Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methotrexate
Orion Pharma (UK) Ltd
L04AX03
Methotrexate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300; GTIN: 6432100013781 6432100058362
PACKAGE LEAFLET: INFORMATION FOR THE USER METHOTREXATE 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 is and what it is used for 2. What you need to know before you take Methotrexate 3. How to take Methotrexate 4. Possible side effects 5. How to store Methotrexate 6. Contents of the pack and other information 1. WHAT METHOTREXATE IS AND WHAT IT IS 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 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 DO NOT TAKE METHOTREXATE IF: - you have significant liver disease (your doctor decides the severity of your disease) - you have significant kidney disease (your doctor decides the severity of your disease) - you have or have had a bone marrow disease or serious blood disorders - you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6) - you are pregnant or breast-feeding (see also section “Pregnancy , breast-feeding Přečtěte si celý dokument
PRODUCT SUMMARY 1. NAME OF THE MEDICINAL PRODUCT Methotrexate 10 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Methotrexate 10 mg per tablet. Excipient with known effect: Each tablet contains 38.5mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet for oral administration. Scored yellow capsule shaped tablets marked ‘M10’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with conventional therapy such as phototherapy and PUVA, and severe psoriatic arthritis. • Active rheumatoid arthritis in adult patients. 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. The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen. IMPORTANT WARNING ABOUT THE DOSAGE OF METHOTREXATE In the treatment of, psoriasis and rheumatoid arthritis Methotrexate MUST ONLY BE USED 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. 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. 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 initiated. The usual dose is 5-25 mg taken once weekly, starting with a low dose and increasing as necessary. The prescriber should specify the day of intake on the prescription. The patient should be fully informed of the risks involved and the clinician should pay par Přečtěte si celý dokument