Fylrevy

FYLREVY is an oestrogen-only product. Posology One tablet should be taken orally once daily at about the same time with or without food, if necessary, with a small amount of water. Continuous administration is recommended. 4) should be used.

2 mg. 9 mg. A progestogen approved for addition to oestrogen treatment should be added continuously. 9 mg. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women. Starting or changing treatment In women who are not taking HRT, or in women who switch from an oestrogen only HRT product or from a continuous combined HRT product, treatment may be started on any convenient day.

In women changing from a cyclic or sequential HRT regimen, treatment should begin on the day following completion of the prior regimen. Management of missed tablets If a tablet has been forgotten, it should be taken as soon as possible.

If more than 12 hours have elapsed, treatment should be continued with the next tablet without taking the forgotten tablet. Missed tablets may increase the likelihood of breakthrough bleeding or spotting in women with a uterus. 3). 2).

Renal impairment Estetrol is not recommended in women with moderate or severe renal impairment. 2). Paediatric population There is no relevant use of estetrol in the paediatric population for the indication of HRT for oestrogen deficiency symptoms in postmenopausal women.

Elderly Estetrol has not been studied for safety and efficacy in women initiating treatment over 65 years of age. No dose recommendation can be made for this population. 4 Method of administration For oral use.

4%). 6%). Apart from uterus-related adverse drug reactions, there was no other difference in the safety profile in women with or without a uterus. 9 mg continuously combined with P4 100 mg). Adverse drug reactions observed during clinical trials are listed in Table 1 and classified according to frequency and system organ class.

Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000) very rare (< 1/10 000) and not known (cannot be estimated from the available data).

Table 1:

Adverse drug reactions System organ class Very common Common Uncommon Infections and infestations Vulvovaginal candidiasis Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma Nervous system disorders Dizziness Vascular disorders Venous thromboembolism Gastrointestinal disorders Abdominal pain lowera, Abdominal pain, Abdominal distension, Nausea, Constipation Skin and subcutaneous tissue disorders Urticaria Musculoskeletal and connective tissue disorders Pain in extremity Reproductive system and breast disorders Vaginal haemorrhageb, Endometrial thickening Disordered proliferative endometrium, Breast pain, Breast tenderness, Nipple pain, Uterine spasm, Endometrial hyperplasia, Endometrial polypc, Adenomyosis, Breast massd, Breast swellinge, Ovarian cyst 10 Vaginal discharge, Vulvovaginal pruritus General disorders and administration site conditions Asthenia Peripheral swelling Investigations Weight increased a Includes pelvic pain b Includes uterine haemorrhage and intermenstrual bleeding c Includes cervical polyp and uterine polyp d Includes Phyllodes tumour, breast cyst, breast scan abnormal e Includes breast enlargement, breast engorgement Description of selected adverse reactions Breast cancer risk • An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestagen therapy for more than 5 years.

8). Higher P4 doses or another progestogen approved for addition to oestrogen treatment may be used, however, safety and tolerability data in combination with estetrol are not available. For the treatment of postmenopausal symptoms, estetrol 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. 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.

g. g. g. angina, myocardial infarction); - Presence or history of severe hepatic disease as long as liver function values have not returned to normal; - Porphyria.