Details for: VIOKACE
Company: NESTLE ENTERPRISES S.A.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02230019 | VIOKACE | PROTEASE; LIPASE; AMYLASE | 57100 UNIT; 10440 UNIT; 56400 UNIT | TABLET | ORAL |
| 02241933 | VIOKACE | LIPASE; PROTEASE; AMYLASE | 20880 UNIT; 112500 UNIT; 113400 UNIT | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
VIOKACE is used for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease that might require pancreatic enzyme therapy, as determined by the doctor. VIOKACE is a prescription medicine used with a proton pump inhibitor medicine (PPI).
What it does
VIOKACE is intended as a replacement therapy when your pancreas, which produces enzymes necessary to digest fat, protein and sugars, has stopped functioning or is not functioning as it should be. The medical term for this condition is pancreatic exocrine insufficiency. Symptoms of pancreatic exocrine insufficiency include steatorrhea (excess of fat in stools).
VIOKACE contains an enzyme mixture that helps you digest food. The enzymes are taken from pig pancreas glands.
The enzymes in VIOKACE work by digesting food as it passes through the gut. You should take VIOKACE before or with a meal or snack. This will allow the enzymes to mix thoroughly with the food.
When it should not be used
VIOKACE should not be used if
- You have known hypersensitivity to porcine protein, pancreatic enzymes or any excipients; and / or during acute pancreatitis or the acute exacerbation of chronic pancreatitis.
What the medicinal ingredient is
The medicinal ingredient in VIOKACE is pancrelipase. VIOKACE is a mixture of pancreatic enzymes (lipase, amylase and protease).
What the non-medicinal ingredients are
Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, stearic acid and talc
What dosage form it comes in
VIOKACE (10,440 USP units lipase): tablets with 10,440 USP units of lipase, 56,400 USP units of amylase and 57,100 USP units of protease.
VIOKACE (20,880 USP units lipase): Tablets with 20,880 USP units of lipase, 113,400 USP units of amylase and 112,500 USP units of protease.
Warnings and precautions
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
Interactions with this medication
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.
Proper use of this medication
Take VIOKACE tablets exactly as your doctor tells you.
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
Always take VIOKACE tablets with enough liquid to swallow the whole tablets. Do not take VIOKACE if you cannot swallow the tablets whole. Do not mix with food or crush or chew the tablets. Be careful to make sure that no VIOKACE is left in your mouth. Crushing, chewing or holding the VIOKACE tablets in your mouth may cause irritation in your mouth, or change the way VIOKACE works in your body.
If you still have fatty stools or other stomach or gut problems (gastrointestinal symptoms), talk to your doctor as your dose may need to be adjusted.
The usual starting dose is 500 lipase units per kilogram body weight per meal. Usually, half the starting dose is given with snacks.
The maximum dose is 2,500 lipase units per kilogram body weight per meal (or less than or equal to 10,000 lipase units/kg body weight per day), or less than 4,000 lipase units/g fat ingested per day
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.
Side effects and what to do about them
Like all medicines, VIOKACE can cause side effects, although not everybody gets them. The following side effects were seen during studies in patients taking VIOKACE.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Abdominal pain | ✔ | ||
| Rash | ✔ | ||
| Unknown | |||
| Hypersensitivi ty (allergic reaction) | ✔ | ||
| Urticaria | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking VIOKACE, contact your doctor or pharmacist
Tell your healthcare professional if you have any side effect that bothers you or that does not go away.
How to store
Keep out of reach of children.
Keep VIOKACE in a dry place and in its original container.
Store VIOKACE in a dry place at room temperature (20°C to 25°C). Protect from heat and moisture.
After opening the bottle, keep it closed tightly between uses to protect from moisture. The VIOKACE bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not eat or throw away the desiccant packet.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by one of the following 3 ways:
- Reporting online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345.
- Complete a Canada Vigilance Reporting Form
and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 1908C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form
and the adverse reaction reporting guidelines are
available on the MedEffect™ Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for healthcare professionals can be found by contacting the sponsor, Nestlé Enterprises S.A., at: 1-833-920-2178.
All trademarks are owned by Société des Produits Nestlé S.A., Vevey, Switzerland and used under license. © 2020 Nestlé.
This leaflet was prepared by:
Nestlé Enterprises S.A.
12, rue Entre-deux-Villes
1800 Vevey Switzerland
Last revised: July 3, 2020