Premarin 1.25mg Coated Tablet

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

ESTROGENS CONJUGATED

Tilgjengelig fra:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC-kode:

G03CA57

INN (International Name):

ESTROGENS CONJUGATED 1.25 mg

Legemiddelform:

COATED TABLET

Sammensetning:

ESTROGENS CONJUGATED 1.25 mg

Resept typen:

POM

Terapeutisk område:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2006-11-09

Informasjon til brukeren

Page 1 of 12 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

PREMARIN
®
 0.3 MG, 0.625 MG & 1.25 MG COATED TABLETS (CONJUGATED ESTROGENS) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
  Keep this leaflet.  You may need to read it again.   
  If you have further questions, please 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 symptoms are the same as yours. 

IN THIS LEAFLET: 
1.  What Premarin is and what it is used for 
2.  Before you take Premarin  
3.  How to take Premarin 
4.  Possible side effects 
5.  How to store Premarin 
6.  Further 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 used for: 

 RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE 

During the menopause, the amount of the estrogen produced by a
woman’s body drops. This can 
cause symptoms such as hot face, neck and chest ("hot flushes").
Premarin alleviates these 
symptoms after menopause. You will only be prescribed Premarin if
your symptoms seriously 
hinder your daily life.  

PREVENTION OF OSTEOPOROSIS 

After the menopause some women may be at risk of developing fragile
bones (osteoporosis). You 
should discuss all available treatment options with your doctor. 
If you are at an increased risk of fractures due to osteoporosis and
other medicines are not 
suitable for you, you can use Premarin 0.625 mg or 1.25 mg Coated
Tablets to prevent 
osteoporosis after 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

Preparatomtale

MT Submission/Approval: 29Oct2012 
UK Ref No: PA 7_0

Page 1 of 15                             
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  NAME OF THE MEDICINAL PRODUCT  

Premarin
®
 1.25mg Coated Tablets 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 1.25 mg Conjugated Estrogens. 

For a full list of excipients, see section 6.1. 

3.  PHARMACEUTICAL FORM 

Coated tablets 

Yellow oval biconvex sugar coated tablets marked with “1.25” in
black ink. 

4.  CLINICAL PARTICULARS 

4.1  THERAPEUTIC INDICATIONS 

-  Hormone replacement therapy for estrogen deficiency symptoms in
postmenopausal women. 

-  Prevention of osteoporosis in postmenopausal women at high risk
of future fractures who are 
intolerant of, or contraindicated for, other medicinal products
approved for the prevention of 
osteoporosis. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

ADULTS: 

Premarin is an estrogen only HRT.   

TREATMENT OF POSTMENOPAUSAL SYMPTOMS 

Premarin 0.3-1.25mg daily is the usual starting dose for women without
a uterus. 
Continuous administration is recommended.   
_ _
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose 
for the shortest duration (see also Section 4.4 Special warnings and
precautions for use) should be 
used. Treatment to control menopausal symptoms should be initiated
with Premarin 0.3mg. If 
symptoms are not adequately controlled, higher doses of Premarin may
be prescribed. Once 
treatment is established the lowest effective dose necessary for the
relief of symptoms should be 
used. Patients should be re-evaluated periodically to determine if
treatment for symptoms is still 
necessary. 

TREATMENT OF OSTEOPOROSIS 

The minimum effective dose is 0.625mg daily for most patients. (See
section 5.1 Pharmacodynamic 
properties)._ _  

MT Submission/Approval: 29Oct2012 
UK Ref No: PA 7_0

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