Pangrol 10000, capsules, 20pcs

Composition

Active ingredient:

pancreatin – 153.5 mg with minimal activity: lipase 10000 units, amylase 9000 units, protease 500 units;

Auxiliary substances:

croscarmellose sodium 5.12 mg,

microcrystalline cellulose 8.52 mg,

hydrogenated castor oil 1.709 mg,

colloidal anhydrous silicon dioxide 0.849 mg,

magnesium stearate 0.849 mg.

Shell composition:

methacrylic acid and ethyl acrylate copolymer (1: 1),

30% dispersion-25 mg,

triethyl citrate-2.51 mg,

simethicone emulsion 30% (dry weight) – 0.015 mg;

talc-5.01 mg.

Composition of the kapusla case:

gelatin – 36.20 mg,

titanium dioxide (E 171) – 0.20 mg;

iron oxide yellow dye (E 172) – 0.20 mg;

iron oxide red dye (E 172) – 0.01 mg.

Capsule cap composition:

gelatin – 23.8 mg;

titanium dioxide (E 171) – 0.4 mg;

quinoline yellow dye (E 104) – 0.2 mg;

Indigo Carmine (E 132) – 0.002 mg

Pharmacological action

Pharmacodynamics

The active ingredient of the drug Pangrol ® 10000 is pancreatin, which is a powder from the pancreas of pigs. The enzymes that make up pancreatin contribute to the breakdown of fats, carbohydrates and proteins that come from food. Pancreatin, having proteolytic, amylolytic and lipolytic effects, compensates for the enzymatic insufficiency of the pancreas, improves the functional state of the gastrointestinal tract, and normalizes digestive processes.

Pharmacokinetics

Gelatin capsules of Pangrol ® 10000 quickly dissolve in the stomach, releasing mini-tablets coated with an enteric (acid-resistant) shell. Thus, the enzymes remain protected from inactivation in the acidic environment of the stomach. The Form of production of the drug provides mixing of mini-tablets with intestinal contents and uniform distribution of enzymes. The dissolution of the shell of mini-tablets and the activation of enzymes occurs at a neutral or slightly alkaline pH in the small intestine. Pancreatin is not absorbed in the gastrointestinal tract, it is excreted in the feces.

Indications

Substitution therapy for pancreatic exocrine insufficiency in adults and children with the following conditions:

• chronic pancreatitis;
• cystic fibrosis;
• pancreatic cancer;
• condition after surgery on the pancreas and stomach (full or partial organ resection);
• after irradiation of the digestive tract, associated with impaired digestion of
• food, flatulence, diarrhea (in combination therapy);
• the narrowing of the pancreatic duct, for example, because of a tumor or gall
• stones;
• syndrome Shwachman-diamond; acute pancreatitis;
• other diseases, accompanied by exocrine pancreatic insufficiency.

Relative enzyme deficiency in the following conditions and situations:

• disorders of the gastrointestinal tract of a functional nature, with acute intestinal infections,
• irritable bowel syndrome;
• consumption of hard-to-digest vegetable or fatty foods;
• Preparation for X-ray and ultrasound examinations of the abdominal organs.

Use during pregnancy and lactation

There are no clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes. No absorption of porcine pancreatic enzymes has been detected in animal studies, so toxic effects on reproductive function and fetal development are not expected.

The use of Pangrol 10000 during pregnancy is possible if the expected benefit to the mother exceeds the possible risk to the fetus.

Based on animal studies that did not reveal a negative effect of pancreatic enzymes, no harmful effects of the drug on the child through breast milk are expected. During breast-feeding, you can take pancreatic enzymes.

Contraindications

• Acute pancreatitis;
• exacerbation of chronic pancreatitis;
• hypersensitivity to porcine pancreatin or other components of the drug.

Side effects

Possible side effects are listed below by descending frequency of occurrence:

• often ( > 1/100, > < 1/10);
• infrequently ( > 1/1000, > < 1/100);
• rarely ( > 1/10000, >< 1/1000);
• very rarely (

From the gastrointestinal tract:  often — nausea, vomiting and bloating. Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of the following adverse reactions was lower or similar to placebo: very common — abdominal pain; common-diarrhea.

Skin and subcutaneous tissue disorders:  rarely-rash; pruritus, urticaria-there is insufficient data to estimate the frequency of cases.

Interaction

No interaction studies have been conducted.

How to take, course of use and dosage

The dose of Pangrol ® 10000 is selected individually depending on the severity of the disease, as well as the volume and composition of the food taken.

Unless otherwise indicated, adults are advised to take 2-4 capsules of Pangrol 10000 at each meal, swallowing the capsules whole (do not chew), and drinking a sufficient amount of liquid (for example, a glass of water).

If taking a whole capsule is difficult for the patient (for example, in young children or elderly patients), you can pour its contents, for example, into a glass, open the capsule by separating the lid from the body, and then take the contents (mini-tablets) with a small amount of liquid or add to liquid food that does not require chewing (for example, applesauce or fruit juice). A mixture of mini-tablets with food or liquid should not be stored (take immediately after preparation).

Increasing the dose of the drug should be carried out only under the supervision of a doctor, while focusing on the dynamics of symptoms (for example, a decrease in steatorrhea, relief of abdominal pain).

It is not recommended to exceed the daily enzyme dose of 15000-20000 lipase units/kg of body weight.

The duration of treatment is determined 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 food at the rate of 500-1000 lipase units. /kg of the child’s body weight for each meal.

In cystic fibrosis, the dose of Pangrol ® 10000 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 during 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 the support of an optimal diet. In most patients, the dose should not exceed 10,000 lipase units / kg / day or 4,000 lipase units / g of fat consumed.

Overdose

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

Treatment:  drug withdrawal, symptomatic therapy.

Special instructions

In patients with cystic fibrosis treated with high doses of pancreatin preparations, strictures of the ileum, cecum and colon (fibrosing colonopathy) are described. As a precautionary measure, if unusual symptoms appear or the nature of symptoms of the underlying disease changes, a medical examination is necessary to exclude colon damage, especially if the drug is used at a dose of more than 10,000 lipase units/kg / day.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Pangrol ® 10000 does not affect the performance of potentially dangerous activities that require special attention and quick response.

Form of production

Capsules

Storage conditions

Under normal conditions

Shelf life

2 years

Active ingredient

Pancreatin

Dosage form

Capsules

Description

Children as prescribed by a doctor, Pregnant women as prescribed by a doctor, For adults, Nursing mothers as prescribed by a doctor

Indications

Chronic pancreatitis, Overeating, Crohn’s disease, Irritable bowel syndrome, Cancer, Preparation for ultrasound and X-ray of the abdominal cavity, Flatulence, Diarrhea, Diet error