Consumer Medicine Information
The Women's Health Initiative (WHI) trial examined the health benefits and risks of combined estrogen plus progestogen therapy (n=16,608) and estrogen-alone therapy (n=10,739) in postmenopausal women aged 50 to 79 years.
The estrogen plus progestogen arm of the WHI trial indicated an increased risk of myocardial infarction (MI), stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis in postmenopausal women receiving treatment with combined conjugated equine estrogens (CEE, 0.625 mg/day) and medroxyprogesterone acetate (MPA, 2.5 mg/day) for 5.2 years compared to those receiving placebo.
The estrogen-alone arm of the WHI trial indicated an increased risk of stroke and deep vein thrombosis in hysterectomized women treated with CEE-alone (0.625 mg/day) for 6.8 years compared to those receiving placebo.
Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestogens were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar.
Therefore, the following should be given serious consideration at the time of prescribing:
Estrogens with or without progestogens should not be prescribed for primary or secondary prevention of cardiovascular diseases.
Estrogens with or without progestogens should be prescribed at the lowest effective dose for the approved indication.
Estrogens with or without progestogens should be prescribed for the shortest period possible for the approved indication.
For the prevention of osteoporosis, estrogen treatment should be considered in light of other available therapies.
What is in this leaflet
This leaflet answers some of the common questions about PROGYNOVA tablets. 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 PROGYNOVA against the benefits they expect it will provide. If you have any concerns about using PROGYNOVA, ask your doctor or pharmacist. Your doctor and pharmacist have more information. Keep this leaflet with the medicine. You may need to read it again.
What PROGYNOVA is used for
PROGYNOVA provides hormone replacement therapy (HT) for the treatment of climacteric complaints after the cessation of monthly bleeding or after removal of the ovaries (ovariectomy). PROGYNOVA is only intended for short term use.
PROGYNOVA contains estradiol valerate, a prodrug of the natural human oestradiol. During the climacteric ('the change of life') the oestradiol production of the ovaries declines. Although the change of life is natural, it often causes distressing symptoms, which are connected with the gradual loss of the hormones produced by the ovaries.
PROGYNOVA replaces the hormone oestradiol that the body no longer makes. The oestradiol prevents or relieves troublesome symptoms (climacteric complaints) such as hot flushes, sweats, sleep disturbances, nervousness, irritability, dizziness, headaches as well as involuntary loss of urine, vaginal dryness and burning.
If you still have a womb (you have not had a hysterectomy) your doctor will prescribe another hormone progestogen to take with PROGYNOVA.
Before you take PROGYNOVA
When you must not take it
Do not take it:
If you are pregnant or breastfeeding.
If you have undiagnosed vaginal bleeding.
If you have or if there is a suspicion of cancer of the breast.
If you have or if there is a suspicion of other malignancies influenced by sex hormones.
If you have or have had liver tumours (benign or malignant).
If you have severe liver disease.
If you recently had a heart attack and/or stroke.
If you have or have had a thrombosis (the formation of a blood clot) in the blood vessels of the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
If you have severely elevated blood levels of triglycerides (special type of blood lipids).
If you have had jaundice or persistent itching during a previous pregnancy or with prior use of hormonal products (oral contraceptives or hormone therapy).
If you have had otosclerosis (a form of hearing loss) with deterioration during pregnancy.
If you have severe diabetes mellitus with changes to your blood vessels.
If you are allergic to any of the ingredients of PROGYNOVA.
If you are not sure whether any of these conditions applies to you, ask your doctor. If any of these conditions appear for the first time while using PROGYNOVA, stop taking it at once and consult your doctor.
Do not take PROGYNOVA after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
Before you start to take it
Your doctor will discuss with you the benefits and risks of PROGYNOVA (see also "How to take PROGYNOVA properly" below). Before starting PROGYNOVA, your doctor should conduct a thorough general medical and gynaecological examination (including the breasts) and pregnancy must be ruled out. PROGYNOVA is not a contraceptive. It will not prevent you from falling pregnant.
If HT is used in the presence of any of the conditions listed below you will need to be kept under close observation. Your doctor can explain this to you. Therefore, if any of these apply to you, tell your doctor before starting to use PROGYNOVA.
you have an increased risk of thrombosis (the formation of a blood clot) in your veins.
The risk increases with age and may also be higher:
if you or anyone in your immediate family has ever had a thrombosis in the blood vessels of the legs or lungs;
if you are overweight;
if you have varicose veins;
if you are already using PROGYNOVA, tell your doctor well in advance of any expected hospitalisation or surgery. This is because the risk of having deep venous thrombosis may be temporarily increased as a result of an operation, serious injuries or immobilisation;
you have fibroids of the womb;
you have or have had endometriosis (the presence of tissue of the lining of the womb in places in the body where it is not normally found);
you have liver or gallbladder disease;
you have had jaundice during pregnancy or previous use of sex steroids;
you suffer from diabetes;
you have elevated levels of triglycerides (a special type of blood lipids);
you have high blood pressure;
you have unusually high or low calcium levels in the blood;
you have low levels of thyroid hormone requiring supplementation;
you have or have had chloasma (yellow brown patches on the skin); if so, avoid too much exposure to the sun or ultraviolet radiation;
you suffer from epilepsy;
you have lumpy or painful breasts (benign breast disease);
you suffer from migraine;
you have the inherited disease called porphyria;
you suffer from inherited deafness (otosclerosis);
you have systemic lupus erythematosus (SLE; a chronic inflammatory disease).
you have or have had chorea minor (illness with unusual movements)
HT and cancer
The risk of cancer of the lining of the womb (endometrial cancer) increases when estrogens are used alone for prolonged periods. Taking a progestogen in addition to the estrogen lowers the increased risk.
Please inform your doctor if you frequently have bleeding irregularities or persistent bleeding during the treatment with PROGYNOVA.
Please inform your doctor if you have suffered from fibrocystic disease of the breasts or if you have first degree relatives (mother, sisters, daughters) who have had breast cancer.
Breast cancer has been diagnosed slightly more often in women who have used Hormone Therapy (HT) than in women of the same age who have never used HT. If you are concerned about this information you should discuss this with your doctor. It is recommended that yearly breast examinations are conducted and regular self examination (monthly) should be carried out.
HT increases the density of mammographic images. This may complicate the mammographic detection of breast cancer in some cases. Therefore your doctor may choose to use other breast cancer screening techniques as well.
In one study, ovarian cancer was reported to occur slightly more often in women who had been on estrogen therapy for longer than 10 years. A survey of 15 other studies did not find an increased risk for women on estrogen therapy. Currently the influence of this replacement therapy on ovarian cancer is not clear.
During or after the use of hormones such as those that are contained in PROGYNOVA, benign liver tumours have rarely occurred, and malignant liver tumours even more rarely. In isolated cases, bleeding from such tumours into the abdominal cavity has endangered life. Although such events are extremely improbable you should inform your doctor about any unusual feelings in your upper abdomen that do not disappear within a short time.
Taking other medicines
Oral contraceptives should not be used. Consult your doctor for contraceptive advice, if required.
Some medicinal products may stop hormone replacement therapy (HT) from working properly. These include medicinal products used for the treatment of epilepsy (e.g. hydantoins, barbiturates, primidone, carbamazepine) and tuberculosis (e.g. rifampicin); antibiotics (e.g. penicillins and tetracyclines) for some other infectious diseases; and herbal medicines containing St John's wort. Always tell the doctor who prescribes HT which medicinal products you are already using. This should include any medicines obtained from supermarkets, health food stores and pharmacies. Also tell any other doctor or dentist who prescribes another medicinal product (or the dispensing pharmacist) that you use PROGYNOVA.
If you are diabetic your doctor may alter the dose of the diabetes medication.
If you are in doubt about any medicinal products that you are taking, ask your doctor.
Excess of alcohol during use of hormone replacement therapy has an influence on the treatment. Your doctor will advise you.
The use of HT may affect the results of certain laboratory tests. Always tell your doctor or the laboratory staff that you are using a hormone replacement therapy.
How to take PROGYNOVA properly
Each blister foil covers 28 days of treatment. You have to take one tablet daily. It does not matter at what time of the day you take your tablet, but once you have selected a particular time, you should keep to it every day. The tablet should be swallowed whole with some liquid. When you have finished each blister foil start the next one on the following day. Never leave a break between blister foils unless your doctor has advised you to. Tablet taking should be continuous.
If you still have a womb (you have not had a hysterectomy) your doctor will prescribe another hormone (progestogen) to take as well. You doctor will advise you how to take this.
If you forget to take it
If you are less than 24 hours late take your tablet as soon as possible, and take the next one at the normal time. If you miss tablets for several days, irregular bleeding may occur.
How long to take it
PROGYNOVA is only intended for short term use. Your doctor will discuss the risks of long term treatment with HT with you. Some recent studies have shown that women using HT have a small increase in breast cancer risk. The risk increases with the length of HT use.
Recent studies with other HT preparations have shown that HT is associated with a small increase in the risk of heart attacks, strokes and 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 women older than 65 years, a different oestrogen taken with a progestogen is associated with a small increase in risk of dementia. The risk may be decreased in younger women and it is not known whether these findings also apply to other HT products such as PROGYNOVA.
If you take too much (overdose)
Telephone your doctor or the Poisons Information Centre (13 11 26) if you think you or anybody else has taken too many PROGYNOVA tablets. You may experience nausea or vomiting and irregular (breakthrough) bleeding.
While you are taking PROGYNOVA
Stop taking it immediately if
You should stop treatment at once and consult your doctor if you have any of the following conditions:
your very first attack of migraine (typically a throbbing headache and nausea preceded by visual disturbances);
worsening of preexisting migraine, any unusually frequent or unusually severe headaches;
sudden disturbances of vision or hearing;
inflamed veins (phlebitis);
itching of the whole body;
unusual upper abdominal complaints if these don't disappear within a short period of time.
If you get a blood clot while you are taking PROGYNOVA or there is a suspicion of this you should stop taking it immediately and contact your doctor. Warning signs to look out for are:
unusual pains or swelling of your arms or legs;
sudden shortness of breath;
PROGYNOVA must also be stopped at once if you become pregnant or if you develop jaundice.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PROGYNOVA. Do not be alarmed by this list of possible side effects. You may not experience any of them.
During the first few months of treatment you may experience some breast tenderness or enlargement. These symptoms are usually temporary and normally disappear with continued treatment. If they do not, contact your doctor.
The following symptoms have been reported in users of various oral HT preparations:
Reproductive system and breast disorders
Changes in vaginal bleeding pattern and abnormal bleeding or flow, breakthrough bleeding, spotting (bleeding irregularities usually subside during continued treatment); dysmenorrhea, changes of vaginal secretion, premenstrual-like syndrome, breast pain, tenderness or enlargement
Dyspepsia, bloating, nausea, vomiting, abdominal pain
Skin and subcutaneous tissue disorders
Rashes, various skin disorders (including pruritus, eczema, urticaria, acne, hirsutism, hair loss, erythema nodosum)
Nervous system disorders
Headache, migraine, dizziness, anxiety/depressive symptoms, fatigue
Palpitations, oedema, muscle cramps, changes in body weight, increased appetite, changes in libido, visual disturbances, intolerance to contact lenses, hypersensitivity reaction
Other side effects not listed above may occur in some patients.
If you notice any unwanted effects not mentioned in this leaflet or if you are unsure about the effect of this product, please inform your doctor or pharmacist.
PROGYNOVA should be stored below 30°C. It should not be used after the expiry date printed on the foil and on the outer box.
PROGYNOVA (1mg) are small round yellow sugar coated tablets packaged in calendar blister strips containing 28 tablets. PROGYNOVA (2mg) are small round blue sugar coated tablets packaged in calendar blister strips containing 28 tablets. Each pack contains 2 blister strips.
PROGYNOVA (1mg) tablets contain 1mg estradiol valerate as the active ingredient. The tablets also contain lactose, maize starch, povidone, talc, magnesium stearate, sucrose, macrogol 6000, calcium carbonate, glycerol, glycol montanate, titanium dioxide, iron oxide yellow.
PROGYNOVA (2mg) tablets contain 2mg estradiol valerate as the active ingredient. These tablets also contain lactose, maize starch, povidone, talc, magnesium stearate, sucrose, macrogol 6000, calcium carbonate, glycerol, glycol montanate, titanium dioxide, indigo carmine.
PROGYNOVA tablets are sugar coated and gluten free.
If you require further information contact your doctor or pharmacist.
PROGYNOVA is distributed in Australia by:
Schering Pty Limited
ABN 50 000 023 361
27-31 Doody Street
Alexandria NSW 2015
Australian Registration numbers:
PROGYNOVA (1mg) - AUST R 10708
PROGYNOVA (2mg) - AUST R 10709
This leaflet was prepared in February 2006