Femoston 1/10 & 2/10/Femoston Conti 1/5 Adverse Reactions

The most commonly reported adverse drug reactions of patients treated with estradiol/dydrogesterone in clinical trials are headache, abdominal pain, breast pain/tenderness and back pain.
The following undesirable effects have been observed with the frequencies indicated as follows during clinical trials (n=5108): (See Table 5).

Click on icon to see table/diagram/image

Breast cancer risk: An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestogen therapy for more than 5 years.
The increased risk in users of oestrogen-only therapy is y lower than that seen in users of oestrogen-progestogen combinations.
The level of risk is dependent on the duration of use (see Precautions).
Absolute risk estimations based on results of the largest randomised placebo-controlled trial (WHI-study) and the largest meta-analysis of prospective epidemiological studies are presented: (See Tables 6, 7 and 8).

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Endometrial cancer risk: Postmenopausal women with a uterus: The endometrial cancer risk is about 5 in every 1000 women with a uterus not using HRT.
In women with a uterus, use of oestrogen-only HRT is not recommended because it increases the risk of endometrial cancer (see Precautions).
Depending on the duration of oestrogen-only use and oestrogen dose, the increase in risk of endometrial cancer in epidemiology studies varied from between 5 and 55 extra cases diagnosed in every 1000 women between the ages of 50 and 65.
Adding a progestogen to oestrogen-only therapy for at least 12 days per cycle can prevent this increased risk. In the Million Women Study the use of five years of combined (sequential or continuous) HRT did not increase the risk of endometrial cancer (RR of 1.0 (0.8-1.2)).
Ovarian cancer: Use of oestrogen-only or combined oestrogen-progestogen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Precautions). A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Risk of venous thromboembolism: HRT is associated with a 1.3-3-fold increased relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. The occurrence of such an event is more likely in the first year of using HRT (see Precautions). Results of the WHI studies are presented: (See Table 9.)

Click on icon to see table/diagram/image

Risk of coronary artery disease: The risk of coronary artery disease is slightly increased in users of combined oestrogen-progestogen HRT over the age of 60 (see Precautions).
Risk of ischaemic stroke: The use of oestrogen-only and oestrogen-progestogen therapy is associated with an up to 1.5-fold increased relative risk of ischaemic stroke. The risk of haemorrhagic stroke is not increased during use of HRT.
This relative risk is not dependent on age or on duration of use, but as the baseline risk is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age, (see Precautions). (See Table 10.)

Click on icon to see table/diagram/image

Other adverse reactions have been reported in association with oestrogen/progestogen treatment (including estradiol/dydrogesterone): Neoplasms benign, malignant and unspecified: Oestrogen dependent neoplasms both benign and malignant, e.g. endometrial cancer, ovarian cancer. Increase in size of progestogen dependent neoplasms, e.g. meningioma.
Blood and lymphatic system disorders: Haemolytic anaemia.
Immune system disorders: Systemic lupus erythematosus.
Metabolism and nutrition disorders: Hypertriglyceridemia.
Nervous system disorders: Probable dementia, chorea, exacerbation of epilepsy.
Eye disorders: Steepening of corneal curvature, contact lenses intolerance.
Vascular disorders: Arterial thromboembolism.
Gastrointestinal disorders: Pancreatitis (in women with pre-existing hypertriglyceridemia).
Skin and subcutaneous tissue disorders: Erythema multiforme, erythema nodosum, chloasma or melasma, which may persist when drug is discontinued.
Musculoskeletal and connective tissue disorders: Leg cramps.
Renal and urinary disorders: Urinary incontinence.
Reproductive system and breast disorders: Fibrocystic breast disease, uterine cervical erosion.
Congenital, familial and genetic disorders: Aggravated porphyria.
Investigations: Total thyroid hormones increased.