Cipramil 20 mg film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Citalopram

Disponibil de la:

PCO Manufacturing Ltd.

Codul ATC:

N06AB; N06AB04

INN (nume internaţional):

Citalopram

Dozare:

20 milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Selective serotonin reuptake inhibitors; citalopram

Statutul autorizaţiei:

Authorised

Data de autorizare:

2001-08-24

Prospect

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPRAMIL
® 20 MG 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. 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 Cipramil is and what it is used for
2.
What you need to know before you take Cipramil
3.
How to take Cipramil
4.
Possible side effects
5.
How to store Cipramil
6.
Contents of the pack and other information
1.
WHAT CIPRAMIL IS AND WHAT IT IS USED FOR
HOW DOES CIPRAMIL WORK
Cipramil 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.
WHAT IS CIPRAMIL USED FOR
Cipramil contains citalopram and is used for the treatment of
depression and when you feel better, to
help prevent these symptoms recurring.
Further, Cipramil is used for long-term treatment to prevent the
occurrence of new depressive
episodes in patients who have recurrent depression.
Cipramil is also beneficial in relieving symptoms in patients prone to
panic attacks.
Ask your doctor if you have any questions about why Cipramil has been
prescribed for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CIPRAMIL
DO NOT TAKE CIPRAMIL:

if you are allergic to citalopram or any of the other ingredients of
this medicine (listed in section
6)

if you take other medicines which belong to a group called monoamine
oxidase inhibitors
(MAOIs).

Caracteristicilor produsului

Health Products Regulatory Authority
26 November 2019
CRN009G03
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cipramil 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg citalopram (as citalopram hydrobromide).
Excipient(s) with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Spain, United Kingdom, France, Hungary, The
Netherlands and Italy:_
White, oval-shaped tablets plain on one side and with a breakline on
the other side.‘C’ is debossed to the left of the breakline
and ‘N’ is debossed to the right of the breakline.
4 CLINICAL PARTICULARS
As per PA0776/001/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0776/001/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Maize starch
Lactose monohydrate
Cellulose, microcrystalline
Copovidone
Glycerol 85%
Croscarmellose sodium
Magnesium stearate
Hypromellose
Macrogol 400
Titanium dioxide (E 171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister pack and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
°
C.
Health Products Regulatory Authority
26 November 2019
CRN009G03
Page 2 of 2
Store in the original package in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 28 tablets in a cardboard outer carton or an
overlabelled outer carton.
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
PPA0465/068/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 24 August 2001
Dat