Premarin 0.625mg Coated Tablets

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 0.625 mg

Legemiddelform:

COATED TABLET

Sammensetning:

ESTROGENS CONJUGATED 0.625 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Withdrawn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 11
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 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
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 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

Preparatomtale

Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Premarin 0.625 mg Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.625 mg conjugated estrogens.
Excipients with known effect:
Each tablet contains lactose monohydrate 54.1 mg and sucrose 45 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Coated Tablet
Maroon oval biconvex sugar-coated tablet marked with “ 0.625” in
white 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 section 4.4) 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.
Prevention_ _of postmenopausal osteoporosis:
Page 2 of 21
When prescribing solely for the prevention of postmenopausal
osteoporosis, therapy should
only be considered for women at significant risk of osteoporosis and
non-estrogen medications
should be carefully considered.
The minimum effective dose is 0.625mg daily for most patients. (see
section 5.1)._ _
Starting or Changing Treatment
In women who are not taking hormone replacement