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Inform postmenopausal women of possible less serious but common adverse reactions of estrogenalone therapy such as headachebreast pain and tendernessnausea and vomiting.

Therapy should be discontinued if a contra-indication is discovered and in the following situations:

Breakthrough bleeding and spotting may occur during the first months of treatmentIf break-through bleeding or spotting appears after some time on therapyor continues after treatment has been discontinuedthe reason should be investigatedwhich may include endometrial biopsy to exclude endometrial malignancy.

Patients with a history of VTE or known thrombophilic states have an increased risk of VTEHRT may add to this riskHRT is therefore contraindicated in these patientssee section 4.3Personal or strong family history of thromboembolism or recurrent spontaneous abortion should be investigated in order to exclude a thrombophilic predisposition.

Clinicalsurveillance of all women using estrogen-alone or estrogen plus progestin therapy is importantAdequate diagnostic measuresincluding directed or random endometrial sampling when indicatedshould be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

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the following additional adverse reactions have been identified during post-approval use of premarin.

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