What is a Patient Information Leaflet and why is it useful?

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

methotrexate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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:

  • acute leukaemias
  • Non-Hodgkin’s lymphoma
  • soft tissue and bone sarcomas
  • solid tumours like breast, lung, head and neck, bladder, cervical, ovarian and testicular cancer.

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

  • if you know that you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6)
  • if you are pregnant, breast-feeding (see section : Pregnancy, breast-feeding and fertility)
  • if you suffer from a problem of excessive drinking (alcoholism)
  • if you have severe liver problems, including fibrosis, alcoholic liver disease and recent or active hepatitis (inflammation of the liver)
  • if you have severe kidney problems, including conditions requiring kidney dialysis
  • if you have any serious blood disorders including severe anaemia or abnormal numbers of blood cells such as low white cells (leucopenia) or low small blood cell numbers (platelets) causing (thrombocytopenia)
  • if you have a medical condition or are receiving medication which lowers your resistance to infection
  • if you are taking antibiotics which prevent the production of folic acid (vitamin B9) such as cotrimoxazole, which are used to treat bacterial infections
  • if you have symptoms which may suggest an active infectious disease (e.g. fever, chills, achiness).

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:

  • have any mild or moderate liver or kidney problems or blood disorders including anaemia
  • have gastro-intestinal (digestive) problems like stomach ulcers or suffer from inflammation and ulceration of the gut
  • have or have ever suffered from mental illness
  • have severe mouth ulcers
  • have diarrhea
  • have any symptoms or signs of infection
  • have excess fluid between the lungs and chest wall (pleural effusion) causing breathlessness or in the abdomen causing swelling of the stomach (ascites). These may affect the levels of methotrexate in your blood
  • are receiving or intend to receive any vaccine, as methotrexate can reduce their effect
  • have diabetes mellitus
  • are an elderly patient or a very young child
  • develop a persistent cough or develop shortness of breath as it may be associated with serious lung disease
  • have received or you are receiving radiotherapy or ultraviolet (UV) radiation concurrently
  • 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.

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”.

Regular check–ups

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:

  • NSAIDs (non-steroidal anti-inflammatory drugs) e.g. ibuprofen, indomethacin, azopropazone or aspirin (for relief of pain or inflammation) including any preparations of these bought without a prescription. Taking these products together with Methotrexate 2.5 mg Tablets can increase its toxic effects
  • diuretics (e.g. loop diuretics like furosemide, hydrochlorothiazide or triamterene – water pills)
  • phenytoin, carbamazepine and valproate (for seizures)
  • antibiotics (used to treat bacterial infections) including penicillin, sulphonamides, trimethoprim/sulfamethoxazole (as cotrimoxazole), neomycin, ciprofloxacin, doxycycline, tetracyclines, chloramphenicol
  • nitrous oxide-based (a gas used in general anaesthesia)
  • vaccinations
  • oral hypoglycaemics (used for lowering blood sugar levels) like metformin
  • olanzapine used for the treatment of schizophrenia
  • pyrimethamine (medication against malaria)
  • digoxin (used to treat heart failure)
  • corticosteroids used for the treatment of arthritis, allergic reactions or skin diseases
  • cytostatics (medication against cancer), e.g. cisplatin
  • retinoids, e.g. acitretin (for psoriasis or skin disorders)
  • immunosuppressant drugs such as leflunomide (used for suppression of inflammatory conditions) or ciclosporin
  • probenecid, sulfinpyrazone(for gout)
  • omeprazole, pantoprazole (for stomach ulcers, heartburn, reflux)
  • theophylline (for asthma)
  • vitamin preparations containing folic acid or similar products
  • p-aminobenzoic acid used to treat skin disorders.

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.

Pregnancy:

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.

Breast-feeding

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.

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").

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.

Pregnancy-related tumours

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.

Breast cancer

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.

Bone cancer

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.

Lung cancer

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.

Bladder cancer

The recommended dose is up to 100 mg are usually given by injection by your doctor or nurse.

Use in children

Leukaemia

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.

Meningeal leukaemia

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.

Adults

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.

  • Methotrexate can make you more likely to catch infections. If you think you have an infection, a sore throat, mouth ulcers, fever, chills, or achiness during treatment you should tell your doctor immediately
  • Methotrexate can cause inflammation of the lung with breathlessness, symptoms of which include persistent cough, experience of pain or difficulty in breathing or becoming breathless, especially during periods of exercise
  • serious illness with blistering of the skin, mouth, eyes and genitals. These may be signs of a condition known as Stevens Johnson Syndrome or Toxic Epidermal necrolysis
  • skin rash and fever with swollen glands, particularly in the first two months of treatment, as these may be signs of a hypersensitivity reaction
  • loss of coordination, loss of ability to speak or understand speech, weakness and inability to move one side of the body or the whole body, convulsions or fits
  • a discolouration or yellowing of the skin and whites of the eyes (jaundice) that could indicate liver damage
  • swelling of the hands, ankles or feet (which may be a sign of kidney damage or failure)
  • a serious infection affecting the whole body (sepsis) characterized by fever, chills, rapid breathing, abnormally low number of neutrophils (white blood cells) and low blood pressure, resulting in death
  • miscarriage, fetal damages.

Tell your doctor straight away if you notice any of the following side effects:

Common: may affect up to 1 in 10 people

  • headache, dizziness, fatigue
  • swelling of the mouth
  • anorexia (eating disorder)
  • feeling sick (nausea) or vomiting
  • loose stools
  • raised liver enzymes
  • a skin rash with reddening of the skin
  • hair loss
  • decreased white blood cell count.

Uncommon: may affect up to 1 in 100 people

  • a lump in your neck, groin or armpits with associated backache, weight loss or night sweats
  • decrease in the number of blood cells
  • reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
  • reduction in blood platelets, which increases risk of bleeding or bruising
  • nose bleed
  • itching
  • blistering and peeling of the top layer of the skin all over the body
  • vaginal ulcers.

Rare: may affect up to 1 in 1,000 people

  • raised blood sugar levels (diabetes mellitus)
  • herpes zoster (shingles) which is a viral disease characterized by a painful skin rash with blisters
  • depression
  • confusion
  • inability to move one half of the body
  • fall in blood pressure
  • tenderness and swelling of the lower extremities (clot in the veins)
  • difficulty in breathing
  • lung disease
  • throat infection
  • swelling of the gums
  • liver damage
  • stomach or intestinal ulcers, bleeding or inflammation of the intestine
  • symptoms of abdominal pain, cramping, diarrhoea, dehydration, fever, nausea, vomiting and weight loss. These could be signs of a condition known as enteritis (inflammation of the intestine)
  • sensitivity to light
  • acne
  • appearance of lightened patches on the skin
  • hives
  • skin ulcers and painful erosions of inflamed areas, in psoriasis patients
  • muscle pain, joint pain
  • weakening or softening of bones
  • an increase in rheumatic nodules
  • loss of interest in, or inability to have sex
  • menstrual disorders
  • impotence.

Very rare: may affect up to 1 in 10,000 people

  • immune disorder
  • fatigue
  • irritation
  • difficulty with speech
  • blurred vision
  • eye infection
  • chest pain or tightness of chest, with difficulty in breathing
  • lung infection
  • vomiting blood
  • small bruises on the skin caused by blood leaking from broken blood vessels
  • boils
  • vasculitis (pain or redness of the blood vessels)
  • dilatation of small blood vessels causing focal red lesions
  • low sperm count
  • abnormally high levels of nitrogen-containing compounds in the blood
  • pain or difficulty in passing urine
  • blood in urine
  • elevation of urea and/or creatinine in the blood
  • infertility
  • enlargement of breasts in men
  • vaginal bleeding
  • dry cough
  • lymphoproliferative disorders (excessive growth of white blood cells).

Not known: frequency cannot be estimated from the available data

  • severe reduction in blood cells which can cause weakness, bruising or make infections more likely
  • high amount of white blood cell
  • mood alteration
  • loss of intellectual functions such as thinking, reasoning
  • drowsiness
  • general feeling of illness
  • other metabolic changes
  • fits (seizures)
  • deficiency of blood supply to the heart muscle
  • fluid in lung
  • syndrome consisting of pleuritic pain and pleural thickening has been reported following high doses
  • pain and inflammation of the body's mucous membrane
  • inflammation of vagina
  • increased risk of toxic reaction
  • bone damage in the jaw (secondary to excessive growth of white blood cells)
  • bleeding from the lungs*.

*(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

  • The active substance is methotrexate. Each tablet contains methotrexate sodium equivalent to 2.5 mg methotrexate
  • The other ingredients are lactose monohydrate, sodium hydroxide, magnesium stearate and starch, pregelatinised.

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:

Mercury Pharmaceuticals Ltd.
Capital House
85 King William Street
London
EC4N 7BL
UK

Manufacturer:

Haupt Pharma Wolfratshausen GmbH
Pfaffenrieder Strasse
5 82515 Wolfratshausen
Germany

This leaflet was last revised in June 2018.

LF-115268-01

723605 UK8