Creon 10000: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per cap Pancreatin powd (produced from porcine pancreas tissue) 150 mg corresponding to amylase activity 8,000 Ph. Eur. units, lipase activity 10,000 Ph. Eur. units, protease activity 600 Ph. Eur. units

Indications/Uses

Disorders of exocrine pancreas function, accompanied by maldigestion. In case of cystic fibrosis to support insufficient pancreatic function.

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Dosage/Direction for Use

Max daily dose: 15,000-20,000 Ph. Eur. lipase units/kg body wt or 4,000 Ph. Eur. lipase units/g of fat intake. Adult & adolescent 20,000-80,000 Ph. Eur. lipase units/meal (corresponding to 2-8 cap of Creon 10000). Individually adjust dose depending on severity of maldigestion & fat content of meal. Childn >4 yr 500 Ph. Eur. lipase units/kg/meal, <4 yr 1,000 Ph. Eur. lipase units/kg/meal.

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Overdosage

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Administration

Should be taken with food: Take cap unopened & w/o chewing w/ or immediately after a meal or snack w/ sufficient fluid. If difficult to swallow, carefully open cap & add pellets to soft food (pH <5.5) which does not require chewing (eg, apple puree) or take pellets w/ sufficient fluid. Immediately use mixt of pellet w/ food or fluid. No product residue should remain in the oral cavity.

Contraindications

Hypersensitivity to pork or to any of the excipients.

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Special Precautions

Dose should not exceed enzyme dose necessary for adequate fat absorption, particularly in patients w/ cystic fibrosis, taking into account the quantity & composition of meals. Dose should only be increased under medical supervision & should aim at improving symptoms (eg, steatorrhoea, abdominal pain). Reports of fibrosing colonopathy in cystic fibrosis patients receiving high doses of pancreatin prep. Assess for unusual abdominal discomfort or change in clinical picture to rule out the possibility of fibrosing colonopathy, particularly in patients taking >10,000 Ph. Eur. lipase units/kg/day. Should not be taken during pregnancy or while breastfeeding unless absolutely necessary.

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Use In Pregnancy & Lactation

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Adverse Reactions

Abdominal pain. Nausea, vomiting, constipation, diarrhoea, satiety.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Creon 10000 detailed prescribing information

Description

View Creon 10000 description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Digestives

ATC Classification

A09AA02 - multienzymes (lipase, protease etc.) ; Belongs to the class of enzyme preparations used as digestives.

Regulatory Classification

Presentation/Packing

Form

Creon 10000 hard cap w/ gastro-resistant pellets

Packing/Price

100's

Creon 10000

Manufacturer:

Abbott

Distributor:

Zuellig

The Glory Medicina