Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Methotrexate
Pfizer Australia Pty Ltd
Medicine Registered
METHOBLASTIN ® TABLETS _Methotrexate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING METHOBLASTIN. This leaflet answers some common questions about METHOBLASTIN. It does not contain all the available information and it does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking METHOBLASTIN against the expected benefits it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT METHOBLASTIN TABLETS ARE USED FOR METHOBLASTIN is used to treat severe psoriasis (a skin condition) and severe rheumatoid arthritis. It is only used to treat these conditions if other treatments have not worked. It is also used to treat some types of cancers. The medicine contains methotrexate, which belongs to a family of medicines called antimetabolites. It may also be called a chemotherapy medicine. The medicine works by blocking an enzyme needed by the body cells to live. This interferes with the growth of some cells that are growing rapidly in psoriasis and cancer. In rheumatoid arthritis, this medicine reduces the overactivity of the immune system leading to less pain, swelling and damage to the joints. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. It is only available with a doctor's prescription. BEFORE YOU TAKE METHOBLASTIN TABLETS _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE METHOBLASTIN IF YOU HAVE AN ALLERGY TO: • any medicine containing methotrexate • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, it Read the complete document
PRODUCT INFORMATION METHOBLASTIN TABLETS ® 2.5 MG AND 10 MG WARNING Methotrexate must be used only by physicians experienced in antimetabolite chemotherapy, or in the case of non-oncological conditions, by a specialist physician. Because of the possibility of fatal or severe toxic reactions the patient should be fully informed by the physician of the risks involved and should be under his constant supervision. Deaths have been reported with the use of methotrexate. In the treatment of psoriasis and rheumatoid arthritis, methotrexate should be restricted to severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established by biopsy and / or after appropriate consultation. 1. Methotrexate may produce marked depression of bone marrow, anaemia, aplastic anaemia, leucopenia, neutropenia, thrombocytopenia and bleeding. 2. Methotrexate may be hepatotoxic, particularly at high dosage or with prolonged therapy. Liver atrophy, necrosis, cirrhosis, fatty changes and periportal fibrosis have been reported. Since changes may occur without previous signs of gastrointestinal or haematological toxicity, it is imperative that hepatic function be determined prior to initiation of treatment and monitored regularly throughout therapy. Special caution is indicated in the presence of pre-existing liver damage or impaired hepatic function. Concomitant use of other drugs with hepatotoxic potential (including alcohol) should be avoided. 3. Malignant lymphomas, which may regress following withdrawal of methotrexate, may occur in patients receiving low-dose methotrexate and, thus, may not require cytotoxic treatment. Discontinue methotrexate first and, if the lymphoma does not regress, appropriate treatment should be instituted. 4. Potentially fatal opportunistic infections, especially _Pneumocystis carinii_ pneumonia, may occur with methotrexate therapy. 5. Methotrex Read the complete document