Pangrol capsules 25000ED, No. 20

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

• narrowing of the pancreatic duct, for example, due to a tumor or gallstones;

• 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.

The dose of PangrolЃ 25000 is selected individually, depending on the severity of the disease, as well as the volume and composition of food intake.

Unless otherwise indicated, adults are advised to take 1-2 capsules of PangrolЃ 25000 with each meal, swallowing the capsules 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 young 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), drinking 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 cannot be stored (take immediately after preparation).

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).

It is not recommended to exceed the daily dose of enzymes, which is 15,000-20,000 lipase units / kg of body weight.

The duration of the course of treatment is set by the doctor and depends on the course of the disease.

For children, the dosage regimen and duration of treatment is set 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.

Application for cystic fibrosis

The dose of PangrolЃ 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 old, and 500 lipase units / kg at each meal for children over 4 years old.

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 4,000 lipase units / g of fat consumed.

Capsule Contents (Enteric-Coated Mini Tablets )

Core:

Active substance:

Pancreatin -356.10 mg

with minimal activity:

lipase 25000 units

amylase 22500 U

protease 1250 U

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.

• acute pancreatitis;

• exacerbation of chronic pancreatitis;

• hypersensitivity to porcine pancreatin or other components of the drug

Carefully

Pregnancy

There are no clinical data on the treatment of pregnant women with preparations containing pancreatic enzymes. In the course of studies on animals, absorption of enzymes of the pancreas of porcine origin was not detected, therefore, toxic effects on reproductive function and fetal development are not expected.

The use of the drug Pangrol 25000 during pregnancy is possible if the expected benefit to the mother outweighs the possible risk to the fetus.

Breastfeeding period

Based on animal studies, during which no negative effects of pancreatic enzymes were detected, no harmful effects of the drug on the baby through breast milk are expected. Pancreatic enzymes can be taken while breastfeeding.

Active substance

Pancreatin

Dosage form

enteric capsules

Composition

Capsule Contents (Enteric-Coated Mini Tablets )

Core:

Active substance:

Pancreatin -356.10 mg

with minimal activity:

lipase 25000 units

amylase 22500 U

protease 1250 U

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.

Description

Opaque hard gelatin capsules of a cylindrical shape with hemispherical ends No. 2: 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.

Pharmacotherapeutic group

digestive enzyme

ATC:
A.09.AA Enzyme preparations

A.09.AA02 Pancreatin

Pharmacodynamics

The active ingredient of PangrolЃ 25000 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, improves the functional state of the gastrointestinal tract (GIT), and normalizes digestion processes.

Pharmacokinetics

Gelatin capsules of PangrolЃ 25000 quickly dissolve in the stomach, releasing enteric-coated mini-tablets. Thus, the enzymes remain protected from inactivation in the acidic environment of the stomach. The form of release of the drug provides mixing of mini-tablets with intestinal contents and uniform distribution of enzymes. Dissolution of the mini-tablet coating 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 feces.

Indications for use

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

• narrowing of the pancreatic duct, for example, due to a tumor or gallstones;

• 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.

Contraindications

• acute pancreatitis;

• exacerbation of chronic pancreatitis;

• hypersensitivity to porcine pancreatin or other components of the drug

Carefully

Pregnancy

There are no clinical data on the treatment of pregnant women with preparations containing pancreatic enzymes. In the course of studies on animals, absorption of enzymes of the pancreas of porcine origin was not detected, therefore, toxic effects on reproductive function and fetal development are not expected.

The use of the drug Pangrol 25000 during pregnancy is possible if the expected benefit to the mother outweighs the possible risk to the fetus.

Breastfeeding period

Based on animal studies, during which no negative effects of pancreatic enzymes were detected, no harmful effects of the drug on the baby through breast milk are expected. Pancreatic enzymes can be taken while breastfeeding.

Method of administration and dosage

The dose of PangrolЃ 25000 is selected individually, depending on the severity of the disease, as well as the volume and composition of food intake.

Unless otherwise indicated, adults are advised to take 1-2 capsules of PangrolЃ 25000 with each meal, swallowing the capsules 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 young 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), drinking 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 cannot be stored (take immediately after preparation).

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).

It is not recommended to exceed the daily dose of enzymes, which is 15,000-20,000 lipase units / kg of body weight.

The duration of the course of treatment is set by the doctor and depends on the course of the disease.

For children, the dosage regimen and duration of treatment is set 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.

Application for cystic fibrosis

The dose of PangrolЃ 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 old, and 500 lipase units / kg at each meal for children over 4 years old.

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 4,000 lipase units / g of fat consumed.

Side effect

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

Very common: abdominal pain; often: diarrhea.

Skin and subcutaneous tissue disorders:

Rare: rash;

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

Overdose

Symptoms: The use of large doses of pancreatic enzymes may be accompanied by hyperuricosuria and hyperuricemia in patients with cystic fibrosis.

Treatment: drug withdrawal, symptomatic therapy.

Interaction

Interaction studies have not been conducted.

special instructions

” пациентов, страдающих муковисцидозом, получавших высокие дозы препаратов панкреатина описаны стриктуры подвздошной, слепой и толстой кишки (фиброзирующа¤ колонопати¤). ¬ качестве меры предосторожности, при по¤влении непривычных симптомов или изменени¤ характера симптомов основного заболевани¤ необходимо медицинское обследование дл¤ исключени¤ поражени¤ толстой кишки, особенно в случае применени¤ препарата в дозе свыше 10000 липазных единиц на кг массы тела в сутки.

¬ли¤ние на способность управл¤ть транспортным средством

ѕангролЃ 25000 не оказывает вли¤ни¤ на выполнение потенциально опасных видов де¤тельности, требующих особого внимани¤ и быстроты реакции.

‘орма выпуска

 апсулы кишечнорастворимые, 25000 ??.

”паковка

ѕо 20, 50 или 100 капсул в полипропиленовом флаконе с полиэтиленовой крышкой, снабженной осушителем.

1 bottle with instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 ? C.

Keep the medicinal product out of the reach of children!

Shelf life

2 years.

Do not use after the expiration date printed on the package.

Conditions of dispensing from pharmacies

Without recipe.