Viokace (Pancrelipase)

Serious Warnings and Precautions

A rare bowel condition called ʺfibrosing colonopathyʺ, where your gut is narrowed, has been reported in patients with cystic fibrosis taking high doses of pancreatic enzymes. As a precaution, consult your doctor if you experience any unusual abdominal symptoms or any change in abdominal symptoms, especially if you are taking more than 10 000 units of lipase/kg body weight/day or more than 4 000 units of lipase/gram fat intake.

Talk to your doctor about all the drugs you are taking before taking VIOKACE.

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or are breast-feeding. Your doctor will decide if you should take VIOKACE and at which dose.

Potential Viral Exposure from the Product Source: The pancreas glands used to make VIOKACE and other pancreatic enzyme products come from pigs used for food. These pigs may carry viruses. When VIOKACE is made several steps are taken to reduce the risk of viruses being spread, including their destruction and testing for specific viruses. The risk of infections caused by these or other unknown or novel viruses cannot be totally ruled out. However, there have not been any cases reported where infection of patients has occurred.

BEFORE you use VIOKACE talk to your doctor or pharmacist if:

• You are allergic to pork (pigs) products
• You have a history of intestinal blockage of your intestines or scarring or thickening of your bowel wall (fibrosing colonopathy)
• You have any other medical conditions
• You are pregnant or might become pregnant
• You are breast-feeding or plan to breast-feed

Common Side Effects of VIOKACE

Tell your doctor if any of the following side effects become severe or don't go away:

• Headache
• Cough or sore throat
• Dizziness
• Nausea or upset stomach
• Nosebleed
• Neck pain
• Feeling full after eating a small amount of food
• Constipation
• Diarrhea
• Greasy stools
• Heartburn
• Gas
• Sore mouth or tongue
• Irritation around the rectum
• Weight loss

Serious Side Effects of VIOKACE

Tell your doctor right away if you experience any of the following serious side effects:

• Signs of an allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, or throat)
• Hoarseness
• Severe nausea or vomiting
• Severe or unusual stomach pain
• Difficulty having bowel movements
• Pain or swelling in your joints, especially in your big toe

There are no known drug interactions with VIOKACE.

Before taking VIOKACE tablets make sure you tell your doctor and pharmacist all the medications (including those without prescription) you are taking.

Do not switch VIOKACE with any other pancreatic enzyme product without first talking to your doctor.

Always take VIOKACE with a meal or a snack and enough liquid to swallow VIOKACE completely. This will allow the enzymes to mix thoroughly with the food and digest it as it passes through the gut. If you eat a lot of meals or snacks in a day, be careful not to go over your total daily dose.

Usual dose:

Your dose is measured in ‘lipase units’. Lipase is one of the enzymes in VIOKACE. Different strengths of pancreatic enzymes may contain different amounts of lipase.

Your doctor should also prescribe a medicine for you called a proton pump inhibitor (PPI) to decrease stomach acid. VIOKACE should be taken with a PPI to help prevent VIOKACE from breaking down in your stomach.

Your doctor will adjust your dose to suit you. It will depend on:

• your illness
• your weight
• your diet
• how much fat is in your stools

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you know or suspect that you have taken more of this product than you normally do, or notice any unusual symptoms, contact your doctor or nearest hospital emergency department immediately. Ensure that you are adequately hydrated during this time by drinking plenty of fluids.

Extremely high doses of pancreatic enzymes have sometimes caused too much uric acid in the urine (hyperuricosuria) and in the blood (hyperuricaemia).

Missed dose:

If a dose of this medication has been missed, take your next dose at the usual time, with your next meal. Do not try to make up for the dose that you have missed.