Pankreatin-Zdorovye, tab. No. 10/tab. No. 10х2

General characteristics. Structure:

International name: pancreatin; main physical and chemical properties: tablets, coated, biconvex form, light pink color, co slight specific smell. On cross section two layers are visible.
structure: 1 tablet contains Pancreatinum of the powder or Pancreatinum granulated 192 mg (not less than 5000 amylolytic Ph. Eur. U. (ME); 7 000 lipolytic Ph. Eur. U. (ME); 400 proteolytic Ph. Eur. U. (ME)); excipients: cellulose microcrystallic, sodium chloride, sodium of a kroskarmeloz, silicon dioxide colloid, magnesium stearate, oydragit L-100 or oydragit L 30 D-55 in terms of dry matter oydragit L-100-55 or L-100-55, talc, a macrogoal 4000, titanium dioxide, acid red 2 C.

Pharmacological properties:

Pharmacodynamics. Polyfermental 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.

Pharmacokinetics. 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 in a dose of 1 - 4 tablet (that corresponds to 7 000 - 28 000 Ph. Eur. U. (ME) of a lipase) with each meal; at inefficiency the dose is increased by 1,5 – 2 times.
For adults the average daily dose makes 42 000 – 147 000 Ph. Eur. U. (ME) of a lipase; at full insufficiency of vneshnesekretorny function of a pancreas the daily dose can be increased to 400 000 Ph. Eur. U. (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 Ph. Eur. U. (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 – 1 000 Ph are younger. Eur. U. (ME) of a lipase/kg (1 tablet / 7 body weight kg), is more senior than 4 years – 500 Ph. Eur. U. (ME) of a lipase/kg (1 tablet / 14 body weight kg) during meal. If the size of body weight of the child is in an interval between sizes multiple 7 for children under 4 years or multiple 14 for children 4 years are more senior, in an initiation of treatment it is recommended to use the drug dose appointed at smaller value of this interval (for example, at the body weight of the child of 20 kg in an initiation of treatment the dose appointed at the body weight of 14 kg is recommended). The maximum daily dose for children – 10 000 Ph. Eur. U. (ME) of a lipase/kg of body weight; the general – no more than 100 000 Ph. Eur. U. (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 PIECES/kg/days (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: a body weight increase, 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 and 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 in the period of a lactation is possible.
Influence on an opportunity to manage vehicles and mechanisms. Drug does not influence ability to control of vehicles and mechanisms.

Side effects:

The following by-effects are sometimes possible. From system of digestion: seldom – nausea, diarrhea, a lock, discomfort in epigastric area; when using high doses at 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 a concomitant use with iron preparations iron absorption decreases. Reduces absorption of folates, reduces hypoglycemic effect of acarbose. At a concomitant use with the antacids containing calcium a carbonate and/or magnesium hydroxide with a tannin, alcohol-containing 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:

On 10 tablets in blisters, No. 10, No. 10х2, No. 10х5, No. 10х10 in blisters in a box; No. 10 in the blister.