Composition and form of release
Composition
Active ingredient: pancreatin;
1 tablet contains pancreatin, which corresponds to the minimum enzymatic activity: 750 amylolytic U Ph. Eur. 1000 lipolytic U Ph. Eur., 75 proteolytic U Ph. Eur.;
excipients: lactose, monohydrate; povidone; calcium stearate; acrylic green 93O31213 [mixture of dry substances: methacrylate copolymer (type C), talc, titanium dioxide (E 171), triethyl citrate, iron oxide yellow (E 172), silicon dioxide colloidal anhydrous, sodium bicarbonate, sodium lauryl sulfate, diamond blue (E 133)].
Release form
The film-coated tablets are enteric-coated.
Pharmacological properties
Pharmacodynamics.
Pancreatin contains excretory enzymes of the pancreas of pigs and cattle: lipase, amylase, trypsin and chymotrypsin – which are involved in the digestion of fats, carbohydrates and proteins, contributing to their more complete absorption in the small intestine. When using pancreatin, the digestion process is normalized, the functional state of the intestine is improved.
Pharmacokinetics.
Due to the acid-resistant coating, the enzymes are inactivated by the hydrochloric acid of the stomach. The dissolution of the shell and the release of enzymes begins in the duodenum. The enzymes are poorly absorbed in the digestive tract, act in the intestinal lumen, and are excreted in the feces.
Indication
dyspepsia; simultaneous consumption of indigestible vegetable, fatty or unusual food; flatulence associated with the above disorders; acceleration of the passage of food in the intestines of a functional nature.
Contraindication
Individual hypersensitivity to pancreatic enzymes of animal origin or to any of the components of the drug. acute pancreatitis, chronic pancreatitis in the acute stage. obstructive intestinal obstruction.
Method of administration and doses.
Tablets should be taken before or during each meal, without chewing, with plenty of liquid. The dose of the drug is set individually by the doctor, depending on the age and degree of enzyme deficiency, and may be changed.
For children aged 3-5 years, a single dose is 1 tablet; 6-7 years – 1-2 tablets; 8-9 years – 2 tablets; 10-14 years – 2-4 tablets.
The duration of treatment is determined by the doctor individually.
Application features
Digestive system disorders may occur in patients with hypersensitivity to pancreatin or in patients with a history of meconium ileus or intestinal resection.
It should be noted that the presence of a methacrylic acid derivative in the composition of the medicinal product may lead to the risk of developing fibrosing colonopathy when using high doses. If signs of colonic obstruction occur during the use of the drug, the patient should be examined for the presence of fibrosing colonopathy as a possible cause of this pathological condition.
To avoid the formation of uric acid stones, the uric acid content in the urine should be controlled.
The medicine contains active enzymes that can damage the oral mucosa, so the tablets should be swallowed whole, without chewing.
When taking the drug before meals, it should be washed down with alkaline liquids (for example, Borjomi mineral water or 0.5-1% sodium bicarbonate solution).
With prolonged use, simultaneous administration of iron preparations is recommended.
The drug contains lactose, therefore, if the patient has been diagnosed with intolerance to some sugars, you should consult a doctor before taking this drug.
Use during pregnancy or breastfeeding
The drug should not be used in patients of reproductive age.
Drivers
There are no reservations.
Children
The drug should be used in children aged 3 to 14 years (see the “Method of administration” section).
Overdose
Symptoms: overdose may increase side effects.
Hyperuricemia and hyperuricosuria have been observed when extremely high doses of the drug were administered. Fibrosing colonopathy may develop when high doses of the drug are administered.
Treatment: drug withdrawal, symptomatic therapy.
Adverse reactions
On the part of the digestive system: diarrhea, constipation, flatulence, discomfort in the stomach, abdominal pain, nausea, vomiting, change in the nature of stools, the appearance of strictures of the colon or ileocecal part of the intestine. In case of unusual abdominal symptoms or increased pain, it is necessary to exclude the possibility of developing fibrosing colonopathy.
On the part of the immune system: allergic reactions, including skin itching, skin rash, runny nose, sneezing, lacrimation, bronchospasm, urticaria, anaphylactic reactions, angioedema.
Metabolic: when using the drug in high doses in children, perianal skin irritation may occur.
Interaction
With simultaneous use of pancreatin with antithrombotic agents, vitamin D antagonists and acetylsalicylic acid, the effect of these drugs is reduced. The effectiveness of non-selective monoamine reuptake inhibitors is also reduced when used together with pancreatin.
When used simultaneously with M-cholinoblockers, the anticholinergic effect is enhanced.
When using pancreatin, the absorption of iron and folic acid may be reduced. Simultaneous use of antacids containing calcium carbonate and/or magnesium hydroxide, with tannin, alcohol-containing products may lead to a decrease in the effectiveness of pancreatin.
Storage conditions
In the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children. Shelf life – 2 years.









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