Estradiol, dydrogesterone.
Each tablet contains estradiol 1 mg and dydrogesterone 5 mg.
Femoston Conti tablets also contain lactose monohydrate, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate, macrogol 400 and the colouring agents, titanium dioxide (E171), yellow and red (E172) iron oxide.
Estradiol is the major female sex hormone (also known as oestradiol).
Pharmacology: Pharmacodynamics: Estradiol: The active component estradiol is chemically and biologically identical to the natural human sex hormone estradiol.
Estradiol is the primary estrogen and the most active of the ovarian hormones. Estrogens affect the release of gonadotrophins by the pituitary gland, contributing to the occurrence of the ovarian cycle. Estrogens cause cyclical changes in the uterus, cervix and vagina, and ensure the retention of tone and elasticity in the urogenital tract.
Estradiol plays an important part in maintaining bone mass and has a preventive effect on the incidence of osteoporotic fractures.
Oral administration of estrogens can have a beneficial effect on the metabolism of lipids and lipoproteins. Treatment with estradiol/dydrogesterone combinations for up to 24 months resulted in a significant decrease in LDL cholesterol levels and a significant increase in HDL cholesterol. Trigylceride levels were raised overall but usually remained within the normal range.
Estrogens also affect the autonomic nervous system and may have indirect positive psychotropic actions.
Dydrogesterone: Dydrogesterone is an orally active progestogen without androgenic side effects.
In the context of continuous combined HRT, dydrogesterone protects against estrogen-induced increased risk of endometrial hyperplasia and/or carcinoma.
The beneficial effects of 17β-estradiol on bone, lipoprotein, glucose and insulin metabolism are maintained in the presence of dydrogesterone.
Pharmacokinetics: Estradiol: Following oral administration, micronized estradiol is readily absorbed, but extensively metabolized. The major unconjugated and conjugated metabolites are estrone and estrone sulphate. These metabolites can contribute to the estrogen activity, either directly or after conversion to estradiol.
Estrogens are secreted in the milk of nursing mothers.
Dydrogesterone: After oral administration of labelled dydrogesterone, on average 63% of the dose is excreted onto the urine. Excretion is complete within 72 hrs.
In humans, dydrogesterone is completely metabolized. The main metabolite of dydrogesterone is 20 α-dihydrodydrogesterone (DHD) and is present in the urine predominantly as the glucuronic acid conjugate.
Mean terminal half lives of dydrogesterone and DHD vary between 5-7 and 14-17 hrs, respectively.
There are no clinically relevant interactions between estradiol and dydrogesterone.
As a hormone replacement therapy (HRT) for the relief of symptoms due to estrogen deficiency and prevention of postmenopausal osteoporosis in women with a uterus.
1 tab/day. Femoston Conti should be taken continuously without a break between packs. It can be taken with or without food.
Starting Femoston Conti: Femoston Conti should be used only in postmenopausal women >12 months after menopause. It is intended to prevent stimulation of the endometrium in postmenopausal women, usually resulting in amenorrhea. Before initiating treatment, pregnancy must be excluded.
Prevention of Osteoporosis: A number of risk factors may contribute to postmenopausal osteoporosis including early menopause, family history of osteoporosis; recent prolonged use of corticosteroids; a small frame; a thin frame; cigarette smoking. If several of these risk factors are present in a patient, consideration should be given to HRT.
For a maximum prophylactic benefit, treatment with HRT should commence as soon as possible after the menopause.
Protection appears to be effective for as long as treatment continues, however, data on estrogen therapy >10 years are limited. A careful reappraisal of the risk/benefit ratio should be undertaken before treating for longer than 5-10 years. For long-term use, see also Precautions.
Changing from other HRT: Patients changing from other HRT preparations to Femoston Conti should do so at the end of the estrogen plus progestogen phase without a tab-free interval.
Femoston Conti should be used only in postmenopausal women >12 months after menopause. If the menopausal status is not known (eg, because of previous use of sequential HRT or oral combination contraceptives), the endogenous estrogen may still be high. This could result in unpredictable bleeding patterns, especially in the 1st few cycles.
Adults and Children: Both estradiol and dydrogesterone are substances with low toxicity. If overdosage is discovered within 2 or 3 hrs and is so large that treatment seems desirable, gastric lavage can safely be used. There is no specific antidote and further treatment should be symptomatic.
Confirmed active venous thromboembolism (deep vein thrombosis, pulmonary embolism) within the 2 years.
A history of recurrent VTE (venous thromboembolism) or known thrombophilic disease in a patient who is not already on anticoagulant treatment. Active or recent arterial thromboembolic disease. Diagnosed, suspected or past history of breast cancer, endometrial carcinoma or other hormone-dependent tumors. Acute or chronic liver disease and a history of liver disease where the liver function tests have failed to return to normal. Cerebral vascular accident. Undiagnosed vaginal bleeding. Known hypersensitivity to any of the ingredients.
Before initiation or reinstituting HRT, a complete personal or family medical history should be taken, together with a general and gynecological examination guided by the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman and follow-up examinations of the breasts and/or mammography should be carried out in accordance with current accepted practices for the well woman, modified according to the clinical needs of the individual.
Breast cancer is diagnosed slightly more often in women on HRT for >5 years than in women not treated with these preparations. There is evidence that the observed higher incidence of breast cancer during HRT is not associated with increased mortality from breast cancer.
Hormone replacement therapy (HRT) may be associated with a 2-3 fold higher relative risk of developing venous thromboembolism (VTE) ie, deep vein thrombosis or pulmonary embolism. The occurrence of such an event is more likely in the 1st year of HRT than later.
Generally recognized risk factors for VTE include a personal history or family history, in particular a history of recurrent VTE or known thrombophilic states, severe obesity and systemic lupus erythematosus (SLE). The role of varicose veins as risk factor for VTE is still unclear.
The risk of VTE may be temporarily increased with prolonged immobilization, major trauma or major surgery. Where prolonged immobilization is liable to follow elective surgery, particularly abdominal or orthopedic surgery to the lower limbs, consideration should be given to temporarily stopping HRT 4-6 weeks earlier, if possible.
If venous thromboembolism develops after initiating therapy, Femoston Conti should be discontinued. Patients should be told to contact their doctors immediately when they are aware of a potential thromboembolic symptom (eg, painful swelling of a leg, sudden pain in the chest, dyspnea).
If any of the following conditions are present, have occurred previously and/or have aggravated during pregnancy or previous hormone treatment, the benefits of treatment should be weighed against the possible risks. In these cases the patient should be closely supervised. It should be taken into account that these conditions may in rare cases, recur or be aggravated during treatment with Femoston Conti.
A history of thromboembolic disorders or the presence of risk factors (as previously mentioned), otosclerosis, multiple sclerosis, systemic lupus erythematosus, porphyria, melanoma, epilepsy, migraine, asthma, liver disease, endometriosis, uterine fibroids, hypertension, cardiac or renal dysfunction and hemoglobinopathies.
Femoston Conti may improve insulin sensitivity and elimination. Diabetic patients should be carefully observed while taking Femoston Conti.
It has been reported that there is an increased risk of gall bladder disease in women receiving postmenopausal estrogens.
Rarely, idiosyncratic hypertension may occur.
Breakthrough bleeding and spotting often occur during the initial months of treatment. If bleeding recurs after a period of amenorrhea or persists after treatment has been discontinued, the etiology of the bleeding should be investigated. This may include an endometrial biopsy.
Indications for Immediate Withdrawal of Therapy: Deep venous thrombosis, thromboembolic disorders, the appearance of jaundice, the emergence of migraine-type headache, sudden visual disturbances, significant increase in blood pressure, pregnancy.
Effects on the Ability to Drive or Operate Machinery: Femoston Conti does not affect the ability to drive or use machines.
Use in pregnancy & lactation: Femoston Conti is not indicated in pregnancy or breastfeeding. If pregnancy occurs during treatment with Femoston Conti, the medication must be withdrawn immediately.
Femoston Conti is not indicated in pregnancy or breastfeeding. If pregnancy occurs during treatment with Femoston Conti, the medication must be withdrawn immediately.
For further information see Contraindications and Precautions.
The following adverse reactions have been reported with estrogen/progestogen therapy:
Genitourinary System: Breakthrough bleeding, spotting, dysmenorrhea, premenstrual-like syndrome, increase in size of uterine fibroids, vaginal candidiasis, change in cervical erosion and in degree of cervical secretion, cystitis-like syndrome.
Breast: Tenderness, enlargement.
Gastrointestinal: Nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice.
Skin: Chloasma or melasma which may persist when Femoston Conti is discontinued, erythema multiforme, erythema nodosum, hemorrhagic eruption, itching, allergic skin reactions.
Eyes: Steepening of corneal curvature, intolerance to contact lenses.
Central Nervous System: Headaches, migraine, dizziness, mental depression, chorea.
Miscellaneous: Increase or decrease in weight, changes in carbohydrate metabolism, aggravation of porphyria, edema, changes in libido, leg cramps.
Estrogens interact with liver enzyme-inducing drugs with increased metabolism of estrogens, which may reduce the estrogen effect. Interactions are documented for the following liver enzyme-inducing drugs: Oxcarbazepine, topiramate, felbamate, barbiturates, phenytoin, rifampicin, carbamazepine. Changes in estrogen serum concentrations may affect the results of certain endocrine or liver function tests.
No drug interactions are known for dydrogesterone.
Incompatibilities: Not applicable.
Instruction for Use/Handling: Not applicable.
Do not store above 30°C.
Shelf-Life: 3 years.
G03CA03 - estradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Femoston Conti film-coated tab
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