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Festal® H (20 tablets) p.s.o sol. / Intestinal.




The instruction for medical use of H FESTAL medicine the Trade name of Festal® of N the International unlicensed name Is not present the Dosage form of the Tablet, covered with a kishechnorastvorimy and sugar cover Structure One tablet contains: active agents: Pancreatinum – 212.5 mg containing not less (in terms of the International Pharmaceutical Federation of F.I.P.: lipases 6000, amylases 4500, proteases 300) excipients: sodium chloride, silicon dioxide colloidal cellulose microcrystalline, krospovidon, the water purified **. structure of a sublayer of a cover: hydroksipropilmetiltsellyuloza, polyethyleneglycol 8000, talc, titan dioxide (E171). structure of a kishechnorastvorimy cover: methacrylic acid copolymer (in the form of dispersion), sodium hydroxide ***, polyethyleneglycol 8000, talc, the titan dioxide (E171). structure of a sugar cover: sucrose, methylparaben, propylparaben, gelatin, glucose syrup, talc, calcium a carbonate, acacias powder, glycerin, the titan dioxide (E171), polyethyleneglycol 6000, the water purified **. ** – is removed in the course of production, *** – use for correction of value rn the Description of the Tablet of white color, round, biconvex, covered with a sugar cover. Pharmacotherapeutic group Drugs, digestant (including fermental drugs). Digestive fermental drugs. Pancreatinum. The ATX A09AA02 code the Pharmacological Pharmacokinetics Pancreatic Enzymes properties – the substances of proteinaceous origin filling shortage of enzymes of a pancreas and promoting digestion and digestion of food. In digestive tract the considerable absorption of pancreatic enzymes is not observed. Implementation of action does not require their absorption. On the contrary, full therapeutic action is carried out in a digestive tract gleam. As they represent proteinaceous molecules, enzymes are exposed further to proteolytic digestion in process of advance on digestive tract, are not absorbed in the form of peptides or amino acids yet. Bioavailability in the course of a gastrointestinal passage the tablet cover resistant to influence of gastric juice protects kislotochuvstvitelny enzymes from deactivation by gastric acid or reduces their destruction. Only after achievement of the neutral or alkalescent environment in a small intestine, enzymes are released after dissolution of a cover. The majority of enzymes is released by in vitro at rn more than 5.5. The maximum enzymatic activity is noted in 30-45 minutes after oral administration. Pancreatinum is not soaked up, but removed with a stake, mainly split or denatured by digestive juices or bacteria. The pharmacodynamics of Festal® of N – the fermental drug compensating insufficiency of vneshnesekretorny function of a pancreas accelerates catabolism of food and eliminates clinical manifestations of the broken digestion. Pancreatinum in structure of Festal® of N is the purified extract of a pork pancreas. Contains pancreatic enzymes – amylase, a lipase and proteases which facilitate digestion of fats, proteins and carbohydrates, promoting their fuller absorption in a small intestine. Pancreatic enzymes catalyze hydrolysis of fats to monoglycerides, glycerin and free fatty acids, proteins in peptides and amino acids, starches in dextrins and korotkotsepochechny sugar as a maltose and a maltrioza in a 12-perstny gut and proximal department of a small intestine, thus, working as the digestive enzymes which are physiologically cosecreted by a pancreas. Indications – insufficiency of vneshnesekretorny function of a pancreas (in chronic pancreatitis, a mucoviscidosis and so forth.) – the chronic inflammatory and dystrophic diseases of a stomach, intestines, liver, gall bladder, a state after a resection or radiation of these bodies which are followed by disturbances of digestion of food, a meteorism, diarrhea (as a part of combination therapy) – for improvement of digestion of food at patients with normal function of digestive tract, in case of errors in a diet and also at disturbances of chewing function, the forced long immobilization, inactive lifestyle – preparation to radiological and to ultrasound examination of abdominal organs the Route of administration and doses take the Drug inside, without chewing, in time or right after food, washing down with a small amount of liquid. Chewing can break a protective kishechnorastvorimy cover therefore premature release of enzymes can cause irritation of a mucous oral cavity and/or reduce therapeutic effect of drug. Adults: on 1-2 tablets 3 times a day. Higher doses are appointed by the doctor. Children are more senior than 6 years: on doctor’s orders. The average daily dose makes on 1 tablet 3 times a day. Duration of treatment can vary of 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). Before radiological or ultrasonography on 2 tablets 2-3 times a day in 2-3 days prior to a research. Side effects – allergic reactions – nausea, an abdominal pain, diarrhea, a constipation, a meteorism – a fibroziruyushchy colonopathy Frequency is unknown: – anaphylactic reactions, including a small tortoiseshell, a Quincke’s disease – a hyper uricosuria at reception of high doses of Pancreatinum – vomiting, irritation of a mucous membrane of an oral cavity – other disturbances from digestive tract at children with cystous fibrosis, intestinal impassability and a constipation, especially at treatment by high doses of pancreatic enzymes of the Contraindication – hypersensitivity to any of drug components – acute pancreatitis – exacerbation of chronic pancreatitis – the children’s age up to 6 years Medicinal interactions At simultaneous use with Festal® of N amplifies absorption of drugs of p-aminosalicylic acid (PASK), streptocides, antibiotics, decrease in absorption of iron preparations at long reception of Pancreatinum is possible. Pancreatic enzymes can suppress absorption of folic acid. At a concomitant use of other drugs with similar action (for example, bicarbonates or Cimetidinum) or at long-term treatment the high doses of Pancreatinum, recommended periodic control of level of folates in blood serum and/or additional intake of folic acid, Cimetidinum can strengthen action of Pancreatinum. N. Pankreatin can lead simultaneous use of the antiacid means containing calcium a carbonate and/or magnesium hydroxide to decrease in efficiency of the drug Festal® can reduce effect of acarbose, according to them it is impossible to accept in common. Drug it is necessary to appoint special instructions In a mucoviscidosis with care, the dose has to be adequate to quantity and quality of the consumed food (the dosage is selected by the attending physician). 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 seldom possible. Use in pediatrics of Festal® of N is not applied at children up to 6 years as this form of dosing is not suitable for small children because of danger of hit in airways. At children 6 years are more senior it can be applied on doctor’s orders. Pregnancy and a lactation At pregnancy and feeding by a breast appoint drug only in urgent cases if the potential advantage for mother exceeds potential risk for the fruit/child. The feature of influence of medicine on ability to run the vehicle or potentially dangerous Festal® mechanisms H does not influence ability to run the vehicle or potentially dangerous mechanisms. Overdose Symptoms: at prolonged use in high doses the increase in level of uric acid in blood plasma and in urine is possible. At children at use of high doses the irritation of skin of perianal area and a mucous membrane of an oral cavity can develop. Treatment: symptomatic therapy. Drug withdrawal. The form of release and packing On 10 tablets place in planimetric bezyacheykovy packings from aluminum foil. On 2 or 10 planimetric bezjyacheykovy packs together with the instruction for medical use in the state and Russian languages put in a pack cardboard. 3 years not to apply a period of storage after the expiration date specified on packing. To Store storage conditions at a temperature below 25 °C, in the dry place. To store out of children’s reach! Prescription status Without prescription the Producer of Sanofi India Limited, India the location Address: Poicha (Rania), Tal. Savli, Dist. Vadodara, Gujarat-391,780, India the Owner of the registration certificate of Sanofi India Limited, Mumbai, India the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Furmanov St. 187B phone number: +7 (727) 244-50-96 fax: +7 (727) 258-25-96 e-mail: the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Furmanov St. of 187 B phone number: +7 (727) 244-50-96 fax: +7 (727) 258-25-96 e-mail:
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