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Description
The instruction for medical use of Noshverin Torgovoye medicine a name Noshverin Mezhdunarodnoye the unlicensed name Drotaverinum Dosage Form of the Tablet of 0.04 g Structure One tablet contains active agent – Drotaverinum a hydrochloride in terms of dry matter of 0.04 g, excipients: lactoses monohydrate, starch corn, magnesium stearate, talc. The description of the Tablet from light yellow till yellowish-green color, round, a ploskotsilindrichesky form with a facet. Pharmacotherapeutic group Digestive tract and metabolism. Drugs for treatment of functional disorders of a GIT. Papaverine and derivatives. Drotaverinum. The ATX A03AD02 code the Pharmacological Pharmacokinetics AbsorbtsiyaDrotaverin properties is quickly soaked up after parenteral and oral administration. RaspredelenieOn highly contacts plasma albumine (95-98%), alpha and beta globulins. The maximum concentration in blood serum is reached in 45-60 minutes after oral administration. BiotransformatsiyaPosle of presistemny metabolism in not changed form comes to a system blood stream 65% of the accepted Drotaverinum dose. It is metabolized in a liver. The VyvedenieBiologicheskiy period of Drotaverinum is 8-10 hours. In 72 hours, drug is almost completely removed from an organism, at the same time about 50% are removed with urine, and about 30% with a stake. Drotaverinum is removed generally in the form of metabolites, not changed drug form in urine is not found. A pharmacodynamics Drotaverinum – derivative isoquinoline which has spasmolytic effect on smooth muscles by oppression of effect of enzyme of phosphodiesterase IV (FDE IV) that leads to increase in concentration of tsAMF and, thanks to an inactivation of an easy chain of a kinase of myosin (MLCK), to relaxation of unstriated muscles. In vitro Drotaverinum suppresses effect of FDE IV enzyme and does not influence action of isoenzymes of phosphodiesterase III (FDE III) and phosphodiesterase V (FDE V). FDE ІV has great functional value for decrease in sokratitelny activity of unstriated muscles therefore selective inhibitors of this enzyme can be useful to treatment of the diseases which are followed by hyper mobility and also various diseases in which there are digestive tract spasms. In cells of unstriated muscles of a myocardium and vessels of tsAMF it is hydrolyzed mainly by FDE III isoenzyme. Drotaverinum affects smooth muscles of gastrointestinal, biliary, urinogenital and vascular systems irrespective of type of their autonomous innervation. It strengthens blood circulation in fabrics thanks to the ability to expand vessels. Indications With the medical purpose at: – the spasms of smooth muscles connected with diseases of a biliary path: a cholecystolithiasis, a cholangiolithiasis, cholecystitis, a pericholecystitis, a cholangitis, a papillitis – spasms of smooth muscles in diseases of an uric path: nephrolithiasis, ureterolithiasis, pyelitis, cystitis, bladder tenesmus. As auxiliary treatment at: – spasms of smooth muscles of digestive tract: a peptic ulcer of a stomach and a duodenum, gastritis, kardio-and/or a pylorospasm, enteritis, colitis, a spastic colitis with a constipation and a syndrome of the angry intestines which are followed by a meteorism – tension headache – gynecologic diseases (dysmenorrhea). Route of administration and doses Adult: the usual average dose makes 120-240 mg a day in 2-3 receptions. Children from 6 to 12 years: the maximum daily dose makes 80 mg (divided into 2 receptions, on 1 tablet (40 mg) 2 times a day). Children are more senior than 12 years: the maximum daily dose makes 160 mg (divided into 2-4 receptions, on 1 tablet (40 mg) 2-4 times a day). Duration of treatment is determined by the doctor depending on character and a course of the disease. Side effect the Possible side effects connected with Drotaverinum use, observed during clinical trials are listed below: very often (& gt, 1/10), it is frequent (& gt, 1/100, & lt, 1/10), sometimes (& gt, 1/1.000, & lt, 1/100), is rare (& gt, 1/10.000, & lt, 1/1.000), is very rare (& lt, 1/10.000), it is not known: it is impossible to estimate on the available data: Disturbances from the immune system Seldom: allergic reaction (Quincke’s edema, urticaria, rash, itching). It is not known: the lethal and non-lethal acute anaphylaxis was registered at the patients receiving treatment in the form of injections. Disturbances from nervous system Seldom: headache, dizziness, insomnia. Disturbances from heart it is rare: cardiopalmus. Disturbances from vessels Seldom: hypotension. The general disorders and disturbances in the injection site: Seldom: local reaction in the injection site of an injection. The message about potential undesirable medicinal reactions of the Message about potential undesirable medicinal reactions after authorization of medicine have huge value. They allow to continue monitoring of balance advantage/risk of medicine. Medical experts ask to report about any expected side reactions to the owner of the trade license, or if that is available, through national reporting system. Contraindications – hypersensitivity to Drotaverinum or other components of drug – heavy abnormal liver functions, kidneys – the profound heart failure – to persons with hereditary intolerance of fructose, deficiency of Lapp-lactases enzyme, glucose galactose malabsorption – children’s age up to 6 years – the lactation period. Medicinal interactions Can be applied in combination with cholinolytics and also as a part of combination therapy to stopping of hypertensive crisis. At simultaneous use with drugs of a levodopa the decrease in antiparkinsonichesky effect of the last is possible. Against the background of antiarrhytmic means, antidepressants the hypotensive effect amplifies. At use with barbiturates (phenobarbital) the spasmolytic effect amplifies. Special instructions With care patients should appoint drug with the profound atherosclerosis of coronary arteries, prostate adenoma, glaucoma. Drug can cause the dispepsichesky phenomena in patients with a lactose intolerance because of its contents in tablets. Use in pediatrics In this dosage form drug is not appointed to children up to 6 years. Pregnancy Safety at use of drug during pregnancy is insufficient, in this regard to pregnant women to apply only in case of urgent indications and after weighing of potential risk and advantage. Drug it is not recommended to appoint the lactation period in the period of a lactation. Features of influence of medicine to run vehicles or potentially dangerous mechanisms Considering side effects of drug, it is necessary to be careful at control of motor transport and the performance of work requiring special attention. Overdose Symptoms: strengthening of side effects of drug, atrioventricular block development (AV blockade), cardiac arrest, paralysis of a respiratory center is possible. Treatment: for simplification of AV blockade apply atropine or izoprenalin intravenously, to restoration of a heart rhythm – atropine or adrenaline intravenously, in paralysis of a respiratory center the artificial ventilation of the lungs is carried out. A form of release and packing On 10 tablets in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished. On 3 blister strip packagings together with the instruction for medical use place in a pack from cardboard. To Store storage conditions in the place protected from light, at a temperature not over 25 ºС. To store out of children’s reach! Period of storage of 5 years. Not to apply after expiry date. Prescription status Without prescription. Lekkhim-Kharkiv CIAO producer, Ukraine, 61115, Kharkiv Region., city of Kharkiv, Severina Pototskogo Street, 36 the Owner of the registration certificate CIAO Lekkhim-Kharkiv, Ukraine, the Name, the address and a contact information (phone, the fax, e-mail) 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: L-Pharma LLP 050061, Republic of Kazakhstan Almaty, mdt. Tastak-1, house. 3
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