País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methotrexate
Alliance Healthcare (Distribution) Ltd
L04AX03
Methotrexate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300
METHOTREXATE 10MG TABLETS PACKAGE LEAFLET: INFORMATION FOR THE USER Your medicine is known by the above name but will be referred to as Methotrexate throughout this leaflet. 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, - severe psoriasis, especially plaque-type, - psoriatic arthritis in adult patients who have tried other treatments but their illness has not improved. Your doctor will be able to explain how Methotrexate 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). - if you have significant kidney disease (your doctor decides the severity of your disease). - if you have or have had a bone marrow disease or serious blood disorders. - if you are allergic (hypersensitive) to methotrexate or any of the other ingredients of Methotrexate tablets. - if you are pregnant or breast-feeding (see also section “Pregnancy, breastfeeding and fertility”). - if you have severe acute or chronic infections or immunodeficiency syndrome. - if you suffer from alcoholism. WARNINGS AND PRECAUTIONS Please tell your doctor or pharmacist if any of the following conditions concern or have concerned you: - Diabetes mellitus treated with insulin. - You have received any vaccinations recently or are you due to have any - You are using any other medicines or vitamin products (Please see section “Other medicines and Methotrexate”) - You have infection Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methotrexate 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Methotrexate 10 mg tablet Each tablet contains methotrexate 10mg _Excipients with known effects _ Each tablet contains 50 mg lactose (as lactose monohydrate) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Methotrexate 10 mg tablet Yellow coloured, capsule shaped, biconvex uncoated tablet with length of 10.00 mm ± 0.20 mm and breadth 5.00 mm ± 0.20 mm, with central breakline on one side and plain on other side. The breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Active rheumatoid arthritis in adult patients. • Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION IMPORTANT WARNING ABOUT THE DOSAGE OF METHOTREXATE TABLETS (METHOTREXATE): In the treatment of rheumatic diseases or diseases of the skin requiring dosing once a week, Methotrexate tablets (methotrexate) MUST ONLY BE TAKEN ONCE A WEEK. Dosage errors in the use of Methotrexate tablets (methotrexate) can result in serious adverse reactions, including death. Please read this section of the summary of product characteristics very carefully. Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a f understanding of the risks of methotrexate therapy. Methotrexate is given once weekly. It must be explicitly pointed out to the patient that methotrexate is applied ONLY ONCE A WEEK. The prescriber should specify the day of intake on the prescription. The prescriber should ensure that patients or their carers will be able to comply with the once wee regimen. Rheumatoid arthritis The usual dose is 7.5 - 15 mg once weekly. The schedule may be adjusted gradually to achiev Llegiu el document complet