מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tamoxifen citrate
DE Pharmaceuticals
L02BA01
Tamoxifen citrate
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030401
NOT KNOWN (cannot be estimated from the available data): • swelling of the face, lips, tongue or throat, difficulty in swallowing or breathing (angioedema). Tamoxifen may cause or worsen symptoms of hereditary angioedema. These side effects are serious. You may need medical attention. The following side effects generally occur after long-term use with Tamoxifen and include a range of menstrual disorders (see below). If you still have periods you may notice that your cycles are disturbed, or may completely stop. VERY COMMON (may affect more than 1 in 10 people): • vaginal discharge • hot flushes • skin rash • feeling sick • swollen arms or legs (fluid retention in the body) • feeling tired • depression COMMON (may affect up to 1 in 10 people): • reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia) • increase in blood fat (triglyceride) levels • light-headedness, headache • tingling or pins and needles sensations in the hands and feet • changes in taste, being sick, diarrhoea, constipation • hair loss • tumour pain • visual disturbance such as cataracts (when the lens of your eye lets through less light) • changes in liver enzyme levels (which may be seen in blood tests), development of “fatty liver” where fatty deposits are seen in the liver • leg cramps, muscle pain • genital itching • uterine fibroids or polyps (non-cancerous growths of the womb), thickening of the womb lining UNCOMMON (may affect up to 1 in 100 people): • blood disorders which may cause you to bruise or bleed more easily or without explanation • scarring of the liver (cirrhosis), normally due to liver damage • high levels of calcium in your blood • changes to your vision and difficulty seeing. RARE (may affect up to 1 in 1,000 people): • short-lived falls in platelet counts (platelets are blood cells) • changes to the cornea (the outer covering of your eye). • abnormal or interrupted menstrual cycle (periods) in premenopausal women • קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamoxifen 20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Tamoxifen Citrate 30.40mg (equivalent to 20mg tamoxifen) Excipient with known effect: Each tablet contains 259.60mg of lactose For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets White, convex tablets with an approximate diameter of 9.5mm printed T20on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tamoxifen tablets are indicated for: 1. The treatment of breast cancer 2. The treatment of anovulatory infertility 3. The primary prevention of breast cancer in women at moderate or high risk (see section 5.1). Women aged less than 30 years old were excluded from primary prevention trials so the efficacy and safety of tamoxifen treatment in these younger women is unknown. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY 1. Breast Cancer Adults The recommended daily dose of tamoxifen is normally 20mg. No additional benefit, in terms of delayed recurrence or improved survival in patients, has been demonstrated with higher doses. Substantive evidence supporting the use of treatment with 30-40mg per day is not available, although these doses have been used in some patients with advanced disease. Elderly people Similar dosing regimens of tamoxifen have been used in the elderly with breast cancer and in some of these patients it has been used as sole therapy. 2. Anovulatory Infertility Before commencing any course of treatment, whether initial or subsequent, the possibility of pregnancy must be excluded. In women who are menstruating regularly, but with anovular cycles, the initial course of treatment consists of 20mg given daily on the second, third, fourth and fifth days of the menstrual cycle. If unsatisfactory basal temperature records or poor pre-ovulatory cervical mucus indicate that this initial course of treatment has been unsuccessful, further courses of treatment may be given during subsequent menstrual periods, increasing קרא את המסמך השלם