Escitalopram 5mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Escitalopram

Available from:

Actavis Group PTC ehf

ATC code:

N06AB; N06AB10

INN (International Name):

Escitalopram

Dosage:

5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Selective serotonin reuptake inhibitors; escitalopram

Authorization status:

Marketed

Authorization date:

2010-03-19

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
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, pharmacist or
nurse.
-
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, 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 is and what it is used for
2.
What you need to know before you take Escitalopram
3.
How to take Escitalopram
4.
Possible side effects
5.
How to store Escitalopram
6.
Contents of the pack and other information
1.
WHAT ESCITALOPRAM IS AND WHAT IT IS USED FOR
Escitalopram is an antidepressant which belongs to the ‘SSRI’
group (selective serotonin reuptake
inhibitors). 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:
–
Depressive disorders (episodes of a major depression)
–
Panic disorder with or without agoraphobia (e.g. fear of leaving the
house, entering shops, being in
crowds and in public places)
–
Social anxiety disorder (social phobia)
–
Generalised anxiety disorder
–
Obsessive-compulsive disorder
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESCITALOPRAM
DO NOT TAKE ESCITALOPRAM
-
if you are allergic to escitalopram or any of the other ingredients of
this medicine (listed in section 6)
-
if you take other medicines which belongs to a group called MAO
inhibitors, including selegiline
(used in the treatmen

Summary of Product characteristics

Health Products Regulatory Authority
08 January 2019
CRN008PCX
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram 5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex, white film-coated tablet (diameter 6 mm) marked
‘E’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of

major depressive episodes

panic disorder with or without agoraphobia

social anxiety disorder (social phobia)

obsessive-compulsive disorder
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Safety of daily doses above 20 mg has not been demonstrated.
Escitalopram is administered as a single daily dose and may be taken
with or without
food.
Posology
_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_
Health Products Regulatory Authority
08 January 2019
CRN008PCX
Page 2 of 19
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.
_Social anxiety disorder_
Usual dosage is 10 mg once daily. Usually 2-4 weeks are necessary to
obtain
symptom relief. The dose may subsequently, depending on individual
patient
response, be decreased to 5 mg or increased to a maximum of 20 mg
daily.
Social anxiety disorder is a disease with a chronic course, and
treatment for 12 weeks
is recommended to consolidate response. Long-