Lexapro 15 mg film-coated tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Escitalopram

Предлага се от:

PCO Manufacturing Ltd.

АТС код:

N06AB; N06AB10

INN (Международно Name):

Escitalopram

дозиране:

15 milligram(s)

Лекарствена форма:

Film-coated tablet

Вид предписание :

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

Терапевтична област:

Selective serotonin reuptake inhibitors; escitalopram

Статус Оторизация:

Authorised

Дата Оторизация:

2011-07-08

Листовка

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LEXAPRO
® 10 MG FILM-COATED TABLETS
LEXAPRO
® 15 MG FILM-COATED TABLETS
LEXAPRO
® 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 Lexapro is and what it is used for
2.
What you need to know before you take Lexapro
3.
How to take Lexapro
4.
Possible side effects
5.
How to store Lexapro
6.
Contents of the pack and other information
1.
WHAT LEXAPRO IS AND WHAT IT IS USED FOR
Lexapro contains the active substance escitalopram. Lexapro 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.
Lexapro 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 Lexapro, 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 LEXAPRO
DO NOT TAKE LEXAPRO

if you are allergic to escitalopram or any of the other ingredients of
this medicine (listed in section 6).

if y

Данни за продукта

Health Products Regulatory Authority
15 May 2020
CRN009Q7S
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lexapro 15 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg escitalopram (as oxalate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Spain, France and The Netherlands:_
Oval, white, scored, film-coated tablet marked with E” and “M on
each side of the score on one side of the tablet.
The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA0805/002/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0805/002/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Microcrystalline cellulose
Colloidal anhydrous silica
Talc
Croscarmellose sodium
Magnesium stearate
Coating:
Hypromellose
Macrogol 400
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
Health Products Regulatory Authority
15 May 2020
CRN009Q7S
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium blister strips in an outer carton. Pack size 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/129/004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 8
th
July 2011
10 DATE OF REVISION OF THE TEXT
May 2020