Zumenon 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Estradiol

Available from:

Sigma Pharmaceuticals Plc

ATC code:

G03CA03

INN (International Name):

Estradiol

Dosage:

2mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040101

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZUMENON
® 2MG TABLETS
(ESTRADIOL (AS HEMIHYDRATE))
YOUR MEDICINE IS KNOWN AS THE ABOVE BUT WILL BE REFERRED TO AS ZUMENON
THROUGHOUT THE REMAINDER OF THIS LEAFLET.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.

This medicine has been prescribed for you. 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 ZUMENON IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZUMENON
3.
HOW TO USE ZUMENON
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ZUMENON
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
Zumenon is a Hormone Replacement Therapy (HRT). It contains the female
hormone oestrogen. Zumenon is used in postmenopausal women with at
least
6 months since their last natural period and women switching from
standard
(cyclic or sequential) HRT on the advice of their doctor.
Zumenon 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").
Zumenon alleviates these symptoms after menopause. You will only be
prescribed Zumenon 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 Zumenon to prevent
osteoporosis after menopause.
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks which need

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zumenon® 2mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg estradiol (as hemihydrate)
Excipient with known effect: each tablet contains 118.2 mg lactose
monohydrate.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Brick-red, round, biconvex, film-coated tablets imprinted with '379'
on one
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women at least 6 months since last menses.
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)
Older people
The experience of treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
One tablet to be taken orally
Zumenon is an oestrogen only continuous HRT for women with or without
a uterus.
In women with a uterus, a progestogen should be added to Zumenon for
12-14 days
each month to reduce the risk to the endometrium. Unless there is a
previous
diagnosis of endometriosis, it is not recommended to add a progestogen
in
hysterectomised women.
_For initiation and continuation of treatment of postmenopausal
symptoms, the lowest _
_effective dose for the shortest duration (see also section 4.4)
should be used. _
In general, treatment should start with Zumenon 1mg. Depending on the
clinical
response, the dosage can afterwards be adjusted to individual need. If
the complaints
linked to oestrogen deficiency are not ameliorated the dosage can be
increased by
using Zumenon 2mg.
Starting Zumenon
In women who are not taking hormone replacement therapy and who are
amenorrhoeic, are hysterectomised, or women who switch from a
continuous
combined hormone replacement therapy, treatment may be started on any
convenient
day. In women transferring from a cyclic or co