Side Effects

Gas, bloating, burping, stomach rumbling/pain, nausea, and cramps may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: stomach/abdominal pain that is severe or doesn’t go away, diarrhea, vomiting, muscle cramps/weakness, irregular heartbeat, mental/mood changes, seizures, bloody stools, rectal bleeding.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Uses

This medication is a laxative used to treat constipation. It may help to increase the number of bowel movements per day and the number of days you have a bowel movement. Lactulose is a colonic acidifier that works by increasing stool water content and softening the stool. It is a man-made sugar solution.

How to use Kristalose

Take this medication by mouth as directed by your doctor, usually once daily for constipation. If you are taking the solution, to improve the taste, you may mix it into fruit juice, water, milk, or a soft dessert. If you are using the crystals in packets, dissolve the contents of the packet in half a glass of water (4 ounces or 120 milliliters), or as directed by your doctor.

Use this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. The dosage is based on your medical condition and response to treatment.

It may take up to 48 hours to have a bowel movement. Tell your doctor if your condition lasts or gets worse.

Precautions

Before taking lactulose, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a low galactose diet (such as a diet that includes few or no milk products), certain other bowel problem (bowel obstruction), diabetes.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication contains different sugars. If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Older adults may be at a greater risk for loss of blood minerals (such as potassium, sodium) while using this drug, especially if they are using it for an extended time.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug are: antacids containing aluminum and/or magnesium, other laxatives.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach cramps, diarrhea.

Do not share this product with others.

If you use this product for a long time, lab and/or medical tests (such as blood mineral levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not freeze because this will make the medication too thick to pour. If it becomes frozen, warm it to room temperature until it is pourable again. A normal darkening of color may occur. If too much darkening occurs and you cannot swallow it, discard the medication and get a refill. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.