Estradiol + Dydrogesterone

Femoston 1/10 and Femoston 2/10, are continuous sequential hormone replacement therapies. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used.

In general, treatment should start with Femoston 1/10. Depending on the clinical response, the dosage can afterwards be adjusted to individual need. If the complaints linked to oestrogen deficiency are not ameliorated the dosage can be increased by using Femoston 2/10

Starting Femoston: In women who are not taking hormone replacement therapy and who are amenorrhoeic, or women who switch from a continuous combined hormone replacement therapy, treatment may be started on any convenient day. In women transferring from a cyclic or continuous sequential HRT regimen, treatment should begin the day following completion of the prior regimen.

Administration-

• For the first 14 days during a 28-cycle, one tablet containing oestradiol is taken daily; during the following 14 days one tablet containing oestradiol and dydrogesterone is taken.
• After a cycle of 28 days, on the 29th day, a new 28-day cycle begins. This means that the treatment should be taken continuously without a break between packs. Femoston can be taken with or without food.
• The days of the week are printed on the back of the blister strips. Firstly, the tablets from the part marked with arrow 1 should be taken, then all the tablets from the part marked with arrow 2 should be taken.
• If a dose has been forgotten, it should be taken as soon as possible. When more than 12 hours have elapsed, it is recommended to continue with the next dose without taking the forgotten tablet. The likelihood of breakthrough bleeding or spotting may be increased.

• No interaction studies have been performed.
• The efficacy of oestrogens and progestogens might be impaired:
• The metabolism of oestrogens and progestogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically the P450 enzymes 2B6, 3A4, 3A5, 3A7, such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamezapin) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
• Ritonavir and nelfinavir, although known as strong inhibitors of CYP450 3A4, A5, A7, by contrast exhibit inducing properties when used concomitantly with steroid hormones.
• Herbal preparations containing St John's Wort (Hypericum perforatum) may induce the metabolism of oestrogens and progestogens via the CYP450 3A4 pathway.
• Clinically an increased metabolism of oestrogens and progestogens may lead to decreased effect and changes in the uterine bleeding profile.

• Known, past or suspected breast cancer;
• Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer);
• Known or suspected progestogen-dependent neoplasms (e.g. meningioma)
• Undiagnosed genital bleeding;
• Untreated endometrial hyperplasia;
• Previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism);
• Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4.);
• Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);
• Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal;
• Porphyria;
• Known hypersensitivity to the active substances or to any of the excipients.

Femoston is not indicated during pregnancy. If pregnancy occurs during medication with Femoston, treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant to inadvertent foetal exposure to combinations of oestrogens and progestogens indicate no teratogenic or foetotoxic effect. There are no adequate data from the use of oestradiol/dydrogesterone in pregnant women. Femoston is not indicated during lactation.

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.

Medical examination/follow up: Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse. Investigations, including appropriate imaging tools, e.g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.

Female Sex hormones

Store in a cool (below 30°C) and dry place, away from light & children.