FEMSEVEN

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 > 1/100 ; < 1/10 >1/1 000 ; < 1/100 >1/10 000 ; < 1/1 000 level) Skin and subcutaneous Hair changes, sweating increased tissue Muscular and skeletal Arthralgia, leg cramps Central & peri nervous Headache Dizziness, paresthesia, migraine system Psychiatric disorders Anxiety, appetite increase, depression, insomnia, nervousness Gastrointestinal system Nausea, dyspepsia, abdominal dis.

g. Mastalgia/ bleeding fibroids mastopathies, breast tenderness, breast enlargement) Body as a whole/general Oedema, fatigue, weight changes dis. 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 developed countries 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.

5) +4 (0 – 9) *WHI study in women with no uterus, which did not show an increase in risk 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.

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.