Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diethylstilbestrol
Teva UK Ltd
L02AA01
Diethylstilbestrol
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030100; GTIN: 5017007131458
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms 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. 1. WHAT DIETHYLSTILBESTROL IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE DIETHYLSTILBESTROL 3. HOW TO TAKE DIETHYLSTILBESTROL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DIETHYLSTILBESTROL 6. FURTHER INFORMATION WHAT DIETHYLSTILBESTROL IS AND WHAT IT IS USED FOR Diethylstilbestrol is a synthetic non-steroidal oestrogen hormone. Diethylstilbestrol is used to treat: • prostate cancer in men • breast cancer in post-menopausal women. BEFORE YOU TAKE DIETHYLSTILBESTROL DO NOT TAKE DIETHYLSTILBESTROL IF YOU: • are allergic (hypersensitive) to diethylstilbestrol or any of the other ingredients of this medicine • are currently suffering from liver disease • have moderate or severe high blood pressure • have any heart problems • have a history of blood clots • have any disorder of the blood vessels in the brain • have hyperlipoproteinaemia (an excess of lipoproteins in the blood) • untreated polycythaemia (increased production of red blood cells), or sickle cell anaemia (altered shape of red blood cells) which causes anaemia • have porphyria (a deficiency of specific enzymes within the body, causing an increase of substances called porphyrins). FEMALE PATIENTS ONLY: • have not yet reached your menopause • have an oestrogen dependant cancer, especially of the genital tract • have endometrial hyperplasia (thickening of the womb lining) • have uterine fibroids (fibrotic lesions in the uterus) • have vaginal bleeding where the cause has not been diagnosed by your doctor • have a history of herpes gestationis, a rare Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diethylstilbestrol 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of diethylstilbestrol. For excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pink, biconvex, film-coated tablets, plain on one side and inscribed APS over 1314 on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diethylstilbestrol tablets are indicated for the treatment of carcinoma of the prostate and metastatic post-menopausal carcinoma of the breast. Diethylstilbestrol is a synthetic non-steroidal oestrogen hormone. It has been in use for many years. However, due to its carcinogenic potential, the use of Diethylstilbestrol is now only justified in the management of malignant disease. It may be used to suppress androgenic hormonal activity in the management of androgen¬dependent carcinomas such as carcinoma of the prostate in males and some post-menopausal carcinomas such as breast cancer in females. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. _Adults: _ Management of prostatic carcinoma: 1 - 3 mg daily. Management of post-menopausal breast carcinoma: 10 - 20 mg daily. _Children: _ Diethylstilbestrol should not be used in children. _Elderly: _ The recommended adult dose is appropriate. 4.3 CONTRAINDICATIONS Diethylstilbestrol is contra-indicated in those who are pregnant (it is not suitable for pre-menopausal women); and children. It is also contra-indicated in the following conditions; oestrogendependent neoplasms especially of the genital tract; pre- menopausal carcinoma of the breast; endometrial hyperplasia or uterine fibromyomata (fibroids). Diethylstilbestrol should not be given where there is undiagnosed vaginal bleeding; a history of herpes gestationis; porphyria; moderate to severe hypertension; severe or active liver disease; hyperlipoproteinaemia; any cardiovascular or cerebrovascular disorder or a history of thrombo-embolism or conditions predisposing to it such as sickle cell Perskaitykite visą dokumentą