Storage:
active substance: pancreatin;
1 tablet contains pancreatin 250 mg, which corresponds to the activity of at least 1000 amylolytic units of Ph. Eur., 1200 lipolytic units Ph. Eur., 80 proteolytic units Ph. Eur.;
excipients: lactose, monohydrate; povidone; calcium stearate; acrylic pink 93O34055 [a mixture of substances: methacrylate copolymer (type C), talc, titanium dioxide (E 171), triethyl citrate, carmine (E 120), silicon dioxide colloidal anhydrous, sodium hydrogen carbonate, sodium lauryl sulfate, Ponceau 4R (E 124) , indigo carmine (E 132)].
Pharmaceutical form. Film-coated tablets, enteric-soluble.
The main physical and chemical properties: tablets of a round shape, covered with a shell, with a smooth, biconvex surface, from light pink to dark pink in color, the presence of a specific smell is allowed. On the fracture, when viewed under a magnifying glass, a core surrounded by one continuous layer is visible.
Pharmacotherapeutic group.
Digestive aids, including enzymes. Polyenzyme preparations.
ATX code A09A A02.
Pharmacological properties.
Pharmacodynamics.
An enzyme preparation from the pancreas of cattle and pigs. Pancreatic enzymes included in the composition of the drug: lipase, a-amylase, trypsin, chymotrypsin – facilitate the process of digestion of proteins, carbohydrates and fats of food, contributing to a more complete absorption of food substances in the small intestine.
Pharmacokinetics.
Thanks to the acid-resistant coating, the enzymes are not inactivated by the hydrochloric acid of the stomach. The dissolution of the membrane and the release of enzymes begins in the duodenum. Enzymes are weakly absorbed in the digestive tract and act in the intestinal lumen.
Clinical characteristics.
Indication.
Dyspepsia; simultaneous consumption of vegetable, fatty and unusual food that is difficult to digest; flatulence associated with the aforementioned disorders; acceleration of the passage of food in the intestines of a functional nature.
Contraindication.
Individual hypersensitivity to pancreatin or other components of the medicinal product. Acute pancreatitis, chronic pancreatitis in the exacerbation phase, intestinal obstruction.
Method of application and dosage.
Adults and children over 6 years of age should take 1-2 tablets orally, during or immediately after a meal, without chewing, with plenty of liquid.
Depending on the type of food consumed or the severity of indigestion during meals, use 2-4 tablets for the purpose of enzyme replacement therapy.
The dose of the drug and the duration of treatment are determined by the nature of the disease and are set by the doctor individually.
Children.
The drug can be used by children aged 6 years and older.
Overdose.
Symptoms: hyperuricemia, hyperuricosuria; children have constipation.
When using the drug in high doses, perianal skin irritation may occur in children.
Treatment: discontinuation of the drug, adequate hydration, symptomatic therapy
Adverse reactions.
From the side of the digestive system: diarrhea, discomfort in the epigastric region of the stomach, nausea, vomiting, flatulence, change in the nature of stools, constipation, intestinal obstruction.
From the side of the immune system: hypersensitivity reactions are possible (including rash, skin itching, sneezing, lacrimation, bronchospasm, dyspnea, urticaria, anaphylactic reactions, angioedema).
From the cardiovascular system: tachycardia.
General disorders: feeling hot, general weakness.
Expiration date.
2 years.
Storage conditions.
Store in the original packaging at a temperature not higher than 25 °C.
Keep out of the reach of children.
Packaging.
10 tablets in a blister, No. 10×1 or No. 10×2, or No. 10×5, or No. 10×6 blisters in a cardboard pack.
Leave category.
Without a prescription.
Producer.
PJSC “VITAMINS”.
The location of the manufacturer and its address of the place of business.
20300, Ukraine, Cherkasy region, Uman city, str. Leninska Iskra, 31.
The applicant
PJSC “VITAMINS”.
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