Lexapro 15 mg Film-coated Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Escitalopram

Dostupné z:

Primecrown 2010 Limited

ATC kód:

N06AB; N06AB10

INN (Medzinárodný Name):

Escitalopram

Dávkovanie:

15 milligram(s)

Forma lieku:

Film-coated tablet

Typ predpisu:

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

Terapeutické oblasti:

Selective serotonin reuptake inhibitors; escitalopram

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2011-05-20

Príbalový leták

LEXAPRO
®
15MG FILM-COATED TABLETS
escitalopram
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 you take other medicines which belong to a group called MAO
inhibitors, including selegiline (used in the treatment of
Parkinson’s
disease), moclobemide (used in the treatment of depression) and
linezolid (an antibiotic).
•
if you are born with or have had an episode of abnormal heart rhythm
(seen at ECG; an examination to evaluate how the heart is
functioning).
•
if you take medicines for heart rhythm problems or that may affect the
heart’s rhythm (see section 2 “Other medicines and Lexapro”).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING LEXAPRO.
Please tell your doctor if you have any other conditi

Súhrn charakteristických

Health Products Regulatory Authority
17 December 2018
CRN008LSW
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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets
_Product imported from France:_
Oval, white, scored, film-coated tablet marked with “EM” on one
side.
The tablet 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 (E 171)
Health Products Regulatory Authority
17 December 2018
CRN008LSW
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strips and
outer carton of the product as marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
No special precautions for storage.
6.5 NATURE AND CONTENTS OF CONTAINER
Over-labelled carton containing two transparent blister strips (14
tablets per strip)
Pack size of 28 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Primecrown 2010 Limited
4/5 Northolt Trading Estate
Belvue Road
Northolt
Middlesex UB5 5QS
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1633/14/3
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20
th
May 2011
10 DATE OF REVISION OF THE TEXT
December 2018