CREON® 5 Capsules are orally administered and contain pancrelipase (lipase 5,000 USP Units, protease 18,750 USP Units and amylase 16,600 USP Units per capsule) which is of porcine pancreatic origin. Each CREON 5 Capsule is filled with 124 mg of delayed-release MINIMICROSPHERES®.

Inactive ingredients include dibutyl phthalate, dimethicone, hydroxypropylmethylcellulose phthalate, light mineral oil and polyethylene glycol. The capsule shells contain gelatin, red iron oxide, titanium dioxide, yellow iron oxide and FD & C blue No. 2. The capsule imprinting ink contains dimethicone, 2-ethoxyethanol, shellac, soya lecithin, and titanium dioxide.

CREON 5 Capsules are indicated for patients with pancreatic exocrine insufficiency as is often associated with:

• cystic fibrosis
• chronic pancreatitis
• post-pancreatectomy
• post-gastrointestinal bypass surgery (e.g., Billroth II gastroenterostomy)
• ductal obstruction from neoplasm (e.g., of the pancreas or common bile duct)

Clinical experience should dictate initial starting dose. Doses should be taken during meals or snacks, not before or after. Do not take without food.

Adults and Children Over 6 Years Old

Usual initial starting dosage is two to four CREON 5 Capsules per meal or snack.

Children Under 6 Years Old

The exact dosage of CREON 5 Capsules should be selected based on clinical experience for this age group. Patients can be started on one to two capsules per meal or snack.

For cystic fibrosis patients, typical doses are 1,500 - 3,000 USP lipase units/kg/meal. Dosage should be adjusted according to the severity of the disease, control of steatorrhea and maintenance of good nutritional status. Doses in excess of 6,000 USP lipase units/kg/meal are not recommended.

Dose increases, if required, should occur with careful monitoring of body weight and stool fat content. When changing strengths of pancreatic enzyme products, care should be taken to maintain equivalent lipase units for each divided dosage.

It is important to ensure adequate hydration of patients at all times while taking pancreatic enzymes.

Where swallowing of capsules is difficult, the capsules may be carefully opened and the MINIMICROSPHERES added to a small amount of soft food, with a pH less than 5.5. The soft food should be swallowed immediately without chewing and followed with a glass of water or juice to insure swallowing.

CREON 5 MINIMICROSPHERES (Pancrelipase Delayed-release Capsules, USP) are available in a two-piece gelatin capsule (orange opaque top half, blue opaque bottom half) imprinted in white with "SOLVAY" and "1205". Each capsule contains tan-colored delayed-release MINIMICROSPHERES of pancrelipase supplied in bottles of:

100.......NDC 0032-1205-01
250.......NDC 0032-1205-07

CREON 5 Capsules must be stored at 25ºC (77ºF); excursions permitted to 15°-30°C (59°- 86°F). [See USP Controlled Room Temperature.] PROTECT FROM MOISTURE. DO NOT REFRIGERATE. Dispense in tight, light-resistant containers. For human consumption only.

Manufactured By: Solvay Pharmaceuticals GmbH, Hannover, Germany. Marketed by: Solvay Pharmaceuticals, Inc. Marietta, GA 30062. Rev Feb 2006. FDA Rev date: n/a

The most frequently reported adverse reactions to pancreatic enzyme-containing products are gastrointestinal in nature which may include nausea, vomiting, bloating, cramping, constipation or diarrhea. Less frequently, allergic-type reactions have also been observed. Very high doses of pancreatin have been associated with hyperuricosuria and hyperuricemia.

No information provided.

Should symptoms of hypersensitivity appear, discontinue medication and initiate symptomatic and supportive therapy if necessary.

Strictures in the ileo-cecal region and/or ascending colon have been reported in cystic fibrosis patients treated with high doses of high-potency pancreatic enzyme supplements containing 20,000 or greater USP units of lipase per capsule. The underlying mechanism is unknown, but caution should be exercised when doses in excess of 6,000 USP units lipase per kg per meal fail to resolve symptoms, especially in patients with a history of intestinal complications such as meconium ileus equivalent, short bowel syndrome, surgery or Crohn's disease. If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel stricture should be investigated including evaluation of pancreatic enzyme therapy.

CREON 5 Capsules MINIMICROSPHERES SHOULD NOT BE CRUSHED OR CHEWED or placed on foods having a pH greater than 5.5. These can dissolve the protective enteric coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy, Category C

Animal reproduction studies have not been conducted with pancrelipase. It is also not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CREON 5 Capsules should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CREON 5 Capsules are administered to a nursing mother.

No information provided.

CREON 5 Capsules are contraindicated in the early stages of acute pancreatitis or in patients who are known to be hypersensitive to pork protein.

The pancreatic enzymes in CREON 5 Capsules are enteric-coated to resist gastric destruction or inactivation. The pancreatic enzymes catalyze the hydrolysis of fats to glycerol and fatty acids, protein into proteoses and derived substances and starch into dextrins and short chain sugars.

CREON 5 Capsules are a pancreatic enzyme product prescribed to promote improved digestion of foods, especially fat. The prescribed dosage should be taken with each meal and snack or as directed by the physician. The capsules can be swallowed whole, or the contents poured on soft, bland food. Care should be taken to avoid chewing or crushing of the capsule contents, which can result in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity. Patients should maintain adequate fluid intake. The prescribed dose range should not be exceeded without calling your doctor.

The most common adverse reactions involve the stomach and intestine including diarrhea, nausea, vomiting, bloating, constipation, stomach cramps or pain. If these symptoms are persistent, contact your doctor.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

PANCRELIPASE ENTERIC-COATED CAPSULE - ORAL

(pan-kreh-LIP-aze)

COMMON BRAND NAME(S): Creon, Pancrease, Pancron, Protilase, Ultrase, Zymase

USES: This medication contains digestive enzymes to help break down and digest fats, starch, and proteins in food. It is used in conditions where the pancreas cannot make or does not release enough digestive enzymes into the small intestines to digest the food (e.g., chronic pancreatitis, cystic fibrosis, cancer of the pancreas, post-pancreatectomy, post-gastrointestinal bypass surgery).

HOW TO USE: Take this medication by mouth with meals and snacks as directed by your doctor. Swallow the capsule whole. If swallowing is difficult, then the capsule may be opened and the contents mixed in a small amount of liquid or soft food that does not need to be chewed (e.g., applesauce). Do not mix the contents of the capsule with alkaline food or liquid (e.g., milk, ice cream, tea). Consult your doctor or pharmacist for more information about what foods/liquids to avoid when mixing. Swallow the food or liquid right away, making sure not to chew the medication. Drink a glass of water or juice after swallowing the food to make sure all the medication is swallowed. Do not save the medication mixture for later.

Dosage is based on your medical condition, diet, and response to therapy.

Drink plenty of fluids while taking this medication unless your doctor tells you otherwise.

Use this medication regularly to get the most benefit from it. Take it with every meal or snack.

If your doctor has recommended that you follow a special diet, it is very important to follow the diet to get the most benefit from this medication.

Do not change brands or dosage forms of pancrelipase without consulting your doctor or pharmacist. Different products may contain different amounts of the digestive enzymes.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Diarrhea, constipation, abdominal pain/cramps, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe constipation, severe stomach/abdominal discomfort, frequent/painful urination, joint pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking pancrelipase, tell your doctor or pharmacist if you are allergic to it; or to pork protein; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas.

Before using this medication, tell your doctor or pharmacist your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: acarbose, miglitol.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting pancrelipase.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this product with others.

MISSED DOSE: If you miss a dose, take the next dose with your next meal or snack as directed. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.