Escitalopram Grindeks 10 mg film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Escitalopram oxalate

Tilgjengelig fra:

AS Grindeks

ATC-kode:

N06AB10

INN (International Name):

Escitalopram oxalate

Legemiddelform:

Film-coated tablet

Terapeutisk område:

escitalopram

Autorisasjon status:

Not marketed

Autorisasjon dato:

2023-10-27

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM GRINDEKS
5 MG FILM-COATED TABLETS
ESCITALOPRAM GRINDEKS 10 MG FILM-COATED TABLETS
ESCITALOPRAM GRINDEKS 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 Escitalopram Grindeks is and what it is used for
2.
What you need to know before you take Escitalopram Grindeks
3.
How to take Escitalopram Grindeks
4.
Possible side effects
5.
How to store Escitalopram Grindeks
6.
Contents of the pack and other information
1.
WHAT ESCITALOPRAM GRINDEKS IS AND WHAT IT IS USED FOR
Escitalopram Grindeks 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.
Escitalopram Grindeks 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 Escitalopram Grindeks,
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 YOU TAKE ESCITALOPRAM GRINDEKS
DO NOT TAKE ESCITALOPRAM GRINDEKS:
-
If you are allergic to escitalopram or any of the other ingredients of
this medicine (listed in

Preparatomtale

Health℃Products℃Regulatory℃Authority
27℃October℃2023
CRN00CQZG
Page℃1℃of℃12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram℃Grindeks℃10℃mg℃film-coated℃tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each℃film-coated℃tablet℃contains℃escitalopram℃oxalate℃equivalent℃to℃10
mg℃escitalopram.℃
For℃the℃full℃list℃of℃excipients,℃see℃section 6.1.
3 PHARMACEUTICAL FORM
Film-coated℃tablet.
White℃to℃off-white,℃oval,℃approximately℃8℃mm℃x℃6℃mm,℃biconvex℃film-coated℃tablet℃with℃inscription℃1℃and℃0℃on℃either℃side℃of℃
score℃line℃on℃one℃side.℃The℃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℃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℃mo