Composition, form of production and packaging
? Tablets covered with enteric-coated (film) white, round, biconvex.
pancreatin 212.5 mg
with enzymatic activity:
amylase 4500 units FIP
lipase 6000 units FIP
protease 300 units FIP
Excipients: lactose, microcrystalline cellulose, sodium starch glycolate, povidone, talc, silicon dioxide colloid, methacrylic acid copolymer, diethyl phthalate, titanium dioxide.
10 pieces. - Strips (1) - cardboard boxes.
10 pieces. - Strips (2) - cardboard boxes.
10 pieces. - Strips (3) - cardboard boxes.
10 pieces. - Strips (4) - cardboard boxes.
10 pieces. - Strips (5) - cardboard boxes.
10 pieces. - Strips (6) - cardboard boxes.
10 pieces. - Strips (7) - cardboard boxes.
10 pieces. - Strips (8) - cardboard boxes.
10 pieces. - Strips (9) - cardboard boxes.
10 pieces. - strips (10) - cardboard boxes.
10 pieces. - Strips (11) - cardboard boxes.
10 pieces. - Strips (12) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
Enzyme preparation. Compensates the insufficiency of the exocrine function of the pancreas, has a proteolytic, amylolytic and lipolytic effect.
The enzymes included in the pancreatin (lipase, alpha-amylase, trypsin, chymotrypsin) promote the cleavage of proteins to amino acids, fats to glycerol and fatty acids, starch to dextrins and monosaccharides. The drug improves the functional state of the gastrointestinal tract, normalizes the digestive process.
Trypsin inhibits the stimulated secretion of the pancreas, has analgesic effect.
Pancreatic enzymes are released from the dosage form in the alkaline medium of the small intestine (as the tablet is coated with an enteric coating protecting the components of the drug from the effects of gastric juice).
The maximum enzymatic activity is observed 30-45 minutes after ingestion.
- substitution therapy for exocrine pancreatic insufficiency (chronic pancreatitis, post-pancreatitis, post-irradiation, dyspepsia, Remkheld's syndrome / gastro-cardial syndrome), cystic fibrosis, flatulence, diarrhea of вЂ‹вЂ‹non-infectious genesis);
- a violation of the assimilation of food (state after resection of the stomach or small intestine);
- to improve the digestion of food for people with normal gastrointestinal function in the event of errors in nutrition (eating fatty foods, eating irregularly, taking large amounts of food) and in cases of malfunctioning, sedentary lifestyle, prolonged immobilization;
- Preparation for X-ray examination and ultrasound of the abdominal cavity organs.
The drug should be taken orally during or after meals, the tablets are not chewed and washed with non-alkaline liquid (water, fruit juices).
The dose is determined individually depending on the degree of digestion disorders.
For adults , prescribe 1-2 tablets. 3 times / day.
For children, the dose is determined individually.
Duration of treatment can vary from several days (if the digestive process is disturbed due to inaccuracies in the diet) to several months and years (if necessary, permanent replacement therapy).
Allergic reactions. In some cases - diarrhea, constipation, a feeling of discomfort in the stomach, nausea (however, the causal relationship of these side effects with the drug is not established, because these reactions refer to symptoms of exocrine pancreatic insufficiency).
With prolonged use in high doses, it is possible to develop hyperuricosuria, an increase in the level of uric acid in the blood plasma.
In case of cystic fibrosis in case of exceeding the necessary dose of pancreatin, development of strictures (fibrous colonopathy) in the ileocecal region in the ascending colon can be possible.
When using pancreatin in high doses, children may experience perianal irritation and irritation of the mucous membrane of the oral cavity.
- exacerbation of chronic pancreatitis;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
The safety of Penzital in pregnancy is not well understood. Therefore, the use of the drug is possible in those cases when the expected benefit for the mother exceeds the potential risk to the fetus.
APPLICATION FOR CHILDREN
For children, the dose is determined individually.
The safety of pancreatin in pregnancy is not well understood. The application is possible in cases where the expected benefit for the mother exceeds the potential risk to the fetus.
In cystic fibrosis, the use of the drug in high doses is not recommended because of the risk of developing strictures (fibrous colonopathy).
The dose of the drug should be adequate to the number of enzymes that is needed to absorb fat, taking into account the quality and quantity of food consumed.
With prolonged use of Penzital simultaneously, iron preparations should be prescribed.
Symptoms: hyperuricosuria, hyperureukemia, in children - constipation.
Treatment: it is necessary to cancel the drug and prescribe symptomatic therapy.
With the simultaneous use of pancreatin with iron preparations, it is possible to reduce absorption of the latter.
Simultaneous use of antacid preparations containing calcium carbonate and / or magnesium hydroxide, reduces the effectiveness of pancreatin.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry place inaccessible to children at a temperature of 2 В° to 25 В° C. Shelf life - 3 years.
Do not use after the expiration date stated on the package.