País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methotrexate
Morningside Healthcare Ltd
L04AX03
Methotrexate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300; GTIN: 5055132712791 5055132712722
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 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 on this leaflet. See section 4. What is in this leaflet: 1. What Methotrexate Tablets are and what they are used for 2. What you need to know before you take Methotrexate Tablets 3.How to take Methotrexate Tablets 4. Possible side effects 5.How to store Methotrexate Tablets 6. Contents of the pack and other information 1. What Methotrexate Tablets are and what they are 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 Tablets might help in your particular condition. 2. What you need to know before you take Methotrexate Tablets Do not take Methotrexate Tablets if you: • are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6). • are pregnant, trying to become pregnant or breast-feeding. Methotrexate may harm your baby (see section on Pregnancy). You and your partner should avoid conception (becoming pregnant or fathering children) for at least 6 months after your treatment with methotrexate has stopped. • have severe liver problems, including fibrosis, cirrhosis and recent or active hepatitis. • have severe Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methotrexate 2.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5mg of methotrexate. Excipients: 11.88 mg lactose (as lactose monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Yellow, circular, biconvex, uncoated tablets plain on both sides, 4.50mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Active rheumatoid arthritis in adult patients. - Severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with conventional therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis. 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 risk of methotrexate therapy. The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen. For doses not realisable/practicable with this strength another strength of this medicinal product is available. IMPORTANT WARNING ABOUT THE DOSAGE OF METHOTREXATE: In the treatment of rheumatoid arthritis and psoriasis, 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 specify the day of intake on the prescription. 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 achieved within 6 weeks. Psoriasis Before starting treatment it is advisable to give the patient a test dose of 2.5–5.0 mg to exclude unexpected toxic effects. If, one week later, appropriate laboratory tests are normal, tr Llegiu el document complet