Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Methotrexate
Orion Corporation
L01BA; L01BA01; L04AX; L04AX03
Methotrexate
10 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Folic acid analogues; methotrexate; Other immunosuppressants; methotrexate
Marketed
2016-10-21
PACKAGE LEAFLET: INFORMATION FOR THE USER METHOTREXATE ORION 2.5 AND 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 Orion is and what it is used for 2. What you need to know before you take Methotrexate Orion 3. How to take Methotrexate Orion 4. Possible side effects 5. How to store Methotrexate Orion 6. Contents of the pack and other information 1. WHAT METHOTREXATE ORION IS AND WHAT IT IS USED FOR The active substance of Methotrexate Orion tablets, methotrexate, is a substance with the following properties: - it suppresses the growth of certain cells in the body that reproduce quickly - it reduces the activity of the immune system (the body’s own defence mechanism). Methotrexate is used to treat: - 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 in adult patients - severe psoriatic arthritis in adult patients - maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over. Your doctor will be able to explain how Methotrexate Orion tablets might help you in your particular condition. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHOTREXATE ORION DO NOT TAKE METHOTREXATE ORION: - if you are allergic (hypersensitive) to methotrexate, or any of the other ingredients of this medicine (listed in section 6) - if you are breast-feeding and additionally, Lire le document complet
Health Products Regulatory Authority 26 April 2023 CRN00DFH3 Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methotrexate Orion 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains methotrexate disodium equivalent to 10 mg methotrexate (anhydrous). Excipient with known effect: 311.2 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Yellow, capsule-shaped, convex, uncoated tablet, engraved with ORN 59 on one side and score on other side, length of 14 mm and width of 6 mm. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Antirheumatic:_ Active rheumatoid arthritis in adult patients _Antipsoriatic:_ 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 _Cytostatic_: Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 WITH REFERENCE TO THE DOSING OF METHOTREXATE ORION (METHOTREXATE): In the treatment of rheumatic diseases, psoriasis or severe psoriatic arthritis, Methotrexate Orion (methotrexate) MUST ONLY BE TAKEN ONCE A WEEK. Dosage errors in the use of Methotrexate Orion (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. It must be explicitly pointed out to the patient that for the therapy of rheumatic diseases, psoriasis or severe psoriatic arthritis methotrexate is administered ONLY ONCE A WEEK. The pr Lire le document complet