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Flavamed® Forte 60 mg effervescent (10 tablets)




The instruction for medical use of Flavamed® medicine Forte the Trade name of Flavamed® Forte the International unlicensed name Ambroxol a hydrochloride the Dosage form of the Tablet sparkling Structure One tablet contains active agent – Ambroxol of a hydrochloride of 60 mg excipients: anhydrous citric acid, Natrii hydrocarbonas, sodium a carbonate anhydrous, sodium saccharin, sodium cyclomate, sodium chloride, sodium citrate, lactose anhydrous, Mannitolum, sorbitol, fragrance cherry ALH code 801, simetikon the Description of the Tablet of round shape, with a surface free of defects, white color, with risky on one party, with a cherry smell. Description of solution: the colourless transparent solution which is not containing particles with a cherry smell 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 1-2.5 hours. Absolute bioavailability – 79%. 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 effect of the first passing through a liver. CYP3A4 – the main enzyme responsible for metabolism of Ambroxol under the influence of which, peimushchestvenno in a liver, conjugates are formed. Elimination half-life makes 10 hours. General clearance: in limits 660ml/mines, the renal clearance is 83% of the general clearance. It is removed by kidneys: 26% in the form of conjugates, 6% – in a free look. Removal decreases in abnormal liver functions that leads to increase in level in blood plasma by 1.3-2 times, but does not demand dose adjustment, except patients with a liver failure of heavy degree (see. Special instructions). Gender and age have no clinically significant impact on pharmacokinetics of Ambroxol and do not demand dose adjustment. Meal does not influence bioavailability of Ambroxol of a hydrochloride. The pharmacodynamics Ambroxol possesses sekretolitichesky and expectorant action, stimulates serous cells of glands of a mucous membrane of bronchial tubes, increases the content of mucous secretion and discharge of surfactant in alveoluses and bronchial tubes, normalizes the broken ratio of serous and mucous components of a phlegm. Activating the hydrolyzing enzymes and strengthening release of lysosomes from cells Klara, reduces viscosity of a phlegm. Increases physical activity of cilia of a ciliary epithelium, increases mukotsiliarny transport of a phlegm. Increase in secretion and mukotsiliarny clearance improves department of a phlegm and facilitates cough. Indications Mucolytic therapy in the acute and chronic bronchopulmonary diseases accompanied with disturbance of education and removal of a phlegm. The route of administration and doses to Adults and teenagers are more senior than 12 years: it is necessary to accept ½ sparkling tablets 3 times a day during the first 2 ‑ 3 days (it is equivalent to three 30 mg to hydrochloride Ambroxol doses), further ½ sparkling pill Flavameda®Forte take twice a day (it is equivalent to two 30 mg – hydrochloride Ambroxol doses). Note: If necessary the dose can be increased by the adult up to 60 mg twice a day (120 mg of Ambroxol of a hydrochloride a day are equivalent). The route of administration of Flavamed®Forte is intended for oral administration. Tablets can be divided into two equal half. To dissolve sparkling tablets in a glass of water and to drink the received solution after meal. Флавамед® Forte it is not necessary to accept longer than 4‑5 days without medical prescription. Information on a dosage in diseases of a liver and kidneys see in the section Special Instructions. Флавамед® it is Forte contraindicated to children up to 12 years Side effects the values Provided below are assumed as a basis at assessment of frequency of emergence of side effects: Very often: ≥ 1/10 it is frequent: ≥ 1/100 – & lt, 1/10 Sometimes: ≥ 1/1000 – & lt, 1/100 is rare: ≥ 1/10000 – & lt, 1/1000 Is very rare: & lt, 1/10000, Is unknown: on the basis of the available data does not give in to assessment. Sometimes – nausea, a stomach ache, vomiting, reactions of hypersensitivity (skin rash, a face edema, difficulty of breath, an itching), temperature increase is Very rare – heavy skin reactions, such as Stephens’s syndrome – Johnson and epidermal necrosis (see. Special instructions) – anaphylactic reactions up to Contraindication shock – hypersensitivity to active ingredient or to any of other components of drug – rare hereditary intolerance of a galactose, deficiency of Lappa lactase, a glucose galactose sprue – children’s age up to 12 years Medicinal interactions the Combined use of the drug Flavamed®Forte and antibechics can cause dangerous stagnation of a secret owing to weakening of a tussive reflex. Therefore the decision on purpose of the combined treatment should be made with special care. Increases penetration and concentration in a bronchial secret of amoxicillin, a tsefuroksim and erythromycin. Special instructions Are available data on very exceptional cases of heavy skin reactions after use of Ambroxol, such as Stephens-Johnson’s syndrome and Lyell’s disease. In case of unusual changes on skin or mucous membranes it is necessary to stop immediately use of Ambroxol and to see a doctor. Due to the possible stagnation of a phlegm in some rare diseases of the bronchial tubes which are followed by formation of a large amount of secretion (for example, in primary tsiliarny dyskinesia) Flavamed® Forte should be applied with extra care. Флавамед® Forte it is necessary to accept with extra care (i.e. with a dose decline or increase in intervals of time between receptions) in a renal failure or a serious illness of a liver and after consultation of the doctor. In a heavy renal failure it is necessary to expect accumulation of the decomposition products of Ambroxol which are formed in a liver. As mucolytic means are capable to destroy a mukozalny barrier of a mucous membrane of a stomach, it is necessary to appoint Ambroxol to patients with a peptic ulcer with extra care. This medicine contains lactose and sorbite. Флавамед® it is Forte contraindicated to patients with seldom found hereditary intolerance of a galactose, a lactose intolerance, disturbance of absorption of glucose galactose or intolerance of fructose. Contains in one tablet of this medicine 5.5 milimol (126.5 mg) sodium in the form of salts. It should be considered to the patients controlling consumption of sodium salts. At use of drug, patients should be careful with intolerance of a histamine. As Ambroxol affects metabolism of a histamine and is capable to cause emergence of symptoms of an allergy (such as headache, congestion of a nose, a skin itching, etc.), prolonged use of this medicine should be avoided. Pregnancy and feeding by a breast Pregnancy of Sufficient data concerning use of Ambroxol for pregnant women is not available. In particular, it concerns the period up to the 28th week of pregnancy. In researches on animals of teratogenic effect of Ambroxol it is not revealed (see the section Preclinical Data on Safety). In the I trimester of pregnancy it is not recommended to use drug. In the II-III trimester of pregnancy drug should be used only after the ratio ‘advantage/risk’ is carefully weighed. A lactation of Observation of animals showed that active ingredient of drug is capable to get into breast milk. As at the moment there is no sufficient experience of use of the drug Flavamed®Forte for nursing mothers, it is necessary to appoint drug only after careful assessment of a ratio ‘advantage/risk’. For prevention of hit of moisture of a tuba to store densely closed. Influence on ability to management of vehicles and to service of potentially dangerous moving Flavamed® mechanisms Forte has no considerable impact on ability to driving and other equipment. Overdose Symptoms: nausea, vomiting, diarrhea Treatment: symptomatic therapy the Form of release and packing On 10 tablets place in the polypropylene tubas which are closed polyethylene traffic jams with desiccant. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions at a temperature not higher than 25 wasps. To store out of children’s reach! 3 years not to use a period of storage after an expiration date. Prescription status Without prescription the Producer / Owner of the registration certificate BERLIN-HEMI AG (MENARINI GROUP) Gliniker Weg 125 12489 Berlin, Germany of Upakovshchik Hermes Artsnaymittel GmbH, Germany the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers concerning quality of products (goods): Representative office of JSC Berlin-Hemi AG in RKTEL.: +7 727 2446183, 2446184, 2446185 Fax: +7 727 2446180 E-mail address:
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