Lactitol (Oral)

Lactitol is used to treat chronic idiopathic (unknown cause) constipation (CIC). It works by increasing peristalsis (contractions) in the colon, which leads to more bowel movements.

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

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for side effects.

Tell your doctor right away if you have ongoing loose stools.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it against the benefits it may provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the use of lactitol in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of lactitol.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be taken together even if an interaction is possible. In these cases, your doctor may adjust the dose or take other precautions. Inform 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 taken around mealtime or with specific foods due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may impact the use of this medicine. Make sure to tell your doctor if you have any other medical conditions, especially:

• Galactosemia (rare metabolic disorder) or
• Stomach or bowel blockage—This medicine should not be used in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require medical attention.

Check with your doctor right away if you experience any of the following side effects:

More common

• Bloated
• excess air or gas in the stomach or bowels
• full feeling
• passing gas

Less common

• Diarrhea
• pressure in the stomach
• swelling of the abdominal or stomach area

Incidence not known

• Difficulty in breathing or swallowing
• fever
• hives, itching, rash
• nausea
• reddening of the skin, especially around the ears
• swelling of the eyes, face, or inside of the nose
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional might also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Body aches or pain
• chills
• cough
• ear congestion
• headache
• loss of voice
• sneezing
• sore throat
• stuffy or runny nose

Less common

• Blurred vision
• dizziness
• nervousness
• pounding in the ears
• slow or fast heartbeat

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Pizensy

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Take this medicine with food.

If you are using the multi-dose bottle:

• Measure the dose by using the bottle top or measuring cap that is marked to 10 grams of powder when filled to the top of white section in the cap marked by the arrow.
• Pour the measured dose into an empty 8-ounce glass.
• Add 4 ounces to 8 ounces of water, juice, or any kind of drink (eg, coffee, tea, soda) to the glass containing the powder.
• Stir thoroughly to dissolve the powder and drink the entire contents of the glass.

If you are using the unit-dose packets:

• Pour the contents of 1 or 2 unit-dose packets into an empty 8-ounce glass.
• Add 4 ounces to 8 ounces of water, juice, or any kind of drink (eg, coffee, tea, soda) to the glass containing the powder.
• Stir thoroughly to dissolve the powder and drink the entire contents of the glass.

If you are taking other medicines by mouth, take them at least 2 hours before or 2 hours after taking lactitol.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (powder for solution):For chronic idiopathic constipation: Adults—20 grams (g) once a day with food. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.