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Methotrexate 10 Mg Tablets

Document: leaflet MAH GENERIC_PL 20117-0172 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Methotrexate 10mg 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 further questions, please ask your doctor or pharmacist.

•    This medicine has been prescribed for you. 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 or pharmacist. This includes any possible side effects not listed on this leaflet. See section

4.

In this leaflet:

1.    What Methotrexate Tablets are and what they are 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 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 if any of the following apply to you

•    You have significant liver disease (your doctor decides the severity of your disease).

•    You have significant kidney disease (your doctor decides the severity of your disease).

•    You have or have had a bone marrow disease or serious blood disorders.

•    You are allergic (hypersensitive) to methotrexate or any of the other ingredients of Methotrexate Tablets.

•    You are pregnant or breast-feeding (see also section “Pregnancy and breast-feeding”).

•    You have severe acute or chronic infections or immunodeficiency syndrome.

•    You suffer from alcoholism.

Warnings and precautions

Please tell your doctor or pharmacist if any of the following apply to you:

•    You have diabetes mellitus treated with insulin.

•    You have received any vaccinations recently or are you due to have any

•    You are using any other medicines or vitamin products (Please see section “Taking other medicines”)

•    You have infections

•    You have ulcerations in your stomach or bowel (peptic ulcer or ulcerative colitis)

•    You are in poor general condition

•    You have or have had any liver or kidney disease.

Methotrexate temporarily affects sperm and egg production. You and your partner should avoid conception (becoming pregnant or fathering children) if currently receiving methotrexate and for at least six months after your treatment with methotrexate has stopped. See also section “Pregnancy and breast-feeding”.

Before treatment is started your doctor may carry out blood tests, 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.

Other medicines and Methotrexate Tablets

Other concomitant medication may affect the efficacy and safety of this medicine. Methotrexate may also affect the efficacy and safety of other medications.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal or natural medicinal products. Remember to tell your doctor about your treatment with Methotrexate, if you are prescribed another medicine while the treatment is still ongoing. It is especially important to tell your doctor if you are using:

•    certain antibiotics (such as penicillins, sulphonamides, trimethoprim/sulfamethoxazole, tetracycline, ciprofloxacin and chloramphenicol);

•    agents that may be harmful to kidneys and liver [e.g. sulphasalazine and leflunomide (medicines for rheumatic diseases), vitamin A and its derivatives, alcohol];

•    anticancer agents (e.g. cisplatin, mercaptopurine);

•    phenytoin (medicine often used to treat epilepsy);

•    aspirin or similar medicines (known as salicylates);

•    non-steroidal anti-inflammatory medicines (medicines taken for pain relief) e.g. ibuprofen and pyrazoles;

•    medicines taken to help control rheumatism e.g. azathioprine;

•    omeprazole or pantoprazole (medicine used to stop the production of stomach acid);

•    diuretics, triamterene (water tablets);

•    probenecid (medicine used to treat gout);

•    folic acid (vitamin preparation);

•    theophylline (medicine used to treat respiratory diseases);

•    cyclosporine (an agent that can suppress or prevent the immune response).

Tell your physician about use of Methotrexate during your next visits.

Methotrexate Tablets with food and drink

Alcohol should be avoided during methotrexate therapy.

Pregnancy and breast-feeding

Pregnancy

Do not use Methotrexate during pregnancy or if you are trying to become pregnant. 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. Therefore, in women of child-bearing age any possibility of pregnancy must be excluded with appropriate measures, e.g. a pregnancy test, before starting treatment. You must avoid becoming pregnant whilst taking methotrexate and for at least 6 months after treatment is stopped. Therefore you must ensure reliable contraception during this whole period (see also section “Warnings and precautions”).

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 wish to become pregnant you should consult a genetic information centre before the planned start of treatment, because methotrexate may be genotoxic, which means that the medicine may cause genetic mutation.

Breast-feeding

Do not breastfeed during treatment, because methotrexate passes into breast milk. If your attending doctor considers treatment with methotrexate absolutely necessary during the lactation period, you must stop breastfeeding.

Male fertility

Methotrexate may be genotoxic. This means that the medicine may cause genetic mutation. Methotrexate can affect sperm and egg production with the potential to cause birth defects. Therefore, you must avoid fathering a child whilst taking methotrexate and for at least 6 months after treatment is stopped. Since treatment with methotrexate may lead to infertility, it might be advisable for male patients to look into the possibility of sperm preservation before starting treatment (see also section “Warnings and precautions”).

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

You can feel fatigue and dizziness during methotrexate treatment. Do not drive or use machines if you have such symptoms.

Methotrexate tablets contain lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Methotrexate Tablets

Always take Methotrexate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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.

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Dosage for rheumatoid arthritis, psoriasis and psoriatic arthritis: Adults: The usual dose is 7.5 to 15mg 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 10mg 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

•    fever

•    yellowing of the skin (jaundice)

•    pain or difficulty in passing urine

•    thirst and/or frequent urination

•    chest pain

•    a dry cough and/or pain or difficulty in breathing or shortness of breath

•    fits (convulsions)

•    loss of consciousness

•    blurred or decreased vision.

Common side effects (occurs in more than 1 of 100 patients and less than 1 of 10 patients):

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) and increase of liver enzymes*.

Uncommon side effects (occurs in more than 1 of 1000 patients and less than 1 of 100 patients):

A 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.

•    Only detected by your doctor.

Rare side-effects (occurs in more than 1 of 10,000 patients and less than 1 of 1000 patient):

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)), sensitivity to light, 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.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

UK

The Yellow Card Scheme at: www.mhra.aov.uk/vellowcard or Ireland

HPRA Pharmacovigilance

Earlsfort Terrace , IRL - Dublin 2

Tel: +353 1 6764971, Fax: +353 1 6762517

Website: www.hpra.ie. e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Methotrexate Tablets

Keep out of the sight and reach of children.

Keep the blister in the outer carton in order to protect from light.

Do not use methotrexate tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via waste water or house hold waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Methotrexate Tablets contain

Each tablet contains 10mg 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 and Manufacturer

Marketing Authorisation Holder:

Momingside Healthcare Ltd 115 Narborough Road Leicester LE3 0PA United Kingdom

Manufacturer

Momingside Pharmaceuticals Ltd 5 Pavilion Way, Loughborough, LE11 5GW United Kingdom

This leaflet was last approved in February 2015

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