Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Methotrexate
Orion Corporation
L04AX; L04AX03
Methotrexate
10 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Other immunosuppressants; methotrexate
Not marketed
2008-10-03
PACKAGE LEAFLET: INFORMATION FOR THE USER METHOTREXATE 10 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-feeding Přečtěte si celý dokument
Health Products Regulatory Authority 23 September 2020 CRN009WQN Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methotrexate 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 10 mg methotrexate. Excipients with known effect: 36.6 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Yellow, convex, capsule-shaped tablet, scored and engraved with M 10 on one side, length 8 mm, breadth 4.5 mm. The tablet can be divided into equal halves. 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 Posology Rheumatoid arthritis and psoriasis Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. IMPORTANT WARNING ABOUT THE DOSAGE OF METHOTREXATE: IN THE TREATMENT OF RHEUMATIC DISEASES, PSORIASIS OR PSORIATIC ARTHRITIS, METHOTREXATE MUST ONLY BE TAKEN ONCE A WEEK. DOSAGE ERRORS IN THE USE OF METHOTREXATE CAN RESULT IN SERIOUS ADVERSE REACTIONS, INCLUDING DEATH. PLEASE READ THIS SECTION OF THE SUMMARY OF PRODUCT CHARACTERISTICS VERY CAREFULLY. The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen. The prescriber should specify the day of intake on the prescription. For doses not realisable/practicable with this strength, another strength of this medicinal product is available. Rheumatoid arthritis The usual dose is 7.5 - 15 mg once weekly. The schedule may be adjusted gradually to achieve an optimal response but should not exceed a total weekly dose of 20 mg. Thereafter the dose should be reduced to the lowest possible effective dose which in most cases is ach Přečtěte si celý dokument