Patient leaflet - Methotrexate 10 mg tablets
1. What Methotrexate Tablets are and what they are 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,
- severe psoriasis, especially plaque-type,
- psoriatic arthritis in adult patients who have tried other treatments but their illness has not improved.
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 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 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 if you are a woman. If you are a man you should avoid fathering a child if you are being given methotrexate at the time and for at least 3 months after the end of your treatment. 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).
Methotrexate may make your skin more sensitive to sunlight. Avoid intense sun and do not use sun-beds or sun-lamp without medical advice. To protect your skin from intense sun, wear adequate clothing or use a sunscreen with a high protection factor.
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).
- Metamizole (synonyms novaminsulfon and dipyrone) (medicine against sever pain and/ or fever)
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 3 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 breast-feeding.
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’.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Methotrexate
10 mg Tablets
I t e m
3. How to take Methotrexate Tablets
Important warning about the dose of Methotrexate Tablets:
Take Methotrexate Tablets only once a week for the treatment of rheumatoid arthritis and psoriasis. Taking too much of Methotrexate Tablets 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.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Alcohol should be avoided while receiving methotrexate. The usual dose is:
The recommended dose is:
Dose in rheumatoid arthritis and psoriasis:
Take Methotrexate Tablets only once a week.
Patients with rheumatoid arthritis or psoriasis will usually take their tablets orally once a week on the same day each week.
- Do not take tablets more often than your doctor has told you to.
- Daily administration can lead to serious toxic effects.
- Take the tablets with a glass of water whilst sitting upright or standing.
- The tablet break line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Dosage for rheumatoid arthritis, psoriasis and psoriatic arthritis:
Adults: The usual dose is 7.5 to 15 mg by mouth, once weekly. This should be adjusted according to your response to treatment and side effects.
Elderly: The doctor may adjust your dose depending on how well your kidneys and liver work.
Children: Not recommended for use in children.
Methotrexate tablets of a lower strength are available and your doctor may prescribe these together with 10 mg tablet to ensure you get the correct dose
If you take more Methotrexate Tablets than you should
This medicine is usually taken once a week. If you take more of the medicine than you should, contact a physician or nearest hospital casualty department immediately. Take your medicine package with you if you go to a doctor or hospital.
An overdose of methotrexate can lead to severe toxic reactions. Overdose symptoms may include easy bruising or bleeding, unusual weakness, mouth sores, nausea, vomiting, black or bloody stools, coughing up blood or vomit that looks like coffee grounds, and decreased urinating. See also section 4.
Take your medicine package with you if you go to a doctor or hospital.
If you forget to take Methotrexate Tablets
Take the forgotten dose 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 a forgotten dose.
Make sure before a holiday or trip, you have enough of your medicine. If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you stop taking Methotrexate Tablets
Do not stop taking the tablets unless your doctor tells you to. If you have any further questions on how to take this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Methotrexate Tablets can cause side effects, although not everybody gets them. In general, the incidence and severity of adverse reactions of methotrexate are related to dose and frequency of administration. Most adverse reactions are reversible if detected early.
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, please contact your doctor immediately:
- unusual bleeding (including vomiting blood) or bruising
- severe diarrhoea
- ulcers in mouth
- black or tarry stools
- blood in the urine or stools
- tiny red spots on the skin
- an allergic reaction such as skin rash or swelling of your lips or tongue • yellowing of the skin (jaundice)
- pain or difficulty in passing urine
- thirst and/or frequent urination
- spitting or coughing blood
- fits (convulsions)
- loss of consciousness
- blurred or decreased vision.
The following side effects have also been reported:
Common (may affect up to 1 in 10 people):
- decreased resistance to infections
- leukocytopaenia (decreased number of white blood cells)*
- nausea, vomiting
- diarrhoea
- unusual fatigue, headache
- dizziness
- loss of appetite
- a red rash
- hair loss
- stomatitis (soreness of the mouth and lips)
- increase of liver enzymes*
Uncommon (may affect up to 1 in 100 people):
- reduction in bone marrow activity manifested by thrombocytopenia (reduction in blood platelets, which increases risk of bleeding or bruising) and other abnormalities developing in the blood*
- anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)
- nosebleed
- serious allergic reaction which causes difficulty in breathing or dizziness • severe illnesses of the lungs
- severe skin rashes, itching
- kidney dysfunction
- vaginal ulceration
- Sunburn-like reactions due to increased sensitivity of the skin to sunlight
* Only detected by your doctor.
Rare (may affect up to 1 in 1000 people):
- depression
- confusion
- muscle weakness on one side of the body
diabetes mellitus
- low blood pressure
- thromboembolia (blockages by clots in the blood)
- shortness of breath
- inflammation of gums pharynx or small intestine
- gastrointestinal ulceration and bleeding
- liver damage (hepatic toxicity, periportal fibrosis, hepatic cirrhosis, acute hepatitis)
- skin reactions (acne, skin depigmentation, urticaria (very itchy rash consisting of a number of raised pale bumpy weals surrounded by red skin))
- erythaema multiforme (itchy, pink-red blotches, symmetrically arranged and starting on the extremities)
- burning in skin psoriatic lesions, skin ulcers, appearance of skin nodules • herpes zoster (a painful skin rash with blisters)
- sepsis (bacteria, fungi or bacterial toxins enter the blood and affect body systems) • weakening or softening of bones
- pain in joints or muscles
- irregular periods in women (periods may stop completely), loss of interest in, or ability to have sex
Very rare (may affect up to 1 in 10,000 people):
- lymphoproliferative disorders (excessive growth of white blood cells) • sensation of numbness or tingling / having less sensitivity to stimulation than normal Frequency not known (cannot be estimated from the available data):
- inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness of breath, breathlessness at rest, chest pain, or fever)
- bone damage in the jaw (secondary to excessive growth of white blood cells) • redness and shedding of skin
- swelling
Your doctor will do tests to check for abnormalities developing in the blood (e.g. low white blood cells, low red cells, low platelets, lymphoma) and changes in the kidneys and the liver.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Tablets
Keep this medicine out of the sight and reach of children. Accidental ingestion can be lethal for children.
This medicinal product does not require any special temperature storage conditions. Keep the blister in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.
Anyone handling methotrexate should wash their hands after administering a dose. To decrease the risk of exposure, parents and care givers should wear disposable gloves when handling methotrexate.
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 Tablets contain
Each tablet contains 10 mg of the active ingredient methotrexate.
The other ingredients are dibasic calcium phosphate (anhydrous), lactose monohydrate, sodium starch glycolate, cellulose microcrystalline, purified talc and magnesium stearate.
What Methotrexate Tablets looks like and contents of the pack
Methotrexate Tablets are yellow coloured, capsule shaped, bi-convex tablets with central break line on one side and plain on other side.
Methotrexate 10 mg Tablets are available in blister packs of 7, 10, 14, 16, 20, 24, 28, 30, 56, 60, 84, 90, 100 and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd.
Unit C, Harcourt Way
Leicester LE19 1WP
United Kingdom
Manufacturer
Morningside Pharmaceuticals Ltd.
5 Pavilion Way, Loughborough, LE11 5GW
United Kingdom
Morningside Pharmaceuticals Ltd. & Aspire Pharma Ltd.
Second Floor, Boss Court, 7 Barton Close, Grove Park,
Leicester, LE19 1SJ, United Kingdom
Aspire Pharma Ltd.
Unit 4, Rotherbrook Court,
Bedford Road, Petersfield,
GU32 3QG, United Kingdom.
This leaflet was last revised in March 2025.
MPL12067 - P1.1
Size: 100 tablets
PL/PA no: PL 20117/0172
Type: Leaflet
Reason for request: Type IAin bulk submission
Version no: 1.1
Date of revision: 31.03.25