PREMARIN 0.625 Milligram Tablet Prolonged Release

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESTROGENS CONJUGATED

Available from:

B & S Healthcare

ATC code:

G03CA57

INN (International Name):

ESTROGENS CONJUGATED

Dosage:

0.625 Milligram

Pharmaceutical form:

Tablet Prolonged Release

Prescription type:

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

Therapeutic area:

Natural and semisynthetic estrogens, plain

Authorization status:

Authorised

Authorization date:

2009-07-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
PREMARIN
®
 0.625MG PROLONGED-RELEASE TABLETS  
PREMARIN
®
 1.25MG PROLONGED-RELEASE TABLETS  
 (conjugated estrogens) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU. 
ƒ 
Keep this leaflet. You may need to read it again. 
ƒ 
If you have any further questions, ask your doctor or pharmacist. 
ƒ 
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. 
ƒ 
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side 
effects not listed in this leaflet. 
The name of your medicine is Premarin 0.625mg Prolonged-release
Tablets and Premarin 
1.25mg Prolonged-release Tablets, but it will be referred
to as Premarin throughout this leaflet.  

WHAT IS IN THIS LEAFLET:  
1.  WHAT PREMARIN IS AND WHAT IT IS USED FOR 
2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREMARIN 
3.  HOW TO TAKE PREMARIN 
4.  POSSIBLE SIDE EFFECTS 
5.  HOW TO STORE PREMARIN 
6.  CONTENTS OF THE PACK AND OTHER INFORMATION 

1. WHAT PREMARIN IS AND WHAT IT IS USED FOR 

Premarin is a Hormone Replacement Therapy (HRT). It contains the
female hormone estrogen. 
Premarin is used to treat some of the symptoms and
conditions associated with the menopause. 
Premarin is usually prescribed for women who have had their
womb removed (hysterectomy). 
However women who have not had this
operation can still take Premarin and their doctor may 
prescribe a second type of tablet containing another hormone called
a progestogen to be taken 
12-14 days per month as well as the Premarin tablets.

Premarin is used for: 
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE 
During the menopause, the amount of the estrogen produced by a
woman’s body drops. T

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Premarin 0.625 mg Prolonged-release tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.625mg conjugated estrogens.
Excipients: Each prolonged-release tablet contains sucrose and lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
_Product imported from the UK:_
Maroon, oval, biconvex, sugar-coated tablet marked with “0.625” in white ink.
4 CLINICAL PARTICULARS
As per PA 0822/095/002.
5 PHARMACOLOGICAL PROPERTIES
As per PA 0822/095/002.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
lactose monohydrate
microcrystalline cellulose
magnesium stearate
hypromellose
sucrose
hydroxypropyl cellulose
macrogol
carnauba wax
edible ink and coating.
The edible ink on maroon tablets contains
hypromellose
titanium dioxide (E171)
propylene glycol (E1520).
The coating on the maroon tablets contains
hypromellose
titanium dioxide (E171)
red aluminium lake (E129)
indigo carmine (E132)
macrogol.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 18/11/2014_
_CRN 2120507_
_page number: 1_
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
Do not store above 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Polyvinylchloride (PVC)/Aluminium foil blisters containing 28 tablets. One carton pack contains 3 blisters.
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 PRODU