Premique 0.625mg/2.5mg Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Conjugated estrogens; Medroxyprogesterone acetate

Available from:

Pfizer Healthcare Ireland

ATC code:

G03FA; G03FA12

INN (International Name):

Conjugated estrogens; Medroxyprogesterone acetate

Dosage:

0.625 mg/2.5 milligram(s)

Pharmaceutical form:

Coated tablet

Prescription type:

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

Therapeutic area:

Progestogens and estrogens, fixed combinations; medroxyprogesterone and estrogen

Authorization status:

Not marketed

Authorization date:

1998-05-28

Patient Information leaflet

PQ 5_0
Page 1 of 10
2016-0014994
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PREMIQUE
®
0.625 MG/2.5 MG COATED TABLETS
(CONJUGATED
ESTROGENS
AND MEDROXYPROGESTERONE ACETATE)
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 further questions, please 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 PREMIQUE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREMIQUE
3.
HOW TO TAKE PREMIQUE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PREMIQUE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT PREMIQUE IS AND WHAT IT IS USED FOR
Premique is a Hormone Replacement Therapy (HRT). It contains two types
of female hormones, an estrogen and
a progestogen. Premique is used to treat some of the symptoms and
conditions associated with the menopause.
Premique 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"). Premique
alleviates these symptoms after menopause.
You will only be prescribed Premique if your symptoms seriously hinder
your daily life.
PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available
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 Premique to prevent osteoporosis after menopause.
You must talk to a doctor if you do not feel better or if you feel
worse after taking this medicine.
2. WHAT YOU NEED TO K

Summary of Product characteristics

Health Products Regulatory Authority
04 October 2019
CRN009CNW
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Premique 0.625mg/2.5mg Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.625mg of conjugated estrogens
†
and 2.5mg of medroxyprogesterone acetate (MPA).
†
Conjugated estrogens contain sodium estrone sulfate, sodium equilin
sulfate, 17α-dihydroequilin, 17α-estradiol, equilenin,
17α-dihydroequilenin, 17β-dihydroequilin, 17 β-dihydroequilenin, 17
β-estradiol and 8,9-dehydro-estrone.
Excipients with known efffect
Contains 98.47mg of lactose monohydrate and 216.0mg of sucrose per
tablet.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Coated tablet.
A peach coloured oval biconvex coated tablet marked with
“0.625/2.5” in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Premique is indicated for hormone replacement therapy (HRT) for
estrogen-deficiency symptoms in postmenopausal women
with an intact uterus.
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 also section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS_
Premique is taken orally in a continuous combined 28-day regimen of
one tablet daily with no break between packs.
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.
_For treatment of moderate to severe vasomotor symptoms, atrophic
vaginitis and atrophic urethritis associated with estrogen _
_deficiency:_ The usual starting dose is one tablet 0.625mg/5.0mg per
day.
_For prevention of osteoporosis associated with estrogen deficiency:_
The usual starting dose is one tablet 0.625mg/5.0mg per day.
For prevention of