Structure and form of release

Structure

Active ingredient: pancreatin;

1 tablet contains Pancreatinum 250 mg that there correspond to activity not less than 1000 amylolytic PIECES of Ph. Eur., 1200 lipolytic ODES of Ph. Eur., 80 proteolytic ODES of Ph. Eur.;

Excipients: lactose, monohydrate; povidone; calcium stearate; acrylic - from pink 93O34055 [mix of substances: methacrylate copolymer (type C), talc, titan dioxide (E 171), triethyl citrate, carmine (E 120), silicon dioxide colloidal anhydrous, Natrii hydrocarbonas, sodium laur2, indigo carmine (E 132)].

release Form

Tablet, coated, kishechnorastvorimy.

Pharmacological properties

Pharmacodynamics. fermental medicament from pancreases of cattle and pigs. pancreatic enzymes which are a part of drug: the lipase, amylase, trypsin, chymotrypsin facilitate process of proteopepsis, carbohydrates and fats of food, promoting fuller absorption of feedstuffs in a small intestine.

Pharmacokinetics. Thanks to an acid resisting covering, enzymes are not inactivated under the influence of hydrochloric acid of a stomach. Dissolution of a cover and release of enzymes begins in a duodenum. Enzymes are poorly soaked up in a digestive tract, work in an intestines gleam.

Indication

• Dyspepsia;
• simultaneous consumption of hard digested vegetable, greasy and unusual food;
• meteorism connected with the above-stated disturbances;
• acceleration of a passage of food in intestines of functional character.

to Adults and children aged from 6 years to accept

inside on 1–2 tablets in time or right after food without chewing, washing down with a large amount of liquid.

Depending on a type of the eaten food or from severity of disturbance of digestion at meal time for the purpose of fermentozamestitelny therapy to apply 2–4 tablets.

Dose of medicament and duration of treatment is defined by the nature of a disease and is established by the doctor individually.

Children. Children can use medicament from 6 years.

Contraindication

Individual hypersensitivity to Pancreatinum or other components of drug. acute pancreatitis, chronic pancreatitis in an aggravation phase, intestinal impassability.

Special instructions

Intestinal impassability — in the presence of the symptomatology reminding this state needs to be remembered a possibility of emergence of intestinal strictures. it is recommended to control all unusual symptoms, especially at reception more than 10,000 units of lipase/kg/days

in order to avoid formation of urate concrements should control the content of uric acid in urine.

Drug contains active enzymes which can injure a mucous membrane of an oral cavity therefore it is necessary to swallow of tablets whole, without chewing.

At prolonged use iron preparations.

At administration of medicament to food should wash down it with alkaline liquids (for example the Borjomi mineral water or 0.5-1% Natrii hydrocarbonas solution).

Drug contains lactose therefore if at the patient the intolerance of some sugars is established, it is necessary to consult with the doctor before taking this drug.

Dye ponso 4R (E124) as a part of medicament can cause allergic reactions.

Use during pregnancy or feeding by a breast. Pancreatinum can be applied during pregnancy or feeding by a breast only on doctor's orders in cases when the expected advantage for mother exceeds potential risk for a fruit or the child.

Ability to influence speed of response at management transport sredstvm or work with other mechanisms. Does not influence.

Side effects

from digestive system: diarrhea, sensation of discomfort in epigastric area of a stomach, nausea, vomiting, a meteorism, change of nature of excrements, a constipation, intestinal impassability.

from the immune system: reactions of hypersensitivity are possible (including rash, an itching of skin, sneezing, dacryagogue, a bronchospasm, dispnoe, urticaria, anaphylactic reactions, a Quincke's disease).

from a cardiovascular system: tachycardia.

General disturbances: feeling of heat, general weakness.

Overdose

Symptoms: hyperuricemia, hyper uricosuria; children have constipations.

At use of medicament in high doses children can have a perianal irritation of skin.

Treatment: medicament withdrawal, sufficient hydration, symptomatic therapy.

Interaction

At simultaneous use of Pancreatinum with antitrombotichesky means, antagonists of vitamin K and acetylsalicylic acid the effect of these medicaments decreases. also the efficiency of non-selective inhibitors of the return neuronalny capture of monoamines at their combined use with Pancreatinum decreases.

At simultaneous use with M-holinoblokatorami the anticholinergic effect amplifies.

.

to decrease in efficiency of Pancreatinum.

Storage conditions

In original packing at a temperature not above 25 °C. to store out of children's reach.