Mezim forte 10s ED 10000 film-coated tablets solution / intestinal.

The instruction for medical use of Mezim medicine forte 10000 Trade name Mezim forte 10000 International unlicensed name Are not present the Dosage form of the Tablet, covered with a kishechnorastvorimy cover Structure One tablet contains: active agent - Pancreatinum of 125 mg with the minimum activity of a lipase of 10,000 PIECES of EF, amylase of 7,500 PIECES of EF, protease of 375 PIECES of EF excipients: lactoses monohydrate, cellulose microcrystalline, krospovidon type A, magnesium stearate, silicon dioxide colloidal anhydrous. structure of a film cover: copolymer of methacrylic acid and etakrilat (1: 1), simetikona emulsion of 30% (dry weight), gipromelloza, triethyl citrate, talc, macrogoal 6000, karmelloza of sodium, polysorbate 80, sodium hydroxide, titan dioxide (E 171), azoruby varnish (E 122). The description of the Tablet, covered with an enterosoluble film cover. Pink color, with slanted edges and almost plane-parallel surfaces, about 4.0 high ±.2 mm. Pharmacotherapeutic group Drugs, digestant, including fermental drugs. Digestive fermental drugs. Pancreatinum. The ATX A09AA02 code the Pharmacological Pharmacokinetics Absorption Powder properties from pancreases is not acquired in digestive tract, and output with a stake, its most part collapses or denatured by gastric juice or bakterialno. The bioavailability the Kishechnorastvorimy covering of tablets protects enzymes, sensitive to acid, from an inactivation gastric juice during 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. As powder from pancreases is not soaked up, data on its pharmacokinetics and bioavailability are absent. The efficiency of powder from pancreases is defined by degree and speed of release of enzymes from a galenovy form and corresponds, thus, to this galenovy form. The pharmacodynamics of Mezim forte 10,000 contains Pancreatinum. Pancreatinum is a powder from pancreases of mammals, usually pigs which along with the emitted pancreatic enzymes a lipase, alpha amylase, trypsin and chymotrypsin contains also other enzymes. Pancreatinum also contains other accompanying substances not having enzymatic activity. The digestive efficiency is defined by activity of enzymes, also, as well as a galenovy form. The enzymatic activity of a lipase and also trypsin content is decisive factor while the amylolytic activity matters only at treatment of a mucoviscidosis as even in chronic pancreatitis the splitting of polysaccharides is not broken. The pancreatic lipase chips off fatty acids from a molecule of a triatsilglitserid in provisions 1 and 3. The formed free fatty acids and 2 monoglycerides are quickly absorbed mainly in an upper part of a small intestine with the participation of bile acids. The lipase of a pancreas of animals – as well as a lipase of the person - is unstable to influence of acids, i.e. its lipolytic function is irreversible is inactivated at value rn lower than 4. Therefore Mezim forte 10,000 is issued in a kishechnorastvorimy dosage form. Trypsin is activated from trypsinogen of an avtokatalicheska or enterokinase of a small intestine, and causes activation activation of other proteolytic enzymes. As well as an endopeptidase, it splits peptide bonds in which the lysine and arginine are involved and, thus, provides proteolysis of amino acids and small peptides along with other enzymes due to splitting of peptide bonds. Alpha amylase, as well as endoamylase, very quickly splits the polysaccharides containing glucose therefore its activity is usually enough, even at connected with a disease significant deterioration in secretory activity of a pancreas. Indications Digestive disorders which are followed by disturbance of digestion and arise owing to a shortcoming or lack of education, release or activity of enzymes of a pancreas in a duodenum. It can be a consequence: chronic pancreatitis of any origin (alcoholic, traumatic, autoimmune, hereditary, medicinal, tropical kaltsifitsiruyushchy, idiopathic), a mucoviscidosis, narrowing of a pancreat duct, for example, in the presence of a tumor or gallstones, full or partial pancreatectomy and pancreatoduodenectomy, the accelerated passing of food masses on intestines owing to a resection of a stomach or a small intestine, at hyperexcitability or intestinal infections, consumption of difficult digested vegetables, fat and unusual products, with the disturbance of nutritive absorption following from here and dyspepsia of disturbances in a gepatobiliarny system, a Gee's disease, inflammatory bowel diseases (in particular Crohn's disease), diabetes. A route of administration and doses the Dosage the Recommended dose on one meal: 2-4 tablets (there correspond 20,000 - 40,000 PIECES of Ph. Eur. lipases). The dose of Mezim forte 10,000 is defined 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 Ph. Eur. on meal, but maybe it is raised. The purpose of the Mezim drug treatment forte 10,000 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 control of the doctor and for the purpose of reduction of expressiveness of symptoms (for example, a steatorrhea, a stomach ache). It is not necessary to exceed the daily dose of enzymes making 15000 - 20000 PIECES of a lipase on kilogram of body weight. It is not necessary to exceed the dose of enzymes necessary for sufficient absorption of fats, taking into account quantity and structure of food, especially at patients with a mucoviscidosis. Mezim forte 10,000 it is necessary to swallow entirely, washing down with a large amount of liquid, it is preferable in the middle of meal. At reception you watch swallowing Mezim forte 10,000 entirely as its efficiency can decrease when chewing, and the enzymes which are contained in drug at release in an oral cavity can injure a mucous membrane of the last. Use duration Duration of use of Mezim forte 10,000 is not limited. It depends on a course of the disease and is defined by the doctor. Side effects Very often ( 1/10) - allergic reactions of immediate type (such as skin rash, small tortoiseshell, sneezing, dacryagogue, bronchospasm, dispnoe), reactions of hypersensitivity in digestive tract. - diarrhea, discomfort in a stomach, an abdominal pain, nausea, vomiting - are described cases of formation of strictures in ileocecal department of intestines and in the ascending colon at the patients with a mucoviscidosis receiving powder from a pancreas in high doses. Frequency is not known - the azoruby (E 122) is capable to cause allergic reactions. Side effects which frequency of emergence is unknown - at patients with a mucoviscidosis, especially at reception of high doses of powder from pancreases, perhaps increased removal of uric acid with urine. Therefore at such patients it is necessary to carry out the analysis on the content of uric acid in urine to avoid formation of stones of uric acid. At emergence of unusual discomfort or metabasis it is necessary to undergo inspection as a precautionary measure for an exception of damage of intestines in a stomach. In particular it concerns the patients accepting more than 10000 units of a lipase on weight kg a day. Contraindications - hypersensitivity to drug components. - acute pancreatitis or chronic pancreatitis in an aggravation phase. Nevertheless, incidental administration of drug is allowed in a phase of the fading aggravation at expansion of a diet if digestive disturbances remain. - children's and teenage age up to 18 years - to persons with hereditary intolerance of fructose, deficiency of enzyme of lactase, glucose galactose malabsorption Medicinal interactions Folic acid At reception of the finished pharmaceutical products containing powder from pancreases the reduction of absorption of folic acid is possible therefore additional intake of folic acid can be required. Acarbose, miglitol Effect of acarbose and a miglitol, antidiabetic drugs for intake, can weaken at a concomitant use Mezim forte 10,000. The special instructions Impassability of Intestines is the known complication at patients with a mucoviscidosis. Therefore in the presence of the symptoms reminding intestinal impassability it is necessary to consider the probability of formation of strictures of intestines also. Mezim forte 10,000 contains active enzymes which at release in an oral cavity, for example when chewing, can injure a mucous membrane of an oral cavity (with formation of ulcers). Therefore at reception you watch swallowing Mezim forte 10,000 entirely. Forte 10,000 pregnant women have no pregnancy and the period of a lactation of Sufficient data on use of Mezim. Concerning impact on pregnancy, development of an embryo/fruit, childbirth or post-natal development of the data obtained in experiments on animals it is not enough. Therefore the potential risk for the person is unknown. In this regard at pregnancy and a lactation it is not recommended to accept Mezim forte 10,000 unless it is absolutely necessary. The feature of influence of medicine on ability to run the vehicle or potentially dangerous Mezim mechanisms forte 10,000 does not influence or makes insignificant impact on ability to control of vehicles and to service of mechanisms. Overdose there Are messages that at reception of very high doses, especially at patients with a mucoviscidosis, increase in concentration of uric acid in blood serum and in urine is possible. A form of release and packing On 10 tablets in blister strip packaging from the aluminum soft foil covered with a film polyvinylchloride and polyamide and aluminum solid foil. On 1, 2, 5 or 10 planimetric packs together with the instruction for use in the state and Russian languages place in a folding cardboard pack. To Store storage conditions at a temperature not higher than 30 wasps. To store out of children's reach! A period of storage 3 years not to apply after an expiration date Prescription status Without prescription the Producer / Owner of the registration certificate BERLIN-HEMI AG(MENARINI GROUP) Gliniker Weg 125 12489 Berlin, Germany
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