Creon

Creon is a prescription medication used to treat exocrine pancreatic insufficiency (EPI), a condition in which the pancreas does not produce enough digestive enzymes. Creon is classified as a pancreatic enzyme replacement therapy (PERT) and contains three essential enzymes, lipase, protease, and amylase. These enzymes replace those that the body cannot produce in adequate amounts and are necessary for breaking down fats, proteins, and carbohydrates during digestion.

Creon is an oral capsule taken with meals and snacks, usually three meals a day and two or three snacks. Capsules should be swallowed whole, or for patients who are unable to swallow capsule contents, may be sprinkled onto a small amount of soft food and taken as directed, without chewing.

Under normal conditions, the pancreas releases digestive enzymes into the small intestine to help process food. In patients with exocrine pancreatic insufficiency, enzyme production is reduced or absent, leading to incomplete digestion and symptoms such as weight loss, diarrhea, greasy or oily stools, bloating, malnutrition, and vitamin deficiencies.

Creon works by replacing the missing pancreatic enzymes to support normal digestion, help the body absorb nutrients more effectively, and reduce symptoms.

EPI can be caused by certain medical conditions including:

• Cystic fibrosis
• Chronic pancreatitis (long-term inflammation of the pancreas)
• Blockage of the pancreatic ducts
• Surgical removal of part or all of the pancreas

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.

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. Creon 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. Give Creon prior to each feeding.

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.

Tell your doctor if you have any changes in weight. Creon doses are based on weight (especially in children and teenagers), and any changes may affect the dose.

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

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

Creon Dosage Forms and Strengths

Creon Delayed-Release Capsules:

• 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase
• 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase
• 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase
• 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase
• 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase

Call your doctor at once if you have symptoms of a rare but serious bowel disorder: severe or unusual stomach pain, vomiting, bloating, diarrhea, or constipation.

Do not chew or keep Creon in your mouth. Creon can irritate the inside of your mouth.

To make sure Creon is safe for you, tell your doctor if you have ever had:

• kidney disease;
• gout;
• high blood uric acid levels (called hyperuricemia);
• diabetes;
• a blockage or scarring in your intestines;
• trouble swallowing pills;
• lactose intolerance; or
• or pork protein allergy.

Tell your doctor if you are pregnant or plan to get pregnant, or if you are breastfeeding or plan to breastfeed.

Common Creon side effects may include:

• stomach pain, gas, vomiting;
• diarrhea, frequent or abnormal bowel movements;
• rectal itching;
• headache, dizziness;
• runny or stuffy nose, cough, sore throat; or
• changes in your blood sugar.

Serious Creon side effects

Emergency medical help if you have signs of an allergic reaction to Creon: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• joint pain or swelling; or
• symptoms of a rare but serious bowel disorder - severe or unusual stomach pain, vomiting, bloating, diarrhea, constipation.

Tell your doctor if your child is not growing at a normal rate while using Creon.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the missed dose with your next meal or snack. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Other drugs may interact with Creon, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

• Store at room temperature between 59°F to 77°F (15°C to 25°C).
• Avoid heat. You may store CREON at a temperature between 77°F to 104°F (25°C to 40°C) for up to 30 days. Throw away any CREON stored at these temperatures for more than 30 days.
• Keep CREON in a dry place and in the original container.
• After opening the bottle, keep it closed tightly between uses to protect from moisture.
• If there is a moisture-absorbing packet (desiccant) in the bottle, keep it in the bottle. Do not eat it or throw it away.

Active Ingredients: lipase, protease, amylase

Inactive Ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.

The shells for the CREON 3,000 USP units of lipase strength capsules contain hypromellose and titanium dioxide. They also may contain carrageenan and potassium chloride.

The shells of the CREON 6,000 USP units of lipase strength capsules may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, FD&C Blue No. 2, red iron oxide, and yellow iron oxide.

The shells of the CREON 12,000 USP units of lipase strength capsules may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide.

The shells for the CREON 24,000 USP units of lipase strength capsules may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide.

The shells of the CREON 36,000 USP units of lipase strength capsules may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2.

Manufactured by: AbbVie Inc. North Chicago, IL 60064, U.S.A.

• What are enteric-coated tablets?