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ZUMENON 1MG FILM-COATED TABLETS

Active substance(s): ESTRADIOL / ESTRADIOL HEMIHYDRATE

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film-coated tablets
Read all of this leaflet carefully before you start using
this medicine.
• 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
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
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 applies to you. If you are not sure
about any of the points below, talk to your doctor before
taking Zumenon,
Do not take Zumenon
• If you have or have ever had breast cancer, or if you
are suspected of having it
• If you have cancer which is sensitive to oestrogens,
such as cancer of the womb lining (endometrium), or if
you are suspected of having it
• If you have any unexplained vaginal bleeding
• If you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated.
• If you have or have ever had a blood clot in a
vein (thrombosis), such as in the legs (deep
venous thrombosis) or the lungs (pulmonary
embolism)
• If you have a blood clotting disorder (such as
protein C, protein S, or antithrombin deficiency)
• If you have or recently have had a disease
caused by blood clots in the arteries, such as a
heart attack, stroke or angina
• If you have or have ever had a liver disease and
your liver function tests have not returned to
normal
• If you have a rare blood problem called
“porphyria” which is passed down in families
(inherited)
• If you are allergic (hypersensitive) to oestradial
or any of the other ingredients of Zumenon (listed
in section 6 Further information)
• if you still have your womb and are not currently
taking some form of progestogen hormone
If any of the above conditions appear for the first
time while taking Zumenon, stop taking it at once
and consult your doctor immediately.
When to take special care with Zumenon
Tell your doctor if you have ever had any of the
following problems, before you start the treatment,
as these may return or become worse during
treatment with Zumenon. If so, you should see your
doctor more often for check-ups:
• fibroids inside your womb
• growth of womb lining outside your womb
(endometriosis) or a history of excessive growth
of the womb lining (endometrial hyperplasia)
• increased risk of developing blood clots (see
“Blood clots in a vein (thrombosis)”)
• increased risk of getting a oestrogen-sensitive
cancer (such as having a mother, sister or
grandmother who has had breast cancer)
• high blood pressure.
• a liver disorder, such as a benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches.
• a disease of the immune system that affects
many organs of the body (systemic lupus
erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing
(otosclerosis)
• a very high level of fat in your blood (triglycerides)
• fluid retention due to cardiac or kidney problems
Stop taking Zumenon and see a doctor immediately
If you notice any of the following when taking HRT:
- any of the conditions mentioned in the ‘DO NOT
take Zumenon’ section
- yellowing of your skin or the whites of your eyes
(jaundice). These may be signs of a liver disease
- a large rise in your blood pressure (symptoms may
be headache, tiredness, dizziness).
- migraine-like headaches which happen for the first
time.
- if you become pregnant
- if you notice signs of a blood clot, such as:
- painful swelling and redness of the legs
- sudden chest pain
- difficulty in breathing
For more information, see ‘Blood clots in a vein
(thrombosis)’
Note: Zumenon is not a contraceptive. If it is less than 12
months since your last menstrual period or you are under
50 years old, you may still need to use additional
contraception to prevent pregnancy. Speak to your doctor
for advice.

HRT and cancer
Excessive thickening of the lining of the womb
(endometrial hyperplasia) and cancer of the lining of
the womb (endometrial cancer)
Taking oestrogen-only HRT will increase the risk of
excessive thickening of the lining of the womb
(endometrial hyperplasia) and cancer of the womb lining
(endometrial cancer).
Taking a progestogen in addition to the oestrogen for at
least 12 days of each 28 day cycle protects you from this
extra risk. So your doctor will prescribe a progestogen
separately if you still have your womb. If you have had
your womb removed (a hysterectomy), discuss with your
doctor whether you can safely take this product without a
progestogen.
In women who still have a womb and who are not taking
HRT, on average, 5 in 1000 will be diagnosed with
endometrial cancer between the ages of 50 and 65.
For women aged 50 to 65 who still have a womb and who
take oestrogen-only HRT, between 10 and 60 women in
1000 will be diagnosed with endometrial cancer (i.e.
between 5 and 55 extra cases), depending on the dose
and for how long it is taken.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal
bleed) while taking Zumenon. But, if you have unexpected
bleeding or drops of blood (spotting) besides your
monthly bleeding, which:
• carries on for more than the first 6 months
• starts after you have been taking Zumenon more than
6 months
• carries on after you have stopped taking
Zumenon
see your doctor as soon as possible
Breast cancer
Evidence suggests that taking combined oestrogenprogestogen and possibly also oestrogen-only HRT
increases the risk of breast cancer. The extra risk
depends on how long you take HRT. The additional
risk becomes clear within a few years. However, it
returns to normal within a few years (at most 5) after
stopping treatment.
For women who have had their womb removed and
who are using oestrogen-only HRT for 5 years, little
or no increase in breast cancer risk is shown.
Women aged 50 to 79 who are not taking HRT, on
average, 9 to 17 in 1000 will be diagnosed with
breast cancer over a 5-year period. For women
aged 50 to 79 who are taking oestrogenprogestogen HRT over 5 years, there will be 13 to
23 cases in 1000 users (i.e. an extra 4 to 6 cases).
• Regularly check your breasts. See your
doctor if you notice any changes such as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel
Ovarian cancer
Ovarian cancer is rare much rarer than breast
cancer. The use of oestrogen-only or combined
oestrogen-progestagen HRT has been associated
with a slightly increased risk of ovarian cancer. The
risk of ovarian cancer varies with age. For example
in women aged 50 to 54 who are not taking HRT, on
average about 2 women in 2000 will be diagnosed
with ovarian cancer over a 5-year period. For
women who have been taking HRT for 5 years,
there will be about 3 cases per 2000 users (i.e.
about 1 extra case).
Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to
3- times higher in HRT users than in non-users,
especially during the first year of taking it.
Blood clots can be serious, and if one travels to the
lungs, it can cause chest pain, breathlessness, fainting or
even death.
You are more likely to get a blood clot in your veins as you
get older and if any of the following applies to you. Inform
your doctor if any of these situations applies to you:
• you are unable to walk for a long time because of
major surgery, injury or illness (see also section 3, If
you need to have surgery)
• you are seriously overweight (BMI >30 kg/m2)
• you have any blood clotting problem that needs longterm treatment with a medicine used to prevent blood
clots
• if any of your close relatives has ever had a blood clot
in the leg, lung or another organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see “Stop taking Zumenon and
see a doctor immediately”.
Looking at women in their 50s who are not taking HRT, on
average, over a 5-year period, 4 to 7 in 1000 would be
expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogenprogestogen HRT for over 5 years, there will be 9 to
12 cases in 1000 users (i.e. an extra 5 cases).
For women in their 50s who have had their womb
removed and have been taking oestrogen-only HRT for
over 5 years, there will be 5 to 8 cases in 1000 users (i.e.
1 extra case).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogenprogestogen HRT are slightly more likely to develop heart
disease than those not taking any HRT.
For women who have had their womb removed and are
taking oestrogen-only therapy there is no increased risk
of developing a heart disease.
Stroke
The risk of getting stroke is about 1.5 times higher in HRT
users than in non-users. The number of extra cases of
stroke due to use of HRT will increase with age.
Looking at women in their 50s who are not taking HRT, on
average, 8 in 1000 would be expected to have a stroke
over a 5-year period. For women in their 50s who are
taking HRT, there will be 11 cases in 1000 users, over 5
years (i.e. an extra 3 cases).
Other conditions
• HRT will not prevent memory loss. There is some
evidence of a higher risk of memory loss in women
who start using HRT after the age of 65. Speak to your
doctor for advice.
Using other medicines
Some medicines may interfere with the effect of Zumenon.
This might lead to irregular bleeding. This applies to the
following medicines:
• Medicines for epilepsy (such as phenobarbital,
phenytoin and carbamazepin)
• Medicines for tuberculosis (such as rifampicin,
rifabutin)
• Medicines for HIV infection (such as nevirapine,
efavirenz, ritonavir and nelfinavir)
• Herbal remedies containing St John’s Wort
(Hypericum perforatum).
Problems due to high levels of the following medicines
may occur when you take Zumenon so careful drug
monitoring and dose decrease may become necessary:
- tacrolimus and cyclosporin – used, for example, for
organ transplants
- fentanyl – a painkiller
- theophylline – used for asthma and other breathing
problems
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Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines including
medicines obtained without a prescription, herbal
medicines or other natural products.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory
staff that you are taking Zumenon, because this medicine
can affect the results of some tests.
Pregnancy and breast-feeding
Zumenon is for use in peri and postmenopausal women
only. If you become pregnant, stop taking Zumenon and
contact your doctor.
Important information about some of the
ingredients of Zumenon
Zumenon tablets contain milk sugar (lactose). If you have
been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this
medicinal product.
3. HOW TO TAKE ZUMENON
Always take Zumenon exactly as your doctor has told
you. You should check with your doctor or pharmacist
if you are not sure.
Take one tablet every day, without a break between
packs. Swallow the tablet with water, with or without
food.
In women with a uterus, a progestagen should normally
be added to Zumenon for 12 - 14 days of each month.
If you are having regular periods you should start taking
Zumenon on day one of bleeding.
If you are not having regular periods and are not taking
any other HRT preparations, or you are switching from a
combined continuous HRT product, you can start taking
Zumenon on any convenient day.
If you are currently using a ‘cyclic’ or ‘sequential’ HRT
preparation (which involves taking an oestrogen tablet or
patch for part of the month, followed by both oestrogen
and progestagen tablet or patch for up to 14 days) start
taking Zumenon the day after you finish the pack i.e. at
the end of the progestagen phase.
Your doctor will aim to prescribe the lowest dose to treat
your symptom for as short as necessary. Speak to your
doctor if you think this dose is too strong or not strong
enough.
You may experience some irregular bleeding or light
bleeding (spotting) during your first few months of taking
Zumenon. If the bleeding is troublesome, or continues
beyond the first few months of treatment you should
discuss this with your doctor.
If you take more Zumenon than you should
If you or somebody else takes too many Zumenon tablets,
they are unlikely to come to any harm. Nausea (feeling
sick), vomiting, sleepiness, dizziness and withdrawal
bleeding may occur. No treatment is necessary, but if you
are worried contact your doctor for advice.
If you forget to take Zumenon
Take the missed tablet as soon as you remember. If it is
more than 12 hours since you took the last one, take the
next dose without taking the forgotten tablet. Do not take
a double dose. Bleeding or spotting may occur if you
miss a dose.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you
are taking Zumenon. You may need to stop taking
Zumenon about 4 to 6 weeks before the operation to
reduce the risk of a blood clot (see section 2, Blood clots
in a vein). Ask your doctor when you can start taking
Zumenon again.
If you stop taking Zumenon
Do not stop taking Zumenon without first talking to your
doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zumenon can cause side effects,
although not everybody gets them.
The following diseases are reported more often in women
using HRT compared to women not using HRT:
• breast cancer
• abnormal growth or cancer of the lining of the womb
(endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous
thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over the age of
65
For more information about these side effects, see
Section 2.
The following serious side effects may occur during
treatment with Zumenon:
- swelling of the skin around the face and neck. This
may cause difficulty breathing.
- heart attack
- heavy, irregular or painful bleeds
If any of these side effects occur you should stop
treatment immediately and contact your doctor.
The following side effects may occur during treatment:
Common (in less than 1 in 10, but more than 1 in 100
patients treated):
- headache
- feeling sick
- leg cramps
- abdominal pain
- pelvic pain
- unscheduled bleeding or spotting
- wind (flatulence)
- feeling weak (asthenia)
- weight changes
- rash or itching
Uncommon (in less than 1 in 100, but more than 1 in
1,000 patients treated):
- hypersensitivity (allergic) reaction such as skin rash,
itching, skin redness
- hives
- painful reddish skin nodules (erythema nodosum)
- feeling down
- depression
- vaginal thrush (a vaginal infection due to a fungus
called Candida albicans)
- symptoms of cystitis
- high blood pressure
- swelling of the ankles, feet or fingers (peripheral
oedema)
- water retention (oedema)
- peripheral vascular disease
- varicose veins
- blood clots in the veins of the legs or lungs (venous
thromboembolism)
- gallbladder disease
- back pain
- indigestion
- nervousness
- dizziness
- fibroids get bigger (growths in the womb increase)
- changes in the cervix (the lower end of the womb)
- problems with your sight
- faster heart beat (palpitations)
- breast pain or tenderness
Rare (in less than 1 in 1,000, but more than 1 in 10,000
patients treated):
- liver disorders, which may include jaundice (yellowing
of the skin), asthenia (feeling weak) or general malaise,
and abdominal pain

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- change in the surface of the eye
- intolerance to contact lenses
- pre-menstrual tension (PMT)
- feeling anxious
- migraine
- vomiting
- feeling bloated
- excessive hair growth
- acne
- muscle cramps
- vaginal discharge
- feeling tired
- swelling of the breasts
- change in sex drive
Very rare (in less than 1 in 10,000 patients treated, not
known (cannot be estimated from the available data)):
- reduction in red blood cells which can make the skin
pale and cause weakness or breathlessness (anaemia)
- chorea (muscle twitches)
- skin discolouration (purpura)
- worsening of porphyria (a metabolic disease)
- stroke
- rash with target-shaped reddening or sores (erythema
multiforme)
- discoloration of the skin especially of the face or neck
known as “pregnancy patches” (chloasma or
melasma)
If unscheduled bleeding occurs after some time on HRT,
you should contact your doctor. If unscheduled bleeding
continues after stopping HRT, it may be necessary to
perform tests to exclude disease of the endometrium (the
lining of the uterus).
Changes can occur in the levels of certain proteins and
hormones in the blood. The action of the hormones in the
body is not affected. You should tell your doctor that you
are taking HRT if you are to have a blood test.
The following side effects have been reported with other
HRTs:
• a disease where the immune system abnormally
attacks many organs of the body (systemic lupus
erythematosus)
• change in metabolism of sugars and starches
(carbohydrate)
• high levels of certain blood fats (hypertriglyceridemia)
• worsening of fits (epilepsy)
• blood clots in the arteries (arterial thromboembolism)
• inflammation of the pancreas (pancreatitis) in women
with pre-existing high levels of certain blood fats
(hypertriglyceridemia)
• a condition where gastric juices, containing acid,
travel back from the stomach into the oesophagus
(gastrooesophageal reflux disease) symptoms include
heartburn
• urinary incontinence
• painful/lumpy breasts (fibrocystic breast disease)
• increased total thyroid hormones
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at: www.
mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE ZUMENON
Keep out of the reach and sight of children.
This medicinal product does not require any special
storage conditions.
Do not use Zumenon after the “use before” date which is
stated on the pack. The “use before” date refers to the
last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.
6. FURTHER INFORMATION
What Zumenon contains
- The active substance is oestradiol (as hemihydrate)
Each tablet contains 1 mg oestradiol hemihydrate.
The other ingredients in the tablet core are:
- lactose
- hypromellose
- maize starch
- colloidal anhydrous silica
- magnesium stearate
The other ingredients in the film coating are:
- hypromellose
- macrogol 400
- titanium dioxide (E171)
What Zumenon looks like and contents of the pack
White round film-coated tablets.
The inscription on the tablets is 379 on one side.
The tablets are packed in a PVC film with a covering
aluminium foil.
The blister strips contain 28 film-coated tablets. There are
84 tablets in each carton.
Marketing Authorisation Holder
BGP Products Ltd.
Abbott House,
Vanwall Business Park,
Vanwall Road, Maidenhead,
SL6 4XE,
UK
Manufacturer
Abbott Biologicals BV
8121 AA, Olst
The Netherlands
This leaflet was last revised in February 2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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