Physicians are advised to discuss the following issues with patients for whom they prescribe COTAZYM® (pancrelipase capsules, USP):

Taking the Capsules

Patients should be instructed not to increase their COTAZYM® (pancrelipase capsules, USP) dose without consulting their physician. If it becomes necessary to open the COTAZYM® capsules, inhalation of the powder or contact with the skin or mucous membranes should be avoided. It is suggested mask and gloves be worn when opening capsules. COTAZYM® should not be taken by patients with known hypersensitivity to antigens of porcine origin. Sensitive individuals may experience allergic reactions.

Folic acid supplementation during pregnancy is important. Daily oral supplementation with folic acid before conception and during pregnancy can substantially reduce the occurrence of neural tube defects (anencephaly and spina bifida). Women should take folic acid if they are pregnant, or are thinking of becoming pregnant during treatment with COTAZYM®.

Concomitant Medication

Patients should be advised not to take COTAZYM® (pancrelipase capsules, USP) together with a combination of calcium carbonate and magnesium hydroxide. Calcium carbonate and magnesium hydroxide may be found in certain antacids. Calcium carbonate can also be found in certain calcium or mineral supplements. COTAZYM® may interfere with the absorption of folic acid and iron. Patients should consult with their physician if taking folic acid or iron containing preparations.

Pregnancy

COTAZYM® (pancrelipase capsules, USP) may interfere with the absorption of folic acid. Folic acid supplementation during pregnancy is important. Daily oral supplementation with folic acid before conception and during pregnancy can substantially reduce the occurrence of neural tube defects (anencephaly and spina bifida). Patients should be advised to notify their physician if they are pregnant or are thinking of becoming pregnant during treatment with COTAZYM® (pancrelipase capsules, USP).

Nursing

Patients should be advised to notify their physician if they are breast-feeding an infant.

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