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PATIENT INFORMATION LEAFLET

Methotrexate 2.5mg tablets

_(methotrexate sodium)_

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, 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 symptoms are the same as yours.

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet,

please tell your doctor or pharmacist._

The name of your medicine is Methotrexate 2.5mg tablets but it will be referred to as Methotrexate throughout this leaflet.

In this leaflet:

1.    What Methotrexate is and what it is used for

2.    Before you take Methotrexate

3.    How to take Methotrexate

4.    Possible side effects

5.    How to store Methotrexate

6.    Further information

1. WHAT METHOAREXATE IS AND WHAT IT IS USED FOR

Methotrexate is 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 mechanisms in the immune system.

Methotrexate can also be used to treat several kinds of cancer when it 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.

2. BEFORE YOU TAKE METHOTREXATE

Do not take Methotrexate if you:

•    know that you are allergic to methotrexate or any of the other ingredients in the tablets (see section 6)

•    are pregnant, breastfeeding or trying for a baby, you and your partner should avoid conception (becoming pregnant or fathering children) for at least six months after your treatment with methotrexate has stopped (see section 2: pregnancy and breastfeeding)

•    suffer from a problem of excessive drinking (alcoholism)

•    have severe liver problems, including alcoholic liver disease and recent or active hepatitis (inflammation of the liver)

•    have severe kidney problems

•    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 (throm bocytopenia)

•    have a medical condition or are receiving medication which lowers your resistance to infection

•    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.

Take special care and talk to your doctor or pharmacist before taking Methotrexate Tablets if you:

•    have any mild or moderate liver or kidney problems or blood disorders

•    have stomach ulcers or suffer from inflammation and ulceration of the gut

•    have severe mouth ulcers

•    have diarrhoea

•    are weak or infirm

•    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

•    have impaired respiratory function

•    are receiving radiotherapy or ultraviolet (UV) radiation concurrently.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking, or have recently taken, 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 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 including penicillins, sulphonamides, trimethoprim/sulfamethoxazole (as cotrimoxazole), neomycin, ciprofloxacin, doxycycline, tetracyclines, chloramphenicol

•    nitrous oxide-based anaesthetics

•    vaccinations

•    oral hypoglycaemics (lower blood sugar levels)

•    olazepine 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 (for gout)

•    omeprazole, pantoprazole (for stomach ulcers, heartburn, reflux)

•    theophylline (for asthma)

•    vitamin preparations containing folic acid or its derivatives.

Taking Methotrexate with food and drink: You should not drink alcohol whilst you are taking this medicine.

Pregnancy and breast feeding: Methotrexate temporarily affects sperm and egg production and can harm unborn babies or cause miscarriages. It MUST NOT be taken during pregnancy or breast feeding. You should avoid becoming pregnant for at least six months after your treatment with methotrexate has stopped.

Men: Methotrexate affects sperm. You should avoid fathering a child for at least six months after your treatment has stopped.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and Using Machines: Methotrexate may make you feel tired, 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.

Important information about some of the ingredients of Methotrexate:

These tablets contain lactose (a sugar). If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE METHOTREXATE

Always take your tablets exactly as your doctor has told you to. This information will also be on the pharmacist's label. If you are not sure how to take your tablets ask your doctor or pharmacist. 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.

ADULTS:

Patients with psoriasis:

USUAL DOSE: between 10 and 25mg (4 to 10 tablets) taken once a week on the same day each week.

Patients with rheumatoid arthritis:

USUAL DOSE: between 7.5 and 20mg (3 to 8 tablets) taken once a week on the same day each week. These doses may alter as your condition changes Patients with cancer:

Your doctor will decide the dose depending on your condition. Methotrexate may be the only drug given or it may be given with other drugs.

Your doctor will want to monitor your progress, usually every 2-3 months, whilst you are receiving Methotrexate.

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.

Do not miss your appointments as these are necessary to ensure that Methotrexate Tablets are used safely.

Your doctor may give you additional medication to help make sure that Methotrexate does not collect in the kidneys.

If you take more Methotrexate 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 left or not.

If you forget to take Methotrexate:

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.

If you have any further questions on the use of this product ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECT

As with all medicines, as well as helping with your illness, methotrexate may cause some unwanted effects although not everybody gets them.

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) should be reported to a doctor immediately.

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

•    Severe skin rash that causes blistering. These may be signs of a condition known as Stevens Johnson Syndrome. Your doctor will stop your treatment in these cases.

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

Common - (affects less than 1 in 10 people):

loose stools

raised liver enzymes

a skin rash with reddening of the skin

hair loss.

boils

vasculitis (pain or redness of the blood vessels)

dilatation of small blood vessels causing focal red lesions pain or difficulty in passing urine blood in urine

elevation of urea and/or creatinine in the

blood

infertility

enlargement of breasts vaginal bleeding.

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

5. HOW TO STORE METHOTREXATE

Keep out of the sight and reach of children.

Do not take your medicine after the expiry date which is stated on the carton/bottle label after ‘Exp'. The date refers to the last day of that month.

Do not store above 25°C. Protect from light.

If your tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.

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

6. FURTHER INFORMATION

What Methotrexate contains

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

What Methotrexate look like and contents of pack:

Methotrexate are yellow, round tablets engraved with ‘2.5' on the one side and scored in half on the other side and engraved with 'M' above the score line and 'I' below it. Methotrexate is available in plastic bottles containing 100 tablets.

Manufactured by: Excella GmbH, Germany.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare,

Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. i i

I POM I

Methotrexate 2.5mg tablets, PL No: 18799/2295    -

Leaflet date: 09.12.2013