Each tablet contains estradiol 1 mg for the first 14 days of cycle (white tablets). For the 2nd part of 14 days of a 28-day cycle, each tablet contains estradiol 1 mg and dydrogesterone 10 mg (gray tablets).
Femoston 1/10 tablets also contain lactose monohydrate, methylhydroxypropylcellulose, maize starch, colloidal anhydrous silica, magnesium stearate and the colouring agents, titanium dioxide (E171) and black iron oxide (E172) (for the grey tablets).
Estradiol is the major female sex hormone (also known as oestradiol).
Pharmacology: Pharmacodynamics: The active ingredient, estradiol, is chemically and biologically identical to the endogenous human estradiol and is, therefore, classified as a human estrogen.
Dydrogesterone is an orally active progestogen. Its activity is comparable to parenterally administered progesterone.
Pharmacokinetics: Following oral administration, micronized estradiol is readily absorbed and metabolized.
After oral administration, dydrogesterone is excreted into the urine. Excretion is complete within 72 hrs. No clinically relevant pharmacokinetic interactions occur between estradiol and dydrogesterone.
Hormone replacement therapy for women with disorders due to natural or surgically induced menopause.
Prevention of postmenopausal osteoporosis.
1 tab (containing estradiol 1 mg) daily during 14 consecutive days per cycle of 28 days and 1 tab (containing estradiol 1 mg and dydrogesterone 10 mg) daily during the remaining 14 days have to be taken. Immediately after 28-day cycle, the next treatment cycle is to be started.
If the patient is still menstruating, it is recommended to begin treatment on the 1st day after onset of menstruation.
If the patient is menstruating infrequently, it is advisable to begin treatment after 10-14 days monotherapy of progestogen ("chemical curettage").
In patients who had their last period more than a year ago, treatment can be started at any time.
There have been no reports of ill-effects from overdosing. Gastrolavage can be utilized within 2 or 3 hrs. There is no specific antidote and further treatment should be symptomatic.
Known or suspected carcinoma of the breast, endometrial carcinoma or other hormone-dependent tumors. Acute or chronic liver disease. History of liver disease where the liver function tests have not returned to normal. History of venous thromboembolic diseases eg, deep venous thrombosis or pulmonary embolism. Abnormal genital bleeding.
Hypersensitivity to one of the components of Femoston 1/10.
Use in pregnancy & lactation: Known or suspected pregnancy is a contraindication.
Femoston is not indicated during breastfeeding.
Physical examination and a complete medical and family history should be taken prior to the initiation of any hormone replacement therapy (HRT) with special reference to blood pressure, palpation of the breasts and the abdomen, and a gynecological examination. Mammography is advisable.
Breast cancer is diagnosed slightly more often in women on hormone replacement therapy for >5 years than in women not treated with these preparations.
There is evidence that the observed higher incidence of breast cancer during hormone replacement therapy is not associated with increased mortality from breast cancer.
Patients who are or have previously been treated with unopposed estrogens should be examined with special care in order to investigate a possible hyperstimulation of the endometrium before commencing therapy.
As a general rule, HRT should not be prescribed for >1 year without a general physical examination, including a gynecological examination. A mammogram on regular intervals is generally advised (1-2 years).
Breakthrough bleedings or abnormal findings at the gynecological examination may be an indication for endometrial assessment.
Femoston 1/10 is not a contraceptive. Patients in the perimenopausal phase are advised to take nonhormonal contraceptive precautions.
Epidemiological studies suggest that hormone replacement therapy in general increases the risk of developing venous thromboembolism.
The risk can be temporarily increased by prolonged immobilization as well as major trauma or surgery. In such cases interruption of hormone replacement therapy in the month before surgery should be considered.
Patients with or developing epilepsy, migraine, cardiac failure, hypertension, porphyria, hemoglobinopathies or otosclerosis should be carefully observed during treatment.
Special care should be taken in patients with uterine leiomyomata and patients with (a history of) endometriosis as estrogens may influence these conditions.
Effects on the Ability to Drive or Operate Machinery: No effects known.
Known or suspected pregnancy is a contraindication.
Femoston is not indicated during breastfeeding.
Breast tenderness may occur during the 1st few months of treatment with the combination. Nausea, headache and edema occur rarely. Symptoms are normally transient. Breakthrough bleeding may occur. Furthermore, skin reactions have been reported.
Estrogens interact with liver enzyme-inducing drugs eg, barbiturates, phenytoin, rifampicin and carbamazepine, which may reduce the estrogen effect.
No drug interactions are known for dydrogesterone.
Incompatibilities: Not applicable.
Instruction for Use/Handling: The tablets are labelled with the days of the week to help the patient make sure each tablet is taken everyday. The patient must always start by taking the white tablets in the half of the pack with an arrow marked "1". When all the white tablets are consumed, the patient should start taking the grey tablets in the other half of the pack marked "2".
The patient should start each new pack the day after the old pack has been consumed. There should be no gap in between packs.
Do not store above 30°C.
Shelf-Life: 3 years.
G03CA53 - estradiol, combinations ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.