Product Details

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, trying to become pregnant or breast-feeding. Methotrexate may harm your baby (see section on Pregnancy). You and your partner should avoid conception (becoming pregnant or fathering children) for at least 6 months after your treatment with methotrexate has stopped. • have severe liver problems, including fibrosis, cirrhosis and recent or active hepatitis. • have severe kidney problems, including conditions requiring kidney dialysis. • have any serious blood disorder, including severe anaemia and clotting problems. • have an alcohol dependency. • have a medical condition or are receiving medication which lowers your resistance to infection. • are taking antibiotics which prevent the production of folic acid (vitamin B9) such as co-trimoxazole, which are used to treat bacterial infections. • have an active infectious disease (e.g. fever, chills, joint pain). • are being treated with live vaccines. • have an ulcer of the oral cavity and gut. • have inflammation of mouth or lips. Recommended follow-up examinations and precautions Even if methotrexate is used in low doses, serious side effects can occur. In order to detect them in time, your doctor must perform monitoring examinations and laboratory tests. Prior to the start of therapy: Before you start treatment, your blood will be checked to see if you have enough blood cells. Your blood will also be tested to check your liver function and to find out if you have hepatitis. Furthermore, serum albumin (a protein in the blood), hepatitis (liver infection) status and kidney function will be checked. The doctor may also decide to run other liver tests, some of these may be images of your liver and others may need a small sample of tissue taken from the liver in order to examine it more closely. Your doctor may also check to see if you have tuberculosis and they may X-ray your chest or perform a lung function test. During the treatment: Your doctor may perform the following examinations: – examination of the oral cavity and the pharynx for changes in the mucous membrane such as inflammation or ulceration – blood tests/ blood count with number of blood cells and measurement of serum methotrexate levels – blood test to monitor liver function – imaging tests to monitor liver condition – small sample of tissue taken from the liver in order to examine it more closely – blood test to monitor kidney function – respiratory tract monitoring and, if necessary, lung function test It is very important that you appear for these scheduled examinations. If the results of any of these tests are conspicuous, your doctor will adjust your treatment accordingly. Elderly patients Elderly patients under treatment with methotrexate should be monitored closely by a physician so that possible side effects can be detected as early as possible. Age-related impairment of liver and kidney function as well as low body reserves of the vitamin folic acid in old age require a relatively low dosage of methotrexate. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Methotrexate Tablets if you have any of the following conditions. This will help them decide if Methotrexate Tablets are suitable for you: • have any mild or moderate kidney disease. • have a stomach ulcer or ulcerative colitis (inflammation and ulceration of the gut). • have any blood disorders or anaemia. • have diarrhoea. • have gastro-intestinal (digestive) problems. • have severe mouth ulcers. • have or have ever suffered from mental illness. • received or you are receiving radiotherapy (x-ray treatment) or UV radiation. • have received any vaccinations recently or you are due to have any, as methotrexate can reduce their effect. • have any symptoms or signs of infection. • have excess fluid, between the lungs and chest wall (pleural effusion) or abdominal swelling (ascites) causing breathlessness. • develop a persistent cough or develop shortness of breath as it may be associated with serious lung disease. • special care is also needed in children, the elderly and in those who are in poor physical condition. • have or have ever had liver damage, dependence on alcohol or abnormal liver function tests. • have diabetes and are being treated with insulin. • have an inactive chronic infection, such as herpes zoster, tuberculosis, hepatitis B or C. • methotrexate temporarily affects sperm and egg production. Methotrexate can cause miscarriage and severe birth defects. You and your partner should avoid having a baby if you are being given methotrexate at the time and for at least 6 months after the end of your treatment with methotrexate. See also section “Pregnancy, breast-feeding and fertility”. Acute bleeding from the lungs in patients with underlying rheumatologic disease has been reported with methotrexate. If you experience symptoms of spitting or coughing up blood you should contact your doctor immediately. If you, your partner or your caregiver notice new onset or worsening of neurological symptoms including general muscle weakness, disturbance of vision, changes in thinking, memory and orientation leading to confusion and personality changes contact your doctor immediately because these may be symptoms of a very rare, serious brain infection called progressive multifocal leukoencephalopathy (PML). Other medicines and Methotrexate Tablets Tell your doctor or pharmacists if you are taking, have recently taken, or might take any other medicines. This includes the following medicines, as the effect of Methotrexate Tablets may be altered when they are taken at the same time: • vaccinations / live virus vaccines • ibuprofen, indomethacin (NSAID’s, non-steroidal anti-inflammatory drugs) which are used for pain or inflammation • aspirin or similar medicines (known as salicylates) • diuretics (water tablets) • medicines used/taken for diabetes • antibiotics (used to treat bacterial infections e.g. chloramphenicol, penicillin, sulfonamides, co-trimoxazole, trimethoprim / sulfamethoxazole, ciprofloxacin and tetracyclines) • thiazides (a group of diuretics used for the treatment of fluid retention e.g. bendroflumethiazide) • hypoglycaemics (used for lowering blood sugar levels e.g. metformin) • p-aminobenzoic acid, acitretin (used to treat psoriasis or skin disorders) • diphenylhydantoins, phenytoin (used to treat epilepsy) • probenicid, sulfinpyrazone (used to treat gout) • acitretin (a medicine used to treat psoriasis) • radiotherapy • vitamin preparations containing folic acid or similar products • nitrous oxide (a gas used in general anaesthesia) • levetiracetam (a medicine used to treat seizures in epilepsy) • loop diuretics (used to treat hypertension and oedema) • sulfasalazine, leflunomide (used to treat arthritis) • cisplatin (used in chemotherapy) • omeprazole, pantoprazole (used to treat indigestion, stomach acid and ulcers) • theophylline (used to treat asthma, bronchitis, emphysema) • mercaptopurine (used to treat acute lymphocytic leukaemia) • cyclosporine (used in organ transplantation). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Methotrexate Tablets with food, drink and alcohol Alcohol should be avoided while receiving methotrexate as it increases the risk of liver damage. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Do not take Methotrexate Tablets during pregnancy except if your doctor has prescribed it for oncology treatment. Methotrexate can cause birth defects, harm the unborn child or cause miscarriage. It is associated with malformations of the skull, face, heart and blood vessels, brain and limbs. It is therefore very important that methotrexate is not given to pregnant women or to women who are planning to become pregnant unless used for oncology treatment. For non-oncological indications, in women of child-bearing age the possibility of a pregnancy must be ruled out, e.g. by pregnancy tests, before treatment is started. Do not take Methotrexate Tablets if you are trying to become pregnant. You must avoid becoming pregnant during treatment with methotrexate and for at least 6 months after the end of treatment. Therefore, you must ensure that you are taking effective contraception for the whole of this period (see also section “Warnings and precautions”). If you become pregnant during treatment or suspect you might be pregnant, speak to your doctor as soon as possible. If you do become pregnant during treatment, you should be offered advice regarding the risk of harmful effects on the child through treatment. If you want to become pregnant, you should speak with your doctor, who may refer you for specialist advice before the planned start of treatment. Methotrexate can cause birth defects, harm unborn babies or cause miscarriages and so it is very important that it is not given to pregnant patients or patients planning to become pregnant. It may also affect women’s periods; they may become less frequent or stop completely. Methotrexate can affect sperm and egg production with the potential to cause birth defects. You and your partner should avoid conception (becoming pregnant or fathering children) for at least six months after your treatment with methotrexate has stopped. As methotrexate may cause genetic mutations, all women who wish to become pregnant are advised to consult a genetic counselling centre, if possible already prior to therapy, and men should seek advice about the possibility of sperm preservation before starting therapy. Male fertility The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes methotrexate less than 30 mg/week. However, a risk cannot be completely excluded and there is no information regarding higher methotrexate doses. Methotrexate can have a genotoxic effect. This means that the medicine can cause genetic mutations. Methotrexate can affect the production of sperm, which is associated with the possibility of birth defects. You should avoid fathering a child or to donate semen during treatment with methotrexate and for at least 6 months after the end of treatment. As treatment with methotrexate at higher doses commonly used in cancer treatment can cause infertility and genetic mutations, it may be advisable for male patients treated with methotrexate doses higher than 30 mg/week to consider sperm preservation before the beginning of treatment (see also section “Warnings and precautions”). Breast-feeding Methotrexate passes into breast milk. You should not take Methotrexate Tablets if you are breastfeeding. Driving and using machines Methotrexate Tablets may cause some side effects which could affect your ability to drive or use machinery for example drowsiness, loss of co-ordination or blurred vision. If you experience these symptoms, do not drive or use any tools or machinery. The full list of side effects are listed in section 4. Methotrexate Tablets contain lactose and sodium If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free