Oestrogens.

Estradiol [oestradiol]

Film-coated tablets.

Tablets, 17- b estradiol 2mg.

Symptomatic treatment of climacteric symptoms for women following oophorectomy or the naturally occurring menopause. Women with intact uteri should use a standard dose of a progestogen in either a sequential or combination regimen. A progestogen is not needed in women who do not have a uterus.

If the patient is menstruating, treatment is started on day 5 of bleeding, or, in hysterectomised or postmenopausal women, on any convenient day.

If a progestogen has been prescribed as a sequential regimen (usually 10-14 days of each 28-day cycle) it should be started on the recommended day of the cycle, considering the day of the first Adgyn Estro tablet to be day 1.

If a progestogen has been prescribed as continuous combined therapy it should be started at therapy it should be started at the same time as Adgyn Estro.

Not recommended.

Known, suspected or past history of breast cancer. Known or suspected oestrogen dependent neoplasia. Undiagnosed abnormal genital bleeding. Known sensitivity to the ingredients of Adgyn Estro. Active or chronic liver disease, or a history of liver disease where the liver function tests have failed to return to normal. Severe cardiac or renal disease. Rotor syndrome and Dubin-Johnson syndrome.

Known or suspected pregnancy. Confirmed active venous thromboembolism (deep venous thrombosis, pulmonary embolism) within the last two years. A history of recurrent VTE or known thrombophilic disease in a patient who is not already on anticoagulant treatment. Pregnancy and lactation.

Exclude presence of genital or breast neoplasia. Small or moderate increased risk of having breast cancer diagnosed in women currently or recently using HRT. Abnormal uterine bleeding. History or increased risk of thromboembolic disorders.

Epilepsy, migraine, asthma, cardiac or renal dysfunction. Otosclerosis, multiple sclerosis, systemic lupus erythematosus, porphyria, melanoma. If jaundice, migraine-like headaches, visual disturbance or a significant increase in blood pressure develop, discontinue therapy. Pre-existing fibroids. Monitor blood pressure regularly in hypertensive women. Diabetes.

Barbiturates, phenytoin, rifampicin, carbamazepine and similar drugs which induce liver enzymes.

Increase in size of uterine fibroids, vaginal candidiasis, change in cervical erosion and in degree of cervical secretion, cystitis-like syndrome; breast secretion; nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice; chloasma or melasma, erythema multiforme, erythema nodosum, haemorrhagic eruption. Steepening of corneal curvature, intolerance to contact lenses; headaches, migraine, dizziness, chorea. Increase or decrease in weight, reduced carbohydrate tolerance, aggravation of porphyria, oedema, change in libido, leg cramps.

REASONS FOR IMMEDIATE DISCONTINUATION OF TREATMENT: Occurence of migraine-type headaches for the first time, frequent severe headaches, acute visual disturbances, signs of thrombophlebitis or thromboembolism, or any other possible prodromal symptoms of vascular occlusion. Rise in blood pressure. Jaundice. Pregnancy. Discontinue six weeks before major elective surgery and during immobilisation entailing risk of thrombosis.

Strakan

(POM)

04 June 2009