Escitalopram 20mg Film-Coated Tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Escitalopram

Boleh didapati daripada:

Bristol Laboratories Limited

Kod ATC:

N06AB; N06AB10

INN (Nama Antarabangsa):

Escitalopram

Dos:

20 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Jenis preskripsi:

Product subject to prescription which may not be renewed (A)

Kawasan terapeutik:

Selective serotonin reuptake inhibitors; escitalopram

Status kebenaran:

Not marketed

Tarikh kebenaran:

2014-12-05

Risalah maklumat

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
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 NOT TAKE THIS MEDICINE

Ciri produk

Health Products Regulatory Authority
15 May 2019
CRN008WXV
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram 20mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 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 ‘4’ on the other side. The
tablet
dimensions are 11.40 x 6.90 mm.
The 20 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
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 consoli