Escitalopram 20 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ESCITALOPRAM

Available from:

Bristol Laboratories Limited

ATC code:

N06AB10

INN (International Name):

ESCITALOPRAM

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ESCITALOPRAM 20 milligram(s)

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2015-02-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESCITALOPRAM 5 MG FILM-COATED TABLETS
ESCITALOPRAM 10 MG FILM-COATED TABLETS
ESCITALOPRAM 15 MG FILM-COATED TABLETS
ESCITALOPRAM 20 MG FILM-COATED TABLETS
Escitalopram oxalate
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 this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
The name of your medicine is Escitalopram 5 mg, 10 mg, 15 mg and 20 mg
film-coated tablets and 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.
Escitalopram 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 this
medicine 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Escitalopram 5 mg film-coated tablets
Escitalopram 10 mg film-coated tablets
Escitalopram 15 mg film-coated tablets
Escitalopram 20 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of escitalopram (as oxalate).
Each film-coated tablet contains 10 mg of escitalopram (as oxalate).
Each film-coated tablet contains 15 mg of escitalopram (as oxalate).
Each film-coated tablet contains 20 mg of escitalopram (as oxalate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White to off white, round, bevelled biconvex film-coated tablets
debossed with
‘J’ on one side and ‘1’ on the other side. The tablet
dimensions are 5.20 mm.
White to off white, oval, scored, biconvex film-coated tablets
debossed with
‘J’ on one side and ‘2’ on the other side. The tablet
dimensions are 7.90 x 5.40
mm.
White to off white, oval, scored, biconvex film-coated tablets
debossed with
‘J’ on one side and ‘3’ on the other side. The tablet
dimensions are 9.80 x 6.20
mm.
White to off white, oval, scored, biconvex film-coated tablets
debossed with
‘J’ on one side and ‘4’ on the other side. The tablet
dimensions are 11.40 x
6.90 mm.
The 10 mg, 15 mg and 20 mg 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.
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 increased to a maximum of 20 mg daily.
Usually 2-4 weeks are necessary to obtain antidepressant response.
After the
symptoms resolve, treatment