CITALOPRAM 20 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CITALOPRAM HYDROBROMIDE

Available from:

WPR Healthcare Limited

ATC code:

N06AB04

INN (International Name):

CITALOPRAM HYDROBROMIDE

Dosage:

20 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

Selective serotonin reuptake inhibitors

Authorization status:

Authorised

Authorization date:

2011-08-05

Patient Information leaflet

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PACKAGELEAFLET: 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 medicines called
selective serotonin reuptake inhibitors 
(SSRIs), also known as antidepressants. 
Citalopram is used to treat: 


depression (major depressive episodes) 


panic disorder (panic attacks,
including those caused by agoraphobia, which is a fear of 
open spaces). 

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 this medicine (listed 
in section 6). 


if you are taking, or have taken within the last two weeks,
any monoamine oxidase 
inhibitors (MAOIs). These medicines are used to treat depress
ion or Parkinson’s 
disease (e.g. selegiline, moclobemide). After stopping
Citalopram you must

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Citalopram 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains citalopram hydrobromide equivalent to 20mg citalopram.
Excipients with known effect: contains lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK:_
White, oval, normal convex film-coated tablets debossed with “CM" scoreline "20” on one side and “G” on the other.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA0577/047/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0577/047/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet Core
Lactose monohydrate
Maize starch
Microcrystalline cellulose
Povidone
Crospovidone
Magnesium stearate
Tablet Coating
Titanium dioxide (E 171)
Lactose monohydrate
Macrogol 4000
Hypromellose (E464)
6.2 INCOMPATIBILITIES
Not applicable.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 27/04/2016_
_CRN 2175007_
_page number: 1_
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
This medicinal product does not require any special storage conditions.
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 PRODUCT OR WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
WPR Healthcare Limited
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland