Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Medroxyprogesterone acetate
Pfizer Ltd
L02AB02
Medroxyprogesterone acetate
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030200; GTIN: 5013457026900
Package leaflet: Information for the user Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Provera Tablets are and what they are used for 2. What you need to know before you take Provera Tablets 3. How to take Provera Tablets 4. Possible side effects 5 How to store Provera Tablets 6. Contents of the pack and other information 1. What Provera Tablets are and what they are used for - This medicine contains medroxyprogesterone acetate, which is one of a group of medicines called ‘Progestogens’. Progestogens act like progesterone, a natural sex hormone. - Medroxyprogesterone acetate can slow down the growth of certain tumours which are sensitive to hormones. - Provera tablets are used in the treatment of cancer in the breast, kidney (in men and women) and in the lining of the womb (endometrial cancer). It is also used to treat cancer which has spread to other parts of the body (metastatic cancer) in post menopausal women (women who have stopped having their periods). - It is not expected that Provera Tablets will be used in children for the above indications. If you are not certain why you are being given this medicine, ask your doctor. - You must talk to a doctor if you do not feel better or if you feel worse. 2. What you need to know before you take Provera Tablets Do not take Provera Tablets: - If you are hypersensitive (allergic) to medroxyprogesterone acetate or other similar hormone medicines or any of the other ingredients of this medicine (listed in section 6). - If you have Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Provera Tablets 200 mg or Medroxyprogesterone Acetate Tablets 200 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg medroxyprogesterone acetate. Excipient with known effect: Each tablet contains 0.278 mg sodium benzoate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Progestogen indicated for the treatment of certain hormone dependant neoplasms, such as: 1. Endometrial carcinoma. 2. Renal cell carcinoma. 3. Carcinoma of breast in post menopausal women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults Endometrial and renal cell carcinoma 200 - 600 mg daily Breast carcinoma 400 - 1500 mg daily The incidence of minor side-effects, such as indigestion and weight gain, increases with the increase in dose. Response to hormonal therapy may not be evident until after at least 8-10 weeks of therapy. Elderly patients:_ _This product has been used primarily in the older age group for the treatment of malignancies. There is no evidence to suggest that the older age group is any less prepared to handle the drug metabolically than is the younger patient. Therefore, the same dosage, contra-indications, and precautions would apply to either age group. Paediatric population: The product is not anticipated for paediatric use in the indications recommended. Method of administration For Oral use. 4.3 CONTRAINDICATIONS Medroxyprogesterone acetate is contraindicated in the following conditions: • thrombophlebitis, thromboembolic disorders, and where there is a high risk of developing such manifestations [presence or history of atrial fibrillation, valvular disorders, endocarditis, heart failure, pulmonary embolism; thromboembolic ischaemic attack (TIA), cerebral infarction; atherosclerosis; immediate post surgery period] • hypercalcaemia in patients with osseous metastases • hypersensitivity to the active substance or to any of the excipients liste Baca dokumen lengkapnya