Etalopro 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Escitalopram

Available from:

Clonmel Healthcare Ltd

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:

Marketed

Authorization date:

2009-12-04

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
ETALOPRO 5MG FILM-COATED TABLETS
ETALOPRO 10MG FILM-COATED TABLETS
ETALOPRO 15MG FILM-COATED TABLETS
ETALOPRO 20MG 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 Etalopro is and what it is used for
2.
What you need to know before you take Etalopro
3.
How to take Etalopro
4.
Possible side effects
5.
How to store Etalopro
6.
Contents of the pack and other information
1.
WHAT ETALOPRO 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.
Etalopro contains escitalopram and 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
ETALOPRO
, 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 ETALOPRO
DO NOT TAKE ETALOPRO
•
if you are allergic to escitalopram or any of the other ingredients of
this medicine (listed in
section 6).
•
i

Summary of Product characteristics

Health Products Regulatory Authority
26 January 2021
CRN00C44N
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etalopro 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Etalopro 10 mg: Each tablet contains 10 mg escitalopram (as oxalate)
Excipient with known effect
One film-coated contains 0.85 mg sodium.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oval shaped (ca. 8.1 x 5.6 mm), white, film-coated tablet with break
line on one side.
_The 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
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 studied for 6 months