Femoston 1/10 mg

/ Abbott

Femoston 1/10 mg is indicated for the treatment of symptoms and not for prevention.

Femoston 1/10 mg is taken orally daily according to a continuous sequential regimen.

For each cycle of 28 days for the first 14 days one white tablet with estradiol is taken once a day and for the following 14 days one grey tablet with estradiol and dydrogesterone is taken once a day, as indicated on the calendar pack for 28 days.
After a cycle of 28 days on the 29th day a new cycle of 28 days begins. The treatment cycles therefore follow one another without a break.
For the treatment of estrogen deficiency in postmenopausal women as an initial and maintenance dose the lowest effective dose should be used and the duration of treatment period should be kept as short as possible.  In case of no improvement of symptoms within 3 months, treatment should be stopped.
In general sequential combined treatment should be started with Femoston 1/10 mg.
Depending on the clinical response the dose can be adjusted accordingly.
In women who are not taking hormone replacement therapy or in women switching from continuous combined hormone replacement therapy, the treatment can be started on any convenient day. In women switching from cyclical or continuous sequential hormone replacement therapy, treatment should start on the day immediately after completion of the previous cycle.
If a tablet is missed it is recommended to take the next tablet without taking the forgotten tablet. Forgetting a tablet may increase the chance of breakthrough bleeding or spotting.
Femoston 1/10 mg can be taken both with and without food.
Paediatric patients
There are no relevant indications for the use of Femoston 1/10 mg in paediatric patients.  

Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women at least 6 months since last menses.
Prevention of osteoporosis in postmenopausal women at high risk of future fractures. Femoston 1/10 mg should only be used in patients who are intolerant of other products, approved for the prevention of osteoporosis or for whom these products are contra-indicated.
Femoston is indicated for women with an intact uterus.
Experience with treatment of women older than 65 years is limited.

Known hypersensitivity to the active ingredients.
Presence or suspicion of breast cancer; history of breast cancer;
Presence or suspicion of estrogen-sensitive tumours (for example endometrial cancer).
Vaginal bleeding of which the cause has not been determined.
Untreated endometrial hyperplasia.
History of active venous thromboembolism (deep vein thrombosis, pulmonary embolism).
Presence of a thrombophilic condition (e.g. protein C, protein S or antithrombin deficiency.
Active or recent arterial thromboembolic disease (angina pectoris, myocardial infarction).
Acute liver disease or history of liver disease as long as the liver function values have not returned to normal.
Porphyry.
Known hypersensitivity to the active ingredients.

For the treatment of symptoms of estrogen deficiency in postmenopausal women, treatment with hormone replacement therapy (HRT) should only be initiated if these symptoms adversely affect the quality of life. A careful appraisal of the advantages and disadvantages of HRT should be carried out regularly, at least annually, and the treatment should only be continued if the advantages outweigh the disadvantages.
Evidence relating to the risks associated with HRT in the treatment of premature menopause is limited. But because of the low absolute risk in young women the balance of advantages and disadvantages for these women are more positive than for older women.
Medical examination / follow up
Before starting HRT or if its use is to be reinstated the use after an interruption, a full medical history (including family history) should be taken. Physical examination (including
gynaecological and breast examination) should be carried out guided by the history, contra-indications and warnings. During the treatment period regular 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 immediately.
Regular examination of the breasts, including imaging techniques such as mammography, should be carried out in accordance with the current guidelines for healthy women, taking into account here the medical need of the individual woman.
gynaecological and breast examination) should be carried out guided by the history, contra-indications and warnings. During the treatment period regular 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 immediately.
Regular examination of the breasts, including imaging techniques such as mammography, should be carried out in accordance with the current guidelines for healthy women, taking into account here the medical need of the individual woman.
Conditions which need supervision
If one of the following conditions is present, was present in the past and/or has been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during the treatment with Femoston 1/10 mg, in particular in case of:
-Leiomyoma (uterine fibroma) or endometriosis
– Risk factors for thromboembolic disorders.
– Risk factors for estrogen-sensitive tumours (breast cancer in first degree family member)
– Hypertension
– Liver disease (liver adenoma)
– Diabetes mellitus with or without vascular symptoms
– Cholelithiasis
– Migraine or (severe) headache
– Systemic Lupus Erythematodes
– A history of endometrial hyperplasia
– Epilepsy
– Asthma
– Otosclerosis
– Meningioma
Reasons for immediate discontinuance of treatment
-Hormone replacement therapy should be discontinued immediately where a contra-indication is discovered and in the following situations:
– Jaundice or deterioration in the liver function
– Significant increase in blood pressure
– New onset of migraine-type headache
– Pregnancy
Endometrial hyperplasia and carcinoma
In women whose uterus has not been removed the risk of endometrial hyperplasia and endometrial cancer is increased if over a prolonged period estrogen-only HRT is taken. The reported increased risk of endometrial cancer in users of estrogen preparations varies from 2 to 12 times as great compared with non-users, depending on the treatment period and the estrogen dose. After stopping the treatment the risk remains high for at least 10 years.
The cyclical combination of an estrogen preparation with a progestagen for at least 12 days per month/per 28-day cycle or continuous combined estrogen-progestagen treatment in women with a uterus protects against the increased risk associated with estrogen preparations.
Breakthrough bleeding and spotting may occur during the first months of the treatment. If breakthrough bleeding or spotting appears after some time on therapy or continues after treatment has been discontinued, further investigation is indicated. This may mean that an endometrial biopsy must be taken to exclude malignancy.
Breast cancer
All the available data indicate an increased risk of breast cancer if women are using combined estrogen and progestagen as HRT and possibly also if they are using estrogen-only as HRT. This risk depends on the duration of use.
Ovarian cancer
Ovarian cancer is much rarer than breast cancer. Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestogen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping. Some other studies, including the WHI trial suggest, that the use of combined HRTs may be associated with a similar,or slightly smaller risk
Venous thromboembolism
HRT is associated with a 1.3 to 3 times higher risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. This is greater during the first year of HRT treatment than afterwards.
Patients with a known thrombophilic status have an increased risk of VTE and HRT may increase the risk further. HRT is therefore contra-indicated in these patients.
General risk factors for the occurrence of VTE are: the use of estrogens, greater age, major surgical intervention, prolonged immobilisation, obesity (Body Mass Index > 30 kg/m2), pregnancy/ postpartum period, systemic lupus erythematodes (SLE) and carcinoma.
There is no consensus about the possible role of varicosis in VTE. As in all postoperative patients, precautions should be taken after surgery to prevent VTE. Where prolonged immobilisation is anticipated after elective surgery, consideration should be given to stopping the HRT 4 to 6 weeks before the operation and only restarting it when the woman is completely mobilised again.
Women without a history of VTE, but with a first degree family member with a history of thrombosis at a young age, should be offered screening after careful information relating to the limitations of such screening (only a proportion of thrombophilic conditions are identified in screening). If a congenital thrombophilic condition is identified, which is accompanied in a family with thrombosis or if the condition is serious (e.g. antithrombin, protein S or protein C deficiencies or a combination of conditions) HRT is contra-indicated.
In women already treated chronically with anticoagulation therapy, careful consideration should be given to the advantages and disadvantages of the treatment.
If VTE develops after initiating therapy, the administration of medication should be discontinued immediately. Patients must be informed that they should contact their doctor immediately if potential thromboembolic symptoms occur (e.g.: painful swelling of a leg, sudden pain in the chest, shortness of breath).
Coronary artery disease (CAD)
There is no evidence from randomised controlled studies of a protective effect against myocardial infarction in women with or without existing coronary artery disease who receive combined estrogen-progestagen or estrogen-only HRT.
Combined estrogen-progestagen therapy:
The relative risk of coronary artery disease during combined estrogen-progestagen HRT is slightly increased. Since the absolute risk of coronary artery disease in the initial situation is greatly age-dependent, the number of extra cases of coronary artery disease as a result of estrogen-progestagen use is very low in healthy women who are close to the menopause. This number will however increase as they get older.
Estrogen monotherapy:
In randomised controlled studies no increased risk of coronary artery disease was found in hysterectomised women using estrogen monotherapy.
Ischemic Stroke
Combined estrogen-progestagen therapy and estrogen monotherapy are associated with an up to 1.5 times higher risk of an ischemic stroke. The relative risk does not change with age or with the time after the menopause. However, because the absolute risk of a CVA in the initial situation is strongly dependent on age, the overall risk of a CVA in women using HRT will increase with age.
Other conditions
Estrogens may cause fluid retention. For this reason patients with a reduced cardiac or renal function must therefore be carefully observed.
Women with a pre-existing hypertriglyceridaemia should be closely followed during estrogen replacement or hormone replacement therapy, since in rare cases in women with this abnormality, the plasma triglycerides increased considerably during estrogen therapy, and have led to pancreatitis.
Estrogens cause an increase in the thyroid binding globulin (TBG), which leads to increased circulating thyroid hormone, measured as the protein bound iodine (PBI), T4 levels (column or RIA) or T3 levels (RIA). The T3-resin uptake is decreased as a result of the increased TBG levels. The free T3 and T4 concentrations remain unchanged. Other binding proteins may also be elevated in the serum, such as corticoid binding globulin (CBG) and the sex-hormone binding globulin (SHBG), leading to increased blood levels of corticosteroids and sex hormones. Free and/or biologically active hormone concentrations remain unchanged. Other plasma proteins may be increased (angiotensin-renin substrate, alpha-1-antitrypsin, ceruloplasmin).
HRT does not improve cognitive functions. There is no evidence of increased risk of possible dementia in women who start using treatment of combined preparations or estrogen preparations after the age of 65 years.
Patients with rare hereditary conditions, such as galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
This combined estrogen-progestagen is not a contraceptive product.
See prescribing information for full details.

Very common: Headache, abdominal pain, back pain, breast pain/ tenderness.
Common: Vaginal candidiasis, depression, nervousness, migraine; dizziness, nausea, vomiting; flatulence , allergic skin reactions (e.g. rash, urticaria, pruritus), menstruation disorders (including postmenopausal, spotting, metrorrhagia; menorrhagia, oligo/ amenorrhoea, irregular menstruation, dysmenorrhoea), pelvic pain, cervical erosion , asthenic disorders (asthenia, fatigue, malaise), peripheral oedema , weight gain.
See prescribing information for full details.

No interaction studies have been carried out.
The efficacy of estrogens and progestagens may be disrupted:
– The metabolism of estrogens (and progestagens) may be increased by concomitant use of substances known to induce enzymes which are involved in the metabolism of medicinal products. This applies particularly for P450 enzymes. These substances include anti-epileptics (phenobarbital, phenytoin, carbamazepine) and antibacterials /antivirals (for example rifampicin, rifabutin, nevirapine, efavirenz).
– Ritonavir and nelfinavir, although known as strong inhibitors do in fact have an inducing effect when used concomitantly with steroid hormones.
– Herbal preparations containing St. John’s wort (Hypericum perforatum) may also increase the metabolism of estrogens (and progestagens).
– Clinically an increased metabolism of estrogens and progestagens may lead to a reduced efficacy and changes in the bleeding pattern.

Pregnancy
Femoston 1/10 mg is not indicated during pregnancy. If pregnancy occurs during the treatment with Femoston 1/10 mg, the treatment should be stopped immediately.
See prescribing information for full details.
Lactation
Femoston 1/10 mg is not indicated in women who are breastfeeding.

Both estradiol and dydrogesterone are substances with a low toxicity. Symptoms such as nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in case of overdose. Specific or symptomatic treatment is probably not necessary.
The information described above also applies after overdose in children.

Contains lactose monohydrate 119.1 mg (white film-coated tablets) and 110.2 mg (grey film-coated tablets).