PROVERA

5 - 10 mg daily for 5 - 10 days commencing on the assumed or calculated 16th - 21st day of the cycle. Treatment should be given for two consecutive cycles. When bleeding occurs from a poorly developed proliferative endometrium, conventional oestrogen therapy may be employed in conjunction with medroxyprogesterone acetate in doses of 5 - 10 mg for 10 days.

5 - 10 mg daily for 5 - 10 days beginning on the assumed or calculated 16th to 21st day of the cycle. Repeat the treatment for three consecutive cycles. In amenorrhoea associated with a poorly developed proliferative endometrium, conventional oestrogen therapy may be employed in conjunction with medroxyprogesterone acetate in doses of 5 - 10 mg for 10 days.

Mild to moderate endometriosis:

Beginning on the first day of the menstrual cycle, 10 mg three times a day for 90 consecutive days. Breakthrough bleeding, which is self- limiting, may occur. No additional hormonal therapy is recommended for the management of this bleeding.

Elderly:

Not applicable Paediatric population: Not applicable Method of administration For oral use.

The table below provides a listing of adverse drug reactions with frequency based on all- causality data from Phase 3 clinical studies that evaluated efficacy and safety of DMPA in gynaecology. Those most frequently (>5%) reported adverse drug reactions were dysfunctional uterine bleeding (19%), headache (12%) and nausea (10%).

The following lists of adverse reactions are listed within the organ system classes, under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (≥1/10) Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).

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

Medical Examination/Follow-Up Before initiating or reinstituting therapy, a complete personal and family medical history should be taken. 4) for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman, but may include, if judged appropriate by the clinician, abdominal and pelvic examination.

Women should be encouraged to participate in the national breast cancer screening programme (mammography) and the national cervical screening programme (cervical cytology) as appropriate for their age. The possibility of genital tract pathology should be considered before commencing treatment in women with abnormal uterine bleeding, especially in women over 45, who may require gynaecological investigation.

6). Doses of up to 30 mg a day may not suppress ovulation and patients should be advised to take adequate contraceptive measures, where appropriate. 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. - Epilepsy - Asthma - Otosclerosis Meningiomas have been reported following long term administration of progestogens, including medroxyprogesterone acetate.

This medicine should be discontinued if a meningioma is diagnosed. Caution is advised when recommending medroxyprogesterone acetate to patients with a history of meningioma. Rare cases of thrombo-embolism have been reported with use of medroxyprogesterone acetate, especially at higher doses.

Causality has not been established. History or emergence of the following conditions require careful consideration and appropriate investigation: signs of a blood clot; migraine or unusually severe headaches or acute visual disturbances of any kind.

Medroxyprogesterone acetate, especially in high doses, may cause weight gain and fluid retention. With this in mind, caution should be exercised in treating any patient with a pre-existing medical condition, such as epilepsy, migraine, asthma, cardiac or renal dysfunction, that might be adversely affected by weight gain or fluid retention.

Some patients receiving medroxyprogesterone acetate may exhibit a decreased glucose tolerance. The mechanism for this is not known. This fact should be borne in mind when treating all patients and especially known diabetics. This product contains lactose and sucrose.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Patients with a history of treatment for mental depression should be carefully monitored while receiving medroxyprogesterone acetate therapy.

Some patients may complain of premenstrual like depression while on medroxyprogesterone acetate therapy.

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 headache

g. 1. Porphyria