Clomentin tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

escitalopram (escitalopram oxalate)

Available from:

Delorbis Pharmaceuticals Ltd.

ATC code:

N06AB10 վերարտադրված դեղ

INN (International Name):

escitalopram (escitalopram oxalate)

Dosage:

20mg (28/2x14/) in blister

Pharmaceutical form:

tablets film-coated

Units in package:

20mg (28/2x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-06-21

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOMENTIN 5 MG FILM-COATED TABLETS
CLOMENTIN 10 MG FILM-COATED TABLETS
CLOMENTIN 15 MG FILM-COATED TABLETS
CLOMENTIN 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.
WHAT IS IN THIS LEAFLET:
1.
What Clomentin is and what it is used for
2.
What you need to know before you take Clomentin
3.
How to take Clomentin
4.
Possible side effects
5.
How to store Clomentin
6.
Contents of the pack and other information
1.
WHAT CLOMENTIN IS AND WHAT IT IS USED FOR
Clomentin 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.
Clomentin 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 Clomentin, even if it takes
some time before you feel any improvement in your condition.
You must talk to your doctor if you do not feel better or you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOMENTIN
DO NOT TAKE CLOMENTIN
•
if you are allergic to escitalopram or any of the other ingredients of
this medicine (listed

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Clomentin 5 mg film-coated tablets
Clomentin 10 mg film-coated tablets
Clomentin 15 mg film-coated tablets
Clomentin 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For 5 mg strength:
Each tablet contains 5 mg escitalopram (as oxalate)
For 10 mg strength:
Each tablet contains 10 mg escitalopram (as oxalate)
For 15 mg strength:
Each tablet contains 15 mg escitalopram (as oxalate)
For 20 mg strength:
Each tablet contains 20 mg escitalopram (as oxalate)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Clomentin 5 mg:
Round, white to off white, biconvex, film coated tablet.
Clomentin 10 mg:
Oval shaped, white to off white, film coated tablet with break line on
one side.
_The tablet can be divided into equal doses. _
Clomentin 15 mg:
Oval shaped, white to off white, film coated tablet with break line on
one side.
_The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses._
Clomentin 20 mg:
Oval shaped, white to off 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.
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 in-
creased to a maximum of 20 mg daily.
Usually 2-4 weeks are necessary to obtain antidepressant response.
After the symptoms resolve, treat-
ment 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 wee