Panzinorm 20000 Forte

General characteristics. Structure:

Active ingredient: 279,44 mg of Pancreatinum (pork) (with fermental activity: lipases of 20 000 PIECES of Ph. Eur., amylases of 12 000 PIECES Ph. Eur., proteases of 900 PIECES Ph. Eur) 269,12.

Excipients: lactoses monohydrate, cellulose microcrystallic, кросповидон, silicon dioxide colloid, anhydrous, magnesium stearate.

The cover of a tablet consists from: a gipromelloza, methacrylic acid and ethyl acrylate copolymer, trietit citrate, titanium dioxide (E171), talc, симетикон an emulsion, fragrance vanilla 54286 C, fragrance of bergamot 54253 T, a macrogoal 6000, a karmelloza of sodium, polysorbate 80.

The fermental drug used at digestive tract diseases including disturbance of functions of secretion of a pancreas.

Pharmacological properties:

Pharmacodynamics. Panzinorm forte 20 000 compensates insufficiency of vneshnesekretorny function of a pancreas. The combined drug which effect is caused by the components which are its part. High lipazny activity plays an important role in treatment of the maldigestiya caused by pancreatic fermental insufficiency. The lipase splits fats by hydrolysis on fatty acids and глицерол, thus, promotes their absorption and absorption of fat-soluble vitamins. Amylase splits carbohydrates on dextrins and sugar whereas protease splits proteins. Has a protective cover thanks to which active enzymes are released in a small intestine where pancreatic enzymes work. 

The enzymes which are a part of Pancreatinum the lipase, amylase and protease facilitate digestion of fats, carbohydrates and proteins that promotes their fuller absorption in a small intestine. Eliminates the symptoms arising owing to digestion disturbance (feeling of weight and overflow of a stomach, a meteorism, feeling of shortage of air, the asthma caused by accumulation of gases in intestines, diarrhea). Improves process of digestion of food at children; stimulates release of own enzymes of a pancreas, stomach and small intestine, and also bile.

Pharmacokinetics. Pancreatic enzymes are released from Panzinorm's tablet forte 20 000 in the alkaline environment of a small intestine since are protected from action of a gastric juice by a film cover. An insignificant part of digestive enzymes is allocated through intestines.

Indications to use:

Panzinorm forte 20 000 is applied at insufficiency of vneshnesekretorny function of a pancreas (chronic pancreatitis, a mucoviscidosis and so forth). At Chronic inflammatory and dystrophic diseases of a stomach, intestines, liver, gall bladder; at states after a resection or radiation of these bodies which are followed by disturbances of digestion of food, a meteorism, diarrhea (as a part of a combination therapy). For improvement of digestion of food at patients with normal function of digestive tract in case of errors in food. For preparation to radiological and to ultrasound examination of abdominal organs. 

Route of administration and doses:

Inside, to accept during food. A pill should be taken entirely, without chewing with enough liquid. The dose and duration of therapy is defined individually   depending on age, degree of insufficiency of a pancreas and a diet.

The adult (in the absence of other instructions) – on 1 tablet 3 times a day during food or light meal. If necessary the single dose is increased twice. Average daily dose: 1-2 tablets 3 times. Before radiological and ultrasonic researches – on 2 tablets 2-3 times a day in 2-3 days prior to inspection. At children drug is used on doctor's orders. To children is aged more senior than 3 years of-100 thousand. Piece/days (in terms of a lipase).

Duration of treatment can vary from a single dose or several days (at disturbance of process of digestion owing to errors in a diet) up to several months or years (in need of continuous replacement therapy).

Features of use:

Panzinorm forte 20 000 it is necessary to accept, without chewing, with enough liquid.

At a mucoviscidosis in case of exceeding of a necessary dose of Pancreatinum (more than 10 000 PIECES of Ph. Eur. lipases on 1 kg of body weight) development of strictures (a fibrous colonopathy) in ileocecal department and in the ascending colon is possible. Therefore at a mucoviscidosis the dose 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.

Panzinorm's use forte 20 000 at pregnancy and in the period of a lactation (breastfeeding) is possible only if the expected positive effect of therapy surpasses possible risk, due to the lack of the clinical data confirming safety of use of enzymes of a pancreas for this category of patients.

It is not known of negative influence on ability of driving and work with other mechanisms.

Side effects:

Panzinorm forte 20 000 seldom causes undesirable effects.

Allergic reactions: dermahemia, skin rash, skin itch, sneezing, suffocation, dacryagogue.

From the alimentary system (at reception of high doses of drug): nausea, vomiting, abdominal pain (including intestinal colic), diarrhea, lock, perianal irritation, irritation of a mucous membrane of an oral cavity. At a mucoviscidosis in case of exceeding of a necessary dose of Pancreatinum (more than 10 000 PIECES of Ph. Eur. lipases on 1 kg of body weight) development of strictures (a fibrous colonopathy) in ileocecal department and in the ascending colon is possible.

Others: hyperuricemia, hyper uricosuria, insufficiency of folates.

Interaction with other medicines:

At simultaneous use with Pancreatinum decrease in absorption of iron preparations (clinically not significantly) and folic acid is possible. It is recommended to control periodically the level of folates and/or purpose of folic acid. The cover of tablets, steady against acid, Panzinorm forte 20 000 is dissolved in a 12-perstny gut. At low value рН in a 12-perstny gut Pancreatinum is not released. Simultaneous use of blockers of H2-histamine receptors (Cimetidinum), hydrocarbonates, inhibitors of the protonew pump can lead to increase in efficiency of Pancreatinum.

Contraindications:

Hypersensitivity to pork protein or other components of drug;

Acute pancreatitis, exacerbation of chronic pancreatitis;

Children up to 3 years (for this dosage form) and the children up to 15 years suffering from a mucoviscidosis.

Overdose:

The overdose by drug Panzinorm forte 20 000 does not cause system intoxication.

Symptoms: nausea, vomiting, diarrhea, hyper uricosuria, hyperuricemia, perianal irritation; seldom the fibrous colonopathy (develops at a mucoviscidosis).

Treatment: drug withdrawal, hydration, symptomatic therapy.

Storage conditions:

To store at a temperature not above 30 °C. To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

The tablets covered with a kishechnorastvorimy cover: on 10 tablets in the blister. On 1, 3 or 10 blisters in a pack cardboard together with the application instruction.