Folex PFS

Oral/Injectable:

See "Methtrexate FDA Warning" for the most serious reactions.

Methotrexate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• drowsiness
• headache
• swollen, tender gums
• decreased appetite
• reddened eyes
• hair loss

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• vomiting
• blurred vision or sudden loss of vision
• sudden fever, severe headache, and stiff neck
• seizures
• confusion or memory loss
• weakness or difficulty moving one or both sides of the body
• difficulty walking or unsteady walking
• loss of consciousness
• impaired speech
• decreased urination
• swelling of the face, arms, hands, feet, ankles, or lower legs
• hives
• itching
• skin rash
• difficulty breathing or swallowing

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take:

• nonsteroidal anti-inflammatory drugs (NSAIDS) such as aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), ibuprofen (Advil, Motrin), magnesium salicylate (Doan's), naproxen (Aleve, Naprosyn) or salsalate.
• acitretin (Soriatane)
• azathioprine (Imuran)
• isotretinoin (Accutane)
• sulfasalazine (Azulfidine)
• tretinoin (Vesanoid)
• chloramphenicol (chloramycetin)
• penicillin
• tetracycline
• folic acid
• phenytoin (Dilantin)
• probenecid (Benemid)
• co-trimoxazole (Bactrim, Septra)
• sulfadiazine
• sulfamethizole (Urobiotic)
• sulfisoxazole (Gantrisin)
• and theophylline (Theocron, Theolair)

This is not a complete list of methotrexate drug interactions. Ask your doctor or pharmacist for more information.

Oral/Injectable:

• Do not drink alcohol while taking methotrexate. Alcohol can increase your risk of liver problems.
• Talk to your doctor before receiving immunizations (vaccinations).
• Do not take NSAIDS (nonsteroidal anti-inflammatory drugs) such as aspirin, ibuprofen, or naproxen without first checking with your doctor.
• Methotrexate may lower the number of white blood cells in your blood, increasing your risk for getting an infection. Avoid people with known infections. Avoid touching your eyes or nose. Wash your hands often.
• Methotrexate may increase your risk of bleeding by lowering the number of platelets in your blood. Tell your doctor right away if you notice any unusual bleeding or bruising.
• Methotrexate may make your skin sensitive to sunlight or ultraviolet light. If you have psoriasis, your sores may get worse if you expose your skin to sunlight while you are taking methotrexate. Plan to avoid unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds and sunlamps) and to wear protective clothing, sunglasses, and sunscreen.
• Methotrexate may cause dizziness or make you feel drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

Do not take this medication if:

• you are pregnant women. Use in the treatment of cancer is justified only when the potential benefit outweighs the risk to the fetus.
• are breastfeeding
• if you abuse alcohol (alcoholism), have alcoholic liver disease, or have other chronic liver disease
• have immunodeficiency syndromes along with rheumatoid arthritis (RA) or psoriasis
• have preexisting blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia, or significant anemia along with RA or psoriasis
• have a known hypersensitivity to methotrexate

Before taking methotrexate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to methotrexate or any of its ingredients
• have low blood folate levels
• are pregnant or breastfeeding
• are having surgery, including dental surgery

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Oral:

• Store at room temperature.
• Protect from light.
• Keep this and all medications out of reach of children.

Injectable:

• Store at room temperatures; excursions permitted to 15° to 30°C (59° to 86°F).
• Protect from light.
• Retain in carton until time of use. Discard unused portion.
• This container closure is not made with natural rubber latex.