Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methotrexate
Orion Pharma (UK) Ltd
L04AX03
Methotrexate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300; GTIN: 6432100013750 6432100013798 6432100013767 6432100023841 6432100058379 6432100058386
1 PACKAGE LEAFLET: INFORMATION FOR THE USER METHOTREXATE 2.5 MG TABLETS methotrexate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Methotrexate is and what it is used for 2. What you need to know before you take Methotrexate 3. How to take Methotrexate 4. Possible side effects 5. How to store Methotrexate 6. Contents of the pack and other information 1. WHAT METHOTREXATE IS AND WHAT IT IS USED FOR The active substance of Methotrexate tablets, methotrexate, is an antimetabolite and immunosuppressant (medicine which affects the reproduction of the body's cells and reduces the activity of the immune system). Methotrexate is used to treat: - active rheumatoid arthritis in adult patients - severe resistant disabling psoriasis,which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids - severe psoriatic arthritis in adult patients Your doctor will be able to explain how Methotrexate tablets might help in your particular condition. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHOTREXATE DO NOT TAKE METHOTREXATE IF: - you have significant liver disease (your doctor decides the severity of your disease) - you have significant kidney disease (your doctor decides the severity of your disease) - you have or have had a bone marrow disease or serious blood disorders. - you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6) - you are pregnant or breast-feeding (see also section “Pregnancy, breast-feedin Citiți documentul complet
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 Citiți documentul complet