Ozym® 20,000 gastro-resistant hard capsules, 200 capsules

Ozym® 20,000 gastro-resistant hard capsules

Ozym® 20,000 is a medicinal product containing digestive enzymes from porcine pancreas, also known as pancreatic powder or pancreatin.This preparation is used to treat digestive disorders caused by reduced or absent pancreatic function, a condition known as exocrine pancreatic insufficiency.No prescription is required for this product.

Active substances / ingredients

The active substance in Ozym® 20,000 is porcine pancreatic powder.One gastro-resistant hard capsule contains 195.2 mg of this pancreatic powder, corresponding to the following enzyme activities: lipase activity of 20,000 Ph. Eur. units, amylase activity of at least 15,000 Ph. Eur. units, and protease activity of at least 900 Ph. Eur. units.

Other ingredients include microcrystalline cellulose, crospovidone, highly dispersed silicon dioxide, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate, talc, simeticone emulsion (containing simeticone, methylcellulose, sorbic acid, and water), montan glycol wax, gelatin, and sodium dodecyl sulfate.

Contraindications

Do not take Ozym® 20,000 if you are allergic to pancreatic powder, pork, or any of the other ingredients of this medicine.The product should not be used during acute inflammation of the pancreas or during acute flare-ups of chronic inflammation in the active phase of the disease.However, during the recovery phase while reintroducing food (bland diet), intake may occasionally be beneficial if digestive problems persist.

Dosage

The recommended dose is 1 to 2 capsules per meal, corresponding to 20,000 to 40,000 Ph. Eur. units of lipase.The required dose depends on the severity of the digestive disorder and may therefore be higher.Any increase in dosage should only be carried out under medical supervision and should be guided by the improvement of symptoms such as fatty stools or abdominal pain.The dose also depends on the fat content of the meal.

A daily dose of 15,000 to 20,000 Ph. Eur. units of lipase per kilogram of body weight should not be exceeded.Particularly in patients with cystic fibrosis, the dose should not exceed the amount of enzyme necessary for adequate fat absorption.

Administration

Take Ozym® 20,000 without chewing, with plenty of fluid, preferably halfway through the meal.The product should not be taken while lying down.Ensure that you swallow the capsule whole without chewing, as chewing can reduce effectiveness and the enzymes may damage the mucous membranes.If you are unable to swallow the hard capsule, you may open it and swallow the enteric-coated micro-tablets contained within without the capsule shell.Make sure not to chew the microtablets and always drink plenty of fluid afterwards.

Patient information

Please speak to your doctor or pharmacist before taking Ozym® 20,000, especially if you suffer from cystic fibrosis and are receiving high doses of pancreatic powder.In rare cases, intestinal strictures may form, which can lead to intestinal obstruction.Symptoms such as nausea, vomiting, belching, bloating, and colicky pain should be investigated by a doctor immediately.

Children under 15 years of age with cystic fibrosis should not be treated with this product.The product has no or negligible influence on the ability to drive or use machines.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.There is insufficient experience regarding the use of the medicine in pregnant women.If you are pregnant or breastfeeding, you should not take the medicine unless your treating doctor considers it absolutely necessary.

Notes

Please do not use this medicine after the expiry date stated on the pack or outer carton.The expiry date refers to the last day of the month indicated.