Sucraid

SUCRAID is available in 118 mL (4 fluid ounces) translucent plastic bottles, packaged two bottles per box. Each mL of solution contains 8,500 International Units (I.U.) of sacrosidase. A 1 mL measuring scoop is provided with each bottle. A full measuring scoop is 1 mL.

Store in a refrigerator at 2°- 8° C (36°- 46°F). Product is sterile until opened. Discard four weeks after first opening due to the potential for bacterial growth.

Protect from heat and light.

Distributed by: QOL Medial, LLC, Vero Beach, FL 32963. Revised: 06/12

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening stomach pain, nausea, vomiting, or diarrhea; or

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Some of these side effects may be symptoms of your CSID condition and not actual side effects of sacrosidase.

Common side effects may include:

• stomach pain, mild nausea;

• mild diarrhea, constipation;

• sleep problems (insomnia);

• headache; or

• nervous feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sacrosidase is used to replace the sucrase enzyme in your body. This enzyme helps digest and absorb sucrose (sugar). It is used in certain conditions (e.g., congenital sucrase-isomaltase deficiency or CSID) where the body is not making enough sucrase.

This medicine is available only with your doctor's prescription.

• It is used to treat an enzyme loss.

Sucraid® (sacrosidase) Oral Solution is indicated as oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).

Patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain.

Overdosage with Sucraid has not been reported.

Sucraid® (sacrosidase) Oral Solution is available in 118 mL (4 fluid ounces) translucent plastic bottles, packaged two bottles per box. Each mL of solution contains 8,500 International Units (I.U.) of sacrosidase. A 1 mL measuring scoop is provided with each bottle. A full measuring scoop is 1 mL.

Store in a refrigerator at 2°- 8°C (36°- 46°F). Product is sterile until opened. Discard four weeks after first opening due to the potential for bacterial growth. Protect from heat and light.

Rx only.

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

To order, or for any questions, call 1-866-469-3773

www.Sucraid.net

NDC# 67871-111-04

Sucraid® (sacrosidase) Oral Solution

Please read this leaflet carefully before you take Sucraid® (sacrosidase) Oral Solution or give Sucraid to a child. Please do not throw away this leaflet. You may need to read it again at a later date. This leaflet does not contain all the information on Sucraid. For further information or advice, ask your doctor or pharmacist.

BEFORE TAKING Sucraid

WARNING: Sucraid may cause a serious allergic reaction. If you notice any swelling or have difficulty breathing, get emergency help right away. Before taking your first and second doses, be sure that there are health professionals nearby (within a few minutes of travel) just in case there is an allergic reaction.

INFORMATION ABOUT YOUR MEDICINE

The name of your medicine is Sucraid (sacrosidase) Oral Solution. It can be obtained only with a prescription from your doctor.

The purpose of your medicine:

Sucraid is an enzyme replacement therapy for the treatment of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID). CSID is a condition where your body lacks the enzymes needed to break down and absorb sucrose (table sugar) and other sugars from starch.

The symptoms of CSID often include frequent watery diarrhea, abdominal pain, bloating, and gas. In many cases, the symptoms of CSID are similar to other medical problems. Only your doctor can make a definite diagnosis of CSID.

Sucraid can help improve the breakdown and absorption of sucrose (table sugar) from the intestine and can help relieve the gastrointestinal symptoms of CSID.

Sucraid does not break down some sugars resulting from the digestion of starch. Therefore, you may need to restrict the amount of starch in your diet. Your doctor will tell you if you should restrict the amount of starch in your diet.

Discuss the following important information with your doctor before you begin to take Sucraid:

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).

Tell your doctor if you have diabetes. With Sucraid, sucrose (table sugar) can be absorbed from your diet and your blood glucose levels may change. Your doctor will tell you if your diet or diabetes medicines need to be changed.

Side effects to watch for:

Some patients may have worse abdominal pain, vomiting, nausea, or diarrhea. Constipation, difficulty sleeping, headache, nervousness, and dehydration have also occurred. Other side effects may also occur. If you notice these or any other side effects during treatment with Sucraid, check with your doctor.

Stop taking Sucraid and get emergency help immediately if any of the following side effects occur: difficulty breathing, wheezing, or swelling of the face.

How to take your medicine:

Each bottle of Sucraid is supplied with a plastic screw cap which covers a dropper dispensing tip. Remove the outer cap and measure out the required dose. Reseal the bottle after each use by replacing and twisting the cap until tight.

Write down the date the sealed bottle is first opened in the space provided on the bottle label. Always throw away the bottle four weeks after first opening it because Sucraid contains no preservatives. For the same reason, you should rinse the measuring scoop with water after each time you finish using it.

To get the full benefits of this medicine, it is very important to take Sucraid as your doctor has prescribed. The usual dosage is 1 to 2 milliliters (mL) with each meal or snack:

1 mL = 1 full measuring scoop (28 drops from the bottle tip) and 2 mL = 2 full measuring scoops (56 drops from the bottle tip).

Measure your dose with the measuring scoop provided (see Figure 1). Do not use a kitchen teaspoon or other measuring device since it will not measure an accurate dose.

Figure 1. Measure dose with measuring scoop.

Mix your dose in 2 to 4 ounces of water, milk, or infant formula (see Figure 2). Sucraid should not be dissolved in or taken with fruit juice.

NEVER HEAT Sucraid OR PUT IT IN WARM OR HOT BEVERAGES OR INFANT FORMULA. Heating Sucraid causes it to lose its effectiveness. The beverage or infant formula should be taken cold or at room temperature.

Figure 2. Mix dose in beverage or infant formula.

It is recommended that approximately half of your dosage be taken at the beginning of each meal or snack and the remainder of your dosage be taken during the meal or snack.

Storing your medicine:

Sucraid is available in 4 fluid ounce (118 mL) see-through plastic bottles, packaged two bottles per box. A 1 mL measuring scoop is provided with each bottle. Always store Sucraid in a refrigerator at 36°F - 46°F (2°C - 8°C). Protect Sucraid from heat and light.

If your bottle of Sucraid has expired (the expiration date is printed on the bottle label), throw it away.

Keep this medicine in a safe place in your refrigerator where children cannot reach it.

QOL Medical, LLC

Vero Beach, FL 32963

www.Sucraid.net
For questions call 1-866-469-3773

Rev 11/14
Part No. 0110

Applies to sacrosidase: oral solution

Gastrointestinal

Common (1% to 10%): Abdominal pain, vomiting, nausea, diarrhea, constipation[Ref]

Hypersensitivity

Common (1% to 10%): Serious hypersensitivity reaction including wheezing[Ref]

Metabolic

Common (1% to 10%): Dehydration[Ref]

Nervous system

Common (1% to 10%): Headache, nervousness[Ref]

General

The most commonly reported side effects were abdominal pain and vomiting.[Ref]

Psychiatric

Common (1% to 10%): Insomnia[Ref]

Some side effects of Sucraid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.