The instruction for medical use
of BROMHEXINE medicine
the Trade name
the International unlicensed
A dosage form
of the Tablet, 8 mg
One tablet contains
active agent – Bromhexine a hydrochloride, 8 mg
excipients: lactoses monohydrate, wheat starch, gelatin, magnesium stearate.
White or almost white, round, biconvex tablets, with a diameter about 7 mm
Expectorant drugs. Mucolytics.
The code of automatic telephone exchange R05CB02
Pharmacokinetics Bromhexine properties is quickly soaked up from the digestive tract (DT) and is exposed to intensive metabolism at ‘the first passing’ through a liver. The bioavailability is about 20%. At healthy patients of Cmax in blood plasma is defined in 1 hour, it is distributed in body tissues. About 85-90% are removed with urine mainly in the form of metabolites. A metabolite of a bromgekisn is Ambroxol. Linking of Bromhexine with proteins of blood plasma high. T1/2 in a terminal phase makes about 12 hours. Bromhexine gets through GEB. In small amounts gets through a placenta. Only small amounts are removed with urine from T1/2 6,5 o’clock. The clearance of Bromhexine or its metabolites can decrease at patients with heavy abnormal liver functions and kidneys.
Mucolytic means with expectorant action. Reduces viscosity of a bronchial secret due to depolarization of the acid polysaccharides which are contained in it and stimulation of secretory cells mucous the bronchial tubes producing the secretion containing neutral polysaccharides. Stimulates production of the endogenous surfactant providing stability of alveolar cells in the course of breath, their protection against adverse factors, improvement of rheological properties of the bronchopulmonary sector, its sliding on an epithelium and expectoration from airways.
– treatment of the dry and unproductive cough accompanying the following respiratory diseases and lungs: a tracheobronchitis, including spastic bronchitis, chronic bronchitis, pneumonia, pulmonary tuberculosis and a pneumoconiosis (the diseases of lungs caused by specific activators).
The route of administration and doses
the Daily dose for adults and children are more senior than 14 years makes 8-16 mg (1-2 tablets) 3 times a day.
A daily dose for treatment of respiratory diseases for children from 6 to 14 years – 4 mg (1/2 tablets) 3 times a day.
The drug is taken inside irrespective of meal, to or later.
Duration of a course of treatment is defined by the attending physician.
– the dispeptic phenomena, tranzitorny increase in activity of aminotransferases in blood serum
– a headache, dizziness – the increased sweating, skin rash
the Contraindication bronchospasm
– hypersensitivity to drug
– pregnancy and the period of a lactation
– children’s age up to 6 years
Bromhexine is incompatible with alkaline solutions. It is necessary to avoid simultaneous use of drug with the codeine and other antibechics suppressing a tussive reflex as department of the diluted phlegm is at a loss.
In a peptic ulcer of a stomach and also at instructions on gastric bleeding in the anamnesis Bromhexine it is necessary to apply under control of the doctor. Patients with a round ulcer have to accept carefully medicine as there is a risk of disturbance of a barrier of a mucous membrane of a stomach. With care to apply at the patients having bronchial asthma in an abnormal liver function (reversible increase in values of some enzymes is noted) and also in a heavy renal failure because of a possibility of accumulation of products of exchange of Bromhexine in an organism.
Medicine contains wheat starch and can cause diarrhea in the presence of a Gee’s disease (gluten enteropathy).
Bromhexine contains lactose that does it improper for patients with a lactose intolerance, a galactosemia or glucosic / galaktoznym a sprue.
During administration of drug it is recommended to drink more water.
There is no feature of influence on ability to run the vehicle or potentially dangerous mechanisms of Data on adverse influence on physical activity.
the poisonings Given concerning cases are absent. At accidental reception of a high dose it is necessary to cause vomiting, to wash out a stomach and to carry out symptomatic treatment.
The form of release and packing
On 20 tablets pack into blister strip packaging from transparent PVC of a film of orange color and aluminum foil.
On 1 blister strip packaging together with the instruction for use in the Russian and state languages place in a cardboard pack.
To Store storage conditions in the dry and protected from light place, at a temperature not above +25 °C.
To store out of children’s reach!
A period of storage
of 5 years
Drug cannot be used after the expiration date specified on packing.
the Producer Balkanpharma-Dupnitsa of the ABP
of 2600 Dupnits,
Bulgaria St. Samokovskoye Highway 3,
ph.: +359/701 58 196, fax: +359/701 58 555.
The address of the organization accepting in the territory of the Republic of Kazakhstan claims on quality of products from consumers
of Predstavitelstvo Aktavis International Ltd in
Almaty Republic of Kazakhstan, 050009, Almaty, Mukanov St. 241, office 1-A.
Ph./fax: 8 (727) 313 74 30, 313 74 31,
E-mail address: firstname.lastname@example.org, website: www.actavis.com