The instruction for medical use of FITOHOL medicine the Trade name of FITOHOL the International unlicensed name Is not present the Dosage form of the Structure Capsule 1 capsule contains active agents – Carrots wild fruits and a calendula of flowers of extract dense (7.75 – 13.4): 1 of Daucus carota and Calendulae flos, extractant ethanol of 70%, in terms of dry matter – 60 mg, the Immortelle of sandy extract of flowers dry of Helichrysi arenarii flos (40:1), extractant ethanol of 50% – 50 mg, C3 Curcumine a complex from Curcumae longae rhizomes (a turmeric long rhizomes) (64 – 66): 1, extractant ethyl acetate – 20 mg, Curcumae longae aetheroleii (oils of a turmeric long (turmeronovy oil)) – 5 mg, Menthae piperitae aetheroleii (peppermint oils) – 7.5 mg, excipients – magnesium a carbonate heavy, lactoses monohydrate, castor oil, magnesium alyumometasilikat (neusilin UFL2), talc, potato starch, structure of a gelatin capsule: the capsule body – the titan dioxide (E 171), ferrous oxide yellow (E 172), gelatin, a capsule lid – the titan dioxide (E 171), ferrous oxide yellow (E 172), gelatin. Description Solid gelatin capsules No. of 0 C body and lid of yellow color. Capsule contents – the granulated powder and/or the condensed weight from yellow till yellow-orange color with an olive-brown shade, with impregnations and a specific smell. Pharmacotherapeutic group Digestive tract and metabolism. Drugs for treatment of diseases of a liver and biliary tract. Drugs for treatment of diseases of a gall bladder. Other drugs for treatment of diseases of biliary tract. ATX A05A X code. The pharmacological Pharmacokinetics Not properties it was studied. The pharmacodynamics of FITOHOL is multicomponent means of natural origin which pharmacological properties are caused by cumulative action of a complex of biologically active agents which are a part of drug. The Holeretichesky (bile-expelling) effect of drug FITOHOL – bilification stimulation − is caused by action of the following components of drug: extract of carrots wild, extract of a marigold of flowers, extract of an immortelle sandy, oils of a turmeric long, peppermint oils. Holekinetichesky effect of drug FITOHOL – improvement of outflow of bile through biliary tract in a duodenum and prevention of stagnation of bile − is caused by existence in its composition of extract of a marigold of flowers, extract of an immortelle sandy and oils of a turmeric long. The Holespazmolitichesky effect of drug FITOHOL – elimination of cricks of bile-excreting channels − is caused by effect of extract of carrots wild and oils of a peppermint. Hepatoprotective effect of drug FITOHOL – improvement of metabolic processes in a liver − is caused by effect of extract of carrots wild, extract of a marigold of flowers, extract of an immortelle sandy, oils of a turmeric long, peppermint oils. Indications – chronic not calculous cholecystitis – dyskinesia of biliary tract – chronic hepatitis (as a part of complex treatment). The route of administration and doses Apply inside. On 1-2 capsules 3 times a day. The drug is taken in 30 minutes prior to food, without chewing, washing down with a small amount of water. The maximum daily dose – 6 capsules. The dosage and duration of a course of treatment are defined by the doctor individually depending on character and a course of the disease. Usually the course of treatment makes 20 days. Carrying out repeated courses of treatment perhaps after coordination with the doctor. Side effects from digestive system: sensation of discomfort and an abdominal distension, rumbling in intestines, diarrhea, an itching in an anus, nausea, an eructation. From the central nervous system: dizziness, drowsiness, a headache, heavy feeling in the head. Other side effects: feeling of heat, face reddening. Contraindications – hypersensitivity to drug components – obstruction of bilious ways – a cholangitis – suppuration (empyema) of a gall bladder – cholelithiasis – acute inflammatory diseases of a liver and gall bladder – a heavy liver failure – a heavy renal failure – impassability of urinary tract – acute diseases of kidneys – children up to 6 years – is contraindicated to persons with hereditary intolerance of fructose, deficiency of Lapp-lactases enzyme, glucose galactose malabsorption Medicinal interactions Interaction with other medicines and other types of interactions are unknown. The special instructions Apply with care in diseases which can result in impassability of bilious ways, and in a serious illness of a liver. In case of developing of diarrhea or an abdominal pain treatment it is necessary to stop and consult with the doctor. Pregnancy and the period of a lactation during pregnancy or feeding by a breast use drug only on doctor’s orders if the expected advantage for the woman exceeds potential risk for a fruit or the child. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Drug does not influence speed of response at control of motor transport or work with other mechanisms. Carefully Overdose So far cases of overdose not to appoint registered by the patient with diabetes. Symptoms: at prolonged use in the doses exceeding recommended strengthening of side reactions is possible. Treatment: drug withdrawal, symptomatic therapy, there is no specific antidote. A form of release and packing On 10 capsules in blister strip packaging from a film polyvinylchloride or from a film polyvinylchloride barrier (Aclar 2000 type) and aluminum foil with the press varnished. On 3 blister strip packagings in a pack together with the instruction 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 above 25 °C. To store out of children’s reach! A period of storage 3 years not to apply after an expiration date Prescription status Without prescription Ukraine PJSC Kiyevmedpreparat Producer, 01032, Kiev, Saksagansky St., 139. The owner of the registration certificate of PJSC Kiyevmedpreparat 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: TD Pharmamed LLP, Almaty, Hodzhanov Street, building 67, settlement 4a Ph.: +7 (727) 344-99-05/06
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