Pankreatin-Zdorovye forte, tab. No. 10х5

General characteristics. Structure:

Active ingredient: Pancreatinum; 1 tablet contains Pancreatinum 384 mg with activity not less than 10000 amylolytic ME, 14 000 lipolytic ME, 800 proteolytic ME; excipients: cellulose microcrystallic, sodium chloride, sodium of a kroskarmeloz, silicon dioxide colloid anhydrous, magnesium stearate, oydragit L-100-55, talc, a macrogoal 4000, titanium dioxide (Е 171), кармоизин (Е 122).

Pharmacological properties:

Drug, digestant. Fills shortage of enzymes of a pancreas, has lipolytic, amylolytic and proteolytic effect, strengthens the proteolysis, carbohydrates and fats in a duodenum, a proximal part of a small bowel that promotes their fuller absorption. Improves a functional condition of digestive tract and normalizes digestion processes.

The main pancreatic digestive enzymes – a lipase, alpha amylase, proteases (trypsin and chymotrypsin) are a part of drug.

The lipase splits neutral fat to monoglycerides and fatty acids which with the participation of bile acids are quickly soaked up in an upper part of a small intestine.

Amylase hydrolyzes starch – at first to dextrins, and then to a maltose (in the conditions of the alkaline environment with the participation of normal intestinal microflora).

Proteases promote the proteolysis to polypeptides and free amino acids. The possibility of inhibition on a feedback mechanism of stimulated secretion of a pancreas under the influence of active trypsin in an upper part of a small intestine with which some anesthetizing effect of drug is connected is supposed.

Tablets have a protective cover, not soluble in acid contents of a stomach which interferes with destruction of pancreatic enzymes under the influence of a gastric juice. Pancreatic enzymes active only in the alkaline environment are also released from a dosage form in the alkaline environment of a small intestine, working in an intestines gleam.

The enzymes which are a part of drug in digestive tract are not soaked up therefore in a system blood-groove are not found; are inactivated in the course of hydrolysis and are digested. A small part of the enzymes which did not undergo hydrolysis is allocated in not changed view with a stake.

Indications to use:

• Replacement therapy at vneshnesekretorny insufficiency of a pancreas: chronic pancreatitis, a pancreatectomy, a state after radiation, dyspepsia, a mucoviscidosis (cystous fibrosis). Chronic diseases of bilious ways, obstruction of pancreat ducts or biliary tract.
• Meteorism, diarrhea of noninfectious genesis.
• Disturbance of digestion of food (a state after a resection of a stomach and a small bowel).
• Improvement of digestion of food at persons with normal function of digestive tract at disturbances of chewing function, at the use of vegetable, greasy or unusual food hard to digest; error cases in food (a large number of food).
• Preparation for X-ray inspection and ultrasonography of abdominal organs (decontamination of intestines).

Route of administration and doses:

Appoint inside in time or right after food, without chewing, washing down with a large amount of liquid (water, fruit juice). The dose of drug depends on age of the patient and degree of insufficiency of a pancreas.

Appoint usually with each meal in a dose of 14 000 - 28 000 ME of a lipase (1-2 tablets); at inefficiency the dose is increased by 1,5 – 2 times. In need of purpose of doses, smaller than 14 000 ME of a lipase, or multiple 7000 ME lipases, use the drug Pankreatin-Zdorovye with twice smaller dosage of enzymes.

For adults the average daily dose makes  42 000 – 147 000 ME of a lipase (3-10 tablets); at full insufficiency of vneshnesekretorny function of a pancreas the daily dose can be increased about 400 000 ME of a lipase that corresponds to daily need of the adult for a lipase.

The maximum daily dose for adults –  15 000 – 20 000 ME of a lipase/kg of body weight.

For children at a mucoviscidosis the dose depends on body weight and makes in an initiation of treatment at children 4 years – 500 ME lipases/kg (1 tablet / 28 are more senior than body weight kg) during meal. If the size of body weight of the child is in an interval between sizes multiple 28, in an initiation of treatment it is recommended to use the drug Pankreatin-Zdorovye with twice smaller dosage of enzymes.

The maximum daily dose for children – 10 000 ME of a lipase/kg of body weight; the general – no more than 100 000 ME.

Duration of treatment can vary of several days (at disturbance of digestion owing to errors in food) up to several months or even years (in need of continuous replacement therapy).

Features of use:

At a mucoviscidosis the dose of drug has to be adequate to amount of enzymes which is necessary for absorption of fats taking into account quality and amount of the consumed food. At a mucoviscidosis it is not necessary to accept drug in doses more than 10 000 ME (in terms of a lipase) because of increase in risk of development of strictures (a fibrous colonopathy) in ileocecal department and in the ascending colon.

Criteria of adequately picked up dose: increase in body weight, normalization of a chair (less than 3 times a day, normalization of a consistence), reduction of abdominal distention.

The children receiving prolonged treatment by drug at a mucoviscidosis have to be under regular medical control.

At prolonged use co-administration of iron preparations is required.

Use during pregnancy or feeding by a breast. Safety of use at pregnancy is studied insufficiently. Use of drug is possible in cases when the expected advantage for mother exceeds potential risk for a fruit. Use of drug during feeding by a breast is possible.

Ability to influence speed of response at control of motor transport or other mechanisms. Drug does not influence ability to control of vehicles and mechanisms.

Children. Drug in this dosage is used to children aged from 4 years.

Side effects:

The following by-effects are sometimes possible. From system of digestion: seldom – nausea, diarrhea, a lock, discomfort in epigastric area; at use of high doses for patients with a mucoviscidosis – strictures in ileocecal department and in the ascending colon, enteric impassability. Other: disturbance of absorption of folic acid, perianal irritation, allergic reactions (at patients with a lactose intolerance and hypersensitivity to Pancreatinum of a pork origin); at prolonged use in high doses – a hyper uricosuria, in excessively high doses – a hyperuricemia.

Interaction with other medicines:

At simultaneous use with iron preparations iron absorption decreases. Reduces absorption of folates, reduces hypoglycemic effect of acarbose. At simultaneous use with the antacids containing calcium a carbonate and/or magnesium hydroxide with a tannin, сïprom-rus.com/admin/preparat_edit.phpиртсодержащими means efficiency of Pancreatinum decreases.

Contraindications:

The increased individual sensitivity to Pancreatinum of a pork origin or to other components of drug, acute pancreatitis, an exacerbation of chronic pancreatitis, intestinal impassability, children's age up to 2 years.

Overdose:

Symptoms: hyper uricosuria, hyperuricemia; children have locks. Treatment: drug withdrawal, symptomatic therapy.

Storage conditions:

To store in the dry, protected from light place at a temperature from 2 °C to 15 °C. To store in the place, unavailable to children.

Period of validity - 2 years.

Issue conditions:

Without recipe

Packaging:

Tablets, coated, kishechnorastvorimy No. 10, No. 10x; 2, No. 10x; 5, No. 20 in blisters in a box; No. 10, No. 20 in the blister.