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Duskonal 30s Retard 200 mg modified-release capsules




The instruction for medical use of DUSKONAL RETARD medicine the Trade name Duskonal Retard Mezhdunarodnoye the unlicensed name Mebeverin Lekarstvennaya the Capsule form with the modified release, 200 mg Structure One capsule contains active agent – a mebeverin of a hydrochloride of a pellet of 70% 285.71 mg (200 mg of a mebeverin of a hydrochloride are equivalent), excipients: sugar balls, mannitol, ethyl cellulose, gipromelloz (HP55), cellulose microcrystalline, K30 povidone, sodium lauryl sulfate, cetyl alcohol, capsule: gelatin, titan dioxide (E171), gland (III) oxide red (E172) Description Solid gelatin capsules size No. of 0 C opaque body of opaque white color and opaque lid of opaque red-brown color. Contents of capsules – pellets of spherical shape of white or almost white color. Pharmacotherapeutic group Drugs for treatment of functional disturbances from a GIT. The drugs used at dysfunctions of intestines. Synthetic holinoblokator – ethers with a tertiary amino group. Mebeverin. The ATX A03AA04 code the Pharmacological Mebeverin Pharmacokinetics Absorption properties quickly and almost is completely soaked up after intake. The real dosage form allows to apply the scheme of reception 2 times a day. Distribution At repeated reception mebeverin does not collect in an organism. Mebeverin’s metabolism a hydrochloride is generally metabolized by esterases which at the first stage split ether on veratric acid and mebeverinovy alcohol. The main metabolite in blood plasma – demetilirovanny carboxylic acid (DMKK). Elimination half-life of DMKK at achievement of stable concentration makes 5.77 hours. At multiple dose of a dose of 200 mg twice a day the maximum concentration (Cmax) of DMKK makes 804 ng/ml, time of achievement of the maximum concentration (tmax) about 3 hours. The relative bioavailability at reception of capsules with the modified release is 97%. Removal per se Mebeverin is not brought out of an organism as it is metabolized completely. Veratric acid is emitted with kidneys. Mebeverinovy alcohol is also emitted with kidneys, partially in the form of the carboxylic acid (CA) and demetilirovanny carboxylic acid (DMKK). The pharmacodynamics Duskonal Retard is spasmolysant of myotropic action, making direct impact on smooth muscles of digestive tract. Eliminates a spasm, without influencing a normal vermicular movement of intestines. Mebeverin blocks natrium channels of a cellular membrane and breaks an entrance of ions of Na + in a cell, also blocks an entrance of ions of Ca2 + via slow channels, limits an exit of ions of K+ from a cell, slows down processes of a cellular membrane and interferes with reduction of fibers of muscles. Has no anticholinergic effect. Indications – the symptomatic treatment of abdominal pain and spasms, disorders of intestines and feeling of discomfort connected with an irritable colon – treatment of the spastic conditions of digestive tract caused by organic diseases of internals the Route of administration and doses of the Capsule accept inside, washing down with enough water in 20 minutes prior to meal. To swallow entirely, without chewing. Adults On 200 mg (1 capsule) 2 times a day (in the morning and in the evening). Duration of use is not limited. If reception of one dose or more is missed, it is necessary to accept the following capsule in compliance with appointment, the passed doses should not be accepted in addition. Elderly patients, at patients with a renal and/or liver failure have no need for dose adjustment. Side effects – dizziness (in some cases), – diarrhea – a constipation – allergic reactions (itching, urticaria, a dieback, a face edema, a Quincke’s edema) of the Contraindication – hypersensitivity to drug components – children’s age up to 18 years Medicinal interactions of the Research on studying medicinal interactions were not carried out. The special instructions Pregnancy and the period of a lactation Drug can be used at pregnancy only if the expected advantage for mother obviously exceeds possible risk for a fruit. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms during treatment should be careful when driving motor transport and during the occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions. Overdose Symptoms: In cases of overdose the increase in excitability of the central nervous system can be observed. The symptoms described at messages about overdose by Duskonal Retard no, or are quickly reversible. Usually describe symptoms from cardiovascular or nervous system. Treatment: Symptomatic treatment is recommended. Specific antidote is not known. Gastric lavage is recommended only in case of intoxication by numerous drugs which was diagnosed within 1 hour from the moment of intake of medicines. The actions interfering absorption are not effective. The form of release and packing On 10 capsules place in blister strip packaging from a film of polyvinyldichloride and aluminum foil. On the 3rd blister strip packagings together with the instruction for use in the state and Russian languages put in a cardboard pack. To Store storage conditions in the place protected from moisture and light at a temperature not above 25 °C. To store out of children’s reach! Not to store in the fridge. Not to freeze. 3 years not to apply a period of storage after an expiration date! Prescription status According to the prescription the Producer UORLD of ILACh DIGNITY MEDICINE. VE TIDZh.A. Highway, TURKEY (Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami Yolu Dzhad. No. 50 K. 1B Zemin 4-5-6, Istanbul, Turkey) the Owner of the registration certificate of UORLD MEDITSIN LTD, GEORGIA (WORLD MEDICINE LTD, GEORGIA) the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of medicines and responsible for post-registration observation of safety of medicine of TROKA-S PHARMA LLP (Republic of Kazakhstan) Republic of Kazakhstan, Almaty, Suyunbaya Avenue 222-b

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