Escitalopram 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Escitalopram

Available from:

Brillpharma (Ireland) Limited

ATC code:

N06AB; N06AB10

INN (International Name):

Escitalopram

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Selective serotonin reuptake inhibitors; escitalopram

Authorization status:

Not marketed

Authorization date:

2014-12-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESCITALOPRAM 5 MG FILM-COATED TABLETS
ESCITALOPRAM 10 MG FILM-COATED TABLETS
ESCITALOPRAM 15 MG FILM-COATED TABLETS
ESCITALOPRAM 20 MG FILM-COATED TABLETS
escitalopram oxalate
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 this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
The name of your medicine is Escitalopram film-coated tablets and
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.
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 this medicine
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 THIS MEDICINE
DO NO

Summary of Product characteristics

Health Products Regulatory Authority
24 May 2021
CRN009YSM
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram 10mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of escitalopram (as oxalate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White to off white, oval, scored, biconvex film-coated tablets
debossed with ‘J’ on one side and ‘2’ on the other side. The
tablet
dimensions are 7.90 x 5.40 mm.
The 10 mg tablet 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
Health Products Regulatory Authority
24 May 2021
CRN009YSM
Page 2 of 13
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