Product Details

. 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 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 oestradiol or any of the other ingredients of Zumenon
(listed in section 6 Further information)
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 oestrogen-progestogen 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 oestrogen-progestogen 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-progestogen 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 long-term 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
oestrogen-progestogen 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 oestrogen-progestogen 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.
Other medicines and Zumenon
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 carbamazepine)
• 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
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.
Zumenon contains lactose
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.