Escivriens 15 mg film-coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Escitalopram

Boleh didapati daripada:

Genthon B.V.

Kod ATC:

N06AB; N06AB10

INN (Nama Antarabangsa):

Escitalopram

Dos:

15 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:

2010-10-15

Risalah maklumat

Date: 05-07-19
Pg 1 of 10
M13.1_03.ECM.hox.tab.002.10.IE.199.01
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCIVRIENS 10 MG FILM-COATED TABLETS
ESCIVRIENS 15 MG FILM-COATED TABLETS
ESCIVRIENS 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 Escivriens is and what it is used for
2.
What you need to know before you take Escivriens
3.
How to take Escivriens
4.
Possible side effects
5.
How to store Escivriens
6.
Contents of the package and other information
1.
WHAT ESCIVRIENS 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.
Escivriens contains escitalopram and is used to treat depression
(major depressive
episodes) and anxiety disorders such as repeated panic attacks (panic
disorder) with or
without fear of experiencing a panic attack in a place or situation
from which escape
is difficult or embarrassing e.g. in public or open spaces
(agoraphobia), fear of being
judged by others and/or publicly behaving in a way that could lead to
embarrassment
(social anxiety disorder), chronic anxiety (generalised anxiety
disorder) and
obsessions or compulsions that interfere with normal life functioning
for example,
repeatedly washing hands or checking locks (obsessive-compul

Ciri produk

Health Products Regulatory Authority
15 October 2019
CRN009679
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escivriens 15 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White, oval, film-coated tables, debossed with 'E9CM' on one side and
on the other side scored and debossed with '15' (one
number on each side of the scoring line)
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
Safety of daily doses above 20 mg has not been demonstrated.
Escitalopram is administered as a single daily dose and may be taken
with or without food.
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 cours