Pancreatin | Pangrol 25000 capsules, 50 pcs.

solid capsular form orange, capsule cap yellowish green.

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

Packaging

50 units

Pharmacological action of

The active ingredient in Pangrol® 25000 is

pancreatin, which is a powder of pig pancreas. The enzymes that make up pancreatin contribute to the breakdown of 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

Pangrol® 25000 gelatin capsules dissolve rapidly in the stomach, releasing mini-tablets coated with an enteric (acid resistant) coating. Thus, 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 an even distribution of enzymes. Dissolution of the membrane of mini-tablets and activation of enzymes occurs at a neutral or slightly alkaline pH in the small intestine.

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

Indications

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

- chronic pancreatitis

- cystic fibrosis

- pancreatic cancer

- a condition after surgery of the pancreas or saphen - after irradiation of the digestive tract, accompanied by a violation of digestion, flatulence, diarrhea (as part of combination therapy)

- narrowing of the pancreatic duct (n for example, due to a tumor or gallstones)

- Schwachmann-Diamond syndrome

- subacute pancreatitis

- other diseases accompanied by exocrine pancreatic insufficiency.

Relative enzyme deficiency in the following conditions and situations:

- functional gastrointestinal disorders,

- for acute intestinal infections

- for irritable bowel syndrome

- the use of indigestible plant or fatty foods.

Preparation for abdominal x-ray and ultrasound examinations.

Contraindications

Acute pancreatitis

exacerbation of chronic pancreatitis

hypersensitivity to porcine pancreatin or other components of the drug.

Use during pregnancy and lactation

Clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes are not available. In animal studies, absorption of porcine pancreatic enzymes 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

Based on animal studies, during which no adverse effects of pancreatic enzymes were detected, no harmful effect of the drug on the baby is expected through breast milk. During breastfeeding, pancreatic enzymes can be taken.

Special instructions

In patients with cystic fibrosis who received high doses of pancreatin preparations, ileal strictures are described. cecum and colon (fibrosing colonopathy).

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

Influence on the ability to drive vehicles and control mechanisms

PangrolВ® 25000 does not affect the execution of potentially hazardous activities that require special attention and speed of response.

Composition of

Capsule contents (mini-tablets, enteric coated)

core: srdlrdprcpcrmgprd lipase 25000 units

amyl s 22500

protease 1250 U

Excipients: sodium croscarmellose - 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 : case: gelatin - 65.40 mg, titanium dioxide (E 171) - 0.30 mg iron dye oxide yellow (E 172) - 0.30 mg iron dye oxide red (E 172) - 0.02 mg cap: gelatin - 42.900 mg of titanium dioxide (E 171) - 0.800 mg quinoline yellow dye (E 104) - 0.300 mg indigo carmine (E 132) - 0.003 mg.

Dosing and Administration

Dose 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, adults should take 1-2 caps. Pangrol® 25000 during each meal, swallowing whole (do not chew), washed down with a sufficient amount of 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 case, and then take the contents (mini-tablets) with a small amount liquids 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 (taken immediately after preparation).

An increase in 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, easing abdominal pain).

Daily dose of enzymes of 15,000-20000 lipase units / kg body weight, exceed is not recommended.

The duration of the course 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, based on 500-1000 lipase units / kg body weight of the child for each meal.

In case of cystic fibrosis, 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 old and 500 lipase units / kg during each meal for children over 4 years. 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 / day or 4000 lipase units / g of consumed fat

Side effects

Possible side effects are listed below in descending incidence rate: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10000, <1 / 1000), very rarely (<1/10000), including individual messages.

From the gastrointestinal tract: often - nausea, vomiting and bloating. Gastrointestinal disorders are mainly related with underlying disease. The frequency of occurrence of the following adverse reactions was lower or similar to those with placebo: very often - pain in the abdomen often - diarrhea.

On the part of the skin and subcutaneous tissues: rarely - rash to assess the frequency of cases, the data is not enough - itching, urticaria.

Drug Interactions

No interaction studies have been conducted

overdose

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

Treatment: withdrawal of the drug, symptomatic therapy.

Storage conditions

The product should be stored out of the reach of children at a temperature not exceeding 25 РC.

Shelf life

2 years

Deystvuyushtee substance

Pancreatin

Terms and conditions

without prescription



capsule dosage form

Possible product names

Pangrol 25000 capsules, 50 pcs.

PANGROL 25000ED. No. 50 CAPS. P / O KSH / SOLV. FL

Berlin-Hemi / Menarini, Germany