Sacrosidase

This medicine sometimes causes a severe allergic reaction. 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.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Sacrosidase sometimes causes a severe allergic reaction. Before you start the medicine, your doctor may recommend a skin test to make sure you are not allergic to sacrosidase.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur. A severe allergic reaction could occur which may require immediate care.

Sacrosidase is usually taken with each meal or snack. It is best to take one half of the dose when you start eating and take the other half during your meal or snack.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Measure your dose using the scoop provided with sacrosidase. Rinse and dry the scoop after each use.

Sacrosidase liquid should be mixed with 2 to 4 ounces of water, milk, or baby formula that is no hotter than room temperature. Do not mix with warm or hot liquids or the medicine will not be as effective.

Do not mix sacrosidase with fruit juice or drink fruit juice when taking the medicine.

Sacrosidase may be only part of a complete program of treatment that also includes a special diet. Follow the diet plan created for you by your doctor or nutrition counselor. Get familiar with the list of foods you must avoid to help control your condition.

Store this medicine in the refrigerator. Do not freeze. Protect from light. Keep the bottle tightly closed when not in use.

When you first open a bottle of sacrosidase, write the date on the label. Throw away any unused sacrosidase 4 weeks after first opening the bottle.

An overdose of sacrosidase is not likely to produce any symptoms.

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.

Other drugs may interact with sacrosidase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sacrosidase, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sacrosidase or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sacrosidase in children and infants over 5 months of age.

Geriatric

No information is available on the relationship of age to the effects of sacrosidase in geriatric patients.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of sacrosidase. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes—Use with caution. May make this condition worse.

• Glycerin (glycerol) allergy or
• Papain allergy or
• Yeast allergy—Should not use in patients with these conditions.

Use sacrosidase as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with meals and snacks.
• Mix with 2 to 4 ounces (60 to 120 mL) of water, milk, or formula.
• Avoid taking this medicine with fruit juice.
• Do not mix sacrosidase in warm or hot drinks.
• Give approximately 1/2 of the dose before, and the rest of the dose during, each meal or snack.
• Wash and dry the scoop after each use. Do not store it in the bottle.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• Store in a refrigerator. Do not freeze.
• Protect from light.
• Protect from heat.
• After opening, throw away any part not used after 28 days.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.