Creon

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking before starting on Creon.

Creon comes as a delayed-release capsule to take by mouth with a meal or snack.

Follow the instructions on your prescription label carefully when taking this medicine. Don't take more or less Creon than is recommended by your doctor.

Don't hold the contents of a Creon capsule in your mouth, as this may cause irritation.

Also, don't inhale the powder of a Creon capsule or allow it to touch your skin. It can irritate your nose, lungs, and skin.

You can open the capsule and sprinkle its contents into pudding or applesauce, if needed. Swallow the mixture immediately without chewing it. Don't save any of the mixture for later.

The contents of a Creon capsule must be swallowed right after the capsule is opened. Discard any unused medicine.

Don't crush or chew Creon capsules.

Pancrelipase is sold under brand names other than Creon. Don't switch to a different brand of the medicine without first talking with your healthcare provider.

Taking Creon regularly results in the greatest benefit. Be sure to get your prescription refilled before you run out of medicine.

Creon Overdose

Symptoms of a Creon overdose may include:

• Diarrhea
• Pain or swelling in your joints

If you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at 800-222-1222.

Missed Dose of Creon

If you miss a dose of Creon, skip it and take your usual dose with your next meal or snack.

Don't double up on doses to make up for a missed one.

Pancrelipase is a prescription medicine for people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Before taking pancrelipase, tell your doctor about all of your medical conditions, including if you:

• are allergic to pork (pig) products
• have a history of blockage of your intestines or scarring or thickening of your bowel wall (fibrosing colonopathy)
• have gout, kidney disease, or high blood uric acid (hyperuricemia).
• have trouble swallowing capsules
• have any other medical condition
• are pregnant or plan to become pregnant. It is not known if pancrelipase will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if pancrelipase passes into your breast milk. You and your doctor should decide if you will take pancrelipase or breastfeed.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and dietary or herbal supplements.

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used following surgical removal of the pancreas.

Pancrelipase may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Creon®, Pancreaze®, Pertzye®, and Zenpep® in children.

Appropriate studies have not been performed on the relationship of age to the effects of Ultresa™ in children younger than 12 months of age, and Viokace™ in children. Safety and efficacy have not been established in these age groups.

Geriatric

No information is available on the relationship of age to the effects of Creon®, Pancreaze®, and Pertzye® in geriatric patients.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Ultresa™, Viokace™, and Zenpep® in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving these medicines.

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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:

• Abnormal blood glucose levels, history of or
• Fibrosing colonopathy (bowel disorder) or
• Gout or
• Hyperuricemia (high uric acid in the blood) or
• Hyperuricosuria (high uric acid in the urine) or
• Intestinal (bowel) blockage, history of or
• Kidney disease or
• Pancreatitis (swelling of the pancreas)—Use with caution. May make these conditions worse.

• Allergy to pork products—Use with caution. Pancrelipase contains pork proteins.

• Lactose intolerance—Viokace™ tablets contains lactose, which can make this condition worse.

This section provides information on the proper use of a number of products that contain pancrelipase. It may not be specific to Creon. Please read with care.

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.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor about anything you do not understand.

Take this medicine with meals or snacks and enough liquid to swallow it completely, unless otherwise directed by your doctor.

When prescribing this medicine for your condition, your doctor may also prescribe a personal diet for you. Follow the special diet carefully. This is necessary for the medicine to work properly. It is also important to drink plenty of water while you are on this medicine.

For patients taking the tablets:

• Viokace™ tablet is used in combination with certain medicines for stomach ulcer called proton pump inhibitors (eg, esomeprazole, lansoprazole, omeprazole, Nexium®, Prevacid®, Prilosec®).
• Swallow the tablets quickly with some liquid, without chewing, to avoid mouth irritation.

For patients taking the delayed-release capsules:

• Swallow the capsule whole.
• Do not crush, break, or chew before swallowing. Do not hold the capsule in your mouth.
• When given to adults or children who can not swallow the capsule, the capsule may be opened and sprinkled on a small amount (about 10 mL or less) of soft food with a pH of 4.5 or less that can be swallowed without chewing, such as applesauce. This mixture must be swallowed immediately and followed with a glass of water or juice. This will ensure complete swallowing of the contents of the capsule and avoid mouth irritation.
• When given to infants, the contents of the capsule may be put directly into the infant's mouth or mixed with a small amount (about 10 mL or less) of soft acidic food with a pH of 4.5 or less, including applesauce, pureed bananas, or pears, followed by 120 mL of formula or breastfeeding. Do not mix the contents of the capsule directly to alkaline foods, such as milk, breast milk, formula, or ice cream. This could reduce the effect of the medicine.
• Pertzye® capsules may also be given through a gastrostomy tube with a diameter of 14 French or larger.
  • Mix the contents of the capsule with soft foods (including applesauce).
  • Remove the plunger and carefully spoon the mixture into the syringe. Replace the plunger partially back.
  • Connect the syringe into the tube feeding port and inject the medicine for 10 to 12 seconds.
  • Flush the tube with 10 mL of water to rinse all of the medicine into the stomach.
• Throw away any unused portions of the mixture. Do not save for later use.

Do not change the brands or dosage forms of pancrelipase without first checking with your doctor. Different products may not work in the same way. If you refill your medicine and it looks different, check with your pharmacist.

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.

• To help digestion:
  • For oral dosage form (capsules):
    • Older adults, adults, and teenagers—One to three capsules before or with meals and snacks. Your doctor may adjust your dose if needed.
    • Children—The contents of one to three capsules sprinkled on food at each meal. Your doctor may adjust your dose if needed.
  • For oral dosage form (delayed-release capsules):
    • Older adults, adults, and children older than 4 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 500 lipase units per kilogram (kg) of body weight per meal. However, the dose is usually not more than 2500 lipase units per kg of body weight per meal (or less than or equal to 10,000 lipase units per kg of body weight per day), or less than 4000 lipase units per gram (g) of fat ingested per day.
    • Children older than 12 months and younger than 4 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 1000 lipase units per kg of body weight per meal. However, the dose is usually not more than 2500 lipase units per kg of body weight per meal (or less than or equal to 10,000 lipase units per kg of body weight per day), or less than 4000 lipase units per gram (g) of fat ingested per day.
    • Children up to 12 months old—
      • Creon®: 3000 lipase units per 120 milliliters (mL) of infant formula or per breastfeeding.
      • Pancreaze®: 2600 lipase units per 120 mL of infant formula or per breastfeeding.
      • Pertzye®: 4000 lipase units (1 capsule) per 120 mL of infant formula or per breastfeeding.
      • Ultresa™: Use and dose must be determined by your doctor.
      • Zenpep®: 3000 lipase units per 120 mL of infant formula or per breastfeeding.
  • For oral dosage form (powder):
    • Older adults, adults, and teenagers—1/4 teaspoonful (0.7 gram) with meals and snacks. Your doctor may adjust your dose if needed.
    • Children—1/4 teaspoonful with meals. Your doctor may adjust your dose if needed.
  • For oral dosage form (tablets):
    • Older adults, adults, and teenagers—
      • Viokace™: Dose is based on body weight and must be determined by your doctor. The starting dose is 500 lipase units per kilogram (kg) of body weight per meal. However, the dose is usually not more than 2500 lipase units per kg of body weight per meal (or less than or equal to 10,000 lipase units per kg of body weight per day), or less than 4000 lipase units per gram (g) of fat ingested per day.
      • One to three tablets before or with meals and snacks. Your doctor may adjust your dose if needed.
    • Children—
      • Viokace™: Use and dose must be determined by your doctor.
      • One to two tablets with meals.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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.

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

You may store Creon® capsules at room temperature for 30 days. Throw away any unused medicine after 30 days.

Store the delayed-release capsules in a tightly-closed container to protect them from moisture.

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

For patients taking the capsules containing the powder:

• If the capsules are opened to mix with food, be careful not to breathe in the powder. To do so may cause harmful effects, such as stuffy nose, shortness of breath, troubled breathing, or tightness in the chest.

For patients taking the powder form of this medicine:

• Avoid breathing in the powder. To do so may cause harmful effects such as stuffy nose, shortness of breath, troubled breathing, or tightness in the chest.

Check with your doctor right away if you or your child have unusual or severe abdominal or stomach pain, trouble passing stool, nausea, or vomiting. These may be symptoms of a rare but serious bowel disorder, called fibrosing colonopathy.

This medicine may cause irritation of the inside of your or your child's mouth if it is not swallowed completely, is crushed or chewed, or is mixed into foods that are not recommended. Follow your doctor's instructions carefully to prevent this.

Pancrelipase may increase uric acid levels in the blood. Check with your doctor if you or your child have joint pain, stiffness, or swelling, lower back, side, or stomach pain, or swelling of the feet or lower legs.

This medicine is made from the pancreas of pigs. The risk of getting a virus from medicines made of pig organs has been greatly reduced in recent years. This is the result of required testing for certain viruses, and testing during manufacture of these medicines. Although the risk of transmitting certain viruses to people who will use the medicine is low, talk with your doctor if you or your child have concerns.

This medicine may cause serious types of allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you or your child are using this medicine.

Tell your doctor if you have a history of abnormal blood glucose levels before taking Zenpep®.

The active ingredient in Creon evaluated in clinical trials is lipase. Creon is dosed by lipase units.

Other active ingredients include protease and amylase. Each Creon delayed-release capsule strength contains the specified amounts of lipase, protease, and amylase as follows:

• 3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase delayed-release capsules have a white opaque cap with imprint “Creon 1203” and a white opaque body.
• 6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase delayed-release capsules have an orange opaque cap with imprint “Creon 1206” and a blue opaque body.
• 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase delayed-release capsules have a brown opaque cap with imprint “Creon 1212” and a colorless transparent body.
• 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase delayed-release capsules have an orange opaque cap with imprint “Creon 1224” and a colorless transparent body.
• 36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase delayed-release capsules have a blue opaque cap with imprint “Creon 1236” and a colorless transparent body.

No drug interactions have been identified. No formal interaction studies have been conducted.

Take Creon exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Do not switch brands of this medicine without your doctor's advice.

Creon should be taken with a meal or snack.

Read all patient information, medication guides, and instruction sheets provided to you. Be especially careful to follow all directions about giving this medicine to a child. Ask your doctor or pharmacist if you have any questions.

Creon is sometimes given with a stomach acid reducer such as Nexium, Prevacid, Prilosec, or Protonix. Follow your doctor's instructions about taking all medicines needed to treat your condition.

Do not crush, chew, or break open a capsule. Swallow the capsule whole with a full glass of water.

Do not hold the pill in your mouth. Pancrelipase can irritate the inside of your mouth.

You may open the Creon capsule and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow the mixture right away without chewing. Do not save for later use. Do not mix the medicine with infant formula or breast milk.

Do not inhale the powder from a Creon capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature, away from moisture and heat. Keep the medicine container tightly closed.

Your medicine bottle may also include a packet or canister of moisture-absorbing preservative. Keep this packet in the bottle at all times.

Call your doctor if you have any worsening of a long-term pancreas problem.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been conducted with pancrelipase. It is not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. Adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. The manufacturer recommends caution when administering pancrelipase during pregnancy.