LEXAPRO 20 MG TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ESCITALOPRAM OXALATE

Boleh didapati daripada:

Lundbeck Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

ESCITALOPRAM OXALATE

Unit dalam pakej:

28Tablet Tablets

Dikeluarkan oleh:

H. LUNDBECK A/S

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LEXAPRO FILM-COATED TABLETS
Escitalopram (as oxalate) (5, 10, 15, 20mg)
1
WHAT IS IN THIS LEAFLET
1.
What Lexapro is used for
2.
How Lexapro works
3.
Before you use Lexapro
4.
How to use Lexapro
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Lexapro
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT LEXAPRO IS USED FOR
Lexapro contains escitalopram and is used to
treat:
•
depression
•
panic disorder with or without
agoraphobia (fear of public or open
spaces)
•
social anxiety disorder/social phobia
(fear or avoidance of social situations)
•
generalised anxiety disorder (generally
feeling very anxious or nervous, even
when there is little or no reason to worry
about them)
•
obsessive-compulsive disorder (OCD)
(persistent, obsessive thoughts that make
you carry out repetitive behaviour)
HOW LEXAPRO WORKS
Lexapro contains the active substance
escitalopram. Lexapro 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.
BEFORE YOU USE LEXAPRO
-
_When you must not use it _
Do not take:
•
if you are allergic to escitalopram or any
of the other ingredients of this medicine
(listed in section
PRODUCT DESCRIPTION
).
•
If you take other medicines which belong
to a group called monoamine oxidase
inhibitors (MAOIs) (see subsection
_Taking other medicines_
). Taking Lexapro
with a MAOI may cause a serious,
sometimes fatal, reaction with features
resembling serotonin syndrome (see
section
SIDE EFFECTS
).
•
at the same time as taking pimozide
(used in the treatment of mental disorders
or nervous system disorders)
-
_Before you start to use it _
Please tell your doctor if you have any other
condition or illness, as your doctor may need
to take th

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PHYSICIAN INFORMATION LEAFLET
Page 1 of 18
PHYSICIAN INFORMATION LEAFLET
Lexapro 5mg, 10mg, 15mg and 20mg film-coated tablets
Escitalopram (as oxalate)
1.
NAME OF THE MEDICINAL PRODUCT
LEXAPRO 5 mg film-coated tablets
LEXAPRO 10 mg film-coated tablets
LEXAPRO 15 mg film-coated tablets
LEXAPRO 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lexapro 5 mg:
Each tablet contains 5 mg escitalopram (as 6.39 mg escitalopram
oxalate)
Lexapro 10 mg:
Each tablet contains 10 mg escitalopram (as 12.77 mg escitalopram
oxalate)
Lexapro 15 mg:
Each tablet contains 15 mg escitalopram (as 19.16 mg escitalopram
oxalate)
Lexapro 20 mg:
Each tablet contains 20 mg escitalopram (as 25.54 mg escitalopram
oxalate)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Lexapro 5 mg:
Round, white, film-coated tablet marked with "EK" on one side.
Lexapro 10 mg: Oval, white, scored, film-coated tablet marked with
"E” and “L" on
each side of the score on one side of the tablet.
Lexapro 15 mg: Oval, white, scored, film-coated tablet marked with
"E” and “M" on
each side of the score on one side of the tablet.
Lexapro 20 mg: Oval, white, scored, film-coated tablet marked with
"E” and “N" on
each side of the score on one side of the tablet.
The 10, 15 and 20 mg 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.
PHYSICIAN INFORMATION LEAFLET
Page 2 of 18
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Safety of daily doses above 20 mg has not been demonstrated.
Lexapro 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-