active substance:Pancreatin (pork)
1 capsule contains 106,213-136,307 mg of Pancreatin with the enzymatic activity of lipase - 10000 IU, amylase - 7200 ED, protease - 400 IU
excipients: methacrylate copolymer dispersion (contains methacrylic acid and ethacrylate copolymer (1: 1), Polysorbate 80, sodium lauryl sulfate, water), triethyl citrate, talc, simeticone emulsion 30% (contains simeticone, methylcellulose, sorbic acid, water)
hard gelatin capsule contains gelatin, titanium dioxide (E 171).The
White, matte capsules filled with beige and brown granules with a characteristic odor.The
the KRKA D. D., Novo mesto, Slovenia.
Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
KRKA, dd, Novo mesto, Slovenia.
Smarjeskacesta 6, 8501 Novo mesto, Slovenia.The
means to improve digestion, including enzymes. Multienzyme preparations. PBX code A09AA02.
Capsules Panzinorm 10000 compensate for the deficiency of pancreatic enzymes, accelerate catabolism and improve the clinical picture in digestive disorders. Active enzymes are released in the small intestine, where they continue to act. High activity of lipase is a key in the treatment of digestive disorders, which are caused by insufficient digestive enzymes. Lipase breaks down fats to fatty acids and monoglycerides, allowing their absorption and absorption of fat-soluble vitamins. Amylase breaks down carbohydrates to dextrins and sugars, protease acts on proteins.
Panzinorm 10000 improves the body's nutrition by improving the absorption of various types of food, as well as prevents or reduces steatorrhea and symptoms associated with digestive disorders.
Panzynorm 10,000 can reduce pain in chronic pancreatitis. This effect is associated with the action of protease, reduces pancreatic secretion. The mechanism of this effect is not exactly studied.
Lack of exocrine function of the pancreas in adults and children due to various diseases, including:The
hypersensitivity to the active substance, pork or other components of the drug.
Acute pancreatitis or exacerbation of chronic pancreatitis.
the Product contains active enzymes that can damage the mucous membrane of the oral cavity, so the capsules should be swallowed whole, without chewing, drinking enough liquid.
in patients with cystic fibrosis, who took high doses of Pancreatin, there were narrowing of the ileocecal intestine and colon (fibrous colonopathy).
as a preventive measure, it is recommended to seek medical advice in case of unusual abdominal symptoms or changes in the nature of abdominal symptoms in order to exclude the possibility of fibrous colonopathy, especially if the patient takes more than 10,000 units of lipase/kg/day.
there is no data on safety of lipase, amylase and protease during pregnancy.
while animal studies have not identified direct or indirect adverse effects on pregnancy, embryo development, birth or postnatal development.
care should be taken to appoint pregnant women. Enzymes are not absorbed from the gastrointestinal tract, but the risk can not be excluded. The drug should be used by pregnant and breastfeeding, only when the expected benefit to the mother exceeds the potential risk to the child.The
there has been no effect on the driving ability and other machinery.The
Used in pediatric practice.
the Dosage of the drug is based on the individual needs of the patient and depends on the degree of digestive disorders and food composition. The drug should be taken during or immediately after a meal.
the Capsule is swallowed whole, without chewing, drinking plenty of fluids or take with a light meal. To facilitate the intake of Panzinorm 10000 (children and the elderly), the capsule can be opened and add acid-resistant granules to liquid food that does not require chewing, such as Apple puree or liquid with neutral or slightly acidic medium (yogurt, grated Apple). This mixture should be taken immediately.
during the treatment of Panzinorm 10000 it is very important to consume a sufficient amount of fluid, especially during the period of increased loss. Lack of fluid can increase constipation.
Dosing for cystic fibrosis.
General recommendations for substitution therapy with pancreatic enzymesThe
the Dose should be selected individually, depending on the severity of the disease, control steatorrhea and maintain proper nutritional status.
maintenance dose for most patients should not exceed 10,000 IU of lipase per kilogram of body weight per day or 4000 IU of lipase per 1 gram of fat consumed.
Dosing for other types of pancreatic exocrine insufficiencyThe
the Initial dose is 10,000 to 25,000 UNITS of lipase during each main meal. However, it is possible that some patients need a higher dose for the elimination of steatorrhea and maintaining adequate nutritional status. According to conventional clinical practice, it is believed that at least 20,000 to 50,000 units of lipase should be taken from food. Dose for reception during the main meals (Breakfast, lunch or dinner) can be from 25,000 to 80,000 UNITS of lipase, and with additional light nutrition between the main meals should be half of the individual dose.
No data on systemic toxicity in overdose. Overdose can cause nausea, vomiting, diarrhea, hyperuricemia and uricosuria, perianal irritation, and very rarely, mainly in patients with cystic fibrosis, colonopathy.
in case of overdose, the drug should be stopped, hydration of the body and symptomatic treatment are recommended.
on the part of the immune system:
hypersensitivity reactions, including rash, itching, redness of the skin, sneezing, urticaria, lacrimation, bronchospasm, obstruction of the respiratory tract, anaphylactic reactions.
from the gastrointestinal tract:
nausea, vomiting, abdominal pain, constipation or diarrhea, flatulence, changes in the nature of the chair, skin irritation around the mouth or anus, especially after taking high doses.
in rare cases in patients with cystic fibrosis, taking the drug in high doses (more than 10,000 UNITS of lipase/kg/day) can lead to the formation of strictures of the colon or the ileocecal part of the intestine. In case of sudden pain or worsening of abdominal pain, in case of flatulence it is necessary to undergo an examination to exclude possible fibrous colonopathy.
influence the results of laboratory and instrumental studies:
hyperuricemia, hyperuricosuria, folic acid deficiency.The
pancreatic Enzymes inhibit the absorption of folic acid. While taking bicarbonates and cimetidine with high doses of pancreatic enzymes, it is recommended to periodically analyze the concentration of folic acid salts in the blood serum and provide additional folic acid intake, if necessary.
pancreatic Enzymes can reduce the efficacy of acarbose and miglitol.
Acid-resistant microgranules contained in Panzinorm 10000, are destroyed in the duodenum. If the acidity of the contents of the duodenum is too high, the enzymes will be released untimely. Reduction of gastric acid secretion, achieved by the inhibitors of N2receptors or proton pump inhibitors, can reduce the dose of Panzinorm 10000 in some patients.
pancreatic Enzymes may reduce iron absorption, but the clinical significance of this interaction is unknown.The
Keep at temperature not exceeding 25oSV original package to protect from moisture.
keep out of reach of children.The
7 capsules in a blister, 3 capsules or 8, or 12 blisters in a box.The
over the counter.
the Preparation of Panzinorm is intended to fill a lack of pancreatic enzymes. It is recommended to receive in dyspepsia, cystic fibrosis, blockage of the biliary tract, disorders of the hepatobiliary system. Due to the presence of pork Pancreatin, the tool quickly normalizes the processes of catabolism and replenishes the enzyme deficiency.
Panzinorm tablets are usually recommended to be Taken in the following order: one capsule to drink before a snack, the remaining daily dose – before the main meal. The amount of the drug per day and the duration of the course of therapy with its use is determined by the attending physician.