מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
METHOTREXATE
Accord Healthcare Limited
L04AX03
METHOTREXATE
TABLET
METHOTREXATE 10 mg
POM
IMMUNOSUPPRESSANTS
Authorised
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER METHOTREXATE 10 MG TABLETS methotrexate “TAKE METHOTREXATE TABLET ONCE A WEEK” 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 or pharmacist. 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 in adults, severe psoriasis, especially plaque-type, in patients who have tried other treatments but their illness has not improved, active psoriatic arthritis, in adult patients acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over 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 or breast-feeding (see section “Pregnancy, breast-feeding and fertility”). have significant liver d קרא את המסמך השלם
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Methotrexate 10 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg methotrexate. Excipient with known effect: Each tablet contains 50 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Methotrexate 10 mg: 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 score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Methotrexate tablet is indicated in the treatment of: Active rheumatoid arthritis in adult patients. Severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with conventional therapy and active psoriatic arthritis in adults Maintenance therapy in acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION IMPORTANT WARNING WITH REFERENCE TO THE DOSING OF METHOTREXATE: METHOTREXATE MUST ONLY BE TAKEN ONCE WEEKLY. INCORRECT DOSING OF METHOTREXATE MAY LEAD TO SERIOUS ADVERSE EFFECTS INCLUDING FATAL OUTCOMES. PLEASE READ THIS PARAGRAPH OF THE SMPC VERY CAREFULLY. Methotrexate should only be prescribed by physicians with experience in the various properties of the medicinal product and its mode of action. Methotrexate is given once weekly. It must be explicitly pointed out to the patient that methotrexate is taken ONLY ONCE A WEEK . It is recommended to specify a certain day of the weeks as “the day for taking methotrexate” on the prescription. Page 2 of 14 Posology 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 25 mg. After the therapeutically d קרא את המסמך השלם