Hospira

PACKAGE LEAFLET: INFORMATION FOR THE USER

Methotrexate 10 mg Tablets

What is in this leaflet:

1.    What Methotrexate is and what it is used for

2.    What you need to know before you take Methotrexate Tablets

3.    How to take Methotrexate Tablets

4.    Possible side effects

5.    How to store Methotrexate Tablets

6.    Contents of the pack and other information

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 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, severe arthritis due to psoriasis, and rheumatoid arthritis.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 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 are allergic to methotrexate, or any of the other ingredients of this medicine (listed in section 6)

•    if you have significant kidney or liver problems

•    if you consume excessive amounts of alcohol

•    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

•    if you have any infection

•    if your immune system is not working as well as it should

Tell your doctor if any of the above applies to you before this medicine is used. Warnings and precautions

Talk to your doctor before taking 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

Special care is also needed in children, the elderly and in those who are in poor physical condition.

Other medicines and methotrexate

Tell your doctor if you are taking/using, have recently taken/used or might take/use any other medicines, 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, esomeprazole and pantoprazole (medicines used to reduce 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)

•    live virus vaccines

•    mercaptopurine (medicine used in the treatment of blood cells cancer)

•    theophylline (medicine used in the treatment of asthma)

Methotrexate Tablets with alcohol

Alcohol increases the risk of liver damage with methotrexate and it should be avoided during the full period of treatment.

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 for advice before taking this medicine.

This medicine must not be used during pregnancy.

Mothers must not breast-feed whilst treatment with methotrexate is 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.

Methotrexate Tablets contain lactose

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 TAKE METHOTREXATE TABLETS

Always take these tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed whole with a drink of water whilst sitting upright or standing.

Recommended Dose

Rheumatoid arthritis:

Take methotrexate tablets once a week. The dose usually starts at 7.5 to 15 mg per week but may rise to 20 mg per week. The dose may be given all at once, or it can be split into 3 doses as 12 hourly intervals over 24 hours.

Psoriasis:

Take methotrexate tablets once a week. The dose is usually between 5 to 25 mg per week. The dose may be given all at once, or it can be split into 3 doses at 12 hourly intervals over 24 hours.

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.

Use in children

This medicine can be used to treat children with severe psoriasis, but should not be used in those under 3 years of age.

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, this medicine 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, abdominal pain, fatty stools, vomiting

•    chest pain (which may be due to heart or lung problems)

These are serious side effects. You may need urgent medical attention.

If any of the following happen, tell your doctor as soon as possible:

•    low blood pressure (you may feel faint)

•    fits

•    blurred vision or eye infection (conjunctivitis)

•    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

•    unusual sensations in the head

•    drowsiness

•    reduced appetite, feeling or being sick

•    irregular periods in women (periods may stop completely)

•    loss of libido/impotence

•    hair loss

•    effects on learning and memory

•    ringing in the ears

•    joint and muscle pain

•    blood clot which causes pain, swelling or redness (cerebral, deep vein, retinal vein or arterial vein)

•    mood alterations

•    inflammation of the lungs, which causes breathlessness, cough and raised temperature, pneumonia

•    shingles (Herpes Zoster)

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.

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:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

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.

Expiry

Do not use this medicine 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

This medicine does not require any special storage conditions.

Disposal

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER 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. Marketing authorisation holder and manufacturer

Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK This leaflet was last revised in 02/2016.