Zumenon 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Estradiol

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

G03CA03

INN (International Name):

Estradiol

Dosage:

1mg

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

ZUMENON
® 1MG TABLETS/OROMONE
® 1MG TABLETS
(estradiol hemihydrate)
Your medicine is known by either of the above names, but will be
referred to
as Zumenon throughout this:
PATIENT INFORMATION LEAFLET
IN THIS LEAFLET:
1) What Zumenon is and what it is used for
2) Before you use Zumenon
3) How to use Zumenon
4) Possible side effects
5) How to store Zumenon
6) Further information
1) WHAT ZUMENON IS AND WHAT IT IS USED FOR
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.
2) BEFORE YOU TAKE ZUMENON
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks which need to be considered when deciding
whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause (due to
ovarian failure or surgery) is limited.
If you have a premature menopause the risks of using HRT may be
different. Please talk to your doctor. Before you start (or restart)
HRT, your
doctor will ask about your own and your family’s medical history.
Your
doctor may decide to perform a physical examination. This may include
an
examination of your breasts and/or an internal examination, if
necessary.
Once you have started on Zumenon you should see your doctor for
regular
check-ups (at least once a year). At these check-ups, discuss with
your
doctor the benefits and risks of continuing with Zumenon. Go for
regular
breast screening, as recommended by your doctor.
DO NOT TAKE ZUMENON
If any of the following ap

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zumenon® 1mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg estradiol (as hemihydrate)
Excipient with known effect: each tablet contains 119.1 mg lactose
monohydrate.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablets
Round, biconvex, white tablets with inscription ‘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.
Older people
The experience 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 continuous sequential HRT
regimen,
treatment should begin the day following completion of the prior
regimen. If the
patient has regular menstruation periods, treatment is started on day
one of bleeding.
Administration
The