Pangrol 10000 capsules, 20 pcs. (Pancreatin)

Latin name

PANGROL 10000

Release form

Enteric-capsules

Packaging

20 pcs.

Pharmacological action of

Pharmacodynamics of

The active ingredient of the drug Pangrol® 10000 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, providing proteolytic, amylolytic and lipolytic effects, compensates for the enzymatic insufficiency of the pancreas, improves the functional state of the gastrointestinal tract, normalizes digestion processes.

Pharmacokinetics

Pangrol® 10000 gelatin capsules dissolve rapidly in the stomach, releasing mini enteric-coated (acid-resistant) coated tablets.

Thus, enzymes remain protected from inactivation in the acidic environment of the stomach. The form of the drug provides mixing of mini-tablets with intestinal contents and a uniform 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

condition after surgical interventions on the pancreas and stomach (full or partial resection of the organ)

after irradiation of the digestive tract, accompanied by a violation of digestion

food, combined with dyspepsia pancreas, for example, due to a tumor or biliary

stones

Schwachman-Diamond syndrome subacute pancreatitis

other diseases accompanied by exocrine insufficiency pancreatic awn.

Relative enzyme deficiency in the following conditions and situations:

gastrointestinal tract disorders of a functional nature, with acute intestinal infections,

irritable bowel syndrome

consuming indigestible vegetable or fatty foods

Preparation for radiological and ultrasound examinations of abdominal organs.

Contraindications

Acute pancreatitis

exacerbation of chronic pancreatitis

hypersensitivity to porcine pancreatin or other components of the drug.

Use during pregnancy and lactation

There are no clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes. 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 PangrolВ® 10000 during pregnancy is possible if the expected benefit to the mother outweighs the potential risk to the fetus.

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

Composition

Active ingredient:

pancreatin - 153.5 mg s minimal activity: lipases 10,000 units, amylases 9,000 units, proteases 500 units

Excipients: croscarmellose sodium

5.12 mg,

microcrystalline cellulose 8.52 mg,

hydrogenated castor oil 1.709 mg,

silicon dioxide colloidal anhydrous 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 .

Capsule body composition:

gelatin - 36.20 mg,

titanium dioxide (E 171) - 0.20 mg

dye iron oxide yellow (E 172) - 0.20 mg

dye iron oxide red (E 172) - 0 , 01 mg.

Composition of capsule cap:

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.

Dosage and administration

Dose 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 caps. Pangrol® 10000 during each meal, swallowing whole capsules (do not chew), drinking plenty of fluids (e.g., 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 taking the contents (mini-tablets) with some 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 (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, component of 15,000-20000 lipase units / kg body weight, it is not recommended to exceed.

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 at the rate of 500-1000 lipase units. / kg body weight of the child for each meal.

For 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 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 4,000 lipase units / g of consumed fat.

Side effects of

Possible side effects are listed below in descending incidence:

often (> 1/100, <1/10)

infrequently (> 1/1000, <1/100)

rarely (> 1/10000, < 1/1000)

is very rare (<1/10000), including individual messages.

From the gastrointestinal tract: often - nausea, vomiting and bloating. Gastrointestinal disorders are mainly associated with the 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.

From the skin and subcutaneous tissue: rarely - rash itching, urticaria - there is insufficient data to estimate the incidence of cases.

overdose

Symptoms: The use 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

Store at a temperature not exceeding 25 ° C.

Expiration

2 years.

Active ingredient

Pancreatin



pharmacy leave terms without a prescription

dosage form

dosage form

capsules

Berlin Chemie / Menarini Germany



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