- methotrexate sodium
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 12762/0231.
Methotrexate 2.5mg Tablets
Package leaflet: Information for the patient
Methotrexate 2.5 mg Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Methotrexate 2.5 mg Tablets are and what they are used for
2. What you need to know before you take Methotrexate 2.5 mg Tablets
3. How to take Methotrexate 2.5 mg Tablets
4. Possible side effects
5. How to store Methotrexate 2.5 mg Tablets
6. Contents of the pack and other information
1. WHAT METHOTREXATE 2.5 MG TABLETS ARE AND WHAT THEY ARE USED FOR
Methotrexate 2.5 mg Tablets are one of a group of medicines called antimetabolites which affect cell growth, including the growth of cancer cells.
Methotrexate can be used to treat severe cases of psoriasis (a skin disease) and rheumatoid arthritis (a disease of the joints). It is usually used for patients who have tried other treatments but their illness has not improved. It helps patients with psoriasis by killing the cells in the skin which are growing too quickly. It is these fast growing cells which cause the raised patches of skin in psoriasis.
In the treatment of rheumatoid arthritis, methotrexate is thought to stop or reduce inflammation in the joints by altering the body's defence mechanism in the immune system.
Methotrexate can also be used to treat several kinds of cancer, in particular:
Methotrexate can be given alone or in combination with other medicines. It is usually used in much higher doses when it is used to treat cancer and it will often be given as an injection rather than tablets.
You should consult your doctor if you are unsure why you have been given Methotrexate 2.5 mg Tablets.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHOTREXATE 2.5 MG TABLETS
Do not take Methotrexate 2.5 mg Tablets
Even though some of the above may be obvious, it is important that your doctor is aware if any of them apply to you.
Warnings and precautions
Important warning about the dose of Methotrexate 2.5 mg Tablets (methotrexate):
Take Methotrexate 2.5 mg Tablets only once a week for the treatment of rheumatic or skin diseases (RA, JIA and psoriasis or psoriatic arthritis).
Taking too much of Methotrexate 2.5 mg Tablets (methotrexate) may be fatal.
Please read section 3 of this leaflet very carefully.
If you have any questions, please talk to your doctor or pharmacist before you take this medicine.
Talk to your doctor, pharmacist or nurse before taking Methotrexate 2.5 mg Tablets if you:
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”.
Whilst being treated with this medicine your doctor will want to monitor your progress on a weekly basis until your therapy is stable. Thereafter, you will be monitored every 2 to 3 months, whilst taking the medicine. These checks may include taking blood and urine samples to check your blood cells and to make sure that your liver and kidneys are working properly. It is important that you do not miss any blood tests.
There may also be a chest x-ray and a physical examination to check for swelling of your lymph nodes (glands in your neck, armpits and groin). Any unusual swellings should also be reported to your doctor.
Other medicines and Methotrexate 2.5 mg Tablets:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. The effects of these medicines may change, especially if you are taking:
Methotrexate 2.5 mg Tablets with food and drink
You should not drink alcohol whilst you are taking this medicine.
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.
Do not use Methotrexate 2.5 mg 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 use Methotrexate 2.5 mg 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 2.5 mg Tablets should not be used during breast-feeding. Methotrexate passes into breast milk. Breast-feeding should be stopped prior to and during treatment with Methotrexate 2.5 mg Tablets.
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").
It may also affect women’s periods; they may become less frequent or stop completely.
Driving and using machines
Methotrexate 2.5 mg Tablets may make you feel drowsy, dizzy or may give you blurred vision. You should not drive or use machines when you first start to take this medicine until you are certain that you are not getting these side effects. If in any doubt, speak to your doctor before you drive or use machines.
Methotrexate 2.5 mg Tablets contains lactose and sodium
These tablets contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
3. HOW TO TAKE METHOTREXATE 2.5 MG TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Do not take more tablets than your doctor has told you to. It will not make you better any faster and it may harm you.
Dosage for treatment of cancer:
Adults, the Elderly and Children
Your doctor will want to monitor your progress, usually every 2-3 months, whilst you are receiving Methotrexate 2.5 mg Tablets.
Before, during and after your treatment you may have tests, such as a chest X-ray, physical examination and blood tests to check that your liver and kidneys are working properly.
The recommended dose for Pregnancy related tumours is 0.25-1 mg /kg up to a maximum of 60 mg every 48 hours for four doses with Calcium Leucovorin rescue. Your doctor will tell you to repeat this treatment at seven-day intervals. Not less than four courses of treatment are usually necessary.
Lymphoma: The recommended dose is 3-30 mg/kg of methotrexate given by injection along with Calcium Leucovorin with the higher doses. It may also be given alongside other medicines as part of chemotherapy.
Burkitt’s lymphoma: The recommended dose is 15 mg/m2 daily orally for five days. It may also be given alongside other medicines as part of chemotherapy.
The recommended dose is 10-60 mg/m2 of methotrexate are usually given by injection by your doctor or nurse alongside other medicines as part of chemotherapy.
The recommended dose is 20-300 mg/kg (approximately 600-9,000 mg/m2) of methotrexate with Calcium Leucovorin rescue are used in the treatment of bone cancer. It may also be given alongside other medicines as part of chemotherapy.
The recommended dose is 20-100 mg/m2 of methotrexate have been included in cyclical combination regimes for the treatment of advanced tumours.
Head and neck cancer
The recommended dose is 240-1,080 mg/m2 methotrexate with calcium Leucovorin are used in the treatment of head and neck cancers.
The recommended dose is up to 100 mg are usually given by injection by your doctor or nurse.
Use in children
The recommended dose is methotrexate 15 mg/m2, parenterally or orally once weekly, in combination with other drugs appears to be the treatment of choice for maintenance of drug-induced remissions.
The recommended dose is up to 15 mg, intrathecally, at weekly intervals, until the CSF appears normal (usually two to three weeks), have been found useful for the treatment of meningeal leukaemia.
Dose in psoriasis:
Take Methotrexate 2.5 mg Tablet only once a week.
USUAL DOSE: between 10 and 25 mg by mouth (4 to 10 tablets) taken once a week on the same day each week. This should be adjusted according to your response to treatment and side effects.
Elderly: No dosage adjustment required.
Children: Not recommended for use in children.
Dose in rheumatoid arthritis:
Take Methotrexate 2.5 mg Tablet only once a week.
USUAL DOSE: between 7.5 and 20 mg (3 to 8 tablets) taken once a week on the same day each week.
These doses may alter as your condition changes.
Do not miss your appointments as these are necessary to ensure that Methotrexate 2.5 mg Tablets are used safely.
Your doctor may give you additional medication to help make sure that methotrexate does not collect in the kidneys.
Blood monitoring should be done for all patients treated with methotrexate. Close monitoring of the blood levels should be done including the complete blood counts, urine tests and in some cases blood methotrexate monitoring along with liver and kidney function tests to detect any problems.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
If you take more Methotrexate 2.5 mg Tablets than you should
If you have taken an overdose of methotrexate or more tablets than the doctor has told you to, you should get medical help immediately either by calling your doctor or by going to the nearest hospital casualty department. Always take the labelled medicine container with you, whether there are any Methotrexate 2.5 mg Tablets left or not.
Inappropriate intake resulting in overdose can sometimes lead to death.
If you forget to take Methotrexate 2.5 mg Tablets
If you forget to take a dose, take it as soon as you remember if this is within two days. However, if you have missed a dose by more than two days, please contact your doctor for advice. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms can be serious.
All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body), spitting or coughing blood* should be reported to a doctor immediately.
*(has been reported for methotrexate used in patients with underlying rheumatologic disease).
Most of the effects listed below will only be seen in patients who are receiving high doses of methotrexate to treat cancer. They are not seen as often and are not as severe at the doses used in the treatment of psoriasis or rheumatoid arthritis.
If you notice any of the following side effects stop taking the medicine and talk to your doctor as soon as possible.
Tell your doctor straight away if you notice any of the following side effects:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
*(has been reported for methotrexate used in patients with underlying rheumatologic disease).
In a small number of patients methotrexate may cause serious side effects and on rare occasions, death. You should contact your doctor immediately if you notice any serious side effects. Certain other unwanted effects can only be detected by your doctor, these include blood disorders, and changes in liver and kidney function or bone density.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE METHOTREXATE 2.5 MG TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original container in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Methotrexate 2.5 mg Tablets contain
What Methotrexate 2.5 mg Tablets look like and contents of the pack
Methotrexate 2.5 mg Tablets are round, biconvex, yellow tablets, engraved with "2.5" on one side. Scored in half on the other side and engraved with "M" above the score line and "1" below it. They are supplied in bottles containing 28 or 100 tablets or blister packs containing 24, 28 or 30 Tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder:
This leaflet was last revised in June 2018.
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