Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Medical Examination/Follow-Up
Before initiating or reinstituting therapy, a complete personal and family medical history should be taken. Physical (including pelvic) examination should be guided by this and by the contraindications (section 4.3) and warnings (section 4.4) 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.
A negative pregnancy test should be demonstrated before starting therapy (see section 4.6).

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. It should be taken into account that these conditions may recur or be aggravated during treatment with Provera, in particular:

- A history of, or risk factors for, thromboembolic disorders (see below) - Risk factors for oestrogen dependent tumours, e.g. 1 degree heredity for breast cancer - Hypertension
- Liver disorders (e.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. Provera should be discontinued if a meningioma is diagnosed. Caution is advised when recommending Provera to patients with a history of meningioma.

Rare cases of thrombo-embolism have been reported with use of Provera, 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.

Provera, 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 Provera 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 Provera therapy. Some patients may complain of premenstrual like depression while on Provera 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

Effects on Driving

4.7   Effects on ability to drive and use machines

                    No adverse effect has been reported.