Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methotrexate
A A H Pharmaceuticals Ltd
L04AX03
Methotrexate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300; GTIN: 5025903011842 5025903009382 5025903015260
_S1336 LEAFLET Methotrexate 20200211 _ muscle pain, joint pain weakening or softening of bones an increase in rheumatic nodules loss of interest in, or inability to have sex menstrual disorders impotence. _ _ VERY RARE: MAY AFFECT UP TO 1 IN 10,000 PEOPLE immune disorder fatigue irritation difficulty with speech blurred vision eye infection chest pain or tightness of chest, with difficulty in breathing lung infection vomiting blood small bruises on the skin caused by blood leaking from broken blood vessels boils vasculitis (pain or redness of the blood vessels) dilatation of small blood vessels causing focal red lesions low sperm count abnormally high levels of nitrogen-containing compounds in the blood pain or difficulty in passing urine blood in urine elevation of urea and/or creatinine in the blood infertility enlargement of breasts in men vaginal bleeding dry cough lymphoproliferative disorders (excessive growth of white blood cells). NOT KNOWN: FREQUENCY CANNOT BE ESTIMATED FROM THE AVAILABLE DATA severe reduction in blood cells which can cause weakness, bruising or make infections more likely high amount of white blood cell mood alteration loss of intellectual functions such as thinking, reasoning drowsiness general feeling of illness other metabolic changes fits (seizures) deficiency of blood supply to the heart muscle fluid in lung syndrome consisting of pleuritic pain and pleural thickening has been reported following high doses pain and inflammation of the body's mucous membrane inflammation of vagina increased risk of toxic reaction bone damage in the jaw (secondary to excessive growth of white blood cells) bleeding from the lungs*. *(has been reported for methotrexate used in patients with underlying rheumatologic disease). In a small number of patients methotrexate may cause serious side effects and on rare occasions, death Prečítajte si celý dokument
1 NAME OF THE MEDICINAL PRODUCT Methotrexate 2.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains methotrexate sodium equivalent to 2.5 mg of methotrexate. Excipient(s) with known effect Lactose monohydrate- 66.166 mg per tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round, biconvex, yellow tablets, engraved with “2.5” on one side. Scored in half on the other side and engraved with ‘M’ above the score line and ‘1’ below it. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Methotrexate is a folic acid antagonist and is classified as an antimetabolite cytotoxic agent. Methotrexate has been used to produce regression in a wide range of neoplastic conditions including acute leukaemias, non-Hodgkin's lymphoma, soft-tissue and osteogenic sarcomas, and solid tumours particularly breast, lung, head and neck, bladder, cervical, ovarian, and testicular carcinoma. The treatment of neoplastic disease. Methotrexate has also been used in the treatment of severe cases of uncontrolled psoriasis, unresponsive to conventional therapy. It is also used in the treatment of adults with severe, active, classical or definite rheumatoid arthritis who are unresponsive or intolerant to conventional therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. ADULTS AND CHILDREN: Methotrexate may be given by oral, intramuscular, intravenous (bolus injection or infusion), intrathecal and intra-arterial routes of administration. Dosages are based on the patient’s body weight or surface area except in the case of intrathecal administration when a maximum dose of 15 mg is recommended. Doses should be reduced in cases of haematological deficiency and hepatic or renal impairment. Larger doses (greater than 10 Prečítajte si celý dokument