Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methotrexate
Cipla EU Ltd
L04AX03
Methotrexate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300; GTIN: 8901117248366 8901117079892
PACKAGE LEAFLET: INFORMATION FOR THE USER METHOTREXATE 2.5 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 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 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 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); if you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”); if you have significant liver disease (your doctor decides the severity of your disease); if you have significant kidney disease ( Прочитайте повний документ
OBJECT 1 METHOTREXATE 2.5 MG TABLETS Summary of Product Characteristics Updated 07-Oct-2020 | Cipla EU Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Methotrexate 2.5 mg Tablets 2. Qualitative and quantitative composition Methotrexate 2.5 mg tablet Each tablet contains methotrexate 2.5 mg. Excipient with known effect Each tablet contains 12.50 mg lactose (as lactose monohydrate). Each tablet contains 0.076 mg sodium For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet Methotrexate 2.5 mg tablet Yellow, circular, biconvex uncoated tablets with dimension of 4.50 mm ± 0.20 mm plain on both sides 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 IMPORTAN Прочитайте повний документ