Mezy forte 20000 tab. No. 20

Structure and form of release

Structure

Active ingredient: powder from a pancreas (pigs)

1 tablet kishechnorastvorimy contains the powder from a pancreas of pigs of 160-222.22 mg having minimum lipolytic activity of 20000 PIECES of EF (units of the European pharmacopeia), minimum amylolytic activity of 12000 PIECES of EF, the minimum proteolytic activity of 900 PIECES of EF;

Excipients: lactose, cellulose microcrystalline, silicon dioxide colloidal, krospovidon, magnesium stearate, gipromelloza, methacrylate copolymer (type A), triethyl citrate, titan dioxide (E 171), talc, simetikon, polyethyleneglycol, polysorbate, sodium of a karmelloz, vanilla fragrance, bergamot fragrance, sodium hydroxide.

release Form

Tablet kishechnorastvorimy.

Pharmacological properties

Pharmacodynamics. active ingredient of medicine mezy forte is powder from pancreases (Pancreatinum) of mammals, usually pigs which, except excretory pancreatic enzymes (a lipase, alpha amylase, trypsin and chymotrypsin), contains also other enzymes. Pancreatinum also contains other accompanying substances not having enzymatic activity.

Pharmacokinetics. Absorption. Powder from pancreases is not acquired in a GIT and removed with a stake. Its most part breaks up or denatured under deystvy digestive juices or bacteria.

Bioavailability. The enterosoluble cover of tablets resistant to effect of gastric juice protects enzymes, sensitive to effect of acid, from an inactivation when passing through a stomach. Only after achievement of the neutral or alkalescent environment in a small intestine enzymes are released after dissolution of a cover. Because powder from a pancreas is not soaked up in a GIT, data on its pharmacokinetics and bioavailability are absent.

Efficiency of powder from pancreases is defined by degree and speed of release of enzymes from a dosage form.

Indication

Disturbance of exocrine function of a pancreas which is followed by digestion disturbance.

Contraindication

Hypersensitivity to active ingredient, meat of pigs (allergy to pork) or any of medicament excipients.

Acute pancreatitis or chronic pancreatitis in an aggravation phase (but incidental use is possible in a phase of the fading aggravation at expansion of a diet in the presence of dysfunctions of a pancreas). Drug should not be used the patient with obturatsionny impassability of intestines.

Use

Recommended dose on meal: 2–4 tablets mezy forte 10,000 or 1 - 2 tablets mezy forte 20,000 (there correspond 20,000-40,000 pieces e. t. lipases).

according to weight of the available insufficiency of function of a pancreas. Usually recommended dose is the dose of a lipase of 20,000-40,000 PIECES of E.F. on 1 meal, but it can be above.

Purpose of the Mezim medicament treatment forte is achievement or maintenance of normal body weight and normalization of frequency of defekation or consistence a calla. Increase in a dose has to be carried out only under observation of the doctor and for the purpose of reduction of expressiveness of symptoms (for example a steatorrhea, a stomach ache).

should not exceed the daily dose of enzymes making 15,000-20,000 PIECES of a lipase on kilogram of body weight.

Tablet Mezim entirely, washing down with a large amount of liquid, at meal time as the efficiency of Mezim medicine forte can decrease when chewing, the enzymes which are contained in medicament at release in an oral cavity can injure her mucous membrane.

Duration of treatment depends on a course of the disease and is defined by the doctor.

At emergence of unusual abdominal discomfort or metabasis as a preventive measure recommends to take place

inspection for an exception of damage of intestines, especially at use by the patient of a dose of 20,000 pieces e. t. lipases on 1 kg of body weight a day.

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

Mezim forte should not be applied to patients with rare hereditary forms of intolerance of a galactose, deficiency of lactase or a sprue of glucose and a galactose.

Period of pregnancy and feeding by a breast

Sufficient data on use of Mezim medicine. There is an insufficient amount of data on influence on pregnancy, development of an embryo/fruit, childbirth or post-natal development which were gained in experiments on animals therefore the potential risk for the person is unknown. In this regard the medicament Mezim forte should not be taken during pregnancy and feeding by a breast unless its use is absolutely necessary.

Children

forte use the Drug Mezim at children 3 years are aged more senior. The dose and duration of use are defined by the doctor.

to Drivers

Influence Mezim forte on ability to run vehicles or to work with other mechanisms is absent or is insignificant.

Overdose

Use of enzymes of a pancreas in very high doses can be followed by a hyperuricemia and a hyper uricosuria. symptomatic treatment.

Side effects

For assessment of frequency of emergence of side effects use the following classification: very often (≥1/10), it is frequent (≥1/100 and 1/10), infrequently (≥1/1000 and 1/100), is rare (≥1/10,000 and 1/1000), is very rare (1/10,000), frequency is unknown (the assessment cannot be carried out on the available data).

from the immune system. Very seldom: allergic reactions of immediate type (skin rash, sneezing, dacryagogue, a bronchospasm, dispnoe), reactions of hypersensitivity with localization in a GIT.

from a GIT. Very seldom: diarrhea, discomfort in a stomach, an abdominal pain, nausea, vomiting. Forming of strictures in ileocecal area and in the ascending part of a colon was described after prescribing of the medicament containing powder from a pancreas in high doses.

Message about the suspected side reactions. Messages about the suspected side reactions after registration of medicine play an important role. It allows to continue observation of a ratio of advantage and risk of medicine. Workers of health care have to report about any suspected side reactions.

At use of the medicaments containing powder from a pancreas the reduction of absorption of folic acid is possible

Interaction that can cause need of its additional receipt in an organism. gipoglikemiziruyushchy effect of acarbose and a miglitol can decrease at simultaneous use of medicament mezy forte 10,000 and mezy forte 20,000.

Storage conditions

At a temperature not above 30 °C.