Zumenon 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Estradiol

Available from:

Viatris UK Healthcare 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; GTIN: 5012781070450

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER ZUMENON
® 1 MG TABLETS
(estradiol (as hemihydrate))
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.
Your medicine is known by the above name but will be referred to as
Zumenon throughout this leaflet.
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
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. WHAT YOU NEED TO KNOW BEFORE YOU USE 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

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