Package leaflet: Information for the patient Methotrexate ...

1 Read all of this leaflet carefully before you starttaking this medicine because it contains importantinformation for Keep this leaflet. You may need to read it If you have any further questions, ask your doctor,pharmacist or This medicine has been prescribed for you only. Donot pass it on to others. It may harm them, even iftheir signs of illness are the same as If you get any side effects talk to your doctor,pharmacist or nurse. This includes any possibleside effects not listed in this leaflet. See section is in this leaflet1. What Methotrexate mg tablets are and what theyare used for2. What you need to know before you takeMethotrexate mg Tablets3. How to take Methotrexate mg Tablets4. Possible side effects5. How to store Methotrexate mg Tablets6.

2 Contents of the pack and other information1. WHAT Methotrexate MG tablets ARE ANDWHAT THEY ARE USED FORM ethotrexate mg tablets are one of a group ofmedicines called antimetabolites which affect cellgrowth, including the growth of cancer can be used to treat severe cases ofpsoriasis (a skin disease) and rheumatoid arthritis (adisease of the joints). It is usually used for patients whohave tried other treatments but their illness has notimproved. It helps patients with psoriasis by killing thecells in the skin which are growing too quickly. It is thesefast growing cells which cause the raised patches ofskin in the treatment of rheumatoid arthritis, Methotrexate isthought to stop or reduce inflammation in the joints byaltering the body's defence mechanism in the can also be used to treat several kinds ofcancer, 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 can be given alone or in combination withother medicines.

3 It is usually used in much higher doseswhen it is used to treat cancer and it will often be givenas an injection rather than should consult your doctor if you are unsure whyyou have been given Methotrexate mg WHAT YOU NEED TO KNOW BEFORE YOU TAKEMETHOTREXATE MG tablets Do not take Methotrexate mg tablets if you know that you are allergic to Methotrexate orany of the other ingredients of this medicine (listed insection 6) if you are pregnant, breast-feeding (see section :Pregnancy, breast-feeding and fertility) if you suffer from a problem of excessive drinking(alcoholism) if you have severe liver problems, including fibrosis,alcoholic liver disease and recent or active hepatitis(inflammation of the liver) if you have severe kidney problems, includingconditions requiring kidney dialysis if you have any serious blood disorders includingsevere anaemia or abnormal numbers of blood cellssuch as low white cells (leucopenia) or low small bloodcell numbers (platelets) causing (thrombocytopenia) if you have a medical condition or are receivingmedication which lowers your resistance to infection if you are taking antibiotics which prevent theproduction of folic acid (vitamin B9)

4 Such as co-trimoxazole, which are used to treat bacterial infections if you have symptoms which may suggest an activeinfectious disease ( fever, chills, achiness).Even though some of the above may be obvious, it isimportant that your doctor is aware if any of them applyto and precautionsImportant warning about the dose ofMethotrexate mg tablets ( Methotrexate ):Take Methotrexate mg tablets only once a weekfor the treatment of rheumatic or skin diseases (RA,JIA and psoriasis or psoriatic arthritis).Taking too much of Methotrexate mg tablets ( Methotrexate ) may be read section 3 of this leaflet very you have any questions, please talk to your doctoror pharmacist before you take this to your doctor, pharmacist or nurse before takingMethotrexate mg tablets if you.

5 Have any mild or moderate liver or kidney problemsor blood disorders including anaemia have gastro-intestinal (digestive) problems likestomach ulcers or suffer from inflammation andulceration of the gut have or have ever suffered from mental illness have severe mouth ulcers have diarrhea have any symptoms or signs of infection have excess fluid between the lungs and chest wall(pleural effusion) causing breathlessness or in theabdomen causing swelling of the stomach (ascites).These may affect the levels of Methotrexate in yourblood are receiving or intend to receive any vaccine, asmethotrexate can reduce their effect have diabetes mellitus are an elderly patient or a very young child develop a persistent cough or develop shortness ofbreath as it may be associated with serious lungdisease have received or you are receiving radiotherapy orultraviolet (UV) radiation concurrently acute bleeding from the lungs in patients withunderlying rheumatologic disease has beenreported with Methotrexate .

6 If you experiencesymptoms of spitting or coughing up blood youshould contact your doctor temporarily affects sperm and eggproduction. Methotrexate can cause miscarriage andsevere birth defects. You and your partner should avoidhaving a baby if you are being given Methotrexate at thetime and for at least 6 months after the end of yourtreatment with Methotrexate . See also section Pregnancy, breast-feeding and fertility .Regular check ups Whilst being treated with this medicine your doctor willwant to monitor your progress on a weekly basis untilyour therapy is stable. Thereafter, you will be monitoredevery 2 to 3 months, whilst taking the medicine. Thesechecks may include taking blood and urine samples tocheck your blood cells and to make sure that your liverand kidneys are working properly.

7 It is important thatyou do not miss any blood may also be a chest x-ray and a physicalexamination to check for swelling of your lymph nodes(glands in your neck, armpits and groin). Any unusualswellings should also be reported to your medicines and Methotrexate mg tablets :Tell your doctor or pharmacist if you are taking, haverecently taken or might take any other medicines. Thisincludes medicines obtained without a prescription. Theeffects of these medicines may change, especially if youare taking: NSAIDs (non-steroidal anti-inflammatory drugs) , indomethacin, azopropazone or aspirin(for relief of pain or inflammation) including anypreparations of these bought without a these products together with mg tablets can increase its toxic effects diuretics ( loop diuretics like furosemide,hydrochlorothiazide or triamterene water pills) phenytoin, carbamazepine and valproate (for seizures) antibiotics (used to treat bacterial infections)including penicillin, sulphonamides,trimethoprim/sulfamethoxaz ole (as cotrimoxazole),neomycin, ciprofloxacin, doxycycline, tetracyclines,chloramphenicol nitrous oxide-based (a gas used in generalanaesthesia) vaccinations oral hypoglycaemics (used for lowering blood sugarlevels)

8 Like metformin olanzapine 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), cisplatin retinoids, acitretin (for psoriasis or skin disorders) immunosuppressant drugs such as leflunomide(used for suppression of inflammatory conditions) orciclosporin probenecid, sulfinpyrazone(for gout) omeprazole, pantoprazole (for stomach ulcers,heartburn, reflux) theophylline (for asthma) vitamin preparations containing folic acid or similarproducts p-aminobenzoic acid used to treat skin mg tablets with food and drinkYou should not drink alcohol whilst you are taking , breast-feeding and fertilityIf you are pregnant or breast-feeding, think you may bepregnant or are planning to have a baby, ask your doctoror pharmacist for advice before taking this medicine.

9 Pregnancy:Do not use Methotrexate mg tablets duringpregnancy except if your doctor has prescribed it foroncology treatment. Methotrexate can cause birthdefects, harm the unborn child or cause miscarriage. Itis associated with malformations of the skull, face, heartand blood vessels, brain, and limbs. It is therefore veryimportant that Methotrexate is not given to pregnantwomen or to women who are planning to becomepregnant unless used for oncology non-oncological indications, in women of child-bearing age the possibility of a pregnancy must be ruledout, by pregnancy tests, before treatment is not use Methotrexate mg tablets if you are tryingto become pregnant. You must avoid becomingpregnant during treatment with Methotrexate and for atleast 6 months after the end of treatment.

10 Therefore, youmust ensure that you are taking effective contraceptionfor the whole of this period (see also section "Warningsand precautions").If you become pregnant during treatment or suspectyou might be pregnant, speak to your doctor as soon aspossible. If you do become pregnant during treatment,you should be offered advice regarding the risk ofharmful effects on the child through you want to become pregnant, you should speak withyour doctor, who may refer you for specialist advicebefore the planned start of mg tablets should not be used duringbreast-feeding. Methotrexate passes into breast should be stopped prior to and duringtreatment with Methotrexate mg fertilityThe available evidence does not indicate an increasedrisk of malformations or miscarriage if the father takesmethotrexate less than 30 mg/week.