Composition, form of production and packaging
? The tablets covered with a cover of white or almost white color, oblong form.
1 tab.
pancreatin 170 mg,
with enzymatic activity:
proteolytic 400 units He. F.
amylolytic 5500 Ud. He. F.
lipolytic 6500 Ud. He. F.
dimethicone 80 mg
Excipients: silicon colloidal dioxide, sorbic acid, methyl parahydroxybenzoate, propyl parahydroxybenzoate, powdered milk powder, hypromellose, acacia gum, copovidone K28.
Composition of the shell: acacia gum, copovidone K 28, magnesium oxide (light), silicon dioxide colloid, povidone, sucrose, shellac, talc, titanium dioxide (E171), macrogol 6000, sodium carmellose 2000, capillary 1295 (beeswax, carnauba wax) .
25 pcs. - blisters (1) - packs of cardboard.
25 pcs. - blisters (2) - packs of cardboard.
25 pcs. - blisters (4) - packs of cardboard.
25 pcs. - blisters (8) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Enzyme preparation. Compensates the insufficiency of the exocrine function of the pancreas.
Pancreatin is a porcine pancreatic powder containing enzymes: lipase, alpha-amylase, trypsin, chymotrypsin, and others.
Lipase cleaves fatty acids at positions 1 and 3 of triglycerides. The free fatty acids formed in this cleavage are absorbed mainly from the upper part of the small intestine with the participation of bile acids.
Trypsin is formed from trypsinogen under the action of enterokinase in the small intestine. It cleaves the bonds between the peptides in which lysine or arginine took part. According to the results of clinical studies, trypsin inhibits secretion of the pancreas by the feedback mechanism. It is believed that the analgesic effect of pancreatin, described in some studies is related precisely to this.
Alpha-amylase, like endoamylase, cleaves polysaccharides containing glucose.
Dimethicone, part of Pancreoflate, eliminates the increased accumulation of gas in the small intestine. It is a chemically inert substance whose mechanism of action is based on changes in the surface tension of gas bubbles in the intestine. These bubbles burst, and the gas in them is released, after which it is absorbed or withdrawn naturally.
PHARMACOKINETICS
Pancreatin and dimethicone are not absorbed from the digestive tract.
INDICATIONS
- dysfunction of the pancreas (lack of exocrine function), for example, chronic pancreatitis and achilles of the stomach;
- digestive disorders in case of liver and biliary tract diseases;
- Digestive disorders after operations on the stomach and small intestine, especially if these diseases are associated with increased gas production and the accumulation of gases in the intestine (flatulence).
DOSING MODE
The drug is taken orally, without chewing, squeezed with enough liquid, during or after a meal.
Adults appoint 1-2 tables. with each meal.
Children at the age of 12 years and older dosing regimen are set individually.
The duration of the course of treatment is determined by the attending physician.
SIDE EFFECT
Dermatological reactions: allergic reactions are possible (in case of intolerance to any component of the drug).
On the part of the digestive system: abdominal pain, stomach discomfort, constipation, diarrhea, nausea, vomiting, hyperuricosuria, increased uric acid level in the blood plasma.
CONTRAINDICATIONS
- children's age till 12 years;
- Hypersensitivity to the components of the drug.
With caution, the drug should be prescribed in the early stages of acute pancreatitis and with exacerbation of chronic, as well as intolerance of galactose, lactase deficiency and impaired glucose-galactose absorption.
PREGNANCY AND LACTATION
Data on the toxic effect on reproductive function and fetal development are not available.
However, since the safety of the use of Pancreoflate in pregnancy and lactation is not well understood, caution should be exercised when it is prescribed.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Possible use according to the indications
APPLICATION FOR CHILDREN
Contraindication: children under 12 years.
OVERDOSE
There are no data on cases of an overdose of Pancreoflate.
DRUG INTERACTION
Simultaneous use of antacid preparations containing magnesium carbonate and / or aluminum hydroxide can lead to a decrease in the efficiency of dimethicone.
There was no clinically significant interaction of pancreatin with other drugs.
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 out of reach of children, dry place at a temperature of no higher than 20 В° C. Shelf life - 2 years.