Escitalopram 15 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Escitalopram

제공처:

Accord Healthcare Ireland Ltd.

ATC 코드:

N06AB; N06AB10

INN (International Name):

Escitalopram

복용량:

15 milligram(s)

약제 형태:

Film-coated tablet

치료 영역:

Selective serotonin reuptake inhibitors; escitalopram

승인 상태:

Marketed

승인 날짜:

2010-04-16

환자 정보 전단

BBBA9114
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
t

제품 특성 요약

Health Products Regulatory Authority
05 March 2021
CRN009ZD9
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram 15 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Oval, biconvex, white film-coated tablet (diameter 7.3 x 10.6 mm) with
score on one side, sidescores and marked with ‘E-’ on
the other side. The tablet can be divided into equal doses.
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_
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.
Health Products Regulatory Authority
05 March 2021
CRN009ZD9
Page 2 of 14
Social anxiety disorder is a disease w