Trexall (Methotrexate Sodium)

Read the Patient Information Leaflet if available from your pharmacist before you start taking methotrexate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Methotrexate is a strong medication. The dosage and how often you take this medication are based on your medical condition and response to treatment. There are many different dosing schedules for this medication (especially for cancer treatment). Therefore, it is very important that you follow your doctor's instructions carefully. Take this medication by mouth as directed by your doctor.

For the treatment of psoriasis or rheumatoid arthritis, take this medication by mouthas directed by your doctor, usually once a week. It may take up to several months before you get the full benefit of this drug.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Drink plenty of fluids while taking this medication unless your doctor tells you otherwise. Doing so helps your kidneys to remove the drug from your body and avoid some of the side effects.

Nausea, vomiting, stomach pain, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mouthsores, diarrhea, signs of anemia (such as unusual tiredness, pale skin), signs of liverproblems (such as dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin), easy bruising/bleeding, black stools, enlarged glands/lymph nodes, bone pain, unusual pain and discoloration of the skin, signs of kidney problems (such as change in the amount of urine), dry cough, muscle weakness.

Get medical help right away if you have any very serious side effects, including: weakness on one side of the body, neck stiffness, severe headache, vision changes, irregular heartbeat, mental/mood changes, seizures.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

This medication can affect sperm production, an effect that may lower male fertility. Consult your doctor for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Before taking methotrexate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, lung disease (such as pulmonary fibrosis), alcohol use, suppressed immune system, blood cell/bone marrow disorders, stomach/intestinal diseases (such as peptic ulcer, ulcerative colitis), any active infection (including chickenpox or recent exposure to it), folic acid deficiency.

Methotrexate can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccineinhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skinblisters/redness.

Methotrexate must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy during and after treatment with methotrexate. Therefore, males and females must use reliable forms of birth control (such as condoms, birth control pills) during treatment. Males should continue to use birth control for at least 3 months after the end of treatment. Females should continue to use birth control for at least 1 menstrual cycle after the end of treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Methotrexate passes into breast milk and may harm a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: acitretin, asparaginase, chloramphenicol, leflunomide, other drugs that can cause kidney problems (such as cisplatin), other drugs that can cause liver problems (such as azathioprine, sulfasalazine, retinoids such as isotretinoin), penicillins, phenytoin, probenecid, procarbazine, pyrimethamine, sulfa medications, tetracyclines.

Certain drugs that reduce stomach acid (proton pump inhibitors-PPIs such as esomeprazole, omeprazole, pantoprazole) may increase the amount of methotrexatein your blood. This effect may increase the risk of side effects, especially with high-dose methotrexate treatment. Ask your doctor or pharmacist for details and ways to lessen the risk of side effects.