IMPORTANT SAFETY INFORMATION:

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About QOL Medical

QOL Medical, LLC is a patient-centric specialty biopharmaceutical company dedicated to improving the quality of life for individuals with rare diseases by increasing awareness of rare and orphan diseases, and improving access to treatments for these diseases. Founded in 2003, QOL Medical is focused on the acquisition and commercialization of orphan products in underserved markets, particularly in the therapeutic areas of gastroenterology and rare diseases.

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QOL Medical, LLC
3405 Ocean Drive
Vero Beach, FL 32963

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    Important Safety Information for Sucraid® (sacrosidase) Oral Solution

    • Sucraid® may cause a serious allergic reaction. If you notice any swelling or have difficulty breathing, get emergency help right away.
    • Tell your doctor if you are allergic to, have ever had a reaction to, or have ever had difficulty taking yeast, yeast products, papain, or glycerin (glycerol).
    • Sucraid® does not break down some sugars that come from the digestion of starch. You may need to restrict the amount of starch in your diet. Your doctor will tell you if you should restrict starch in your diet.
    • Tell your doctor if you have diabetes, as your blood glucose levels may change if you begin taking Sucraid®. Your doctor will tell you if your diet or diabetes medicines need to be changed.
    • Some patients treated with Sucraid® may have worse abdominal pain, vomiting, nausea, or diarrhea. Constipation, difficulty sleeping, headache, nervousness, and dehydration have also occurred in patients treated with Sucraid®. Check with your doctor if you notice these or other side effects.
    • Sucraid® has not been tested to see if it works in patients with secondary (acquired) sucrase deficiency.
    • NEVER HEAT SUCRAID® OR PUT IT IN WARM OR HOT BEVERAGES OR INFANT FORMULA. Do not mix Sucraid® with fruit juice or take it with fruit juice. Take Sucraid® as prescribed by your doctor. Normally, half the dose of Sucraid® is taken before a meal or snack and the other half is taken during the meal or snack.
    • Sucraid® should be refrigerated at 36°F-46°F (2°C-8°C) and should be protected from heat and light.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

    Indication

    Sucraid® (sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of Congenital Sucrase-Isomaltase Deficiency (CSID).