The instruction for medical use of HALIKSOL® medicine the Trade name of Haliksol® the International unlicensed name Ambroxol Dosage Form of the Tablet, 30 mg Structure One tablet contains active agent – Ambroxol a hydrochloride of 30 mg, excipients: lactoses monohydrate, cellulose microcrystalline, sodium of starch glikolit (type A), povidone (K-30), magnesium stearate. The description White or almost white, round flat tablets with a facet, with an engraving of the stylized letter E and figure 231 on one party and risky – on other party, without or almost flavourless. Pharmacotherapeutic group Drugs for treatment of diseases of a respiratory system. Drugs for elimination of symptoms of cold and cough. Expectorant drugs. Mucolytics. Ambroxol. The ATX R05CB06 code the Pharmacological Pharmacokinetics Absorption Ambroxol properties is almost completely soaked up from digestive tract. Ambroxol is exposed to active metabolism of the first passing in a liver. The absolute bioavailability of Ambroxol after intake is about 79%. Distribution quickly and considerably passes Ambroxol from blood into fabrics, reaching the highest concentration in lungs. The volume of distribution is 552 l. In therapeutic doses about 90% of the accepted dose contacts proteins of blood plasma. Ambroxol gets through a placental barrier. Concentration of drug in an organism of a fruit is 2-4 times higher, than at mother. Also it is found in breast milk and cerebrospinal fluid. Biotransformation After intake about 30% of a dose is exposed to metabolism of the first passing. Ambroxol, is generally metabolized in a liver with forming of conjugates with glucuronic acid, di-bromantranilovoy of acid (about 10% of a dose) and some insignificant metabolites. Researches of microsomes of a liver of the person established that CYP3A4 cytochrome is responsible for transformation of Ambroxol into di-bromantranilovuyu acid. Removal Within 3 days after intake about 6% of a dose is removed in an invariable form, and about 26% – are removed by kidneys in the conjugated form. Terminal time of semi-removal is about 10 hours. The general clearance is about 660 ml/min. of plasma, and the renal clearance is about 83% of the general clearance. Age and sex from the clinical point of view do not influence Ambroxol pharmacokinetics, thus, there is no need for change of a dose. Meal does not affect bioavailability of Ambroxol of a hydrochloride. Special groups of patients At a heavy renal failure elimination half-life increases in this connection accumulation of metabolites of Ambroxol is possible. In abnormal liver functions the clearance of Ambroxol goes down, and its concentration in plasma increases by 1.3 – 2 times. Due to the wide therapeutic range of Ambroxol of a hydrochloride there is no need for change of a dose. The pharmacodynamics Ambroxol – the active component of the drug Haliksol which is an active metabolite of Bromhexine belongs to benzylamine group of mucolytic substances. Ambroxol strengthens formation of lysosomes and increases activity of hydrolytic enzymes in the cells cosecreting slime. It promotes destruction of the fibers consisting of acid mucopolysaccharides in a bronchial secret. Drug stimulates serous cells of glands of a mucous membrane of bronchial tubes, reducing viscosity of a phlegm and normalizing a ratio of mucous and serous components of a phlegm. Ambroxol increases surfactant content in lungs as Klara in small pneumatic ways directly affects pnevmotsita of the 2nd type and a cell and also function of ciliate cells improves. As a result of it the viscosity of the allocated secret decreases and the mukotsiliarny clearance becomes more effective. Fluidifying of a secret and increase in mukotsiliarny clearance facilitates expectoration of a phlegm. In pharyngitis Ambroxol considerably reduces pain and hyperaemia of a mucous throat. At inhalation, drug quickly kills the pain and unpleasant feelings connected with pain in an ear throat-nose. Ambroxol has anti-inflammatory properties as inhibits release of cytokines from the circulating and fabric mononuclear and polimorfoyaderny cells. Drug promotes fluidifying of slime and at inflammations of a nose and throat. After use of Ambroxol, concentration of antibiotics (amoxicillin, a tsefuroksim, erythromycin) in the secret allocated by bronchial tubes increased. The clinical importance of this fact is unknown. Indications – acute and chronic respiratory diseases, followed by discharge of a viscous phlegm: bronchitis, bronchial asthma and a bronchoectatic disease, a chronic obstructive pulmonary disease, pneumonia (in complex therapy) the Route of administration and doses of the Tablet should be accepted irrespective of meal and to wash down with a large amount of liquid. Plentiful intake of liquid promotes fluidifying of slime at treatment by Ambroxol. With the help the risks a tablet can be divided into 2 equal doses. Adults and children are more senior than 12 years: the recommended daily dose in the first 2-3 days of treatment – on 1 tablet 3 times a day. The therapeutic effect can be enhanced, accepting 2 tablets twice a day. The drug Haliksol in a dosage form syrup is recommended to children up to 12 years. In a heavy renal failure it is necessary to appoint reduced doses or to increase intervals between administrations of drug. Duration of treatment is defined by the doctor individually depending on a clinical condition of the patient and averages 4-5 days. At Haliksol’s reception over 5 days if the state did not improve, recommended consultation of the doctor. Side effects the Frequency of side reactions is defined as follows: Very often (≥ 1/10), it is frequent (≥ 1/100 to & lt, 1/10), infrequently (≥ 1/1000, & lt, 1/100), is rare (≥ 1/10,000 and & lt, 1/1000), is very rare (& lt, 1/10,000), frequency is unknown (frequency cannot be estimated on the basis of the available data). Narusheniya from the immune system seldom: frequency is unknown to reaction of hypersensitivity: anaphylactic reaction, including an acute anaphylaxis, a Quincke’s disease and naggers Narusheniya from nervous system often: disturbance of flavoring feelings is rare: weakness, a headache of Narusheniya from the respiratory system, bodies of a thorax and mediastinum it is frequent: pharyngeal hypesthesia seldom: discharges from Narusheniya’s nose from digestive tract often: numbness of a mouth, nausea infrequently: dryness in a mouth, vomiting, dyspepsia, complaints to gastrointestinal disorders, an abdominal pain, diarrhea seldom: salivation, heartburn very seldom: a constipation frequency is unknown: feeling of dryness in Narusheniya’s throat from skin and hypodermic fabrics seldom: skin rash, a small tortoiseshell frequency is unknown: heavy reactions from skin (including a mnogoformny erythema, Stephens-Johnson’s syndrome, a syndrome of a toxic epidermal necrolysis and sharp generalized eczematic pustulez Narusheniya from kidneys and urinary tract it is very rare: a dysuria the General disorders and disturbances in the injection site infrequently: fever, reactions from mucous membranes of the Message about expected side reactions Providing data on expected side reactions of drug is very important point allowing to carry out continuous monitoring of a ratio risk/advantage of medicine. Health workers should provide information on any expected adverse reactions on the contacts specified at the end of the instruction and also through the national system of collection of information. Contraindications – hypersensitivity to active ingredient to Ambroxol, Bromhexine or any of drug excipients – patients with rare inherited disorders of shipping of a galactose, deficiency of Lapp-lactases enzyme, glucose malabsorption – galactoses – pregnancy and the period of a lactation – children’s age up to 12 years. Medicinal interactions At simultaneous use of the drug Haliksol with some antibiotics (amoxicillin, tsefuroksimy, erythromycin, docsitsilliny) – strengthening of their penetration into a bronchial secret. At simultaneous use of the drug Haliksol with antibechics (for example, codeine) – department of the phlegm diluted by Ambroxol is at a loss. Special instructions Before use of the drug Haliksol it is necessary to consider a possibility of reactions of hypersensitivity. Use of the drug Haliksol for patients with disturbance of motor function of bronchial tubes (for example, at a rare syndrome of motionless cilia) or plentiful expectoration demands extra care because of danger of stagnation of a bronchial secret. Very exceptional cases of severe damages of skin such as Stephens Johnson’s syndrome / toxic epidermal necrolysis and sharp generalized exanthematous pustulez are registered at hydrochloride Ambroxol use. In case of the progressing skin defeats it is necessary to stop immediately intake of Ambroxol of a hydrochloride and to see a doctor. Use of the drug Haliksol in a renal failure and a serious illness of a liver demands extra care. At heavy disturbance of renal function or a liver failure the accumulation of metabolites of Ambroxol is possible. At patients with a peptic ulcer of digestive tract it is necessary to estimate a ratio of advantage and risk of treatment. Each tablet contains 84 mg of lactose that should be considered to patients with rare inherited disorders of shipping of a galactose, deficiency of Lapp-lactases enzyme, glucose malabsorption – galactoses Pregnancy and the period of a lactation Ambroxol gets through a placental barrier. Straight lines or indirect adverse effects of Ambroxol on a pregnancy course, development of an embryo/fruit, childbirth and postnatal development are not revealed. Clinical experience of use of Ambroxol did not reveal adverse effects on a course of pregnancy or fetation after the 28th week of pregnancy. Nevertheless, drug is recommended to be used with care. Nevertheless, as well as at use of other medicines during pregnancy, drug is recommended to be used with care. In the I trimester the drug Halikol use is not recommended. Ambroxol is emitted in breast milk therefore it is not recommended to be accepted during breastfeeding. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms of the Research about influence of medicine on ability to run the vehicle or potentially dangerous mechanisms were not carried out. There are no data on cases of influence of the drug Haliksol on the above-stated abilities. Overdose Symptoms: nausea, vomiting, diarrhea and other symptoms from digestive system. Treatment: At overdose, first of all, it is necessary to cause vomiting then to offer the patient drink (milk, tea). If the drug was taken within 1-2 hours, fast evacuation of contents of a stomach is recommended. After that against the background of symptomatic therapy activated carbon is appointed. It is necessary to monitorirovat a condition of a cardiovascular system constantly. A form of release and packing On 10 tablets in blister strip packaging from PVH/PVDH//aluminum foil. On the 2nd blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions in the place protected from light, at a temperature not over 30C. To store out of children’s reach. Not to apply a period of storage of 5 years after an expiration date. Prescription status Without prescription Budapest CJSC Pharmaceutical Plant Egis Producer 1106, st. Keresturi, 30-38 Hungary Phone number: (36-1) 803-5555, fax: (36-1) 803-5529 Owner of the registration certificate of CJSC Pharmaceutical Plant Egis, Hungary 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: Representation in RK CJSC EGIS Pharmaceutical Plant 050060, Almaty, Zharokov St. of 286 G ph. + 7 (727) 247 63 34, + 7 (727) 247 63 33, fax: + 7 (727) 247 61 41, e-mail:
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