ASANDOZ

PACKAGE LEAFLET: INFORMATION FOR THE USER

Methotrexate 2.5 mg Tablets Methotrexate 10 mg Tablets

Methotrexate

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Read all of this leaflet carefully before you start using 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Methotrexate is and what it is used for

2.    Before you use Methotrexate

3.    How to use Methotrexate

4.    Possible side effects

5.    How to store Methotrexate

6.    Further information

1. WHAT METHOTREXATE IS AND WHAT IT IS USED FOR

Methotrexate tablets contain the active ingredient methotrexate. Methotrexate is referred to as a cytotoxic, most commonly used to kill cells in tumours.

Methotrexate tablets are used to treat rheumatoid arthritis and severe uncontrolled psoriasis. It is usually used for patients who have tried other treatments but their illness has not improved. In the treatment of rheumatoid arthritis, methotrexate is thought to stop or reduce inflammation by altering the body’s defences.

Methotrexate 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. Methotrexate is used to treat acute leukaemia.

Methotrexate can be given alone or in combination with other medicines.

Your doctor will be able to explain how Methotrexate tablets might help in your particular condition.

2. BEFORE YOU USE METHOTREXATE

Do not use Methotrexate

•    if you are allergic (hypersensitive) to methotrexate (active substance) or any of the

other ingredients of Methotrexate Tablets

•    if you 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 three months after your treatment with methotrexate has stopped

•    if you have severe liver problems including fibrosis, cirrhosis and recent or active hepatitis

•    if you have severe kidney problems

•    if you have any serious blood problems including anaemia (low levels of white and red blood cells) and clotting problems

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

•    if you have an active infectious disease (e.g. fever, chills, joint pain)

•    if you are in general poor condition

•    if you abuse alcohol

•    if you have a lung disease caused by adverse reactions of methotrexate.

Take special care with Methotrexate

•    if you have reduced bone marrow function

•    if you have reduced kidney function

•    if you have gastro-intestinal disorders such as gastric ulcer, inflammation of the guts, inflammation of the mucous membrane of the mouth

•    if you are in poor condition due to diarrhoea

•    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 (x-ray treatment)

•    if you have received any vaccinations recently or you are due to have any, as methotrexate can reduce their effect.

Methotrexate should only be used in children and elderly with extreme caution.

Methotrexate can cause inflammation of the lung with breathlessness. If you develop a persistent cough, experience pain or difficulty breathing, or become breathless, you should seek medical attention.

Whilst being treated your doctor will want to monitor your progress on a weekly basis until therapy is stable. Thereafter you will be monitored every 2-3 months, whilst taking the medicine.

These checks may include taking blood and urine samples, chest x-ray and a physical examination.

This will include a routine examination of your lymph nodes (glands in your neck, armpits and groin). Any unusual swellings should also be reported to your doctor.

Methotrexate must only be given to you under the supervision of a doctor experienced in its use.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription in particular:

NSAIDs (non-steroidal anti-inflammatory drugs) e.g. ibuprofen, indomethacin or aspirin (for pain relief or inflammation, antibiotics (chloramphenicol, penicillin, sulphonamides, trimethoprim/sulfamethoxazole and tetracyclines), etretinate (treatment for psoriasis or skin disorders), diphenylhydantoins (for epilepsy), probenecid, phenytoin (an antiepileptic), vinca alkaloids and doxorubicin (cytostatics), barbiturates (hypnotic), living vaccines, vitamin preparations or oral iron preparations containing folic acid.

Using Methotrexate with food and drink

Alcohol should be avoided while receiving methotrexate.

Pregnancy and breast-feeding

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

Pregnancy: Do not use Methotrexate during pregnancy. 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 three months after your treatment with methotrexate has stopped.

Breast-feeding: Do not use Methotrexate when you breast-feed.

Driving and using machines

The ability to drive a car or to handle machinery can be affected when taking Methotrexate.

Important information about some of the Ingredients of Methotrexate

Methotrexate contains lactose monohydrate. Do not take this medicine if your doctor has told you that you do not tolerate certain kinds of sugar.

3. HOW TO USE METHOTREXATE

Take Methotrexate tablets once a week.

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

The tablets must be taken 1 hour prior to or 1 k to 2 hours following a meal.

The usual dose is:

Dosage for rheumatoid arthritis:

You will usually take your tablets once a week on the same day each week. The dose will normally be between 7.5 and 20 mg. However, this may be changed depending upon your response to treatment.

Dosage for psoriasis:

For severe psoriasis, the usual start dose is 2.5 mg three times per week with intervals of 12 hours or 1 single dose of 7.5 mg once weekly.

Dosage for treatment of tumours:

The doctor will calculate the dosage required from your body surface. Your doctor will decide the correct dose for you, if you want more information you should ask your doctor. Elderly patients may need smaller doses of methotrexate.

During treatment your doctor will carry out blood tests, 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.

If you have the impression that the effect of Methotrexate is too strong or too weak, talk to your doctor or pharmacist.

If you use more Methotrexate than you should

If you have taken 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 tablets left or not.

If you forget to use 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 stop using Methotrexate

Your doctor will decide when to stop treatment with Methotrexate.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Methotrexate can cause side effects, although not everybody gets them.

Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Serious side effects

If you develop any of the following side effects, contact your doctor as soon as you can:

•    lung complaints (symptoms may be general illness, dry, irritating cough, shortness of breath, breathlessness at rest, chest pain, or fever)

•    severe peeling or blistering of the skin

•    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

•    fever

•    yellowing of the skin (jaundice)

•    pain or difficulty in passing urine

•    thirst and/or frequent urination

•    fits (convulsions)

•    loss of consciousness

•    blurred or decreased vision

Methotrexate may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/sore pharynx/sore mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check for possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

Methotrexate may cause serious (sometimes life-threatening) side effects. Therefore, your doctor will do tests to check for abnormalities developing in the blood (e.g. low white blood cells, low platelets, lymphoma) and changes in the kidney and the liver.

The following side effects have also been reported:

Common (it occurs in between 1 and 10 out of 100 patients)

•    loss of appetite

•    nausea (feeling sick)

•    vomiting

•    tummy pain

•    inflammation and ulcers in the throat

•    increase in liver enzymes,

•    reduced blood cell formation with decrease in white and/or red blood cells and/or platelets (leukopenia, anaemia, thrombocytopenia)

•    headache

•    tiredness

•    drowsiness

•    inflammation of the lungs (pneumonia) with dry, non-productive cough

•    shortness of breath

•    diarrhoea

•    rash

•    reddening of the skin

•    itching.

Uncommon (it occurs in between 1 and 10 out of 1000 patients)

•    decrease in the number of blood cells and platelets

•    dizziness

•    confusion

•    depression

•    inflammation of blood vessels

•    lung damage

•    ulcers and bleeding in the digestive tract

•    liver disorders

•    diabetes

•    decreased blood protein

•    nettle rash (alone)

•    light sensitivity

•    brown skin

•    hair loss

•    increase of rheumatic nodules

•    shingles

•    painful psoriasis

•    joint or muscle pain

•    osteoporosis (reduction of bone mass)

•    inflammation and ulcers of the bladder (possibly with blood in the urine)

•    painful urination

•    severe allergic reactions

•    inflammation and ulcers of the vagina

•    slow wound healing.

Rare (it occurs in less than 1 and 10 out of 10,000 patients)

•    inflammation of the sac around the heart

•    fluid in the sac around the heart

•    severe visual disturbance

•    mood fluctuation

•    slow blood pressure

•    blood clots

•    sore throat

•    interruption of breathing

•    asthma

•    inflammation of the digestive tract

•    inflamed gums

•    abnormal digestion

•    acute hepatitis (inflammation of the liver)

•    changed colour of nails

•    acne

•    red or purple spots due to vessel bleeding

•    bone fracture

•    kidney failure

•    decrease or absence of urine

•    electrolyte disturbances

•    defective sperm formation

•    menstruation disorders.

Very rare (it occurs in less than 1 out of 10,000 patients)

•    infections

•    severe failure of the bone marrow

•    liver failure

•    swollen glands

•    sleeplessness

•    pain

•    muscle weakness

•    pins and needles

•    changes in sense of taste (metallic taste)

•    inflammation of the lining of the brain causing paralysis or vomiting

•    red eyes

•    damage to the retina of the eye

•    fluid in the lungs

•    vomiting blood

•    cold sores

•    protein in the urine

•    fever

•    loss of sex drive

•    problems having an erection

•    infection around a fingernail

•    severe complication of the digestive tract

•    boils

•    small blood vessels in the skin

•    fungal infections

•    damage to the blood vessels of the skin

•    vaginal discharge

•    infertility.

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.

5. HOW TO STORE METHOTREXATE

Keep out of the reach and sight of children.

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

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 Tablets contain

•    The active substance is methotrexate.

•    The other ingredients are lactose monohydrate, maize starch, potato starch, microcrystalline cellulose, magnesium stearate and colloidal anhydrous silica.

What Methotrexate Tablets look like and contents of the pack

2.5 mg: Light yellow round shaped tablets with a diameter of 7 mm; may contain yellow to red sprinkles.

10 mg: Light yellow, capsule shaped tablets with a score on one side, with a major axis of 15 mm and a minor axis of 7 mm; may contain yellow to red sprinkles.

Methotrexate 2.5 mg and 10 mg Tablets are available in pack sizes of 4, 8, 10, 12, 16, 20, 24, 28, 50 and 100 tablets in white polypropylene tablet containers sealed with a white polyethylene lid in cartons.

Methotrexate 2.5 mg Tablets are also available in pack sizes of 4, 8, 10, 12, 16, 20, 24, 28, 50 and 100 tablets in PVC/PVDC blisters sealed with aluminium foil in cartons.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

EBEWE Pharma Ges.m.b.H. Nfg.KG A-4866 Unterach, AUSTRIA.

Manufacturer

EBEWE Pharma Ges.m.b.H. Nfg.KG A-4866 Unterach, AUSTRIA or

Salutas Pharma GmbH,

Otto-von-Guericke Allee 1,

39179 Barleben,

Germany.

Distributor

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

This leaflet was last revised in 11/2014.

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Artwork Proof Box

Ref: V012 - Update in line with SPC