Evorel 50

/ Janssen

Adults: Evorel is an oestrogen-only HRT patch applied to the skin twice weekly. For initiation and continuation of treatment of menopausal symptoms, the lowest effective dose for the shortest duration should be used.
Treatment of oestrogen deficiency symptoms: Therapy should be started with one Evorel 50 patch (delivering 50 micrograms of estradiol/24 hours) and the dose adjusted after the first month if necessary depending on efficacy and signs of over-oestrogenisation (eg breast tenderness). For aintenance therapy the lowest effective dose should be used; For woman with a uterus, doses of oestradiol above 50 µg/day have not been studied and are therefore not recommended. For women without a uterus, a maximum dose of 100 micrograms of estradiol/24 hours should not be exceeded. Progestogen use: For women with an intact uterus progestogen should normally be added to Evorel for the prevention of adverse endometrial effects, eg hyperplasia and cancer. The egimen may be either cyclic or continuous sequential. Only progestogens approved for addition to oestrogen treatment may be prescribed (eg oral norethisterone, 1mg/day or medroxyprogesterone acetate, 2.5mg/day [continuous] or 5-10 mg/day for 12-14 days [cyclical])and should be added for at least 12-14 days every month/28 day cycle. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.
Guidance on how to start therapy: Post-menopausal women currently not on HRT may start Evorel at any time.
Switching from other HRT:  The switch from another oestrogen-only therapy in post-menopausal women to Evorel may occur at any time. Women on a continuous combined regimen wishing to switch from another oestrogen to Evorel may do so at any time.

Deficiency symptoms by absence of Estrogen after the menopause or after surgical removal of the ovarians. They comprise hot flushes, insomnia, atrophies of the urogenital system,changes of mood and increasing loss of the bone substance, which can lead to osteoporosis. In women with intact uterus, estrogen substitution must always be supplemented with a sequential gestagen therapy.

Known hypersensitivity to the active substances or to any of the excipients, Known current or past or suspected breast cancer, Known or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer) or pre-malignant tumors (e.g. untreated atypical endometrial hyperplasia), Undiagnosed genital bleeding, Pregnancy or lactation, Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal, Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism), Known thrombophilic conditions, Active or recent past arterial thromboembolic disease (e.g. cerebrovascular accident, myocardial infarction), Porphyria.

Before starting, and periodically during estrogen replacement therapy, it is recommended that the patient be given a thorough physical and gynecological examination. A complete medical and family history should be taken. Repeated breakthrough bleeding, unexpected vaginal bleeding and changes noticed during breast examination require further evaluation. A careful appraisal of the risk/benefit ratio should be undertaken before initiation of long-term treatment. 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 favorable than in older women.
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. It should be taken into account that these conditions may recur or be aggravated during treatment with this product, in particular: Leiomyoma (uterine fibroids) or endometriosis, Risk factors for thromboembolic disorders, Risk factors for estrogen dependent tumors, e.g. first degree relative with breast cancer, Hypertension, Liver disorders (e.g. liver adenoma), Diabetes mellitus, Cholelithiasis, Migraine or severe headache, Systemic lupus erythematosus, A history of endometrial hyperplasia, Epilepsy, Mastopathy. otosclerosis.
Conditions which require monitoring while on oestrogen therapy: Oestrogens may cause fluid retention. Cardiac or renal dysfunction should be carefully observed, Disturbances or mild impairment of liver function, History of cholestatic jaundice, Pre-existing hypertriglyceridaemia. Rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.
For full details see prescribing information.

The safety of this product was evaluated in 102 subjects who participated in a multicenter, double-blind, randomized, placebo-controlled clinical study (N93-012) of this product.
For full details see prescribing information.

Barbiturates, carbamazepine, dichloralphenazone, griseofulvin, phenytoin, primidone, rifampicin. Coumarin anticoagulants, bile acids, antihypertensives, diuretics, topical corticosteroids.
For full details see prescribing information.

The use of this product is contraindicated in pregnancy or lactation. If pregnancy occurs during medication with this product, treatment should be withdrawn immediately.

Symptoms of overdose may include breast pain or tenderness, nausea, breakthrough bleeding, abdominal cramps and/or bloating. Removing the patch can reverse these symptoms.