Pangrol 25000 caps. p / o ksh / sol. 25000 UNITS (fl.) # 20

Dosage form

opaque hard gelatin capsules of a cylindrical shape with hemispherical ends No. 0: the capsule body is light orange, the capsule cap is yellowish-green.

Capsule contents: enteric-coated cylindrical mini-tablets, light beige in color with a shiny surface.

Structure

Composition for one capsule:

Capsule contents (enteric-coated mini-tablets):

Core:

Active ingredient: Pancreatin - 356.10 mg with minimum activity: lipase 25000 IU, amylase 22500 IU, protease 1250 IU

Excipients: croscarmellose sodium - 11.87 mg, microcrystalline cellulose - 19.77 mg, hydrogenated castor oil - 3.96 mg, anhydrous colloidal silicon dioxide - 1.97 mg, magnesium stearate - 1.97 mg

Shell: methacrylic acid and ethyl acrylate copolymer (1: 1), 30% dispersion - 57.9 mg, triethyl citrate - 5.82 mg, simethicone emulsion 30% (dry weight) - 0.036 mg

talc - 11.63 mg

Capsule:

Body: gelatin - 65.40 mg, titanium dioxide (E 171) - 0.30 mg

iron dye yellow oxide (E 172) - 0.30 mg

iron dye red oxide (E 172) - 0.02 mg

Cap: gelatin - 42,900 mg

titanium dioxide (E 171) - 0.800, mg

quinoline yellow dye (E 104) - 0.300 mg

indigo carmine (E 132) - 0.003 mg.

pharmachologic effect

The active ingredient of the Pangrol® 25000 preparation is pancreatin, which is a powder from the pancreas of pigs.

The enzymes that make up pancreatin help break down fats, carbohydrates and proteins from food.

Pancreatin, having a proteolytic, amylolytic and lipolytic effect, compensates for the enzymatic insufficiency of the pancreas, the gland, improves the functional state of the gastrointestinal tract (GIT), and normalizes the digestive processes.

Pharmacokinetics

Gelatinous capsules of Pangrol® 25000 quickly dissolve in the stomach, releasing enteric-coated (acid-resistant) coated mini-tablets.

Thus, the enzymes remain protected from inactivation in the acidic environment of the stomach.

The release form of the drug provides mixing of mini-tablets with intestinal contents, and uniform distribution of enzymes.

Dissolution of the membrane, mini-tablets and activation of enzymes occurs at neutral or slightly alkaline pH in the small intestine.

Pancreatin is not absorbed in the gastrointestinal tract, excreted in the feces.

Side effects

Possible side effects are listed below in descending frequency of occurrence: often (> 1/100, < 1/10), infrequently (> 1/1000, < 1/100), rarely (> 1/10000, < 1/1000), very rarely (< 1/10000), including isolated messages.

Gastrointestinal disorders:

Often: nausea, vomiting, and bloating.

Gastrointestinal disorders are mainly associated with an underlying disease.

The incidence of the following adverse reactions was lower or similar to those with placebo.

Very often: pain in the abdomen

often: diarrhea.

Skin and subcutaneous tissue disorders:

Rare: rash

pruritus, urticaria - insufficient data to estimate the frequency of cases.

Selling features

Available without a prescription

Special conditions

In patients suffering from cystic fibrosis who received high doses of pancreatin drugs, strictures of the ileum, cecum and colon (fibrosing colonopathy) have been described.

As a precautionary measure, if unusual symptoms appear or the nature of the symptoms of the underlying disease changes, a medical examination is necessary to exclude lesions of the colon, especially if the drug is used at a dose of more than 10,000 lipase units per kg of body weight per day.

The effect of the drug on the ability to drive vehicles and other mechanisms

Pangrol® 25000 does not affect the performance of potentially hazardous species

activities requiring special attention and speed of reaction.

Indications

Name ENG

PANGROL 25000

Clinical and pharmacological group

Enzyme preparation

ATX code

Multienzymes (lipase, protease etc.)

Dosage

25000ED

Structure

Composition for one capsule: Contents of the capsule (mini-tablets, enteric coated): Core: Active ingredient: Pancreatin - 356.10 mg with minimum activity: lipase 25000 IU, amylase 22500 IU, protease 1250 IU Excipients: croscarmellose sodium - 11.87 mg, microcrystalline cellulose - 19.77 mg, hydrogenated castor oil - 3.96 mg, anhydrous colloidal silicon dioxide - 1.97 mg, magnesium stearate - 1.97 mg Shell: methacrylic acid and ethyl acrylate copolymer (1: 1), 30% dispersion - 57.9 mg, triethyl citrate - 5.82 mg, simethicone emulsion 30% (dry weight) - 0.036 mg talc - 11.63 mg Capsule: Body: gelatin - 65.40 mg, titanium dioxide (E 171) - 0.30 mg iron dye yellow oxide (E 172) - 0.30 mg iron dye red oxide (E 172) - 0.02 mg Cap: gelatin - 42,900 mg titanium dioxide (E 171) - 0,800, mg quinoline yellow dye (E 104) - 0.300 mg indigo carmine (E 132) - 0.003 mg.

Indications

Replacement therapy for insufficiency of exocrine pancreatic function in adults and children under the following conditions:

chronic pancreatitis

cystic fibrosis

pancreas cancer

conditions after surgical interventions on the pancreas and stomach (complete or partial resection of the organ)

after irradiation of the digestive tract, accompanied by impaired digestion

food, flatulence, diarrhea (as part of combination therapy)

narrowing of the pancreatic duct, for example, due to a tumor or biliary

stones

Schwachman-Diamond syndrome

subacute pancreatitis

other diseases accompanied by exocrine pancreatic insufficiency.

Relative enzyme deficiency in the following conditions and situations:

functional gastrointestinal tract disorders, with acute intestinal infections,

irritable bowel syndrome

the use of indigestible plant or fatty foods

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

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

INN / Active ingredient

pancreatin

Contraindications

Acute pancreatitis

exacerbation of chronic pancreatitis

hypersensitivity to porcine pancreatin or other components of the drug.

Specifications

Category

Enzymes

Scope of the drug

Gastrointestinal tract

Release form

Capsules

Manufacturer country

Italy

Package quantity, pcs

twenty

Scope of application

Gastroenterology

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Berlin-Chemie

The amount of the dosage form in the primary package

20 pcs.

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Digestive Enzyme Remedy

Anatomical and therapeutic characteristics

A09AA02 Polyenzyme preparations (lipase + protease, etc.)

Dosage form

Enteric capsules

Expiration date in days

730

Dosage (volume) of the substance in the preparation

pancreatin 356.10 mg

Package weight, g

thirty

Mode of application

:

The dose of the drug Pangrol 25000 is selected individually, depending on the severity of the disease, as well as the volume and composition of food intake. < br> Unless otherwise indicated, adults should take 1-2 capsules of Pangrol® 25000 with each meal, swallowing whole (do not chew), drinking plenty of liquid (for example, a glass of water). If it is difficult for a patient to take a whole capsule (for example, in small children or elderly patients), you can pour its contents, for example, into a glass, opening the capsule by separating the cap from the body, and then take the contents (mini-tablets) with some liquid or added to liquid foods that do not require chewing (such as applesauce or fruit juice).Mixture of mini-tablets with food or liquid must not be stored (take immediately after preparation). < br> An increase in the dose of the drug should be carried out only under the supervision of a physician, focusing on the dynamics of symptoms (for example, a decrease in steatorrhea, a decrease in abdominal pain). < br> The daily dose of enzymes, which is 15000-20000 lipase units / kg of body weight, is not recommended to be exceeded. < br> The duration of the course of treatment is established by the doctor and depends on the course of the disease. < br> For children, the dosage regimen and duration of treatment is determined by the doctor depending on the severity of the disease and the composition of the food at the rate of 500 - 1000 lipase units / kg of the child's body weight for each meal. < br> Application for cystic fibrosis < br> The dose of Pangrol 25000 depends on body weight and should be 1000 lipase units / kg at the beginning of treatment for each meal for children under 4 years of age, and 500 lipase units / kg at each meal for children over 4 years of age. The dose of the drug should be selected individually, depending on the severity of the disease, under the control of steatorrhea and support for an optimal diet. In most patients, the dose should be no more than 10,000 lipase units / kg of body weight per day or 4000 lipase units / g of fat consumed.In most patients, the dose should be no more than 10,000 lipase units / kg of body weight per day or 4000 lipase units / g of fat consumed.In most patients, the dose should be no more than 10,000 lipase units / kg of body weight per day or 4000 lipase units / g of fat consumed.

Information on technical characteristics, delivery set, country of manufacture