Sucraid (Page 3 of 4)

Instructions for Use

SUCRAID^® (Su-kreid)
(sacrosidase)
oral solution118 mL Multiple-Dose Bottle

Read this Instructions for Use before you start taking or giving SUCRAID to a child, and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child’s medical condition or treatment.

Important information you need to know before taking or giving SUCRAID:

• Your healthcare provider will decide the right dose of SUCRAID for you or your child. Do not change the dose of SUCRAID without talking to your healthcare provider.
• The dose of SUCRAID depends on body weight. Your healthcare provider will tell you how much SUCRAID you should take or give your child.
  • The dose for a child 33 pounds (15 kg) or less is 1 mL or 28 drops of SUCRAID in 2 ounces of water, milk, or infant formula.
  • The dose for a child or adult more than 33 pounds (15 kg) is 2 mL or 56 drops of SUCRAID in 4 ounces of water, milk, or infant formula.
• SUCRAID can only be dissolved with cold or room temperature water, milk, or infant formula. Do not put SUCRAID in warm or hot liquids. Do not dissolve SUCRAID with fruit juice. Do not take or give SUCRAID with fruit juice.
• Do not warm or heat the mixed solution before taking or giving SUCRAID.
• Measure your dose or your child’s dose of SUCRAID using the measuring scoop that comes with the SUCRAID bottle. Do not use a kitchen teaspoon or other measuring device.
• SUCRAID should be taken or given with each meal or snack. Half of the SUCRAID dose should be taken or given at the beginning of each meal or snack. Take or give the remaining SUCRAID dose during the meal or snack.
• Do not use the SUCRAID multiple-dose bottle if the seal has been damaged. Contact your pharmacist or healthcare provider if you cannot use the SUCRAID multiple-dose bottle.

Supplies needed to take or give SUCRAID:

• SUCRAID 118 mL multiple-dose bottle
• 1 measuring scoop (included in SUCRAID carton)
• 2 to 4 ounces of cold or room temperature water, milk, or infant formula (not included)
• Meal or snack (not included)

How to take or give SUCRAID:

Step 1: Check the expiration date on the SUCRAID bottle. Do not use SUCRAID after the expiration date on the bottle

has passed.

Step 2: Write down the date the bottle is first opened in the space provided on the bottle label.

Step 3: Each bottle of SUCRAID has a plastic screw cap that covers a dropper dispensing tip. Remove the plastic screw cap by twisting it to the left.

Step 4: Use the measuring scoop that comes in your SUCRAID carton to measure your or your child’s prescribed dose. See Figure 1. Reseal the bottle after each use by replacing and twisting the plastic screw cap to the right until tight.

Step 5: Mix your or your child’s prescribed dose in 2 ounces or 4 ounces of cold or room temperature water, milk, or infant formula as instructed by your healthcare provider. See Figure 2.

Step 6: Take or give half of the mixed solution at the beginning of each meal or snack. Take or give the remaining mixed solution during the meal or snack.

Step 7: Rinse the measuring scoop with water after each use.

Throwing away (disposal of) SUCRAID:

• Throw away (discard) the SUCRAID multiple-dose bottle and any remaining medicine in your household trash 4 weeks after first opening.

How should I store SUCRAID?

• Store the SUCRAID multiple-dose bottle in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Protect SUCRAID from heat and light.

Keep SUCRAID and all medicines out of the reach of children.

Manufactured by:QOL Medical, LLC Vero Beach, FL 32963

U.S. License No. 2195

For more information, go to www.sucraid.com or call 1-866-469-3773.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: May 2022

Patient Information SUCRAID® (Su-kreid)sacrosidaseoral solution

What is SUCRAID? SUCRAID is an oral replacement therapy for people who were born with a sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID). People with this condition cannot digest certain sugars.It is not known if SUCRAID is safe and effective in children under 5 months of age.

Do not take or give your child SUCRAID if you or your child: are allergic to yeast, yeast products, glycerin (glycerol), or papain. See the end of this Patient Information leaflet for a complete list of ingredients in SUCRAID. have had a positive skin test for sacrosidase.

Before you take or give your child SUCRAID, tell your healthcare provider about all of your medical conditions, including if you or your child: have diabetes. SUCRAID can interact with the food in your diet and may change your blood sugar levels. Your healthcare provider will tell you if your diet or diabetes medicines need to be changed. are pregnant or plan to become pregnant. It is not known if SUCRAID will harm your unborn baby. are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take SUCRAID while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take or give SUCRAID? See the detailed Instructions for Use that come with this Patient Information leaflet for instructions about the right way to take or give SUCRAID. SUCRAID should be taken or given exactly as prescribed by your healthcare provider. Do not change the dose of SUCRAID without talking to your healthcare provider. SUCRAID comes in a 118 mL multiple-dose bottle or a 2 mL single-use container. Your healthcare provider will decide which type of SUCRAID is best for you to use at home. The dose of SUCRAID depends on body weight. Your healthcare provider will tell you how much SUCRAID you should take or give your child. The dose for a child 33 pounds (15 kg) or less is 1 mL or 28 drops of SUCRAID in 2 ounces of water, milk, or infant formula. The dose for a child or adult more than 33 pounds (15 kg) is 2 mL or 56 drops of SUCRAID in 4 ounces of water, milk, or infant formula. SUCRAID can only be dissolved in cold or room temperature water, milk, or infant formula. Do not put SUCRAID in warm or hot liquids. Do not dissolve SUCRAID with fruit juice. Do not take or give SUCRAID with fruit juice. Do not warm or heat the mixed solution before taking or giving SUCRAID. Measure your dose or your child’s dose of SUCRAID using the measuring scoop that comes with the SUCRAID bottle. Do not use a kitchen teaspoon or other measuring device. SUCRAID should be taken or given with each meal or snack. Half of the SUCRAID dose should be taken at the beginning of each meal or snack. Take or give the remaining SUCRAID dose during the meal or snack. Rinse the measuring scoop with water after each use. SUCRAID does not break down some sugars found in foods that have starch, such as wheat, rice, and potatoes. Your healthcare provider may tell you to avoid eating foods with starch.

What are the possible side effects of SUCRAID? SUCRAID may cause serious side effects, including: Severe allergic reaction can happen in some people taking SUCRAID. Symptoms of a severe allergic reaction include: difficulty breathing swelling of the face, lips, mouth, or tongue wheezing Your healthcare provider may need to monitor you or your child carefully when first starting treatment with SUCRAID. Get medical help right away and tell your healthcare provider as soon as possible if you or your child have any of the symptoms listed above. Other side effects of SUCRAID may include: stomach (abdominal) pain nausea constipation headache dehydration vomiting diarrhea difficulty sleeping nervousness These are not all of the possible side effects of SUCRAID. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store SUCRAID? Store the SUCRAID multiple-dose bottle and 2 mL single-use container in the refrigerator between 36°F to 46°F (2°C to 8°C). The SUCRAID single-use container may be stored between 59°F to 77°F (15° to 25°C) for up to 3 days. Protect SUCRAID from heat and light. Keep SUCRAID and all medicines out of the reach of children.

General information about the safe and effective use of SUCRAID. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SUCRAID for a condition for which it was not prescribed. Do not give SUCRAID to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SUCRAID that is written for health professionals.

What are the ingredients in SUCRAID? Active ingredient: sacrosidase.Inactive ingredients: Citric acid, glycerol, sodium hydroxide, and water. Manufactured by:QOL Medical, LLC Vero Beach, FL 32963U.S. License No. 2195For more information, go to www.sucraid.com or call 1-866-469-3773.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: May 2022