Mucosolvan Max 75 mg (10 capsules)

The instruction for medical use of MAX. LAZOLVAN® medicine the Trade name LAZOLVAN MAX Mezhdunarodnoye the unlicensed name Ambroxol Dosage Form of the Capsule of the prolonged action of 75 mg Structure 1 capsule contains active agent – Ambroxol a hydrochloride of 75 mg, excipients: krospovidon, wax of karnaubskiya, stearyl alcohol, magnesium stearate, structure of the capsule: gelatin, the titan dioxide (E171), ferrous oxide red (E172), ferrous oxide yellow (E172), water cleaned, blackened structure: shellac, isopropyl alcohol, propylene glycol, titan dioxide (E171). The description the Oblong solid gelatin capsules consisting of an opaque red lid and the orange opaque body. White ink on a cap put the inscription MUC 01, on the body - a symbol of the Boehringer Ingelheim company. Capsule contents - round, zheltovato white granules with a smooth, brilliant surface, the powder mixed with a small amount. Pharmacotherapeutic group Drugs for elimination of symptoms of cold and cough. Expectorant drugs. Mucolytics. Ambroxol. ATX R05CB06 code Pharmacological Pharmacokinetics Absorption properties. Absorption high and almost full, a lineynozavisima from a therapeutic dose. The maximum plasma concentration is reached within 6.5 hours. Absolute bioavailability – 95%. Distribution. Distribution fast and extensive, with the highest concentration in tissue of lungs. The volume of distribution is about 552 l. Communication with proteins of blood plasma makes about 90%. Metabolism and removal. About 30% of the dose accepted inside are exposed to presistemny metabolism. Ambroxol the hydrochloride under the influence of the main CYP3A4 enzyme is metabolized mainly in a liver by a glyukuronization and partially breaks up to dibromantranilovy acid (about 10% of a dose). After intake, in 3 days, 26% of a dose also about 6% in a free form were found in urine in connected. Elimination half-life makes about 10 hours. The general clearance – within 660 ml/min., renal clearance is about 8% of the general clearance. It is removed by kidneys: about 83% of the general dose are allocated in 5 days after reception. Removal decreases in an abnormal liver function that leads to increase in level in blood plasma by 1.3-2 times. Gender and age do not influence pharmacokinetics of Ambroxol and do not demand dose adjustment. Meal does not influence bioavailability of Ambroxol of a hydrochloride. The Ambroxol pharmacodynamics a hydrochloride - active ingredient of the drug LAZOLVAN MAX. Preclinical trials showed that Ambroxol increases secretion of slime in airways, increases production of pulmonary surfactant, stimulates physical activity of cilia of a ciliary epithelium, leading to improvement of mukotsiliarny transport of a phlegm. Kliniko-pharmakologichesky researches confirmed increase in mukotsiliarny clearance that promotes decrease in viscosity of a phlegm and facilitates cough. At patients with a chronic obstructive disease of easy (HOBL) of result of long-term treatment (6 months) of the drug LAZOLVAN MAX (capsules of the prolonged action of 75 mg) the considerable decrease in aggravations in 2 months of treatment was observed. Besides, weakening of such symptoms of a disease as complicated otkhozhdeny phlegms, cough, an asthma, auskultativny signs in comparison with placebo was noted. Besides, it was noted that the course of the disease and need for antibiotic treatment were shorter in comparison with placebo. Mestnoanesteziruyushchy effect of Ambroxol is caused by dose-dependent reversible blockade of the cloned neural natrium channels. Under the influence of hydrochloride Ambroxol the release of cytokines from blood and also from fabric mononuclear and polimorfnuklearny cells considerably decreases. Clinical trials on patients with a sore throat showed considerable reduction of pain and reddening in a throat. Indications Sekretolitichesky therapy of the acute and chronic bronchopulmonary diseases which are characterized by disturbance of secretion and the complicated phlegm otkhozhdeniye the Route of administration and doses Adults and children are more senior than 12 years: 1 capsule of 1 times a day (75 mg of Ambroxol of a hydrochloride a day are equivalent). Duration of reception is not limited, but it is not necessary to take the drug more than 4-5 days without consultation of the doctor. The capsule should be swallowed entirely, washing down with enough liquid (for example, waters, tea or fruit juice), regardless of meal. It is forbidden to open or chew the capsule! Granules in the capsule emit active agent during passing through digestive system. Side effects the Undesirable phenomena are given below on system and organ classes and frequency on the following classification: very often ≥ 1/10 it is frequent ≥ 1/100 to & lt, 1/10 infrequently ≥1/1000 to & lt, 1/100 is rare ≥1/10.000 to & lt, 1/1000 is very rare also lt, 1/10.000 frequency are unknown undesirable reactions which frequency is unknown as it cannot be estimated on the basis of the available Narusheniya's data from the immune system Seldom: - reaction of hypersensitivity Frequency is unknown: - anaphylactic reactions, including an acute anaphylaxis, a Quincke's disease and naggers Narusheniya from skin and hypodermic fabrics Seldom: - rash, urticaria Frequency is unknown: - heavy skin reactions (including a multiformny erythema, Stephens-Johnsona/syndrome a toxic epidermal necrolysis and sharp generalized exanthematous pustulez) Narusheniya from a GIT Often: - nausea Infrequently: - vomiting, diarrhea, dyspepsia, abdominal pain Very seldom: - the increased Narusheniya's salivation from the respiratory system, bodies of a thorax and mediastinum the Frequency is unknown: - an asthma (as a symptom of reaction of hypersensitivity) Complications of the general character and reaction in the injection site Infrequently: - fever, local reactions of a mucous membrane of the Contraindication - hypersensitivity to Ambroxol to a hydrochloride or other components of drug - children's age up to 12 years Medicinal interactions it was not reported about clinically significant adverse interactions with other drugs. Intake of Ambroxol and antibiotics (amoxicillin, tsefuroksy, erythromycin) can lead to the increased penetration and concentration of the last in a bronchopulmonary secret and a phlegm. Special instructions Are registered very exceptional cases of severe damages of skin such as Stephens-Johnson's syndrome and toxic epidermal necrolysis, at hydrochloride Ambroxol use. Mainly they are caused by weight of a basic disease and/or the accompanying treatment. At patients signs of the beginning of a nonspecific disease with the following symptoms can be shown: fervescence, all body pain, rhinitis, cough and sore throat. Emergence of these signs can lead to unnecessary symptomatic treatment by anti-cold drugs. In case of skin defeats it is necessary to see immediately a doctor and to stop intake of Ambroxol of a hydrochloride. Patients with a rare syndrome of primary tsiliarny dyskinesia should use the drug LAZOLVAN MAX with care, in connection with risk of accumulation of a secret. Use of the drug LAZOLVAN MAX is shown to patients with a dekompensirovanny renal failure only after consultation with the doctor. Ambroxol as any active agent which is metabolized in a liver and emitted by kidneys can cause accumulation of metabolites in a liver in patients with a heavy renal failure. Fertility, pregnancy and period of a lactation Pregnancy. Ambroxol the hydrochloride gets through a placental barrier. Preclinical trials did not show direct or indirect negative impact on pregnancy, fetation, childbirth and post-natal development. Extensive clinical experience of use of drug after the 28th week of pregnancy did not show signs of an adverse effect on a fruit. Nevertheless, it is not recommended to use the drug LAZOLVAN MAX in the period of the I trimester of pregnancy. Lactation. Ambroxol the hydrochloride is allocated with breast milk therefore it is not recommended to take the drug during breastfeeding. Fertility. Preclinical trials did not show direct or indirect negative impact on fertility. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Researches were not conducted. There are no messages about cases of influence of drug on ability to drive the car or mechanisms during the post-marketing period. Overdose Symptoms: signs are comparable to the known side effects: nausea, vomiting, diarrhea, dyspepsia. Treatment: symptomatic therapy. A form of release and packing On 10 capsules in planimetric packing from polyvinylchloride and/or polyvinyl dichloride and aluminum foil. On 1 planimetric packing together with the instruction for medical use in the state and Russian languages in a pack from cardboard. To Store storage conditions at a temperature up to 30 wasps. To store out of children's reach! Period of storage 3 years. Not to use after the expiration date specified on packing. Prescription status Without prescription of Proiswoditel Boehringer Ingelcheim Pharm GmbH and To. KG, Ingelheim, Germany Packer Delfarm Village of Reims. Ampere-second., France the Name and the country of the owner of the registration certificate of Sanofi-Aventis Doychland GmbH, Frankfurt, Germany the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Furmanov St. 187 of B phone number: +7 (727) 244-50-96 fax: +7 (727) 258-25-96 e-mail: quality.info@sanofi.com 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:
To Develop Kazakhstan.Pharmacovigilance@sanofi.com