Methotrexate Tablets
Methotrexate 10 mg Tablets
1. WHAT METHOTREXATE IS AND WHAT IT IS USED FOR
Methotrexate is an anti-metabolite medicine (medicine which affects how the body’s cells grow) and immunosuppressant (medicine which reduces the activity of the immune system).
Methotrexate is used in large doses (on its own or in combination with other medicines) to treat certain types of cancer such as leukaemia. In smaller doses it can be used to treat severe psoriasis (a skin disease with thickened patches of inflamed red skin, often covered by silvery scales) when other treatments are not effective.
2. BEFORE YOU USE METHOTREXATE TABLETS
Your doctor may perform several tests such as blood tests, x-rays and physical examinations before treatment with Methotrexate tablets is started, and at regular intervals during treatment.
Do not take Methotrexate Tablets
• if you have shown signs of hypersensitivity (severe allergy) to methotrexate, or any of the other ingredients in the past
• if you have significant kidney or liver problems
• if you have been told you have (or think you have) a blood disorder such as low levels of white blood cells, red blood cells (anaemia) or platelets
• if you are pregnant or breast feeding
Tell your doctor if any of the above applies to you before this medicine is used. Take special care with Methotrexate Tablets
• if you have a stomach ulcer or ulcerative colitis (inflammation and ulceration of the gut)
• if you have an infection
• if you have mild kidney problems
• if you have a medical condition which causes a build up of fluid in the lining of your lungs or in your abdomen (the fluid will need to be drained before methotrexate treatment is started)
• if you are to have radiotherapy (risk of tissue and bone damage may be increased)
• if you are to have any vaccinations
Tell your doctor if any of the above applies to you before this medicine is used.
Special care is also needed in children, the elderly and in those who are in poor physical condition.
Taking/using other medicines
Special care is needed if you are taking/using other medicines as some could interact with methotrexate, for example:
• non-steroidal anti-inflammatory medicines e.g. ibuprofen (medicines taken for pain relief)
• aspirin or similar medicines (known as salicylates)
• medicines taken to help control rheumatism e.g. leflunomide, azathioprine and sulphasalazine
• omeprazole (medicine used to stop the production of stomach acid)
• diuretics (water tablets)
• medicines used/taken for diabetes (including insulin and tablets)
• antibiotics such as penicillins, sulphonamides, co-trimoxazole, trimethoprim, tetracycline, chloramphenicol and para-aminobenzoic acid
• phenytoin (medicine often used to treat epilepsy)
• vitamin supplements containing folic acid
• probenecid (medicine used to treat gout)
• nitrous oxide (used for general anaesthesia and pain relief)
• retinoids, such as acitretin (a medicine used to treat psoriasis) or isotretinoin (used to treat severe acne)
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Methotrexate Tablets and drinking alcohol
Alcohol increases the risk of liver damage with methotrexate and it should be avoided during the full period of treatment.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding before this medicine is used.
This medicine must not be used during pregnancy other than in the most exceptional circumstances in the treatment of cancer; where the potential benefit to the mother is considered to be greater than the risk to the unborn baby.
Mothers must not breast-feed whilst treatment with methotrexate in ongoing.
Due to the risk of birth defects, both men and women must avoid conception during methotrexate treatment and for at least 6 months after treatment is stopped.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines if you experience any side effect (e.g. dizziness, drowsiness or blurred vision) which may lessen your ability to do so.
Important information about one of the ingredients of Methotrexate Tablets
These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO USE METHOTREXATE TABLETS
Always take these tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The tablets should be swallowed whole with a drink of water whilst sitting upright or standing.
Dose
Psoriasis:
The dose is usually between 10 to 25 mg per week.
Cancer chemotherapy:
The dose will be calculated by your doctor and will depend on the type of cancer being treated and your size. The tablets are normally taken daily for a number of days followed by a rest period, after which treatment is started again.
Before treatment is started your doctor may carry out blood tests to check the levels of cells in your blood, and also to check how well your kidneys and liver are working. You may also have a chest X-ray. Further tests may also be done during and after treatment. Do not miss appointments for blood tests.
If you take more Methotrexate Tablets than you should
See your doctor or go to a hospital Accident and Emergency (Casualty) Department at once. Take your medicine container and show it to the doctor or nurse who treats you.
If you forget to take Methotrexate Tablets
Do not take a double dose to make up for forgotten tablets. Ask your doctor for advice.
4. POSSIBLE SIDE EFFECTS
Like all medicines, methotrexate can cause side effects, although not everybody gets them. However, Methotrexate is a very toxic medicine and some patients have died, or become very ill whilst being treated with it. During treatment you should watch for any side effects and report them to your doctor.
If any of the following happen, tell your doctor immediately:
• severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint
• inflammation of the lung with breathlessness – you may develop a persistent cough, experience pain or difficulty breathing, or become breathless
• symptoms of an infection e.g. fever, chills, achiness, sore throat
• unexpected bleeding e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
• black tarry stools
• a sore mouth, particularly if you have a number of ulcers or blisters inside of the mouth or on the tongue
• skin rashes or blistering to the surfaces of the eyes, nose, vagina or anus (back passage)
• inflammation of the vagina
• diarrhoea
These are serious side effects. You may need urgent medical attention.
If any of the following happen, tell your doctor as soon as possible:
• fits
• blurred vision
• dizziness
• difficulty with speech
• muscle weakness
• diabetes (you may feel the need to drink more than usual)
• abnormally easily broken bones (osteoporosis)
• vasculitis (pain or redness of the blood vessels)
• itching or the appearance of lightened patches on the skin, bruises, boils and increased sensitivity to sunlight
• jaundice (yellowing of the skin)
• pain in the stomach, loins or abdomen
• cystitis (you may need to pass urine more often than usual, which may be painful)
• eye irritation
• headaches
• drowsiness
• reduced appetite, feeling or being sick
• irregular periods in women (periods may stop completely)
• loss of libido/impotence
• hair loss
Methotrexate may lead to problems with your blood, liver and kidneys. Your doctor will take blood samples to check for these problems and may ask you to have a small sample of your liver taken for testing (liver biopsy).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Effects on fertility
Treatment with methotrexate may reduce fertility in men and women. Fertility is thought to go back to normal after methotrexate treatment is stopped. Tell your doctor if you have concerns.
5. HOW TO STORE METHOTREXATE TABLETS
Keep out of the reach and sight of children
Expiry
This medicine must not be used after the expiry date which is stated on the label and carton after ‘EXP‘. Where only a month and year is stated, the expiry date refers to the last day of that month.
Storage
There are no specific storage requirements.
Disposal
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
- What Methotrexate Tablets contain
The active substance is methotrexate. Each tablet contains 10 milligrams (mg) of methotrexate.
The other ingredients are maize starch, lactose, pre-gelatinized starch, polysorbate 80, microcrystalline cellulose and magnesium stearate.
- What Methotrexate Tablets look like and contents of the pack
Methotrexate 10 mg Tablets are yellow and shaped like a capsule. They are marked ‘M10′ on one side with a break-line on the other.
Methotrexate 10 mg Tablets are supplied in plastic bottles containing 100 tablets.
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