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SPC, UK: PROVERA Tablets (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Provera 10 mg Tablets.

Qualitative and quantitative composition

Each tablet contains 10 mg medroxyprogesterone acetate. Excipients with known effect: Lactose monohydrate 110 mg, sucrose 2 mg. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablets.

Therapeutic indications

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

Posology and method of administration

Posology 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 ...

Contraindications

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, ...

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 ...

Interaction with other medicinal products and other forms of interaction

Aminoglutethimide administered concurrently with Provera may significantly depress the bioavailability of Provera. Interactions with other medicinal treatments (including oral anti-coagulants) have rarely ...

Pregnancy and lactation

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 If pregnancy occurs during medication with Provera, treatment should be withdrawn immediately.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 ...

Effects on ability to drive and use machines

No adverse effect has been reported.

Undesirable effects

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 ...

Overdose

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Progestogens – Pregnen (4) derivatives ATC code: G03DA02 Medroxyprogesterone acetate has actions and uses similar to those of progesterone. MPA has minimal androgenic activity ...

Pharmacokinetic properties

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 (Tmax) was 2-6 hours and the average peak serum concentration (Cmax) ...

Preclinical safety data

None stated.

List of excipients

Lactose Sucrose Maize starch Liquid Paraffin Talc Calcium Stearate Purified Water

Incompatibilities

Not applicable.

Shelf life

Shelf life: 5 years.

Special precautions for storage

Glass bottles: None. Blister packs: Store below 25°C.

Nature and contents of container

HDPE tamper-evident bottles with LDPE push-fit tamper evident caps, containing 50 tablets. Aluminium foil/PVC blisters, containing 10, 20, 30, 50, 90 or 100 tablets. Not all pack sizes may be marketed. ...

Special precautions for disposal and other handling

None.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, CT13 9NJ, UK

Marketing authorization number(s)

PL 00057/1033

Date of first authorization / renewal of the authorization

Date of first authorisation: 21 September 2010

Date of revision of the text

10/2016

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