Pangrol capsules

International non-proprietary name or grouping name:

pancreatin

Dosage Form:

enteric capsules

The composition of one capsule:

Capsule contents (enteric-coated mini-tablets): Core:

Active substance:

Pancreatin - 356.10 mg

with minimal activity:

Excipients: Croscarmellose sodium - 11.87 mg, microcrystalline cellulose - 19.77 mg, castor oil, hydrogenated - 3.96 mg, colloidal anhydrous 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 solid gelatin capsules of cylindrical shape with hemispherical ends No. 0: the capsule body is light orange in color, the cap is yellowish-green. Capsule contents: cylindrical mini-tablets, covered with an enteric coating, light beige color with a shiny surface.

Pharmacotherapeutic group:

digestive enzyme agent

Pharmacological properties

Pharmacodynamics

The active ingredient of the drug Pangrol^® 25,000 is Pancreatin, which is a powder from the pancreas glands of pigs. Enzymes that are part of pancreatin, contribute to the breakdown of fats, carbohydrates and proteins from food. Pancreatin, providing a proteolytic, amylolytic and lipolytic effect, compensates for the enzymatic insufficiency of the pancreas, improves the functional state of the gastrointestinal tract (GIT), normalizes digestion. Pharmacokinetics

Gelatin capsules of the drug Pangrol * 25,000 quickly dissolve in the stomach, releasing mini-tablets coated with an enteric (acid-resistant) coating. 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 mini-tablet shell and enzyme activation occurs at a neutral or weakly alkaline pH in the small intestine. Pancreatin is not absorbed in the gastrointestinal tract, excreted in feces.

Indications for use

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

• chronic pancreatitis;
• cystic fibrosis;
• pancreas cancer;
• conditions after surgery on the pancreas and stomach (complete or partial resection of the organ);
• after irradiation of the digestive tract organs, accompanied by a violation of food digestion, flatulence, diarrhea (as part of combination therapy);
• narrowing of the pancreatic duct, for example, due to swelling or gallstones;
• Shwachman-Diamond Syndrome; subacute 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, in acute intestinal infections, irritable bowel syndrome;
• the use of hard-to-digest plant or fatty foods;
• Preparation for X-ray and ultrasound examinations of the abdominal cavity organs.

Contraindications

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

Use during pregnancy and during breastfeeding

Pregnancy

Clinical data on the treatment of pregnant women with preparations containing pancreatic enzymes are not available. Animal studies have not revealed absorption of pancreatic enzymes of porcine origin; therefore, no toxic effects on reproductive function and fetal development are expected.

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 effect of pancreatic enzymes was detected, no adverse effect of the drug on the baby through breast milk is expected. During lactation, pancreatic enzymes can be taken.

Dosage and administration

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 the food taken.

Unless otherwise indicated for adults should take 1-2 capsules of the drug Pangrol^®25000 during each meal, swallowing whole (do not chew), drinking enough liquid (for example, a glass of water). If taking a whole capsule for a patient is difficult (for example, in young children or elderly patients), you can pour its contents, for example, into a glass, opening the capsule by separating the lid from the body, and then take the contents (mini-tablets) with some liquid or add to liquid food that does not require chewing (for example, apple sauce or fruit juice). A mixture of mini-tablets with food or liquid can not be stored (taken immediately after preparation).

Increasing the dose of the drug should be carried out only under the supervision of a physician, focusing on the dynamics of symptoms (for example, reduction of steatorrhea, easing pain in the abdomen).

The daily dose of enzymes, which is 15,000-20000 lipase units / kg body weight, is not recommended to exceed.

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 are 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 body weight of the child for each meal.

Application in cystic fibrosis

The dose of the drug Pangrol 25000 depends on body weight and should be at the beginning of treatment 1000 lipase units / kg for each meal for children younger than 4 years, and 500 lipase units / kg for each meal for children older than 4 years. 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 be no more than 10,000 lipase units / kg 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 individual messages.

Violations of 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 those with placebo:

Often: abdominal pain;

often: diarrhea.

Violations of the skin and subcutaneous tissues:

Seldom: rash;

Itching, urticaria - not enough data to assess the frequency of cases.

Overdosage

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

Treatment: drug withdrawal, symptomatic therapy.

Interaction with other drugs

Interaction studies were not conducted.

special instructions

In patients with cystic fibrosis who received high doses of pancreatin preparations, the ileum, caecum and colon strictures (fibrosing colonopathy) are described. As a precautionary measure, if unusual symptoms appear or the nature of the symptoms of the underlying disease changes, a medical examination is required to rule out colon lesions, especially if the drug is used in a dose of over 10,000 lipase units per kg of body weight per day.

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

Pangrol^® 25000 does not affect the performance of potentially hazardous activities that require special attention and quick response.

Storage conditions

Store at a temperature not higher than 25 ° С.

Keep the medicine out of the reach of children!