ESCITALOPRAM 10 Milligram Film Coated Tablet

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

ESCITALOPRAM OXALATE

可用日期:

Cipla (EU) Limited

ATC代码:

N06AB10

INN（国际名称）:

ESCITALOPRAM OXALATE

剂量:

10 Milligram

药物剂型:

Film Coated Tablet

处方类型:

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

治疗领域:

Selective serotonin reuptake inhibitors

授权状态:

Authorised

授权日期:

2013-11-08

资料单张

KS75 A
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM 5 MG FILM-COATED TABLETS
ESCITALOPRAM 10 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 or 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 or pharmacist
or nurse. This includes any possible 
side effects not listed in this leaflet.

WHAT IS IN THIS LEAFLET

1. What this medicine is and what it is used for.

2. Before you take this medicine

3. How to take this medicine

4. Possible side effects

5. How to store this medicine

6. Contents of the pack and other information
  1.  WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
This medicine 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.  
This medicine 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, generalised anxiety disorder and 
obsessive-compulsive disorder).  
  2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
DO NOT TAKE THIS MEDICINE:
  If you are allergic (hypersensitive) to escitalopram or
any of the other ingredients of this medicine (see section  
  6 “Contents of the pack and other information”). 
  If you take other medicines that belongs to a group
called MAO inhibitors, including sele

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram 10 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Escitalopram 10 mg Film-Coated Tablets: Each film-coated tablet contains 10 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-Coated Tablet
White to off white, round, biconvex film coated tablets with “E10” debossed on one side and break line on the other
side. The 10 mg tablets can be divided into equal halves. Diameter- 7.50 mm to 7.70 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
Safety of daily doses above 20 mg has not been demonstrated.
Escitalopram Tablets 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 2-4 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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