Composition, form of production and packaging
? Capsules intestine-soluble opaque hard gelatinous cylindrical shape with hemispherical ends No. 0: Capsule of light orange capsule, lid capsule of yellowish-green color. Contents of capsules: mini-tablets of cylindrical shape, covered with enteric coating, light beige color with shiny surface.
1 caps.
pancreatin 356.10 mg
with a minimum lipase activity of 25,000 units
amylase 22500 units
protease 1250 U
Excipients: croscarmellose sodium 11.87 mg, microcrystalline cellulose 19.77 mg, castor hydrogenated oil 3.96 mg, silicon dioxide colloidal anhydrous 1.97 mg, magnesium stearate 1.97 mg.
Ingredients of the enteric coating of mini tablets: methacrylic acid and ethyl acrylate copolymer (1: 1), 30% dispersion 57.9 mg, triethyl acetate 5.82 mg emetic simethicone 30% (dry weight) 0.036 mg, talc 11.63 mg.
The composition of the capsule body: gelatin 65.4 mg, titanium dioxide (E171) 0.3 mg, iron dye oxide yellow (E172) 0.3 mg, ferric iron oxide red (E172) 0.02 mg.
Composition of capsule capsule: gelatin 42.9 mg, titanium dioxide (E171) 0.8 mg, dye quinoline yellow (E104) 0.3 mg, indigocarmine (E132) 0.003 mg.
20 pcs. - vials of polypropylene (1) - packs cardboard.
50 pcs. - vials of polypropylene (1) - packs cardboard.
100 pieces. - vials of polypropylene (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
The active substance of the drug Pangrol В® 25000 is pancreatin, which is a powder from the pancreas of pigs. Enzymes that are part of pancreatin, contribute to the breakdown of fats, carbohydrates and proteins coming from food. Pancreatin, providing proteolytic, amylolytic and lipolytic action, compensates for the enzymatic pancreatic insufficiency, improves the functional state of the gastrointestinal tract, normalizes the digestive process.
PHARMACOKINETICS
Gelatin capsules of the preparation PangrolВ® 25000 dissolve rapidly in the stomach, releasing mini-tablets coated with an enteric-acid (acid-resistant) coating. Thus, the enzymes remain protected from inactivation in the acidic environment of the stomach. The form of the preparation provides mixing of mini-tablets with intestinal contents and uniform distribution of enzymes. The dissolution of the mini-tablet shell and activation of the enzymes occurs with a neutral or slightly alkaline pH in the small intestine. Pancreatin is not absorbed into the digestive tract, it is excreted with deadly masses.
INDICATIONS
Substitution therapy of insufficiency of exocrine pancreatic function in adults and children under the following conditions:
- chronic pancreatitis;
- cystic fibrosis;
- pancreas cancer;
- condition after surgery on the pancreas and stomach (complete or partial resection of the organ);
- after irradiation of the digestive tract, accompanied by a violation of food digestion, flatulence, diarrhea (as part of combination therapy);
- narrowing of the duct of the pancreas (for example, because of a tumor or gallstones);
- Shvakhman-Diamond syndrome;
- subacute pancreatitis;
- other diseases accompanied by exocrine pancreatic insufficiency.
Relative enzyme failure in the following conditions and situations:
- Gastrointestinal disorders of a functional nature,
- with acute intestinal infections;
- with irritable bowel syndrome;
- the use of indigestible vegetable or fatty foods.
Preparation for X-ray and ultrasound examinations of the abdominal cavity organs.
DOSING MODE
The dose of Pangrol В® 25000 is selected individually depending on the severity of the disease, as well as the volume and composition of the food taken.
If there are no other indications, adults should take 1-2 caps. of the preparation PangrolВ® 25000 during each meal, swallowing whole (do not chew), squeezed with enough liquid (for example, a glass of water). If it is difficult for a patient to receive a whole capsule (for example, in small children or elderly patients), it is possible to pour out its contents, for example, into a glass, opening the capsule by separating the lid from the body, and then taking the contents (mini tablets) or add to liquid food that does not require chewing (for example, apple puree or fruit juice). Mixture of mini-tablets with food or liquid is not to be stored (taken immediately after preparation).
An increase in the dose of the drug should be carried out only under the supervision of the doctor, while focusing on the dynamics of symptoms (for example, reduction of steatorrhea, easing of pain in the abdomen).
The daily dose of enzymes, which is 15,000-20,000 lipase units / kg body weight, 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 dosing regimen and duration of treatment are determined by the doctor, depending on the severity of the disease and food composition at a rate of 500-1000 lipase units / kg body weight of the child for each meal.
In cystic fibrosis, the dose of Pangrol В® 25000 depends on the body weight and should be at the beginning of treatment 1000 lipase units / kg for each meal for children under 4 years 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 the steatorrhea and the support of the optimal diet. In most patients, the dose should not exceed 10,000 lipase units / kg / day or 4000 lipase units / g of consumed fat
SIDE EFFECT
Possible side effects are given below on the descending incidence frequency: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10000, <1/1000), very rarely (<1/10000), including individual messages.
From the digestive tract : often - nausea, vomiting and bloating. Gastrointestinal disorders are mainly related to the underlying disease. The incidence 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 tissues: rarely - a rash; to assess the frequency of cases of data is not enough - itching, hives.
CONTRAINDICATIONS
acute pancreatitis;
- exacerbation of chronic pancreatitis;
- Hypersensitivity to pancreatin of porcine origin or other components of the drug.
PREGNANCY AND LACTATION
Clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes are absent. In the course of studies on animals, no absorption of pancreatic enzymes of porcine origin was detected, therefore, toxic effects on reproductive function and development of the fetus are not expected.
The use of Pangrol В® 25000 during pregnancy is possible if the expected benefit for the mother exceeds the possible risk to the fetus
Based on animal studies, during which no adverse effects of pancreatic enzymes have been identified, no harmful effect of the drug on the baby through breast milk is expected. During breastfeeding, you can take pancreatic enzymes.
APPLICATION FOR CHILDREN
For children, the dosing regimen and duration of treatment are determined by the doctor, depending on the severity of the disease and food composition at a rate of 500-1000 lipase units / kg body weight of the child for each meal.
SPECIAL INSTRUCTIONS
In patients with cystic fibrosis who received high doses of pancreatin preparations, iliac, blind and colon strictures (fibrosing colonopathy) are described. As a precautionary measure, when unusual symptoms or changes in the nature of the symptoms of the underlying disease appear, a medical examination is necessary to exclude the defeat of the colon, especially if the drug is administered at a dose of more than 10,000 lipase units / kg of body weight per day.
Impact on the ability to drive vehicles and manage mechanisms
Pangrol В® 25000 does not affect the performance of potentially hazardous activities requiring special attention and speed of response.
OVERDOSE
Symptoms: the use of large doses of pancreatic enzymes can be accompanied by hyperuricosuria and hyperuricemia in patients with cystic fibrosis.
Treatment: withdrawal of the drug, symptomatic therapy.
DRUG INTERACTION
There were no studies on the interaction.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place inaccessible to children at a temperature of no higher than 25 В° C. Shelf life - 2 years.
Do not use after the expiration date stated on the package
