Constulose

• Actavis Mid Atlantic LLC,

• Actavis Pharma, Inc.

• Actavis, Inc.

• Harber Pharmaceutical Co.

• Mason Vitamins, Inc.

Constulose is part of the drug class:

• Osmotically acting laxatives

You should not use this medication if you are on a special diet low in galactose (milk sugar).

Before taking lactulose, tell your doctor if you have diabetes or if you need to have any type of intestinal test using a scope (such as a colonoscopy).

It may take up to 48 hours before you have a bowel movement after taking lactulose.

Stop using lactulose and call your doctor at once if you have severe or ongoing diarrhea.

The liquid form of lactulose may become slightly darker in color, but this is a harmless effect. However, do not use the medicine if it becomes very dark, or if it gets thicker or thinner in texture.

If you use lactulose over a long period of time, your doctor may want you to have occasional blood tests. Do not miss any scheduled appointments.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The liquid form of lactulose may become slightly darker in color, but this is a harmless effect. However, do not use the medicine if it becomes very dark, or if it gets thicker or thinner in texture.

Lactulose powder should be mixed with at least 4 ounces of water. You may also use fruit juice or milk to make the medication taste better.

It may take up to 48 hours before you have a bowel movement after taking lactulose.

If you use lactulose over a long period of time, your doctor may want you to have occasional blood tests. Do not miss any scheduled appointments.

Store lactulose at room temperature away from moisture and heat.

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

• Do not take antacids at the same time as Constulose. Talk with your doctor.
• Measure liquid doses carefully. Use the measuring device that comes with this medicine. If there is none, ask the pharmacist for a device to measure Constulose.
• Mix liquid with water, milk, or fruit juice to make it taste better.

What do I do if I miss a dose?

• If you take this medicine on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Constulose is taken on an as needed basis. Do not take more often than told by the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burping.
• Stomach cramps.
• Gas.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Precise frequency data are not available.

Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia.

Nausea and vomiting have been reported.

Signs And Symptoms:

There have been no reports of accidental overdosage. In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms. Medication should be terminated.

Oral LD50: The acute oral LD50 of the drug is 48.8 mL/kg in mice and greater than 30 mL/kg in rats.

Dialysis: Dialysis data are not available for lactulose. Its molecular similarity to sucrose, however, would suggest that it should be dialyzable.

Lactulose has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Lactulose should only be given during pregnancy when need has been clearly established.