Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
METHOTREXATE
Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom
L04AX03
METHOTREXATE 10 mg
TABLET
METHOTREXATE 10 mg
POM
IMMUNOSUPPRESSANTS
Withdrawn
2015-01-12
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER METHOTREXATE 2.5 MG TABLETS METHOTREXATE 10 MG TABLETS methotrexate ▼DO NOT EXCEED THE WEEKLY DOSE OF THIS MEDICINE DUE TO TOXICITY HAZARDS. 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 or pharmacist. 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 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 Methotrexate Tablets contain the active ingredient methotrexate. 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, in patients who have tried other treatments but their illness has not improved, - severe psoriatic arthritis. 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 (hypersensitive) to methotrexate, or any of the other ingredients of this medicine (listed in section 6); if you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”); if you have significant liver disease (your doctor decides Baca dokumen lengkapnya
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methotrexate 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 10 mg tablet: each tablet contain methotrexate 10mg Excipients with known effects Each 10 mg tablet contain 50 mg lactose (as lactose monohydrate) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet 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 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 This medicine should be taken once a week. Do not exceed the weekly dose of this medicine due to toxicity hazards in psoriasis and rheumatoid arthritis.The prescriber may specify the day of intake on the prescription. Rheumatoid arthritis The usual dose is 7.5 - 15 mg once weekly. The planned weekly dose may be administered in three divided doses over 36 hours. 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, treatment may be Page 2 of 13 initiated. The usual dose is 7.5–15 mg taken once weekly. The planned weekly dose administered as three divided doses over 24 hours. As necessary, the total weekly dose can be Baca dokumen lengkapnya