Pancreatin tablets p / o 25ED, No. 60

Substitution therapy for exocrine pancreatic insufficiency: chronic pancreatitis; pancreatectomy after irradiation; dyspepsia; cystic fibrosis.

Flatulence diarrhea of ??non-infectious genesis Remheld syndrome (gastrocardiac syndrome).

Impaired assimilation of food (condition after resection of the stomach and small intestine); to improve the digestion of food in persons with normal function of the gastrointestinal tract in case of errors in nutrition (consumption of fatty foods, irregular meals) and in cases of impaired chewing function, a sedentary lifestyle, prolonged immobilization.

Preparation for X-ray and ultrasound examination of the abdominal organs.

Inside. The drug is taken during or after meals without chewing and drinking a non-alkaline liquid (water, fruit juices).

The dose is determined individually depending on the degree of indigestion. Adults usually take 2-4 tablets 3-6 times a day. The maximum daily dose is 16 tablets. In children over 6 years of age, the drug is used as directed by a doctor. The dose is determined individually. Usually, 1 tablet is prescribed 3 times a day.

The duration of treatment can vary from several days (if the digestive process is disturbed due to dietary errors) to several months or years (if constant replacement therapy is necessary).

Active substance:

Pancreatin - 0.1g

Core Auxiliaries:

potato starch - 31,000 mg

gelatin - 8,140 mg

calcium stearate - 3,120 mg

lactose monohydrate (milk sugar) - to obtain a core 312 mg

Excipients of the shell:

Methacrylic acid and - 13.706 mg

ethyl acrylate copolymer

[1: 1] (KollicoatЃMAE 100 P)

Talc - 4.349 mg

polysorbate (tween-80) - 2,750 mg

povidone (kollidone 30) 1.310 mg

titanium dioxide (titanium dioxide) - 0.810 mg

dye azorubin (acid-0.021 mg

red 2C, card

moazine, E 122)

Hypersensitivity to the components of the drug acute pancreatitis exacerbation of chronic pancreatitis in children under 6 years of age.

The drug contains lactose monohydrate, therefore its use is not recommended for patients with rare hereditary diseases associated with galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Carefully:

In case of cystic fibrosis, the drug should be prescribed with caution because the dose should be adequate to the quantity and quality of food consumed; the use of high doses of pancreatin is not recommended due to the increased risk of developing strictures (fibrous colonopathy).

Criteria for an adequately selected dose: an increase in body weight, normalization of stool (less than 3 times a day, normalization of consistency), a decrease in abdominal distention.

Trade name of the drug

Pancreatin

International non-proprietary name

Pancreatin

Dosage form

enteric film-coated tablets

Composition

Composition for one tablet

Active substance:

Pancreatin - 0.1g

Core Auxiliaries:

potato starch - 31,000 mg

gelatin - 8,140 mg

calcium stearate - 3,120 mg

lactose monohydrate (milk sugar) - to obtain a core 312 mg

Excipients of the shell:

Methacrylic acid and - 13.706 mg

ethyl acrylate copolymer

[1: 1] (KollicoatЃMAE

100 R)

Talc - 4.349 mg

polysorbate (tween-80) - 2,750 mg

povidone (kollidone 30) 1.310 mg

titanium dioxide (titanium dioxide) - 0.810 mg

dye azorubin (acid-0.021 mg

red 2C, card

moazine, E 122)

Description

Film-coated tablets, pink or dark pink, biconvex. On the cross-section, two layers are visible: the outer one is pink or dark pink in color, the inner one is from white with a yellowish or brown tint to brown interspersed with light brown to dark brown. The presence of a specific smell is allowed.

Pharmacotherapeutic group

Digestive Enzyme Remedy

ATX code

A09AA

Pharmacodynamics:

Compensates for the lack of exocrine pancreatic function has a proteolytic amylolytic and lipolytic effect.

The enzymes included in pancreatin (lipase amylase trypsin chymotrypsin) promote the breakdown of proteins to amino acids of fats to glycerol and fatty acids of starch to dextrins and monosaccharides.

Improves the functional state of the gastrointestinal tract, normalizes the digestion processes.

Trypsin inhibits the stimulated secretion of the pancreas by providing an analgesic effect.

Pharmacokinetics:

Pancreatic enzymes are released from the dosage form in the alkaline environment of the small intestine. protected from the action of gastric juice by the membrane.

The maximum enzymatic activity is observed 30-40 minutes after oral administration. Most of the enzymes are inactivated as a result of autolysis and proteolysis. A small part of the digestive enzymes is excreted through the intestines.

Indications:

Substitution therapy for exocrine pancreatic insufficiency: chronic pancreatitis; pancreatectomy after irradiation; dyspepsia; cystic fibrosis.

Flatulence diarrhea of ??non-infectious genesis Remheld syndrome (gastrocardiac syndrome).

Impaired assimilation of food (condition after resection of the stomach and small intestine); to improve the digestion of food in persons with normal function of the gastrointestinal tract in case of errors in nutrition (consumption of fatty foods, irregular meals) and in cases of impaired chewing function, a sedentary lifestyle, prolonged immobilization.

Preparation for X-ray and ultrasound examination of the abdominal organs.

Contraindications:

Hypersensitivity to the components of the drug acute pancreatitis exacerbation of chronic pancreatitis in children under 6 years of age.

The drug contains lactose monohydrate, therefore its use is not recommended for patients with rare hereditary diseases associated with galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Carefully:

In case of cystic fibrosis, the drug should be prescribed with caution because the dose should be adequate to the quantity and quality of food consumed; the use of high doses of pancreatin is not recommended due to the increased risk of developing strictures (fibrous colonopathy).

Criteria for an adequately selected dose: an increase in body weight, normalization of stool (less than 3 times a day, normalization of consistency), a decrease in abdominal distention.

Pregnancy and lactation:

The safety of using pancreatin during pregnancy has not been studied enough. Application is possible in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

During lactation, the use of pancreatin is not contraindicated.

Method of administration and dosage:

Inside. The drug is taken during or after meals without chewing and drinking a non-alkaline liquid (water, fruit juices).

The dose is determined individually depending on the degree of indigestion. Adults usually take 2-4 tablets 3-6 times a day. The maximum daily dose is 16 tablets. In children over 6 years of age, the drug is used as directed by a doctor. The dose is determined individually. Usually, 1 tablet is prescribed 3 times a day.

The duration of treatment can vary from several days (if the digestive process is disturbed due to dietary errors) to several months or years (if constant replacement therapy is necessary).

Side effects:

Allergic reactions. Rarely - diarrhea, constipation, feeling of discomfort in the stomach, nausea (the cause-and-effect relationship of the development of these reactions with the action of pancreatin has not been established, since these phenomena refer to symptoms of exocrine pancreatic insufficiency). With prolonged use in high doses, hyperuricosuria and hyperuricemia may develop. With cystic fibrosis, if the required dose of pancreatin is exceeded, strictures (fibrous colonopathy) may develop in the ileocecal region in the ascending colon.

When using pancreatin in high doses in children, perianal irritation and irritation of the oral mucosa may occur.

Overdose:

Symptoms: hyperuricosuria, hyperuricemia. Children have constipation. Treatment: drug withdrawal symptomatic therapy.

Interaction:

With the use of pancreatin, a decrease in the absorption of iron and folic acid is possible. The simultaneous use of antacids containing calcium carbonate and / or magnesium hydroxide can lead to a decrease in the effectiveness of pancreatin.

Special instructions:

The dose of the drug should be adequate to the amount of enzymes that is necessary for the absorption of fats, taking into account the quality and quantity of food consumed.

With prolonged use, iron supplements are prescribed at the same time.

Impact on the ability to drive vehicles. Wed and fur .:

The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Release form / dosage:

Enteric film-coated tablets 25 UNITS

Packaging:

10 20 30 50 60 80 100 tablets each in a dark glass jar of the BTS type or in a jar with a tight glass sealed lid with a sealing element or a plastic tightening lid or in a polymer jar of BP type made of polypropylene or low or high pressure polyethylene.

But 10 tablets in a blister strip made of polyvinyl chloride film and printed aluminum foil lacquered or from paper with polyethylene coating.

Each can or no 1 2 3 5. 6 8 10 blisters together with instructions for the use of the drug are placed in a carton box.

Storage conditions:

At a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date.

Vacation conditions

Without recipe

Manufacturer

Biosynthesis JSC, 440033, Penza, st. Friendship, 4, Russia

Marketing Authorization Holder / Organization Receiving Consumer Claims:

Biosynthesis JSC