Pizensy (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 checks your progress at regular visits to ensure this medicine is working properly and to look for unwanted effects.

Tell your doctor immediately if you have ongoing loose stools.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This decision will be made together with your doctor. 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, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have been no appropriate studies on the effects of lactitol in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the use of lactitol.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might happen. In these cases, your doctor may need to 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

Some medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

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

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.

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.