Meverin 30s 200 mg capsule

The instruction for medical use of MEVERIN® medicine the Trade name of Meverin® the International unlicensed name Mebeverin Lekarstvennaya a form of the Capsule of 200 mg Structure One capsule contains active agent – the mebeverin of a hydrochloride, pellets containing substance in terms of a mebeverin a hydrochloride of 200 mg the excipients which are a part of pellets: sucrose, starch corn, povidone, ethyl cellulose, talc, shellac structure of a cover of capsules: gelatin, titan dioxide (E 171) Description Solid gelatin capsules number 1, white color. Contents of capsules – granules (pellet) of color, white or almost white, or white with a creamy shade, spherical shape. 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. ATX A03A A04 code Pharmacological Pharmacokinetics Absorption properties. Mebeverin is quickly and completely soaked up after intake in the form of tablets or suspension. Thanks to the prolonged release of drug from the capsule it can be accepted twice a day. Distribution. At multiple dose mebeverin does not collect in an organism. Biotransformation. Mebeverina a hydrochloride is mainly metabolized by esterases which at the initial stage split radio bonds, at the same time veratric acid and mebeverinovy alcohol is formed. 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. Removal. Mebeverin per se is not excreted as it is metabolized completely, metabolites are removed almost completely. Veratric acid is emitted with urine. Mebeverinovy alcohol is also emitted with kidneys, partially in the form of the carboxylic acid (CA) and demetilirovanny carboxylic acid (DMKK). Pharmacokinetic researches with participation of children were not conducted. The pharmacodynamics Mebeverin is myotropic spasmolysant with direct action on smooth muscles of digestive tract. It eliminates a spasm, without affecting normal motility of intestines. The exact mechanism of action is unknown, but numerous mechanisms, such as decrease in permeability of an ion channel, blockade of the return capture of noradrenaline, local anesthetic effect, water absorption change, can cause local action of a mebeverin on digestive tract. By means of these mechanisms mebeverin possesses the anti-spastic action leading to normalization of motility of intestines without causing a constant relaxation of smooth muscle cells of digestive tract (so-called hypotonia). System side effects, typical anticholinergic effects are absent. Indications - the symptomatic treatment of abdominal pain and spasms, disorders of intestines and feeling of discomfort in intestines 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 (not less than 100 ml). Capsules should be swallowed entirely, without chewing. Adults On 200 mg (1 capsule) 2 times a day (in the morning and in the evening). Duration of reception is not limited. In case reception of one dose or more is missed, it is necessary to accept the following capsule according to appointment, the passed doses should not be accepted in addition. Side effects the Listed below side effects are known from post-marketing practice therefore their frequency cannot be precisely estimated. - allergic reactions, generally in the form of skin manifestations: urticaria, a dieback, a face edema, a Quincke's edema - reactions of hypersensitivity (anaphylactic reactions) of the Contraindication - hypersensitivity to active ingredient or any auxiliary component of drug - children's and teenage age up to 18 years - hereditary intolerance of fructose, sakharazo-izomaltazny insufficiency, a glucose galactose sprue Medicinal interactions of the Research on studying medicinal interactions were not carried out. Researches on interaction of a mebeverin and alcohol on animals who showed lack of interaction both in vivo, and in vitro were conducted. Special instructions Special clinical groups of patients of Special researches with participation elderly or patients with a renal and/or liver failure were not carried out. Post-marketing experience did not reveal specific risk factors for patients of these groups and also there are no special recommendations about dosing. Pregnancy and the period of a lactation of Meverin® is not recommended to pregnant women as data on use of a mebeverin in this group of patients are limited. It is not recommended to appoint Meverin® to the women nursing the baby in view of lack of data. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms of the Research about influence of drug on ability to driving and control of mechanisms were not carried out. The Pharmakodinamichesky and pharmacokinetic profile and also experience of post-registration use do not show any harmful effects of a mebeverin on ability to driving and control of mechanisms. Overdose Symptoms: Theoretically in cases of overdose the increase in excitability of the central nervous system can be observed. In cases of overdose of a mebeverin the symptoms were absent or were lungs and quickly disappeared. The described symptoms of overdose were observed from cardiovascular or nervous system. Treatment: Specific antidote is not known. Symptomatic treatment is recommended. Gastric lavage is performed if it is known that except Meverin also other drugs, within 1 hour after reception are taken. The actions interfering absorption are not necessary. The form of release and packing On 10 capsules place in blister strip packaging from a film of polyvinylchloride and aluminum foil with the press varnished. On 3 blister strip packagings together with instructions for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions in original packing at a temperature not higher than 25 wasps. To store out of children's reach! 2 years not to use a period of storage after expiry date. Prescription status Without prescription Ukraine PJSC Kiyevmedpreparat Producer, 01032, Kiev, Saksagansky St., 139 the Owner of the registration certificate of PJSC Kiyevmedpreparat, Ukraine the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine: TD Pharmamed LLP, Almaty, Hodzhanov Street, building 67, settlement 4a Ph.: +7 (727) 344-99-05/06