S-Oropram 20mg Film-Coated Tablets

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

ESCITALOPRAM

Mevcut itibaren:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC kodu:

N06AB10

INN (International Adı):

ESCITALOPRAM 20 mg

Farmasötik formu:

FILM-COATED TABLET

Kompozisyon:

ESCITALOPRAM 20 mg

Reçete türü:

POM

Terapötik alanı:

PSYCHOANALEPTICS

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2009-11-19

Bilgilendirme broşürü

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
S-OROPRAM 5 MG FILM-COATED TABLETS
S-OROPRAM 10 MG FILM-COATED TABLETS
S-OROPRAM 15 MG FILM-COATED TABLETS
S-OROPRAM 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 S-Oropram is and what it is used for
2.
What you need to know before you take S-Oropram
3.
How to take S-Oropram
4.
Possible side effects
5.
How to store S-Oropram
6.
Contents of the pack and other information
1.
WHAT S-OROPRAM IS AND WHAT IT IS USED FOR
S-Oropram
contains
the
active
substance
escitalopram.
S-Oropram
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.
S-Oropram 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 S-Oropram, 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 S-OROPRAM
DO NOT TAKE S-OROPRAM
-
If you are allergic to escitalopram or any of the other ingredients of
this m

Ürün özellikleri

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
S-Oropram 5 mg film-coated tablets
S-Oropram 10 mg film-coated tablets
S-Oropram 15 mg film-coated tablets
S-Oropram 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
S-OROPRAM 5 MG
Each film-coated tablet contains escitalopram oxalate equivalent to 5
mg escitalopram.
S-OROPRAM 10 MG
Each film-coated tablet contains escitalopram oxalate equivalent to 10
mg escitalopram.
S-OROPRAM 15 MG
Each film-coated tablet contains escitalopram oxalate equivalent to 15
mg escitalopram.
S-OROPRAM 20 MG
Each film-coated tablet contains escitalopram oxalate equivalent to 20
mg escitalopram.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
S-OROPRAM 5 MG
Round, biconvex, white film-coated tablet (diameter 6 mm) marked
‘E’ on one side.
S-OROPRAM 10 MG
Oval, biconvex, white film-coated tablet (6.4 mm x 9.25 mm) with score
on one side, sidescores and marked
with ‘E’ on the other side. The tablet can be divided into equal
doses.
_ _
S-OROPRAM 15 MG
Oval, biconvex, white film-coated tablet (7.3 mm x 10.6 mm) with score
on one side, sidescores and marked
with ‘E-’ on the other side. The tablet can be divided into equal
doses.
S-OROPRAM 20 MG
Oval, biconvex, white film-coated tablet (8 mm x 11.7 mm) with score
on one side, sidescores and marked
with ‘E’ on the other side. 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
PAGE 2 OF 14
-
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 antidepre