Possible side effects
5.
How to store Escitalopram film-coated tablets
6.
Contents of the pack and other information
1. WHAT ESCITALOPRAM FILM-COATED TABLETS IS AND WHAT IT IS USED FOR
Escitalopram film-coated tablets
contains the active substance escitalopram. Escitalopram film-
coated tablets 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.
Escitalopram film-coated tablets contain escitalopram and are 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 fil-
coated tablets, 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 FILM-COATED
TAB

Summary of Product characteristics

Health Products Regulatory Authority
25 May 2023
CRN00DF28
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram 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
White to off-white, oval, approximately 11.60 mm in length, 7.10 mm in
width, biconvex film coated tablets with score line on
one side and plain on 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
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 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.
Health Products Regulatory Authority
25 May 2023
CRN00DF28
Page 2 of 13
Social anxiety disorder is a disease with a chronic course, and