zumenon 1 mg
film-coated tablets
What you should know about Zumenon
Please read this leaflet before you take your medicine, and keep it safe because you may want to read it again. If you have any questions or are not sure about anything, ask your doctor or a pharmacist.
What is in Zumenon?
Zumenon belongs to a group of medicines known as Hormone Replacement Therapy or HRT.
Each tablet contains 1 mg estradiol hemihydrate. The tablets are white and can be recognised by the following markings: 'a letter S above a triangle’ on one side and ‘379’ on the other.
The estradiol in the tablets is made from plant materials. The tablets also contain: lactose, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate, macrogol 400 and titanium dioxide (E171).
Zumenon is available as a three month (84 tablets) calendar pack, which is marked with the days of the week to help you remember to take your tablets.
The marketing authorisation holder is
Zumenon is made by
What is Zumenon for?
Zumenon is an estrogen only continuous HRT for peri and postmenopausal women, used to treat the symptoms of the menopause (change of life). These symptoms vary from woman to woman, and can include hot flushes, night sweats, sleeping difficulties, dryness of the vagina and urinary problems.
Zumenon is suitable for peri and postmenopausal women who may or may not still be having their periods and women switching from standard (cyclic or sequential) HRT on the advice of their doctor.
Zumenon 1mg is not a contraceptive. If you need contraception you should use a non-hormonal method.
How does Zumenon work?
Zumenon contains estradiol. These hormones replace the estradiol you produce in your ovaries from puberty until the menopause. Your body’s natural estrogen is also called estradiol. Estradiol replaces your body's natural estrogen, controlling your menopausal symptoms. Women who still have a womb should normally take some form of progesterone (a progestagen), because estrogen alone can cause problems due to a build up of the womb lining.
When needed, a progestagen such as dydrogesterone 10 mg should normally be added to Zumenon for 12 - 14 days each month. Taking dydrogesterone for part of each monthly cycle (with Zumenon) helps prevent a build up of the womb lining by inducing a
regular monthly bleed (see ‘Endometrial cancer’).
Before taking Zumenon
Before you take your medicine, you should make sure that it is safe for you to do so. If you answer yes to any of the following questions, do not take Zumenon:
- Do you have, have you had, or does your doctor think you might have, breast cancer?
- Have you had or does your doctor think that you might have a tumour which is made worse by estrogens (e.g. endometrial cancer)?
- Do you have or are you being treated for a blood clot in an artery or in a vein in your leg or anywhere else (a deep vein thrombosis), or a blood clot that has travelled to your lung or other parts of your body (an embolus)? Have you had one of these conditions in the past?
- Do you have angina, or have you ever had a heart attack or stroke?
- Has your doctor told you that you have porphyria (a metabolic disorder)?
- Are you allergic to any of the tablet ingredients?
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
If any of the following apply to you, you should check with your doctor before you start taking Zumenon:
- you have or have had serious liver disease; or
- you have irregular or unusually heavy periods; or
- you have or have had endometrial hyperplasia; or
- you are pregnant.
Medical check-ups
Before you start taking HRT, your doctor should ask about your own and your family’s medical history.
Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination - but only if these examinations are necessary for you, or if you have any special concerns.
Once you’ve started on HRT, you should see your doctor for regular check-ups (at least once a year).
At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.
Be sure to:
go for regular breast screening and cervical smear tests
regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.
If you have (or had in the past, or are at risk of getting) any of the following conditions, your doctor may want to see you more often for check-ups:
- fibroids or endometriosis
- blood clots in the legs or lungs
- tumours related to estrogens
- high blood pressure
- liver complaints
- sugar diabetes
- gall stones
- migraine or severe headache
- systemic lupus erythematosus (SLE) (a disease which affects the skin and major organs)
- epilepsy (fits)
- asthma
- otosclerosis (a type of deafness)
Safety of HRT
As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.
Effects on your heart or circulation
Heart disease
HRT is not recommended for women who have heart disease, or have had heart disease recently.
If you have had heart disease, talk to your doctor to see if you should take HRT.
HRT will not help to prevent heart disease.
Studies with one type of HRT (containing conjugated estrogen plus the progestagen MPA), have shown that women may be slightly more likely to get heart disease during the first year of taking the medication.
For other types of HRT, the risk is likely to be similar, although this is not yet certain.
If you get:
- a pain in your chest that spreads to your arm or neck
See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.
Stroke
Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:
- getting older
- high blood pressure
- smoking
- drinking too much alcohol
- an irregular heartbeat
If you are worried about any of these things,
or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.
Compare
Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.
For women in their 50s who are taking HRT, the figure would be 4 in 1000.
Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.
For women in their 60s who are taking HRT, the figure would be 15 in 1000.
If you get:
- unexplained migraine-type headaches, with or without disturbed vision
See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.
Blood clots
HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.
These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death.
This condition is called pulmonary embolism, or PE. DVT and PE are examples of a condition called venous thromboembolism, or VTE.
You are more likely to get a blood clot:
- if you are seriously overweight
- if you have had a blood clot before
- if any of your close family have had blood clots
- if you have had one or more miscarriages
- if you have any blood clotting problem that needs treatment with a medicine such as warfarin
- if you’re off your feet for a long time because of major surgery, injury or illness
- if you have a rare condition called SLE
If any of these things apply to you, talk to your doctor to see if you should take HRT.
Compare
Looking at women in their 50s who are not taking HRT — on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.
For women in their 50s who are taking HRT, the figure would be 7 in 1000.
Looking at women in their 60s who are not taking HRT — on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.
For women in their 60s who are taking HRT, the figure would be 17 in 1000.
If you get:
- painful swelling in your leg
- sudden chest pain
- difficulty breathing
See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot.
If you’re going to have surgery,
make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.
Effects on your risk of developing cancer
Breast cancer
Women who have breast cancer, or have had breast cancer in the past, should not take HRT.
Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking estrogen-only HRT for 5 years is about the same as for a woman of the same age who’s still having periods over that time and not taking HRT. The risk for a woman who is taking estrogen plus progestagen HRT is higher than for estrogen-only HRT (but estrogen plus progestagen HRT is beneficial for the endometrium, see ‘Endometrial cancer’ below).
For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping.
Your risk of breast cancer is also higher:
- if you have a close relative (mother, sister or grandmother) who has had breast cancer
- if you are seriously overweight
Compare
Looking at women aged 50 who are not taking HRT — on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.
For women who start taking estrogen-only HRT at age 50 and take it for 5 years, the figure will be 33 and 34 in 1000 (i.e. an extra 1-2 cases).
If they take estrogen-only HRT for 10 years, the figure will be 37 in 1000 (an extra 5 cases).
For women who start taking estrogen plus progestagen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (i.e. an extra 6 cases).
If they take estrogen plus progestagen HRT for 10 years, the figure will be 51 in 1000 (i.e. an extra 19 cases).
If you
notice
any changes in your breast, such as:
- dimpling of the skin
- changes in the nipple
- any lumps you can see or feel
Make an appointment to see your doctor as soon as possible.
Endometrial cancer (cancer of the lining of the womb)
Taking estrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestagen as well as the estrogen helps to lower the extra risk.
If you still have your womb, your doctor may prescribe a progestagen as well as estrogen. If so, these may be prescribed separately, or as a combined HRT product.
If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen without a progestagen.
If you have had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestagen as well as an estrogen.
Your product, Zumenon is an estrogen-only product
Compare
Looking at women who still have an uterus 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 who take estrogen-only HRT the number will be 2 to 12 times higher, depending on the dose and how long you take it.
The addition of a progestagen to estrogen-only HRT substantially reduces the risk of endometrial cancer.
If you get
breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking HRT.
But if the bleeding or spotting:
- carries on for more than the first few months
- starts after you have been on HRT for a while
- carries on even after you have stopped taking HRT
Make an appointment to see your doctor.
It could be a sign that your endometrium has become thicker.
Ovarian cancer
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.
Some studies have indicated that taking estrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.
Are you taking any of these other medicines?
If you are taking anticonvulsants (eg. phenobarbital, phenytoin, carbamezapine), anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz), ritonavir, nelfinavir or herbal preparations containing St John’s Wort (Hypericum perforatum), talk to your doctor or a pharmacist. These other medicines may stop Zumenon working properly.
How to take Zumenon
Generally your doctor will start you on Zumenon 1mg.
Your doctor will aim to give you the lowest dose for the shortest time to treat your symptoms. The dose can then be increased, by your doctor, if necessary.
Take one tablet every day, without a break between packs. Swallow the tablet with water, with or without food.
In women with an uterus, a progestagen such as dydrogesterone 10 mg should normally be added to Zumenon for 12 - 14 days of each month.
If you are having regular periods you should start taking Zumenon within five days of the start 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 estrogen tablet or patch for part of the month, followed by both estrogen 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.
If you forget to take a tablet, take the next one 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. If you miss a tablet, it is more likely that you will have irregular bleeds.
Overdose
If you (or someone else, e.g. a child) take too many Zumenon tablets, they are unlikely to do any harm.
Nausea, vomiting, sleepiness and dizziness may occur.
No treatment is necessary, but if you are worried, contact your doctor for advice.
Zumenon 1mg Side Effects
Some women may have side effects when taking Zumenon, but they usually disappear after the first few months. In the list of possible side effects given below, we give an indication of how likely it is that you will get these side effects: ‘common’ means less than one in ten patients may experience this side effect; ‘uncommon’ means less than one in a hundred; ‘rarely’ means less than one in a thousand; and ‘very rarely’ means less than one in ten thousand patients.
Infections: Symptoms of cystitis; thrush; (uncommon)
Tumours: Breast cancer; fibroids get bigger; (uncommon)
Blood changes: Anaemia (iron deficiency); (very rare)
Mental problems: Depression; change in sex drive; nervousness; (uncommon)
Nervous system: Headache; migraine; (common). Dizziness; (uncommon.) Chorea (muscle twitches); (very rare)
Eye changes: Intolerance to contact lenses; change in the surface of the eye; (rare)
Heart: Heart attack; (very rare)
Blood vessels: High blood pressure; peripheral vascular disease; varicose veins; venous thromboembolism (blood clots in the legs, pelvis or lungs); (uncommon). Stroke; (very rare)
Gut complaints: Nausea; abdominal pain; flatulence (wind); (common). Indigestion; (uncommon). Vomiting; (very rare)
Liver complaints: Gall bladder disease; (uncommon). Liver function changes (e.g. jaundice); (rare)
Skin complaints: Allergic skin reactions (including rash or itching); (uncommon). Skin discolouration; swelling or red patches on the skin ;(very rare)
Muscle and bone: Leg cramps; (common). Back pain; (uncommon)
Reproductive system: Tender breasts; irregular bleeds and spotting; pelvic pain; (common). Vaginal discharge; painful periods; heavy or irregular periods; (uncommon). Swollen breasts; pre-menstrual tension (PMT); (rare)
Inherited conditions: Porphyria (a metabolic disorder) gets worse; (very rare)
General complaints: Asthenia (feeling weak); (common). Fluid retention; (uncommon)
Investigations: Weight changes (up or down); (common).
Tumours related to estrogens (both benign and malignant) have been associated with HRT (see ‘Effects on your risk of developing cancer’ above).
Dementia: HRT will not prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.
Usually, side effects are not common and do not usually last long. If any of these side effects do last for a long time or you notice any other side effects and you are worried about them, please contact your doctor or a pharmacist for advice.
You should stop taking Zumenon and contact your doctor if:
- you develop any of the conditions listed in the ‘Before taking Zumenon’ section; or
- you develop a blood clot (see ‘Blood clots’); or
- you get sudden problems with your vision, severe headaches or migraines (see ‘Stroke’); or
- you develop jaundice (yellowing of the skin); or
- you become pregnant; or
- your blood pressure increases.
How to store your medicine
Do not store above 30°C. Do not take the tablets after the expiry date shown on the pack. Store all medicines where children cannot see or reach them.
Take any unused tablets back to a pharmacy (chemist).
This leaflet was last approved in October 2009.
Remember
This medicine is for you. Please do not offer it to your family and friends, even if they have the same symptoms as you.
registered trade mark
1069706
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