Pangrol 10000 - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspenteric-coated capsules

Composition:

Contents of the capsule (mini-tablets, covered with enteric coating):

Core:

Active substance:

Pancreatin -153.5 mg

with minimal activity:

lipase 10000 units

amylase 9,000 units

500 U proteases

Auxiliary substances: croscarmellose sodium - 5,12 mg, cellulose microcrystalline - 8.52 mg, castor hydrogenated oil - 1.709 mg, silicon dioxide colloidal anhydrous - 0.849 mg, magnesium stearate - 0.849 mg.

Shell: methacrylic acid and ethyl acrylate copolymer (1: 1), 30% dispersion 25.0 mg, triethyl citrate 2.51 mg emulsion simethicone 30 % (dry weight) - 0.015 mg; talc - 5.01 mg;

Capsule: body: gelatin - 36.20 mg, titanium dioxide (E 171) - 0.20 mg; ferric iron oxide yellow (E 172) - 0.20 mg; ferric oxide red oxide (E 172) - 0.01 mg; lid: gelatin - 23,800 mg; titanium dioxide (E 171) - 0.400 mg; dye quinoline yellow (E 104) - 0.200 mg; indigo carmine (E 132) 0.002 mg.

Description:Opaque hard gelatin capsules of cylindrical shape with hemispherical ends No. 2: capsule body of light orange color, capsule lid of yellowish-green color. Contents of capsules: mini tablets of cylindrical shape, covered with enteric coating, light beige color with shiny surface.

Pharmacotherapeutic group:digestive enzyme

Pharmacodynamics:The active substance of the drug Pangrol® 10000 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 effects, compensates for the enzymatic insufficiency of the pancreas, improves the functional state of the gastrointestinal tract (GIT), normalizes the digestive process.

Pharmacokinetics:

Gelatin capsules of Pangrol® 10000 rapidly dissolve in the stomach, releasing mini-tablets coated with an enteric-acid (acid-fast) coat. 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 It is not absorbed into the digestive tract, it is excreted with caloric 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;

- Syndrome Shvahmana-Diamond;

- subacute pancreatitis;

- Other diseases accompanied by exocrine pancreatic insufficiency.

Relative enzyme failure in the following conditions and situations:

- GI disorders of a functional nature, with acute intestinal infections, irritable bowel syndrome;

- use of indigestible vegetable or fatty foods;

Preparation for X-ray and ultrasound examinations of the abdominal cavity organs.

Contraindications:

- acute pancreatitis;

- exacerbation of chronic pancreatitis;

- increased sensitivity to pancreatin of porcine origin or other components of the drug.

Pregnancy and lactation:

Pregnancy

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 has been detected, therefore, toxic effects on reproductive function and fetal development are not expected.

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

Breastfeeding period

Based on animal studies, during which no adverse effects of pancreatic enzymes have been identified, no adverse effect of the drug on the baby through breast milk is expected. During breastfeeding, you can take pancreatic enzymes.

Dosing and Administration:

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.

If there is no other indication, adults it is recommended to take 2-4 capsules of the drug Pangrol® 10000 during each meal, swallowing the capsules whole (do not chew), squeezed with enough liquid (for example, a glass of water). If a whole patient capsule is difficult to take (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 taking the contents (mini tablets) liquid 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, amounting to 15000-20000 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.

Children The dosage regimen and the duration of treatment are determined by the physician, depending on the degreethe severity of the disease and the composition of food at the rate of 500 - 1000 lipase units / kg of the body weight of the child for each meal.

Application for cystic fibrosis

The dose of Pangrol® 10000 depends on 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 at 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 an optimal diet. In most patients, the dose should not be more than 10,000 lipase units / kg body weight per day or 4000 lipase units / g of consumed fat.

Side effects:

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.

Disorders from the gastrointestinal 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 that of placebo:

Often: pain in the abdomen; often: diarrhea.

Disturbances from the skin and subcutaneous tissues:

Rarely: rash;

Itching, hives - to estimate the frequency of data cases is not enough.

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.

Interaction:

There were no studies on the interaction.

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 per kg of body weight per day.

Effect on the ability to drive transp. cf. and fur:

Pangrol® 10000 does not affect the performance of potentially hazardous activities requiring special attention and speed of response.

Form release / dosage:

Capsules enteric, 10,000 units.

Packaging:

For 20, 50 or 100 capsules in a polypropylene vial with a polyethylene lid equipped with a desiccant.

1 bottle with instructions for use in a cardboard pack.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep the medicine out of the reach of children!

Shelf life:

2 years.

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001292

Date of registration:28.11.2011

The owner of the registration certificate:Berlin-Chemie / Menarini Pharma, GmbH Berlin-Chemie / Menarini Pharma, GmbH Germany

Manufacturer: & nbsp

APTALIS PHARMA, S.r.l Italy

Representation: & nbspBERLIN-CHEMI / MENARINI PHARMA GmbH BERLIN-CHEMI / MENARINI PHARMA GmbH Germany

Information update date: & nbsp17.08.2015

Illustrated instructions

Instructions

Pangrol®10000 (Pangrol® 10000)