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Femoston Conti

Femoston Conti Special Precautions

estradiol + dydrogesterone

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
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.
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