Escitalopram Teva 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Escitalopram

Available from:

Teva Pharma B.V.

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:

2009-03-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESCITALOPRAM TEVA 5 MG FILM-COATED TABLETS
ESCITALOPRAM TEVA 10 MG FILM-COATED TABLETS
ESCITALOPRAM TEVA 15 MG FILM-COATED TABLETS
ESCITALOPRAM TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Escitalopram Teva
3.
How to take Escitalopram Teva
4.
Possible side effects
5.
How to store Escitalopram Teva
6.
Contents of the pack and other information
1
WHAT ESCITALOPRAM TEVA IS AND WHAT IT IS USED FOR_ _
Escitalopram Teva contains the active substance escitalopram.
Escitalopram Teva 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 Teva 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 Escitalopram Teva, 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 TEVA

Summary of Product characteristics

Health Products Regulatory Authority
26 November 2021
CRN00CMF9
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram Teva 10 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
10 MG
Each film-coated tablet contains 10 mg escitalopram (as oxalate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex film-coated tablet, debossed with “10” on
one side of the tablet and scored on the other side of the
tablet.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of

major depressive episodes

panic disorder with or without agoraphobia

social anxiety disorder (social phobia)

generalised anxiety disorder

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 mon