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Mezim forte 3500 IU (80 coated tablets)




The instruction for medical use of Mezim medicine forte the Trade name Mezim forte the International unlicensed name Is not present the Dosage form of the Tablet, film coated Structure One tablet contains active agent – Pancreatinum ** (with the minimum activity of a lipase of 3,500 PIECES of EF, amylase of 4,200 PIECES of EF, with the minimum general activity of protease 250 PIECES of EF) excipients: microcrystalline cellulose, sodium of starch glikolit (type A), silicon dioxide colloidal anhydrous, magnesium stearate, structure of a cover: polyacrylate of 30% dispersion in terms of dry matter, talc, a gipromelloz, azoruby varnish (E 122), an emulsion of a simetikon, the titan dioxide (E 171), a macrogoal 6000. ** – Pancreatinum (powder of pancreases) the Description of the Tablet, film coated pink color, a cylindrical form, with a plane-parallel surface, with a facet. Pharmacotherapeutic group Drugs, digestant, including fermental drugs. Digestive fermental drugs. Pancreatinum. The ATX A09AA02 code the Pharmacological Pharmacokinetics Pankreatin properties is not soaked up in digestive tract, and output with a chair, and its most part is split and denatured under the influence of digestive juices or bacteria. The pharmacodynamics Fermental drug of pork origin contains pancreatic enzymes – amylase, a lipase, trypsin and chymotrypsin which facilitate digestion of carbohydrates, fats and proteins that promotes their fuller absorption in a small intestine. Drug compensates insufficiency of vneshnesekretorny function of a pancreas and promotes improvement of processes of digestion. Indications of Mezim® it is forte applied for the purpose of substitution of digestive enzymes at the disturbances of exocrine function of a pancreas (for example, in chronic pancreatitis or a mucoviscidosis) which are followed by digestion disturbance and also at decrease in comprehensibility of nutrients at a meteorism, a gastrocardial syndrome, and, in particular, after the combined resection of a stomach and a small intestine, at the accelerated passing of food masses on intestines (as a result of hyperexcitability or infectious diseases of digestive tract), at disturbances from a gepatobiliarny system, dyspepsia, and in cases of the simultaneous consumption of vegetables hard to digest, greasy and unusual food. Except that, Mezim® forte apply by preparation for diagnostic tests with obtaining the image (ultrasonic, radiological researches) for the purpose of elimination of swelling of intestines at the meteorism which developed against the background of the disturbances of digestion described above. The route of administration and doses the Dose is defined individually depending on extent of disturbance of digestion. Tablets are not chewed and wash down with water. On 1-2 tablets before food. If necessary in addition at meal time take 2-4 more pill. It is not recommended to exceed the daily dose of enzymes making 15000–20000 PIECES of a lipase at the rate on body weight kg. Duration of treatment of Mezim® forte depends on the course of the disease and is established by the attending physician. Side effects Very seldom (1/10000) – allergic reactions of immediate type – allergic reactions from digestive tract (such as diarrhea, disturbances from a stomach and nausea) after intake of powder from pancreases – at patients with a mucoviscidosis the forming of strictures in ileocecal area and the ascending part of a colon after purpose of high doses of powder from pancreases was observed Frequency is unknown – at patients with a mucoviscidosis, especially after reception of high doses of drug, excretion of uric acid with urine can increase. Therefore at such patients it is necessary to check removal of uric acid with urine not to allow formation of stones of uric acid – an azoruby (E 122) it is capable to cause emergence of allergic reactions of the Contraindication – hypersensitivity to pork, azoruby varnish (E 122) and to other components of drug – acute pancreatitis – chronic pancreatitis in an aggravation phase. Nevertheless, incidental appointment is acceptable in a phase of the fading aggravation at expansion of a diet if there are symptoms of the residual or remaining disorder of function of a pancreas – the children’s and teenage age up to 18 years Medicinal interactions At reception of Mezima® forte can decrease absorption of folic acid therefore it is necessary to take this drug in addition. The effect of oral anti-diabetic drugs of acarbose and a miglitol can be reduced at the accompanying reception of Mezim® forte. The special instructions Mezim® forte contains active enzymes which at their release in an oral cavity (for example, when chewing), can lead to injury of her mucous membrane with possible formation of ulcers. Therefore Mezim® forte needs to accept without chewing, entirely swallowing a tablet. In a mucoviscidosis in case of exceeding a necessary dose of Pancreatinum the development of strictures (fibrous colonopathy) in ileocecal department and in the ascending part of a colon is possible. Forte pregnant women have no pregnancy and the period of a lactation of Sufficient data on drug Mezim® use. Data on impact on pregnancy course, development of an embryo/fruit, the childbirth or post-natal development received in experiments on animals are not enough. Therefore the potential risk for the person is unknown. In this regard at pregnancy and a lactation Mezim forte it is not necessary to accept unless it is absolutely necessary. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Special precautionary measures are not required. Overdose Symptoms: strengthening of side effects of drug is possible. Treatment: symptomatic. The form of release and packing On 20 tablets place in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished or a film polyamide/aluminium/polyvinylchloride and the printing aluminum foil varnished or a film polyvinylchloride / polyethylene/polyvinylidene chloride and the printing aluminum foil varnished. On 1 or 4 planimetric packs together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. 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 Proizvoditel Berlin-Hemi AG (Menarini Group) Gliniker Weg 125 12489 Berlin, Germany the Owner of the registration certificate Berlin-Hemi AG (Menarini Group) Gliniker Weg 125 12489 Berlin, Germany

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