Document: leaflet MAH BRAND_PL 00057-1010 change

• leaflet MAH BRAND_PL 00032-0343
• leaflet MAH BRAND_PL 00057-1010

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Package leaflet: Information for the user Regular Check-ups

MaXtreX 2.5mg 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 or pharmacist.

•    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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Maxtrex Tablets are and what they are used for

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

3.    How to take Maxtrex Tablets

4.    Possible side effects

5.    How to store Maxtrex Tablets

6.    Contents of the pack and other information

1. What Maxtrex Tablets are and what they are used for

Maxtrex Tablets contain the active ingredient methotrexate. Methotrexate is referred to as a cytotoxic medicine. It is most commonly used to kill cells in tumours.

Maxtrex Tablets can be used to treat rheumatoid arthritis. 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.

Maxtrex Tablets can also be used to treat severe, uncontrolled psoriasis. It is usually used for patients who have tried other treatments but their condition has not improved.

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. Maxtrex is used to treat a wide range of tumours, 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.

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

You should consult your doctor if you are unsure why you have been given Maxtrex 2.5mg Tablets.

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

Do not take Maxtrex Tablets if you:

•    are allergic to methotrexate, or any of the other ingredients of this medicine (listed in section 6).

•    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.

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

•    have severe kidney problems, including conditions requiring kidney dialysis.

•    have any serious blood problems including severe anaemia and clotting problems.

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

•    are taking antibiotics which prevent the production of folic acid (vitamin B9) such as co-trimoxazole, which are used to treat bacterial infections.

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

Warnings and precautions

Talk to your doctor or pharmacist before

taking Maxtrex Tablets if you have any of

the following conditions. This will help them

decide if Maxtrex Tablets are suitable for you:

•    have any mild or moderate kidney disease

•    have any blood disorders or anaemia

•    have diarrhoea

•    have gastro-intestinal (digestive) problems,

•    have or have ever suffered from mental illness

•    received or you are receiving radiotherapy (x-ray treatment)

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

•    have any symptoms or signs of infection

•    have excess fluid, between the lungs and chest wall or abdominal swelling (ascites),

•    develop a persistent cough or develop shortness of breath as it may be associated with serious lung disease.

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 Maxtrex Tablets

Tell your doctor or pharmacists if you are taking, have recently taken, or might take any other medicines. This includes the following medicines, as the effect of Maxtex Tablets may be altered when they are taken at the same time:

•    vaccinations

•    aspirin, ibuprofen, indometacin (NSAID’s, non-steroidal anti-inflammatory drugs) which are used for pain or inflammation

•    antibiotics (used to treat bacterial infections e.g. chloramphenicol, penicillin, sulphonamides, co-trimoxazole, trimethoprim, ciprofloxacin and tetracyclines)

•    thiazides (a group of diuretics used for the treatment of fluid retention e.g. bendroflumethiazide)

•    hypoglycaemics (used for lowering blood sugar levels e.g. metformin)

•    p-aminobenzoic acid, acitretin (used to treat psoriasis or skin disorders)

•    diphenylhydantoins, phenytoin (used to treat epilepsy)

•    probenicid, sulfinapyrazone (used to treat gout)

•    vitamin preparations containing folic acid or similar products

•    nitrous oxide (a gas used in general anaesthesia).

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

Taking Maxtrex Tablets with food and drink

Alcohol should be avoided while receiving methotrexate.

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.

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.

You should not take Maxtrex Tablets if you are breast-feeding.

Driving and using machines

Maxtrex Tablets may cause some side effects which could affect your ability to drive or use machinery for example drowsiness, loss of co-ordination or blurred vision. If you experience these symptoms, do not drive or use any tools or machinery. The full list of side effects are listed in Section 4.

Maxtrex Tablets contains lactose

Lactose is a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Maxtrex 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.

Alcohol should be avoided while receiving methotrexate.

The usual dose is:

Dosage for rheumatoid arthritis: Adults

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

Elderly

Elderly patients may need smaller doses of methotrexate.

Children

Not recommended for use in children.

Dosage for psoriasis:

Adults

For severe psoriasis, the usual dose is 10 to 25mg by mouth, 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.

Dosage for treatment of cancer: Adults, the Elderly and Children

•    Your doctor should give you a test dose of 5 to 10mg by injection one week before starting treatment.

•    The doctor will calculate the dosage required from your body surface area (m²), and the dose expressed as mg/m².

•    Maxtrex Tablets are usually given as single doses, not exceeding 30mg/m², for up to five days.

•    A rest period of at least two weeks is advised between treatments, to allow recovery from any side effects.

•    Doses in excess of 100mg are usually given by injection by your doctor or physician.

•    Doses of more than 70mg/m² should not be administered without calcium folinate rescue or blood levels of methotrexate being checked 24 to 48 hours after taking your medicine.

•    These doses may be reduced if you are receiving other medication. Your doctor will decide the correct dose for you, if you want more information you should ask your doctor.

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

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

If you take more Maxtrex Tablets than you should

If you accidentally take too many Maxtrex Tablets contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there are any Maxtrex Tablets left or not.

Inappropriate intake resulting in overdose can sometimes lead to death.

If you forget to take Maxtrex 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 missed dose.

If you stop taking Maxtrex Tablets

Do not stop taking Maxtrex Tablets unless your doctor tells you to. Should you need to stop taking Maxtrex Tablets, your doctor will have decided which is the best method for you.

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

4. Possible side effects

Like all medicines, this medicine can 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.

•    Severe skin rash that causes blistering, (this can affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson Syndrome. Your doctor will stop your treatment in these cases.

•    Persistent cough, pain or difficulty breathing or become breathless; methotrexate can cause diseases of the lungs e.g. fluid in lungs.

•    Skin rash and fever with swollen glands, particularly in the first two months of treatment, as these may be signs of a hypersensitivity reaction.

•    Sore throat, fever, chills or achiness; methotrexate can make you more likely to catch infections.

•    Severe allergic reaction (anaphylactic reaction) - although very rare you may experience a sudden itchy skin rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), wheeze, and you may feel you are going to faint. If this happens you should seek medical attention immediately.

Other side effects that may occur are:

•    Drowsiness

•    Convulsions

•    Loss of coordination

•    Confusion

•    Liver damage (seen as yellowing of the skin and whites of the eye)

•    Kidney damage

•    Low levels of white and red blood cells and cells that clot blood

•    Infection, reduced resistance to infection

•    Abnormal red blood cell function

•    May encourage the development of diabetes

•    Inability to move

•    Inability to move in one half of the body

•    Dizziness

•    Headaches, Blurred vision

•    Loss of ability to speak or understand speech

•    Slow thought process

•    Mood alteration

•    Black or tarry stools

•    Skin ulcers and erosions of inflamed areas, in psoriasis patients

•    Damaged skin becomes inflamed on re-exposure to radiation and sunlight

•    Reduced ability to become pregnant and reduced ability to father children

•    Blood in the urine

•    Raised liver enzymes

•    Weakening or softening of bones

•    Unusual sensations in the head

•    Anorexia (eating disorders)

•    Loss of interest in, or inability to have sex

•    Stomach pains and soreness of the mouth, throat and lips

•    Inflamed blood vessels

•    Feeling sick, being sick and/or diarrhoea, decreased absorption from intestines

•    Irritation or swelling of the vaginal tissues

•    Vaginal ulcers

•    Pain or difficulty in passing urine

•    The need to pass urine more often than usual

•    Joint and muscle pain

•    Chills and fever

•    Changes in skin colouration

•    Hair loss

•    Red spots on the skin, skin lesions, acne, boils

•    Flaking skin, redness

•    Itchiness and rash

•    Sensitivity to light

•    Eye irritation

•    Tiredness

•    General feeling of illness

•    Other metabolic changes

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

5. How to store Maxtrex Tablets

Keep this medicine out of the sight and reach of children.

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

Do not use this medicine after the expiry date which is stamped on the carton and label. The expiry date refers to the last day of that month. 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 Maxtrex Tablets contains

Each tablet contains 2.5mg of the active ingredient methotrexate.

The other ingredients are maize starch, lactose, pregelatinised starch, polysorbate 80, microcrystalline cellulose, magnesium stearate and purified water.

What Maxtrex Tablets looks like and contents of the pack

Maxtrex 2.5mg Tablets are yellow, round in shape and have ‘M2.5' written on one side of the tablets.

Maxtrex Tablets are available in plastic bottles containing 100 tablets.

Maxtrex Tablets are also available in packs containing 2 blisters with 12 tablets in each blister.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Pfizer Limited

Ramsgate Road Sandwich Kent, CT13 9NJ United Kingdom

Manufacturer Orion Corporation

Farmos PO Box 425 SF 20101 Turku Finland

Company Contact address:

For further information please contact Medical Information at Pfizer Limited on 01304 616161.

This leaflet was last revised in 06/2014

Ref: MX 9_0

2014-0020866/1