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FEMSEVEN is a brand name for Estradiol (also known as Oestradiol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. (See also section 4.4)…
Verbatim from this product's MHRA label. Tap a section to expand.
e. each patch is replaced with a new one after 7 days. In women with an intact uterus, the addition of a progestogen for at least 12 to 14 days every month/28 day cycle is essential to help prevent any endometrial hyperplasia induced by the oestrogen.
4 (Special warnings and precautions for use - “Endometrial hyperplasia”). Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women. 4) should be used. Therefore, therapy should normally be started with one FemSeven patch (delivering 50 micrograms of estradiol in 24 hours).
If the prescribed dose does not eliminate the menopausal symptoms, the dose should be adjusted stepwise after the first few months by using a transdermal patch delivering 75 or 100 micrograms estradiol per day. A maximum of 100 micrograms estradiol per day should not be exceeded.
If there are persistent signs of overdose, such as breast tenderness, the dose should be reduced accordingly. Hysterectomised women not taking HRT or transferring from another HRT product may start treatment with FemSeven on any convenient day.
The same holds true for non- hysterectomised women not taking HRT or transferring from a continuous combined HRT product. In non-hysterectomised women switching from sequential HRT regimens, treatment with FemSeven should start after the previous treatment regimen has ended.
Consecutive new patches should be applied to different sites. , buttocks, hip or abdomen. FemSeven must not be applied on or near the breasts. The patch should be applied to clean, dry, healthy and intact skin. The patch should be applied to the skin as soon as it is removed from its wrapping.
The patch is applied by removing both parts of the protective liner and then holding it in contact with the skin for at least 30 seconds (warmth is essential to ensure maximal adhesive strength). Should part or all of a patch detach prematurely (before 7 days) it should be removed and a new patch applied.
To aid compliance it is recommended the patient then continues to change the patch on the usual day. This advice also applies if a patient forgets to change the patch on schedule. Forgetting a patch may increase the likelihood of break-through bleeding or spotting.
g. pruritus, erythema, eczema, urticaria, oedema and changes in skin pigmentation. They were mostly mild skin reactions and usually disappeared 2 – 3 days after patch removal. These effects are usually observed with transdermal oestrogen replacement therapy.
g. MedDRA SOC level) Common ADRs > 1/100 ; < 1/10 Uncommon ADRs >1/1 000 ; < 1/100 Rare ADRs >1/10 000 ; < 1/1 000 Skin and subcutaneous tissue Hair changes, sweating increased Muscular and skeletal Arthralgia, leg cramps Central & peri nervous system Headache Dizziness, paresthesia, migraine Psychiatric disorders Anxiety, appetite increase, depression, insomnia, nervousness Gastrointestinal system dis.
g. Mastalgia/ mastopathies, breast tenderness, breast enlargement) Vaginal discharge, breakthrough bleeding Worsening of uterine fibroids Body as a whole/general dis. Oedema, fatigue, weight changes 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 lower than that seen in users of oestrogen-progestogen combinations. 4) • 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.
0 *Taken from baseline incidence rates in England in 2015 in women with BMI 27 (kg/m2) Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
8 *Taken from baseline incidence rates in England in 2015 in women with BMI 27 (kg/m2) Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
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 risk 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 (see "Breast cancer" below).
g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual. Conditions which need supervision If any of the following conditions are present, have occurred previously and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
g. g. liver adenoma) - Diabetes mellitus with or without vascular involvement - Cholelithiasis - Migraine or severe headache - Systemic lupus erythematosus - A history of endometrial hyperplasia (see below) - Epilepsy - Asthma - Otosclerosis.
Reasons for immediate withdrawal of therapy Therapy should be discontinued in case a contra-indication is discovered and in the following situations: - Jaundice or deterioration in liver function - Significant increase in blood pressure - New onset of migraine-type headache - Pregnancy Endometrial hyperplasia and carcinoma • In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administrated alone for prolonged periods.
g. g. 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; - Known hypersensitivity to the active substance or to any of the excipients; - Porphyria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5) +4 (0 – 9) * WHI study in women with no uterus, which did not show an increase of breast cancer. ‡When the analysis was restricted to women who had not used HRT prior to the study there was no increased risk apparent during the first 5 years of treatment: After 5 years, the risk was higher than in non-users.
Endometrial cancer risk Postmenopausal women with a uterus The endometrial cancer risk is about 5 in every 1 000 women with a uterus not using HRT. 4). 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 1 000 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. 2)). 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.
e. deep vein thrombosis or pulmonary embolism. 4). 3) 5 (1-13) *Study in women with no uterus […]
8). After stopping treatment, risk may remain elevated for at least 10 years. • The addition of a progestogen cyclically for at least 12 days per months/28 day cycle or continuous combined oestrogen-progestogen therapy in non- hysterectomised women prevents the excess risk associated with oestrogen- only HRT.
625 mg and patches 50 μg/day the endometrial safety of added progestogens has not been demonstrated. • Break-through bleeding and spotting may occur during the first months of treatment. If break-through bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
• Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis. Therefore, the addition of progestogens to oestrogen replacement therapy should be considered in women who have undergone hysterectomy because of endometriosis, if they are known to have residual endometriosis.
Breast cancer The overall evidence shows an increased risk of breast cancer in women using oestrogen- progestogen or oestrogen-only HRT, that is dependent on the duration of taking HRT. Combined oestrogen-progestrogen therapy • The randomised placebo-controlled trial the Women’s Health Initiative study (WHI), and a meta-analysis of prospective epidemiological studies are consistent in finding an increased risk of breast cancer in women taking combined oestrogen-progestogen for HRT that becomes apparent after about 3 years (1-4) (see.
8). Oestrogen-only therapy • The WHI trial found no increase in the risk of breast cancer in hysterectomised women using oestrogen-only HRT. 8). Results from a large meta-analysis showed that after stopping treatment, the excess risk will decrease with time and the time needed to return to baseline depends on the duration of prior HRT use.
When HRT was taken for more than 5 years, the risk may persist for 10 years or more. HRT, especially oestrogen/progestogen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.
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.
8). e. deep vein thrombosis or pulmonary embolism. The occurrence of such an event is more likely in the first year of HRT than later (see section […]