Provera Tablets 2.5 mg

Provera Tablets 5 mg

Provera Tablets 10 mg

Each tablet contains 2.5 mg medroxyprogesterone acetate Ph. Eur.

Each tablet contains 5 mg medroxyprogesterone acetate Ph. Eur.

Each tablet contains 10 mg medroxyprogesterone acetate Ph. Eur.

Tablets for oral use

Progestogen. Indicated for dysfunctional (anovulatory) uterine bleeding, secondary amenorrhoea and for mild to moderate endometriosis.

Oral.

Adults:

Dysfunctional (anovulatory) uterine bleeding: 2.5 - 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.

Secondary amenorrhoea: 2.5 - 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.

5 mg & 10 mg only

Breakthrough bleeding, which is self-limiting, may occur. No additional hormonal therapy is recommended for the management of this bleeding.

All strengths

Elderly: Not applicable

Children: Not applicable

Known, past or suspected breast cancer;

Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism);

Active or recent arterial thromboembolic disease (e.g angina, myocardial infarction);

Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal;

Known hypersensitivity to the active substances or to any of the excipients;

Porphyria

Whether administered alone or in conjunction with oestrogens, Provera should not be employed in patients with abnormal uterine bleeding until a definite diagnosis has been established and the possibility of genital malignancy eliminated.

Rare cases of thrombo-embolism have been reported with use of Provera, especially at higher doses. Causality has not been established.

Doses of up to 30 mg a day may not suppress ovulation and patients should be advised to take adequate contraceptive measures, where appropriate.

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.

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.

Aminoglutethimide administered concurrently with Provera may significantly depress the bioavailability of Provera.

Interactions with other medicinal treatments (including oral anti-coagulants) have rarely been reported, but causality has not been determined. The possibility of interaction should be borne in mind in patients receiving concurrent treatment with other drugs.

The metabolism of progestogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).

Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal preparations containing St John's wort (Hypericum perforatum) may induce the metabolism of progestogens.

Clinically, an increased metabolism of progestogens may lead to decreased effect.

Pregnancy

Provera is not indicated during pregnancy. If pregnancy occurs during medication with Provera, treatment should be withdrawn immediately.

The results of most epidemiological studies to date relevant to inadvertent foetal exposure to progestogens indicate no teratogenic or foetotoxic effect.

Lactation

Provera is not indicated during lactation.

Medroxyprogesterone acetate and its metabolites are secreted in breast milk, but there is no evidence to suggest that this presents any hazard to the child.

No adverse effect has been reported.

The following medical events have been occasionally to rarely associated with the use of progestogens:

In animals Provera has been shown to be capable of exerting an adreno-corticoid effect, but this has not been reported in the human, following usual dosages. The oral administration of Provera at a rate of 100 mg per day has been shown to have no effect on adrenal function.

Medroxyprogesterone acetate has actions and uses similar to those of progesterone.

MPA has minimal androgenic activity compared to progesterone and virtually no oestrogenic activity.

Progestogens are used in the treatment of dysfunctional uterine bleeding, secondary amenorrhoea and endometriosis.

MPA is rapidly absorbed from the G-I tract with a single oral dose of 10-250 mg. The time taken to reach the peak serum concentration (T_max) was 2-6 hours and the average peak serum concentration (C_max) was 13-46.89 mg/ml.

Unmetabolised MPA is highly plasma protein bound. MPA is metabolised in the liver.

MPA is primarily metabolised by faecal excretion as glucuronide conjugated metabolite.

Metabolised MPA is excreted more rapidly and in a greater percentage following oral doses than after aqueous intramuscular injection

None stated

None known.

2.5mg & 5mg: Store bottle pack at controlled room temperature (15-30°C)

Store blister pack below 25°C

None.

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

2.5 mg: PL 0057/1034

5 mg: PL 0057/1037

10 mg: PL 0057/1033

November 2011

Ref: PV 4_1