Escitalpro 5 mg film-coated tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Escitalopram oxalate

Disponible des:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Codi ATC:

N06AB; N06AB10

Designació comuna internacional (DCI):

Escitalopram oxalate

Dosis:

5 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

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

Área terapéutica:

Selective serotonin reuptake inhibitors; escitalopram

Estat d'Autorització:

Marketed

Data d'autorització:

2009-12-22

Informació per a l'usuari

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESCITALPRO 5 MG FILM-COATED TABLETS
ESCITALPRO 10 MG FILM-COATED TABLETS
ESCITALPRO 15 MG FILM-COATED TABLETS
ESCITALPRO 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 Escitalpro is and what it is used for
2.
What you need to know before you take Escitalpro
3.
How to take Escitalpro
4.
Possible side effects
5.
How to store Escitalpro
6.
Contents of the pack and other information.
1.
WHAT ESCITALPRO IS AND WHAT IT IS USED FOR
Escitalpro belongs to a group of medicines called Selective Serotonin
Re-uptake Inhibitor (SSRI)
antidepressants. These medicines act on the serotonin-system in the
brain by increasing the serotonin
level.
Escitalpro can be given to treat the following conditions:
•
depression (major depressive episodes)
•
panic disorder which may or may not be associated with agoraphobia
(fear of open spaces)
•
Social anxiety disorder
•
Generalised anxiety disorder
•
Obsessive-compulsive disorder.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESCITALPRO
DO NOT TAKE ESCITALPRO
•
if you are allergic to escitalopram or any of the other ingredients of
this medicine (listed in
section 6)
•
if you take other medicines that belong to a group called MAO
inhibitors, including selegiline
(used in the treatment of Parkinson’s disease), moclobemide (used in
the treatment of
depression) and linezolid (an antibiotic)
•
if you are born with or have had an episode of abnormal heart rh

Fitxa tècnica

Health Products Regulatory Authority
04 May 2021
CRN00C4H3
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalpro 5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Escitalpro 5 mg film-coated tablets: each tablet contains 5 mg
escitalopram (as oxalate)
Excipient with known effect:
5 mg film-coated tablets contain 0.4 mg lactose (as lactose
monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Escitalpro 5 mg film-coated tablets: white, film-coated tablet marked
with EC 5 on one side and “G” on the other. The tablets
are circular with a diameter of 5.5 mm.
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 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.
_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 chro