Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions about Zumenon. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Zumenon against the benefits they expect it will provide.
If you have any concerns about using Zumenon, ask your doctor or pharmacist. Your doctor and pharmacist have more information.
Keep this information with the medicine. You may need to read it again.
When you must not use Zumenon
Do not use Zumenon or other oestrogens, with or without progesterone to prevent heart attacks, stroke or dementia. A study called the Women's Health Initiative indicated increased risk of heart attack, stroke, breast cancer, and blood clots in the legs or lungs in women receiving treatment with a product containing conjugated oestrogens 0.625 mg and the progestogen medroxyprogesterone acetate (MPA). The researchers stopped the study after 5 years when it was determined the risks were greater than the benefits in this group. The Women's Health Initiative Memory Study indicated increased risk of dementia in women aged 65-79 years taking conjugated oestrogens and MPA. There are no comparable data currently available for other doses of conjugated oestrogens and MPA or other combinations of oestrogens and progestogens. Therefore, you should assume the risks will be similar for other medicines containing oestrogen and progestogen combinations.
Talk regularly with your doctor about whether you still need treatment with Zumenon.
Treatment with oestrogens, with or without progestogens should be used at the lowest effective dose and for the shortest period of time.
What Zumenon is used for
Zumenon is a hormone replacement therapy (HRT). It contains the hormone oestradiol.
Zumenon helps to relieve the discomfort many women feel during and after the menopause. Women with an intact womb will commonly be prescribed Zumenon and another tablet, a progestogen, to protect the lining of the uterus from over stimulation.
Once you start taking Zumenon, symptoms such as hot flushes and excessive sweating are usually relieved within a few days, but other symptoms such as skin tone and vaginal dryness may take a few weeks to be relieved.
Your doctor may prescribe Zumenon for a condition not described in this leaflet. If you are unsure why you have been prescribed Zumenon, ask your doctor.
HRT should not be used for the long-term maintenance of general health or to prevent heart disease. It is not suitable for birth control and it will not restore fertility.
How it works
Oestradiol is a natural female sex hormone called an oestrogen. It is the same hormone that your ovaries were producing before the menopause.
The menopause occurs naturally in the course of a woman's life, usually between the ages of 45 and 55. After menopause your body produces much less oestrogen than it did before. This can cause unpleasant symptoms such as a feeling of warmth in the face, neck and chest, "hot flushes" (sudden intense feelings of heat and sweating throughout the body), sleep problems, irritability and depression. Some women also have problems with urine control or with dryness of the vagina causing discomfort during or after sex. Oestrogens can be given to reduce these symptoms.
After the age of 40, and especially after the menopause, some women develop osteoporosis. This is a thinning of the bones that makes them weaker and more likely to break, especially the bones of the spine, hip and wrist. The risk of osteoporosis is increased by lack of oestrogen. Oestrogens can be given to reduce this risk if other treatments are not suitable.
Women who still have a uterus must take both oestrogen and progestogen as part of HRT. This is because oestrogen stimulates the growth of the lining of the uterus (called the endometrium). Before menopause this lining is removed during your period through the action of a natural progestogen. After menopause, taking oestrogen on its own as HRT may lead to irregular bleeding and to a disorder called endometrial hyperplasia. Progestogens such as dydrogesterone help to protect the lining of the uterus from developing this disorder.
Zumenon is not a contraceptive and will not prevent pregnancy. Ask your doctor about your need for contraception.
Ask your doctor if you have any questions why Zumenon has been prescribed for you.
HRT should not be used to prevent heart disease or dementia.
The medicine is available only with a doctor's prescription.
Before you take Zumenon
When you must not take it
Do not use Zumenon if you have an allergy to:
Oestradiol, the active ingredient, or to any of the other ingredients listed at the end of this leaflet
any other medicine containing oestrogen, including the birth control pill.
Signs of allergy include a skin rash, itching, shortness of breath, and/or swelling of the face, lips, tongue or other parts of the body.
Do not use Zumenon if you have:
Cancer of the breast or uterus (womb) or any other oestrogen dependent cancer, or you have had this condition in the past
blood clots in your blood vessels, now or in the past. You may have had painful inflammation of the veins or blockage of a blood vessel in the legs, lungs, brain or heart
a condition that increases the tendency for you to get blood clots
endometriosis (a disorder of the uterus that may cause painful periods and abnormal bleeding)
abnormal vaginal bleeding that has not been investigated
severe liver disease
a condition called porphyria
a tumour of the pituitary gland or hypothalamus
a disease of the connective tissue
hearing loss due to a problem with the bones in the ear called otosclerosis
to treat any other complaints unless your doctor advises you to do so.
If you are not sure whether any of the above conditions apply to you, your doctor can advise you.
Do not use Zumenon if you are pregnant or breast-feeding. It may affect your baby.
Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering, or if the tablets do not look quite right. In that case, return it to your pharmacist.
You must stop taking Zumenon four weeks before certain types of surgery. Please consult your doctor.
Do not give this medicine to anyone else.
Before you start to take it
You must have a thorough medical check-up before starting HRT for the first time or recommencing HRT.
Tell your doctor if you have:
A family history of breast cancer
Nodules, lumps or cysts in your breasts or any other benign breast condition (not cancer)
Fibroids or other benign tumours of the uterus (not cancer)
Unusual or irregular bleeding or spotting from the vagina
High blood pressure
Liver problems, including yellowing of the skin and whites of the eyes and a condition called porphyria
Had a problem in the past with a condition called cholestatic jaundice when you were pregnant or took an oestrogen (eg birth control pill or HRT)
Systemic lupus erythematosus
Gall bladder disease
A high level of triglycerides (fats) in the blood
High or low levels of calcium in the blood.
Tell your doctor if you are likely to have an increased risk of developing blood clots in your blood vessels. The risk increases as you get older and it may also be increased if:
Anyone in your immediate family has ever had blood clots in the blood vessels of the legs or lungs
You are overweight
You have varicose veins
You have a disorder called systemic lupus erythematosus (SLE).
Your doctor will give you a thorough examination before prescribing Zumenon and will give further examinations regularly during treatment. Your doctor is likely to check your blood pressure, breasts, and tummy. You may also be advised to have a mammogram.
Taking other medicines
Tell your doctor if you are taking birth control pills. Zumenon is not a contraceptive. Since pregnancy may be possible early in the menopause while you are still having menstrual periods, you should ask your doctor to suggest another (non-hormonal) method of birth control.
Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Zumenon may interfere with each other. These include:
Herbal medicines containing St John's wort
Some medicines for epilepsy such as phenytoin, phenobarbitone and carbamazepine
Some antibiotics and anti-infectives such as rifampicin and ritonavir
Zumenon may affect these medicines or they may affect how well it works. You may need to take different amounts of your medicines or take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while you are using Zumenon.
Zumenon will NOT influence your ability to drive or to operate machinery or equipment.
If you have not told your doctor about any of these things, tell him or her before you start taking Zumenon tablets.
Treatment with oestrogens alone over a prolonged period may expose women with an intact womb to an increased risk of cancer of the lining of the womb.
How to take Zumenon
Follow all directions given to you by your doctor or pharmacist carefully. These instructions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help. The usual dose is one tablet daily.
If you have not had a period for twelve months or more or if you have had a hysterectomy, you can start Zumenon immediately.
If you are having irregular periods, start taking Zumenon on day 5 of the menstrual cycle.
If your uterus is still intact your doctor may prescribe another medicine to take with Zumenon during part of your menstrual cycle.
Tablets should preferably be taken at the same time each day and should be swallowed whole with water.
The pack is labelled with the days of the week to help you with taking your tablets every day.
You should start each new pack the day after you have finished the current pack. Do not leave a gap between packs.
How long to take it
Although some women have no symptoms of the menopause or only mild ones, and may not need extra hormones, other women may need to use Zumenon.
Your doctor can advise you how long you may need to take Zumenon.
Your doctor can discuss the risks and benefits of long-term treatment with HRT in your particular case. Some recent studies have shown that women using HRT have a small increase in breast cancer risk after several years of use. The risk increases with the length of HRT use.
Recent studies have also shown that HRT is associated with a small increase in the risk of heart attacks, strokes, blood clots, including clots in the lungs. On the other hand the risk of hip fractures and bowel cancer may be reduced.
Another study has shown that in women older than 65 years, HRT is associated with a small increase in the risk of dementia, including Alzheimer's disease. It is not known if this finding applies to younger women.
If you forget to take it
If it is within 12 hours of your normal dose time, you can take the missed tablet as soon as you remember and then take the next tablet at your normal time. This may mean taking two tablets in the one day.
If it is almost time for your next dose, skip the tablet you missed, and take your next tablet at the normal time.
If you have forgotten to take more than one tablet, discuss this with your doctor.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you, or anyone else has taken too many Zumenon tablets, telephone your doctor or pharmacist immediately, or contact the Poisons Information Centre (telephone 13 11 26 in Australia or 0800 764 766 in New Zealand) Or go to casualty at your nearest hospital immediately if you think you or anybody else may have taken too much Zumenon. In general, taking too many Zumenon tablets will not make you ill.
Keep the packaging and the Consumer Medical Information so that your doctor or pharmacist will know which medicine was taken.
While you are taking Zumenon
Things you must do
Tell your doctor immediately if you have any sore veins or suspected blood clots, disturbances in vision, sudden onset of migraine, significant increase in blood pressure, or yellowing of the skin or eyes (jaundice) while taking Zumenon tablets. Your doctor will probably tell you to stop taking the tablets. Regular medical check-ups are recommended, including the pelvic organs, cervical smear (if necessary), and breasts, particularly if you have breast lumps or a family history of breast cancer.
If you are still having periods of any kind, you should continue to use non-hormonal contraceptive methods (such as a condom) to prevent pregnancy.
If you become pregnant while using Zumenon, tell your doctor immediately. It should not be used while you are pregnant.
See your doctor at least once a year for a check-up. Some women will need to go more often. Your doctor will:
check your breasts and order a mammogram at regular intervals
check your uterus and cervix and do a pap smear at regular intervals
check your blood pressure and cholesterol level.
Check your breasts each month and report any changes promptly to your doctor. Your doctor or nurse can show you how to check your breasts properly.
Tell your doctor that you are using Zumenon well in advance of any expected hospitalisation or surgery. If you go to hospital unexpectedly, tell the doctor who admits you that you are using it. The risk of developing blood clots in your blood vessels may be temporarily increased as a result of an operation, serious injury or having to stay in bed for a prolonged period. If possible, this medicine should be stopped at least 4 weeks before surgery and it should not be restarted until you are fully mobile.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Zumenon.
Tell any other doctor, dentist or pharmacist who treats you that you are using Zumenon.
Things you must not do
Do not use Zumenon to treat any other complaints unless your doctor tells you to.
Do not let others use this medication even if their symptoms seem similar to yours.
Do not take more or less than the recommended amount.
Do not stop taking Zumenon without checking with your doctor first.
Never allow others to take medicines recommended for you and never use medicines prescribed for others.
Tell your doctor as soon as possible if you do not feel well while you are using Zumenon. All medicines can have side effects. Often they are not serious but sometimes they can be. You may need medical treatment if you get some side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other part of the body; shortness of breath, wheezing or troubled breathing
signs that blood clots may have formed, such as sudden severe headache, sudden loss of coordination, blurred vision or sudden loss of vision, slurred speech, numbness or tingling in an arm or leg, painful swelling in the calves or thighs, chest pain, difficulty breathing, coughing blood
pain or tenderness in the abdomen, which may be accompanied by fever, loss of appetite, nausea and vomiting
a yellow colour to the skin or eyes, itching, dark coloured urine or light coloured bowel motions.
The above side effects are serious, requiring urgent medical attention or hospitalisation. These side effects are rare.
Tell your doctor if you notice any of the following and they worry you:
irregular vaginal bleeding or spotting (if bleeding is heavy, check with your doctor as soon as possible)
tender, painful or swollen breasts
redness, irritation or itching under the patch
vaginal itching, inflammation or fluid discharge
swelling of the lower legs, ankles, fingers or abdomen due to fluid retention
nausea (feeling sick), abdominal cramps, vomiting, heartburn, wind, diarrhoea
rise in blood pressure
weakness or dizziness
depression, nervousness, rapid changes in mood, difficulty sleeping
change in sex drive
acne, itchy or dry skin, skin discolouration
Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may happen in some people.
Do not hesitate to report any other side effects to your doctor or pharmacist.
After using Zumenon
Keep your Zumenon tablets in their pack, in a dry place where the temperature stays below 30°C.
Protect them from sunlight by keeping them in their box.
Do not store Zumenon or any other medicine in the bathroom or near a sink.
Heat and dampness can destroy all medicines.
Keep your Zumenon where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Do not use Zumenon tablets after the expiry date (EXP) shown on the strip and carton, even if it has been stored properly.
Medicines cannot be stored indefinitely.
Once you have finished using Zumenon, ask your pharmacist what to do with any that is left over.
Zumenon is available in packs containing two blister strip packs. Each blister strip contains 28 round, biconvex, brick-red, film-coated tablets of 7 mm diameter each containing 2 mg oestradiol bearing the inscription "379" on one side and "S" on the other.
Zumenon tablets each contain 2 mg of the oestrogen hormone, oestradiol anhydrous (equivalent to 2.06 mg oestradiol hemihydrate).
The tablets also contain: lactose, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate.
The colour ingredient used in the tablets is Opadry OY-6957 pink.
Zumenon is manufactured in The Netherlands for:
A division of Solvay Biosciences Pty Ltd
Level 1, Building 2, 20 Bridge Street
Pymble NSW 2073
The Australian Register Number for Zumenon is: AUST R 75888
Date of preparation: October 2006.