Escivriens 20 mg film-coated tablets

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Escitalopram

থেকে পাওয়া:

Genthon B.V.

এটিসি কোড:

N06AB; N06AB10

INN (International Name):

Escitalopram

ডোজ:

20 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Film-coated tablet

প্রেসক্রিপশন টাইপ:

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

Therapeutic area:

Selective serotonin reuptake inhibitors; escitalopram

অনুমোদন অবস্থা:

Not marketed

অনুমোদন তারিখ:

2010-10-15

তথ্য লিফলেট

M13.1_03.ECM.hox.tab.IE.199.01 IE/H/0199/001,003/IA/013
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCIVRIENS 10 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 (generalized anxiety disorder) and obsessions or
compulsions that interfere
with normal life functioning for example, repeatedly washing hands or
checking locks
(obsessive-compulsive disorder).
2.
WHAT YOU NEED TO KNOW BEFO

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
03 February 2021
CRN00C2LD
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escivriens 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White, oval, biconvex, film coated tablets, with score on one face and
side scores. The unscored face is marked with an "E". The
dimensions for the 20mg film coated tablets are 8.0 mm x 11.7 mm.
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.
Health Products Regulator