Details for: CREON MINIMICROSPHERES MICRO
Company: BGP PHARMA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02445158 | CREON MINIMICROSPHERES MICRO | LIPASE; AMYLASE; PROTEASE | 5000 UNIT / 100 MG; 5100 UNIT / 100 MG; 320 UNIT / 100 MG | GRANULES FOR SUSPENSION, DELAYED RELEASE | 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
CREON MINIMICROSPHERES® is used by children and adults for the treatment of pancreatic exocrine 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, including but not limited to cystic fibrosis (a rare inherited disorder), acute pancreatitis (an attack of acute inflammation of the pancreas) or chronic pancreatitis (chronic inflammation of the pancreas), pancreatic surgery/pancreatectomy, gastrectomy (surgical removal of all or part of the stomach), pancreatic cancer, gastrointestinal bypass surgery (e.g. Billroth II gastroenterostomy) (surgical opening between the stomach wall and intestine), ductal obstruction of the pancreas or common bile duct (e.g. from tumor) and ShwachmanDiamond Syndrome (genetic disorder).
What it does
CREON MINIMICROSPHERES® is intended as 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).
CREON MINIMICROSPHERES® contains an enzyme mixture
that helps you digest food. The enzymes are taken from pig
pancreas glands.
CREON MINIMICROSPHERES® contains small granules which
slowly release the pancreatic enzymes in your gut (gastro-resistant
granules, called minimicrospheres).
The enzymes in CREON MINIMICROSPHERES® work by
digesting food as it passes through the gut. You should take
CREON MINIMICROSPHERES® during or after a meal or snack.
This will allow the enzymes to mix thoroughly with the food.
When it should not be used
CREON MINIMICROSPHERES® should not be used
- If you have known hypersensitivity or allergy to porcine protein, pancreatic enzymes or to any other ingredient in this product.
What the medicinal ingredient is
The medicinal ingredient in CREON MINIMICROSPHERES® is pancreatin. CREON MINIMICROSPHERES® is a mixture of pancreatic enzymes (lipase, amylase and protease).
What the non-medicinal ingredients are
CREON MINIMICROSPHERES® MICRO contains cetyl
alcohol, dimethicone 1000, hypromellose phthalate, macrogol
4000 and triethyl citrate.
CREON MINIMICROSPHERES® 10, 20, 25 and 35 contains
cetyl alcohol, dimethicone 1000, gelatin, hypromellose phthalate,
iron oxides, macrogol 4000, sodium lauryl sulphate, titanium
dioxide and triethyl citrate.
What dosage form it comes in
CREON MINIMICROSPHERES® MICRO is available as round,
light brown gastro-resistant granules (minimicrospheres), with
5,000 Ph. Eur. units of lipase, 5,100 Ph. Eur. units of amylase,
and 320 Ph. Eur. units of protease per spoonful (100 mg).
CREON MINIMICROSPHERES® 10 is available as brown and
transparent capsules. They contain gastro-resistant granules
(minimicrospheres) with 10,000 Ph. Eur. units of lipase,
11,200 Ph. Eur. units of amylase, and 730 Ph. Eur. units of
protease per capsule.
CREON MINIMICROSPHERES® 20 is available as brown and
transparent capsules. They contain gastro-resistant granules
(minimicrospheres) with 20,000 Ph. Eur. units of lipase,
22,400 Ph. Eur. units of amylase, and 1,460 Ph. Eur. units of
protease per capsule.
CREON MINIMICROSPHERES® 25 is available as Swedish
orange and transparent capsules. They contain gastro-resistant
granules (minimicrospheres) with 25,000 Ph. Eur. units of lipase,
25,500 Ph. Eur. units of amylase, and 1,600 Ph. Eur. units of
protease per capsule.
CREON MINIMICROSPHERES® 35 is available as red brown
and transparent capsules. They contain gastro-resistant granules
(minimicrospheres) with 35,000 Ph. Eur. units of lipase,
35,700 Ph. Eur. units of amylase, and 2,240 Ph. Eur. units of
protease per capsule.
Warnings and precautions
Serious Warnings and Precautions
- A rare bowel condition called “fibrosing colonopathy”, 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.
CREON MINIMICROSPHERES® and other pancreatic enzyme
products are made from the pancreas of pigs, the same pigs used
for food. These pigs may carry viruses. Although it has never been
reported, it may be possible for a person to get a viral infection
from taking pancreatic enzyme products that come from pigs.
BEFORE you use CREON MINIMICROSPHERES® talk to
your doctor or pharmacist if you:
- are allergic to pork (pig) products
- have a history of intestinal blockage of your intestines or scarring or thickening of your bowel wall (fibrosing colonopathy)
- have any other medical condition
- are pregnant or might become pregnant
- are breast-feeding or plan to breast-feed
- have trouble swallowing capsules
Interactions with this medication
No interaction studies have been performed.
Proper use of this medication
Do not switch CREON MINIMICROSPHERES® with any other pancreatic enzyme product without first talking to your doctor.
Usual Dose
Your dose is measured in ‘lipase units’. Lipase is one of the
enzymes in CREON MINIMICROSPHERES®.
Different strengths of pancreatic enzymes may contain different
amounts of lipase.
Always follow your doctor’s advice on how much CREON
MINIMICROSPHERES® to take.
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.
Cystic fibrosis
- The usual starting dose for infants is 2,000 to 5,000 lipase units for each feeding (usually 120 mL). CREON MINIMICROSPHERES® MICRO can be given to infants.
- The usual starting dose for children under 4 years of age is 1,000 lipase units per kilogram body weight per meal. Usually, half the standard dose is given with snacks.
- The usual starting dose for children 4 years of age and over, adolescents and adults is 500 lipase units per kilogram body weight per meal. Usually, half the standard dose is given with snacks.
- The usual dose for a meal is between 25,000 and 80,000 lipase units.
- The usual dose for a snack is half the dose for a meal.
- In certain conditions, such as with acute pancreatitis, CREON MINIMICROSPHERES® should be taken when food intake has started again.
Always take CREON MINIMICROSPHERES® during or after a meal or a snack. This will allow the enzymes to mix thoroughly with the food and digest it as it passes through the gut.
How to take CREON MINIMICROSPHERES®
- Swallow the capsules whole.
- Do not crush or chew the capsules.
- If it is difficult to swallow the capsules, open them carefully and add the granules to a small amount of soft acidic food or mix them with acidic liquids. Acidic soft foods could for example be apple sauce or yogurt. Acidic liquids could be apple, orange or pineapple juice. Alternatively the minimicrospheres can be mixed with a small amount of milk on a (weaning) spoon and given to the infant immediately. The minimicrospheres should not be added to a baby’s bottle.
- Swallow the mixture immediately, without crushing or chewing and drink some water or juice. Mixing with nonacidic foods, or crushing or chewing of the granules may cause irritation in your mouth or change the way CREON MINIMICROSPHERES® works in your body.
- Do not hold CREON MINIMICROSPHERES® capsules or its content in your mouth.
- Do not store the mixture.
- As a general rule, drink plenty of liquid every day.
Take CREON MINIMICROSPHERES® until your doctor tells you to stop. Many patients will need to take CREON MINIMICROSPHERES® for the rest of their lives.
Overdose
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, CREON MINIMICROSPHERES® can cause
side effects, although not everybody gets them. The following side
effects were seen during studies in patients taking CREON
MINIMICROSPHERES®.
| Very common: | Pain in stomach (abdomen) |
| Common: | Bloating (abdominal distention), constipation, diarrhea*, nausea, vomiting |
| Uncommon: | Rash |
| Frequency unknown: | Severe itching (pruritus) and hives (urticaria) |
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Unknown frequency | |||
| Allergic reactions
(anaphylactic
reactions)
- trouble breathing - swollen lips |
✔ | ✔ | |
| Fibrosing colonopathy (abnormal narrowing of the gut) | ✔ | ✔ | |
This is not a complete list of side effects. For any unexpected
effects while taking CREON MINIMICROSPHERES
® ,
contact your doctor or pharmacist.
Tell your healthcare professional if you have any side effect that
bothers you or does not go away.
How to store
Keep out of the reach of children.
Store at temperatures not exceeding 25ºC in a tightly-closed
container to protect from moisture.
Once opened, store at temperatures not exceeding 25ºC, keep the
container tightly-closed to protect from moisture and use within 6
months.
Reporting side effects
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and
unexpected side effects to Health Canada. Your report may help to identify new side effects
and change the product safety information.
3 ways to report:
- Online at MedEffect ((www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at 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
The most recent version of this document plus the full Product
Monograph, prepared for health professionals can be found at:
www.mylan.ca
or by contacting the sponsor, BGP Pharma ULC, Etobicoke,
Ontario, M8Z 2S6 at:
1-844-596-9526
This leaflet was prepared by BGP Pharma ULC.
Last revised: