IMVAGGIS

Posology During the first 3 weeks of treatment one pessary is administered daily. Thereafter a maintenance dose of 1 pessary twice a week is recommended. 4). 4). Method of administration The pessary should be introduced deeply into the vagina, preferably in the evening before going to bed.

Missed dose • During daily use within the first 3 weeks of treatment:

If a missed dose is not realized before the next day, it should not be replaced. In that case the usual dosing schedule should be resumed. • During twice-weekly use: If the administration of the medicinal product has been forgotten at a scheduled date during the twice-weekly maintenance treatment, the missed dose should be administered as soon as possible.

At the beginning of treatment, when the vaginal epithelial layers are still atrophic, local irritation may occur as a sensation of heat, pain and/or itching but the undesirable effects are often transient and of mild intensity. The reported undesirable effects have been classified according to frequency of appearance: System Organ Class Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Gastrointestinal disorders anorectal discomfort Renal and urinary disorders dysuria Reproductive system and breast disorders vulvovaginal burning, pruritus and pain vaginal discharge Class effects associated with systemic HRT The following risks have been associated with systemic HRT and apply to a lesser extent for estrogen products for vaginal application of which the systemic exposure to estrogen is very low.

4). 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). 5-fold increased relative risk of ischaemic stroke. The risk of haemorrhagic stroke is not increased during use of HRT. 4). 6) 3 (1 – 5) ** No differentiation was made between ischaemic and haemorrhagic stroke.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 risks 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.

03 mg pessary must not be combined with estrogen preparations for systemic treatment, as there are no studies of safety and risks with estrogen concentrations attained in combination treatment. 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.

03 mg pessary. 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 (SLE); − A history of endometrial hyperplasia (see below); − Epilepsy; − Asthma; − Otosclerosis.

Reasons for immediate withdrawal of therapy Therapy should be discontinued in case a contraindication is discovered, and in the following situations: − Jaundice or deterioration in liver function; − Significant increase in blood pressure; − New onset of migraine-type headaches; − Pregnancy.

Endometrial hyperplasia and carcinoma An increased risk of endometrial hyperplasia or uterine cancer has not been attributed to treatment with estriol by vaginal use. In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when systemic estrogens are administered alone for prolonged periods.

For estrogen products for vaginal application of which the systemic exposure to estrogen is very low, it is not recommended to add a progestagen. Endometrial safety of long-term (more than one year) or repeated use of local vaginally administered estrogen is uncertain.

Therefore, if repeated, treatment should be reviewed at least annually. Unopposed estrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis. Therefore caution is advised when using this product in women who have undergone hysterectomy because of endometriosis, especially if they are known to have residual endometriosis.

If bleeding or spotting appears at any time on therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy. The following risks have been associated with systemic HRT and apply to a lesser extent for estrogen products for vaginal application of which the systemic exposure to the estrogen is very low.

However, they should be considered in case of long term or repeated use of this product. Breast cancer Epidemiological evidence from a large meta-analysis suggests no increase in risk of breast cancer in women with no history of breast cancer taking low dose vaginally applied estrogens.

It is unknown if low dose vaginal estrogens stimulate recurrence 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 estrogen-only systemic HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.

e. deep vein thrombosis or pulmonary embolism. 8). Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk. 3). Generally recognised risk factors for VTE include use of estrogens, older age, major surgery, prolonged immobilisation, obesity (BMI > 30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE) and cancer.

There is no consensus about the possible role of varicose veins in VTE. As in all postoperative patients, prophylactic measures need be considered to prevent VTE following surgery. If prolonged immobilisation is to follow elective surgery temporarily stopping HRT 4 to 6 weeks earlier is recommended.

Treatment should not be restarted until the woman is completely mobilised. In women with no personal history of VTE but with a first degree relative with a history of thrombosis at young age, screening may be offered after careful counselling regarding its limitations (only a proportion of […]

− Known, past or suspected breast cancer; − Known or suspected estrogen-dependent malignant tumours (e. g. endometrial cancer); − Undiagnosed genital bleeding; − Untreated endometrial hyperplasia; − Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism); − Known thrombophilic disorders (e.

g. g. 1.