Prescribing Information Important Safety Information
Treatment

Dietary Supplements

Some individuals with Congenital Sucrase-Isomaltase Deficiency (CSID) have used over-the-counter dietary supplements with varying degrees of success. Some individuals have found dietary supplements to be helpful in reducing the gastrointestinal symptoms associated with isomaltase deficiency.

Therefore, they have looked into supplements for this purpose. It should be noted that dietary supplements differ from prescription medication in several important ways. First, dietary supplements are not FDA-approved. This means that they are not subject to the same standards of rigor or manufacturing quality control as prescription medications. Secondly, there are vast potency differences between dietary supplements and prescription medications.

Finally, enzymes are proteins and are subject to degradation. Most dietary enzyme supplements are not dispensed in refrigerated packages. As a result, the enzymes contained in these supplements may not survive the packaging and shipping process intact. Before taking a dietary supplement, you should discuss it with your physician.

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IMPORTANT SAFETY INFORMATION:

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Important Safety Information for Sucraid® (sacrosidase) Oral Solution

Indication

Sucraid® (sacrosidase) Oral Solution is indicated for the treatment of sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID), in adult and pediatric patients 5 months of age and older.

Contraindication

Sucraid® is contraindicated in patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain.

Warnings, Precautions, and Additional Important Safety Information

  • Severe Hypersensitivity Reactions
    Sucraid® may cause a severe hypersensitivity reaction (a serious allergic reaction). If you notice any swelling of your face, lips, mouth, or tongue, or have difficulty breathing, experience wheezing, rash, or itchiness, get emergency help right away. Sucraid® contains papain, which is associated with hypersensitivity reactions.
  • 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).
  • Increased Blood Glucose Levels in Patients With Diabetes Mellitus
    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.
  • Restricting Starch in Your Diet
    Sucraid® does not break down some sugars that come from the digestion of starch so you may still experience symptoms of CSID while taking Sucraid®. 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.
  • 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 of the dose of Sucraid® is taken just 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; single-use containers can be removed from refrigeration and stored at 59°F-77°F (15°C-25°C) for up to 3 days (72 hours). Refer to Instructions for Use for full information on how to take Sucraid®.

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.