Premarin 1.25 mg Prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Conjugated estrogens

Available from:

Pfizer Healthcare Ireland

ATC code:

G03CA; G03CA57

INN (International Name):

Conjugated estrogens

Dosage:

1.25 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

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

Therapeutic area:

Natural and semisynthetic estrogens, plain; conjugated estrogens

Authorization status:

Marketed

Authorization date:

1988-07-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PREMARIN
®
0.625 MG
PROLONGED-RELEASE TABLETS
PREMARIN
®
1.25 MG
PROLONGED-RELEASE TABLETS
(CONJUGATED OESTROGENS)
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 oestrogen. 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 oestrogen 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 treatmen

Summary of Product characteristics

Health Products Regulatory Authority
10 January 2024
CRN00DZVQ
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Premarin 1.25 mg Prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25 mg conjugated oestrogens
Excipients with known effect:
Each tablet contains lactose monohydrate 120.3 mg, sucrose 115.0 mg
and Sunset Yellow (E110) 0.0199 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-releaseTablet.
Yellow, oval, biconvex, coated tablets branded with ‘1.25’ in
black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Premarin is indicated for Hormone replacement therapy (HRT)for
oestrogen deficiency symptoms in menopausal women and
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.
(See section 4.4)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Premarin is an oestrogen only HRT.
Posology
_Adults_
Premarin 0.625-1.25 mg 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. Patients should be re-evaluated
periodically to determine if treatment for symptoms is still
necessary.
Vasomotor symptoms:
_ _
0.625-1.25 mg daily depending on the response of the individual.
Atrophic vaginitis, kraurosis vulvae, atrophic urethritis:
_ _
0.625-1.25 mg daily depending on the response of the individual.
Prophylaxis of postmenopausal osteoporosis:
Health Products Regulatory Authority
10 January 2024
CRN00DZVQ
Page 2 of 18
When prescribing solely for the prevention of postmenopausal
osteoporosis, therapy should only be considered for women at
significant risk of osteoporosis and non-oestrogen medications should
be carefully considered.
The minim