ESCITALOPRAM

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

ESCITALOPRAM OXALATE

Tilgængelig fra:

Accord Healthcare Limited

ATC-kode:

N06AB10

INN (International Name):

ESCITALOPRAM OXALATE

Dosering:

10 Milligram

Lægemiddelform:

Film Coated Tablet

Recept type:

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

Terapeutisk område:

escitalopram

Autorisation status:

Marketed

Autorisation dato:

2012-01-13

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM 5 MG
FILM-COATED TABLETS
ESCITALOPRAM 10 MG
FILM-COATED TABLETS
ESCITALOPRAM 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 or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Escitalopram film-coated tablets is and what it is
used for
2. What you need to know before you take Escitalopram
film-coated Tablets
3. How to take Escitalopram film-coated tablets
4. Possible side effects
5. How to store Escitalopram film-coated tablets
6. Contents of the pack and other information 1. WHAT ESCITALOPRAM FILM-COATED
TABLETS IS AND WHAT IT IS USED FOR
Escitalopram film-coated tablets contain escitalopram and
are 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).
Escitalopram film-coated tablets 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.
It may take a couple of weeks before you start to feel
better. Continue to take Escitalopram fil-coated tablets,
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 KNO

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg escitalopram (as oxalate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
White to off-white, oval, approximately 8.10mm in length, 5.60mm in
width, biconvex film coated tablets with
inscription ‘1’ and ‘0’ on either side of score line on one
side and plain on other side.
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 film-coated tablets are 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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___