Pronunciation:

LAK-ti-tol

Brand Names:

• Pizensy

Uses of This Medicine:

Lactitol is used to treat chronic idiopathic (unknown cause) constipation (CIC). It works by increasing peristalsis (contractions) in the colon, leading to an increase in the number of bowel movements.

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

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lactitol in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lactitol in the elderly.

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.

Other 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.

Other interactions—

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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 unwanted effects.

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

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

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 adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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 occur in some patients. If you notice any other effects, check with your healthcare professional.

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