The instruction for medical use of Bronhikum® C medicine the Trade name of Bronhikum® About the International unlicensed name Is not present the Dosage form of the Pastil Structure One pastil contains active agent – a thyme extract liquid (1:2 – 2.5) (extractant: 10% ammonia solution – glycerin of 85% – ethanol of 90% – the water purified (1:20:70:109)) – 100 mg excipients: sucrose, the povidone, menthol which is dried up by method of raspylitelny drying (menthol – 5.688 mg, gum acacia – 11.812 mg), the cineole which is dried up by method of raspylitelny drying (cineole – 1.626 mg, gum acacia – 9.214 mg), stearic acid, silicon dioxide colloidal anhydrous, magnesium stearate. The description Round, slightly convex, cream color, with insignificant impregnations of a pastil, with a diameter from 12.5 to 12.7 mm and from 6.1 to 6.6 mm thick. Pharmacotherapeutic group Drugs for elimination of symptoms of cold and cough. Expectorant drugs. The ATX R05CA code the Pharmacological Drug properties has expectorant, spasmolytic and antibacterial effects. Expectorant action is caused by the enhanced tsiliarny activity of a bronchial epithelium owing to reflex stimulation of vagus nerve in a mucous membrane of a stomach and direct stimulation of serous ferruterous cells after a resorption pulmonary excreta. Indications – symptomatic therapy in infectious and inflammatory diseases of upper airways, followed by cough with the hardly separated phlegm. Route of administration and doses Adult: to slowly rassasyvat 2 – 3 pastils in a mouth, several times a day. Children are more senior than 6 years: to slowly rassasyvat 1-2 pastils in a mouth, several times a day. Not to apply to children 6 years are younger. A route of administration For intake. At reception of pastils, please, observe the instruction: – accept pastils, having distributed them on several receptions in day with observance of whenever possible equal intervals between receptions – let’s pastils of Bronhikum With be dissolved slowly in a mouth – tell the doctor if you consider that action of pastils of Bronhikum With too strong or weak. Duration of a course of treatment is defined by the doctor with features of a disease, tolerance of medicine and the reached effect. In case of the admission of acceptance of medicine, it is necessary to continue to accept it as usual and without accepting a double dose. Side effects Undesirable reactions are given below on a class of a system of bodies and frequency of their emergence. Frequency is designated as: very often (≥1/10), it is frequent (from ≥1/100 to & lt, 1/10), is not frequent (from ≥1/1.000 to & lt, 1/100), is rare (from ≥1/10.000 to & lt, 1/1.000), is very rare (& lt, 1/10.000), it is not known (it cannot be estimated on the available data). Very seldom – allergic rash, a small tortoiseshell, the hypostasis of a throat, language, lips and a throat which is followed by an otdyshka (so-called Quincke’s edema) Frequency is not known – gastric disorders – reaction of hypersensitivity – an acute anaphylaxis – a Quincke’s disease in case of undesirable effects during use of Bronhikum With, it is necessary to stop immediately administration of drug and to see a doctor. If any of side effects takes the serious form or if you notice any side effects which are not listed in this instruction, report about it, please, to the attending physician. It is important to report the message about the suspected adverse reactions about the suspected side reactions during the post-registration period of use of medicine. It allows to conduct continuous monitoring of a ratio advantage/risk of drug. Experts in the field of health care are obliged to report about any cases of the suspected side reactions through national reporting system. Contraindications – hypersensitivity to any of medicine components, or to plants of family of a mint family (Lamiaceae) – persons with hereditary intolerance of fructose, glucose malabsorption – galactoses, deficiency of enzyme of invertase-isomaltase – children’s age up to 6 years Medicinal interactions are not established. Special instructions Patients need to see immediately the attending physician at emergence of an asthma, high temperature or a purulent phlegm. The components of natural origin which are contained in Bronhikum® With cause existence of heterogeneous inclusions that does not affect efficiency of medicine. Information for patients with diabetes One pastil corresponds 0.07 GU (grain units). Drug contains sucrose. It is not necessary to accept to persons with hereditary intolerance of fructose, glucose malabsorption – galactoses, deficiency of enzyme of invertase-isomaltase. Not to apply use in pediatrics for children 6 years are younger. The data obtained about use of drug in this age group are not enough. Pregnancy and the period of a lactation Due to the lack of special researches use of pastils of Bronhikum With is not recommended at pregnancy and a lactation. There is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Special cautions. Overdose any case of overdose Bronkhikum С was Not registered. The scientific reports concerning poisoning with a thyme no. A form of release and packing On 10 pastils in blister strip packaging from a film of polyvinylchloride and aluminum foil. On the 2nd blister strip packaging together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! A period of storage 2 years not to take the drug after an expiration date Prescription status Without prescription the Producer Sanofi-Aventis Sp.z. the lake about (Sanofi-Aventis Sp.z.o.o), the location Address: st. of Lyubelsk 52, 35-233, Rzhezhov, Poland the Owner of the registration certificate of Sanofi, Paris, France 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 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: firstname.lastname@example.org 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: Kazakhstan.Pharmacovigilance@sanofi.com
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