ESCITALOPRAM 10 Milligram Film Coated Tablet

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Preparatomtale Preparatomtale (SPC)
01-05-2024

Aktiv ingrediens:

ESCITALOPRAM OXALATE

Tilgjengelig fra:

Ranbaxy Ireland Limited

INN (International Name):

ESCITALOPRAM OXALATE

Dosering :

10 Milligram

Legemiddelform:

Film Coated Tablet

Resept typen:

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

Autorisasjon status:

Authorised

Autorisasjon dato:

0000-00-00

Informasjon til brukeren

                                Package leaflet: Information for the user 
 
ESCITALOPRAM 10 MG FILM-COATED TABLETS
 
ESCITALOPRAM 20 MG FILM-COATED TABLETS 
 
ESCITALOPRAM (AS 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, 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.  
 
 
 
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 contains escitalopram and is used to treat depression
(major 
depressive episodes) and anxiety disorders (such as panic disorder
with or 
without agoraphobia, social anxiety disorder, and
obsessive-compulsive 
disorder). 
 
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.  
 
 
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  that belongs to a group called
MAO inhibitors, 
including selegiline (used in the treatment of
Parkinson´s disease), 
                                
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Preparatomtale

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram 10 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of escitalopram equivalent to 12.77 mg of escitalopram oxalate.
Excipient with known effect
Each film-coated tablet contains 50.00 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Escitalopram Ranbaxy 10 mg: White to off-white, oval biconvex film-coated tablets, debossed with "E” and “8"
on either side of the eye breakline on one side and plain on the other side.
The 10 mg tablets can be divided into equal halves.
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
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.
_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 to 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
                                
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