Citalopram 20 mg Film-coated Tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Citalopram

Disponível em:

WPR Healthcare Limited

Código ATC:

N06AB; N06AB04

DCI (Denominação Comum Internacional):

Citalopram

Dosagem:

20 milligram(s)

Forma farmacêutica:

Film-coated tablet

Tipo de prescrição:

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

Área terapêutica:

Selective serotonin reuptake inhibitors; citalopram

Status de autorização:

Authorised

Data de autorização:

2017-01-20

Folheto informativo - Bula

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CITALOPRAM 20MG FILM-COATED TABLETS
Citalopram
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 Citalopram is and what it is used for
2.
What you need to know before you take Citalopram
3.
How to take Citalopram
4.
Possible side effects
5.
How to store Citalopram
6.
Contents of the pack and other information
1.
WHAT CITALOPRAM IS AND WHAT IT IS USED FOR

Citalopram belongs to a group of antidepressants known as selective
serotonin reuptake
inhibitors (SSRIs).

Citalopram is used for the treatment of depression (major depressive
episodes).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM
DO NOT TAKE CITALOPRAM

If you are allergic to citalopram or any of the other ingredients of
Citalopram (listed in section 6).

If you are taking, or have taken in the last 2 weeks an antidepressant
medicine of the type called
monoamine oxidase inhibitors (MAOIs) e.g. selegiline or moclobemide.

If you are treated with linezolid (an antibiotic medicine) unless you
are under close observation
and monitoring of blood pressure.

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. Also refer
to the section “Other medicines and Citalopram” below.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Citalopram if you:

Suffer from di

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Citalopram 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains citalopram hydrobromide equivalent to
20mg citalopram.
Excipients with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK_:
Oval, white tablets with a break-line on one side.
4 CLINICAL PARTICULARS
As per PA0749/019/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0749/019/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet Core
Copovidone
Croscarmellose sodium (E466)
Glycerol (E422)
Lactose monohydrate
Magnesium stearate (E470b)
Maize starch
Microcrystalline cellulose
(E171)
Tablet Coating
Hypromellose (E464)
Microcrystalline cellulose
(E460i)
Macrogol stearate 40 (E431)
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
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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
Do not store above 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips in an outer carton. Pack size: 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUC