Pancreatin tablets p / o 10 000 ED, No. 20

- Lack of exocrine pancreatic function (chronic pancreatitis, cystic fibrosis and others);

- chronic inflammatory-dystrophic diseases of the stomach, intestines, liver of the gallbladder;

- conditions after resection or irradiation of the gastrointestinal tract, accompanied by impaired digestion of food with flatulence diarrhea (as part of combination therapy);

- to improve the digestion of food in patients with normal gastrointestinal tract function in case of inaccuracies in nutrition;

- preparation for X-ray and ultrasound examination of the abdominal organs;

- gastrointestinal disorders of a functional nature (with acute intestinal infections, irritable bowel syndrome and others).

The dose of Pancreatin 10,000 is set individually depending on the disease and the severity of symptoms.

Unless otherwise instructed, adults should take 2-4 tablets of Pancreatin 10,000 with meals. The drug is taken orally without breaking or chewing the tablet (the effectiveness of Pancreatin 10,000 may decrease when chewed and pancreatic enzymes, when released, can irritate the oral mucosa) with a sufficient amount of liquid (for example, a glass of water).

It is not recommended to exceed the daily dose of pancreatic enzymes corresponding to 15000-20000 IU of lipase / kg of body weight.

An increase in the dose should be carried out only under the supervision of a physician, while focusing on symptoms (for example, a decrease in steatorrhea and abdominal pain). The duration of treatment is determined by the doctor and can vary from several days (in case of indigestion due to an error in the diet) to several months or even years (if constant substitution therapy is necessary).

In children, the dosage is determined by the doctor.

For one tablet:

Active ingredient: Pancreatin - 125,0001 mg, corresponding to the enzymatic activity: lipase - not less than 10,000 U, amylase - not less than 7,500 U, protease - not less than 375 U

Excipients: lactose monohydrate - 101.6002 mg, microcrystalline cellulose - 52,000 mg, crospovidone - 18,000 mg, magnesium stearate - 1.867 mg, colloidal silicon dioxide (aerosil) - 1.533 mg

Shell composition: methacrylic acid and ethyl acrylate copolymer (1: 1) - 12,200 mg, talc - 6,780 mg, titanium dioxide - 5,050 mg, hypromellose - 4,800 mg, triethyl citrate - 3,900 mg, polysorbate 80 (tween 80) - 0,690 mg, sodium carmellose - (sodium carboxymethyl cellulose) - 0.440 mg, macrogol 6000 (polyethylene glycol 6000) - 0.210 mg, simethicone emulsion 30% (dry weight) - 0.163 mg, dye azorubin (carmoisine) - 0.022 mg

1 The amount may vary depending on the lipolytic activity of the parent substance. It is permissible to use a substance with lipolytic activity from 80 U / mg to 44 U / mg.

2 The amount may vary depending on the lipolytic activity of the parent substance - from 101,600 mg to 0,000 mg.

3 The emulsion contains simethicone (30%), emulsifiers (5-10%), preservatives (0.5-1.0%), purified water (60-65%).

- Hypersensitivity to any of the components of the drug;

- acute pancreatitis or chronic pancreatitis in the acute stage. Nevertheless, it is possible to use it in the phase of a damping exacerbation with the expansion of the diet if there are signs of indigestion;

- hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

- children's age up to 3 years (for this dosage form).

Trade name of the drug

Pancreatin 10000

International non-proprietary name

Pancreatin

Dosage form

enteric film-coated tablets

Composition

For one tablet:

Active ingredient: Pancreatin - 125,0001 mg, corresponding to the enzymatic activity: lipase - not less than 10,000 U, amylase - not less than 7,500 U, protease - not less than 375 U

Excipients: lactose monohydrate - 101.6002 mg, microcrystalline cellulose - 52,000 mg, crospovidone - 18,000 mg, magnesium stearate - 1.867 mg, colloidal silicon dioxide (aerosil) - 1.533 mg

Shell composition: methacrylic acid and ethyl acrylate copolymer (1: 1) - 12,200 mg, talc - 6,780 mg, titanium dioxide - 5,050 mg, hypromellose - 4,800 mg, triethyl citrate - 3,900 mg, polysorbate 80 (tween 80) - 0,690 mg, sodium carmellose - (sodium carboxymethyl cellulose) - 0.440 mg, macrogol 6000 (polyethylene glycol 6000) - 0.210 mg, simethicone emulsion 30% (dry weight) - 0.163 mg, dye azorubin (carmoisine) - 0.022 mg

1 The amount may vary depending on the lipolytic activity of the parent substance. It is permissible to use a substance with lipolytic activity from 80 U / mg to 44 U / mg.

2 The amount may vary depending on the lipolytic activity of the parent substance - from 101,600 mg to 0,000 mg.

3 The emulsion contains simethicone (30%), emulsifiers (5-10%), preservatives (0.5-1.0%), purified water (60-65%).

Description

Round, biconvex coated tablets from light pink to dark pink, a characteristic odor is allowed. Surface roughness is allowed. On a cross-section, the core is light beige interspersed with from almost white to light brown.

Pharmacotherapeutic group

Digestive Enzyme Remedy

ATX code

A09AA

Pharmacodynamics:

Pancreatin is a powder from the pancreas of pigs.

Pancreatic enzymes that are part of pancreatin have a proteolytic amylolytic and lipolytic effect and promote the breakdown of proteins, fats and carbohydrates, improve the functional state of the gastrointestinal tract (GIT), thus normalizing digestion processes.

Pharmacokinetics:

The tablets of Pancreatin 10 000 are coated with an acid-resistant coating that is resistant to the action of gastric hydrochloric acid and thereby protects the pancreatic enzymes contained in the preparation from inactivation. Dissolution of the enteric coat and release of enzymes occurs at neutral or slightly alkaline pH values. Pancreatic enzymes are not absorbed from the gastrointestinal tract.

Indications:

- Lack of exocrine pancreatic function (chronic pancreatitis, cystic fibrosis and others);

- chronic inflammatory-dystrophic diseases of the stomach, intestines, liver of the gallbladder;

- conditions after resection or irradiation of the gastrointestinal tract, accompanied by impaired digestion of food with flatulence diarrhea (as part of combination therapy);

- to improve the digestion of food in patients with normal gastrointestinal tract function in case of inaccuracies in nutrition;

- preparation for X-ray and ultrasound examination of the abdominal organs;

- gastrointestinal disorders of a functional nature (with acute intestinal infections, irritable bowel syndrome and others).

Contraindications:

- Hypersensitivity to any of the components of the drug;

- acute pancreatitis or chronic pancreatitis in the acute stage. Nevertheless, it is possible to use it in the phase of a damping exacerbation with the expansion of the diet if there are signs of indigestion;

- hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

- children's age up to 3 years (for this dosage form).

Pregnancy and lactation:

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

Method of administration and dosage:

The dose of Pancreatin 10,000 is set individually depending on the disease and the severity of symptoms.

Unless otherwise instructed, adults should take 2-4 tablets of Pancreatin 10,000 with meals. The drug is taken orally without breaking or chewing the tablet (the effectiveness of Pancreatin 10,000 may decrease when chewed and pancreatic enzymes, when released, can irritate the oral mucosa) with a sufficient amount of liquid (for example, a glass of water).

It is not recommended to exceed the daily dose of pancreatic enzymes corresponding to 15000-20000 IU of lipase / kg of body weight.

An increase in the dose should be carried out only under the supervision of a physician, while focusing on symptoms (for example, a decrease in steatorrhea and abdominal pain). The duration of treatment is determined by the doctor and can vary from several days (in case of indigestion due to an error in the diet) to several months or even years (if constant substitution therapy is necessary).

In children, the dosage is determined by the doctor.

Dose for children and adults with cystic fibrosis

In patients with cystic fibrosis, the dose should be selected taking into account the severity of the symptoms of the disease, the control of steatorrhea and the maintenance of an adequate nutritional status (see section 'Special instructions').

The dose should not exceed 10,000 units of lipase / kg of body weight per day.

In children, the dosage regimen and duration of treatment is established by the doctor depending on the severity of digestive disorders and the composition of the diet at the rate of 1000 U of lipase / kg of the child's body weight for each meal for children under 4 years of age and 500 U of lipase / kg of the child's body weight for every meal for children over 4 years old.

If after treatment there is no improvement or the symptoms worsen or new symptoms appear, you should consult your doctor.

Use the drug only according to the indications for the method of use and in the doses indicated in the instructions.

Side effects:

Possible side effects are listed below in descending frequency of occurrence: very often (? 1/10) often (? 1/100 to <1/10) infrequently (? 1/1000 to <1/100) rarely (? 1/10000 to < 1/1000) very rarely (<1/10000) the frequency has not been established (it is impossible to estimate from the available data).

Immune system disorders

Very rare: immediate allergic reactions (such as skin rash, hives, sneezing, lacrimation, bronchospasm, dyspnea), gastrointestinal hypersensitivity.

Gastrointestinal disorders

Very rare: diarrhea abdominal discomfort abdominal pain nausea vomiting; the formation of strictures in the ileocecal and ascending colon in patients with cystic fibrosis when using high doses of pancreatin.

Violations of the genitourinary system

Frequency unknown: hyperuricosuria (see section 'Special instructions').

If you have any side effects indicated in the instructions or they are aggravated or you notice any other side effects not specified in the instructions, inform your doctor.

Overdose:

Symptoms : hyperuricosuria, hyperuricemia (especially in patients with cystic fibrosis taking high doses of enzyme preparations).

Treatment : symptomatic therapy, drug withdrawal.

Interaction:

It is possible to reduce the absorption of folic acid when used simultaneously with pancreatin preparations.

The effect of hypoglycemic agents for oral administration (such as acarbose miglitol) may be reduced when used simultaneously with preparations of digestive enzymes containing enzymes that break down carbohydrates (for example, amylase).

If you are using the above or other drugs (including over-the-counter), consult your doctor before using Pancreatin 10,000.

Special instructions:

In acute pancreatitis or exacerbation of chronic pancreatitis (at the stage of exacerbation attenuation) during the period of restorative dietary nutrition, it is advisable to take Pancreatin 10,000 against the background of existing and / or remaining exocrine pancreatic insufficiency in the future.

In patients with cystic fibrosis, especially when taking high doses of pancreatin, hyperuricosuria can be observed, therefore, in this group of patients, it is necessary to control the concentration of uric acid in the urine.

In the above group of patients, strictures in the ileocecal and ascending colon are described.

As a precautionary measure, when unusual abdominal discomfort or changes in the nature of complaints appear, especially when taking more than 10,000 U of lipase / kg of body weight per day, a medical examination is necessary.

The drug Pancreatin 10,000 contains active enzymes that, when released in the oral cavity, for example when chewed, can damage the oral mucosa (up to the formation of ulcers). Therefore, the tablet must be swallowed whole.

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

Pancreatin 10,000 does not affect the ability to drive vehicles and other mechanisms.

Release form / dosage:

Enteric film-coated tablets 10,000 IU.

Packaging:

10 tablets in a blister made of polyvinyl chloride film and aluminum foil.

2 6 8 blister packs of 10 tablets with instructions for use are placed in a carton box.

Storage conditions:

At a temperature not higher than 25 ? C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Vacation conditions

Without recipe

Manufacturer

AO 'Industrial pharmaceutical company Obnovlenie' (AO 'PFK Obnovlenie'), g. Novosibirsk, ul. Station, 80, Russia

Marketing Authorization Holder / Organization Receiving Consumer Claims:

JSC 'PFK Obnovlenie'