The instruction for medical use
Bromhexine 8 Berlin-Hemi
the Trade name
Bromhexine 8 Berlin-Hemi
the International unlicensed
name Bromhexine Dosage Form
of the Tablet, coated, 8 mg
One tablet covered with a cover contains Structure:
active agent – Bromhexine a hydrochloride of 8 mg,
excipients: corn starch, lactoses monohydrate, magnesium stearate, gelatin, silicon dioxide colloidal anhydrous
structure of a cover: sucrose, calcium a carbonate, magnesium a carbonate easy, talc, a macrogoal 6000, glucose liquid (in terms of dry matter), the titan dioxide (E 171), K25 povidone, wax of karnaubskiya, quinolinic yellow (E 104).
of the Tablet with slightly biconvex surface, coated from yellow color to chartreuse, with a kernel of almost white color.
Expectorant drugs. Mucolytics. Bromhexine.
The ATX R05CB02 code
Pharmacokinetics At properties intake Bromhexine is soaked up almost completely, time of its semi-removal is pribl. 0.4 h Cmax at intake make 1 h. Effect of the first passing through a liver – about 80%. Biologically active agents are formed in the course of removal. Linking with proteins of plasma makes 99%.
Decrease in concentration in plasma is multiphase process. Time of semi-removal after which it is terminated is about an hour. Besides, final time of semi-removal is, about, 16 h. It is caused by redistribution of small amounts of Bromhexine in fabrics. Distribution volume – about 7 l on body weight kg. Bromhexine does not kumulirutsya in an organism.
Bromhexine breaks a placental barrier and also gets into cerebrospinal fluid and mother’s milk.
Removal – mainly through kidneys as metabolites are formed in a liver. In view of high extent of linking of Bromhexine with proteins and its considerable volume of distribution and also in view of its slow redistribution from fabrics in blood, removal of a little considerable part of drug by means of dialysis or an artificial diuresis it is improbable.
In a serious illness of a liver it is possible to expect decrease in clearance of initial substance. In a heavy renal failure the lengthening of time of semi-removal of Bromhexine is possible. In physiological conditions in a stomach perhaps nitrozirovany Bromhexine.
represents Bromhexine synthetic derivative vegetable active ingredient of a vazitsin. It possesses sekretolitichesky action and promotes evacuation of a secret from bronchial tubes. Researches showed that this drug increases a share of a serous component in a bronchial secret. It facilitates phlegm transport due to reduction of its viscosity and strengthening of work of a ciliary epithelium.
Against the background of use of Bromhexine the increase in concentration of antibiotics of amoxicillin, erythromycin and Oxytetracyclinum in a phlegm and a bronchial secret is noted. The clinical value of this effect is not found out.
– sekretolitichesky therapy in acute and chronic diseases of the bronchial tubes and lungs which are followed by difficult separated phlegm
the Route of administration and doses
Adults take 3 times a day 1-2 pill of Bromhexine 8 Berlin-Hemi (that corresponds to 24-48 mg of Bromhexine of a hydrochloride a day).
Patients with body weight accept less than 50 kg on 1 tablet of Bromhexine 8 Berlin-Hemi 3 times a day.
In heavy disorders of function of a liver or kidneys the dosage is recommended to be reduced.
A pill is taken after a meal, without chewing, with a large amount of liquid. Sekretolitichesky action of drug is supported due to intake of liquid.
Duration of treatment is defined individually according to indications and the course of the disease. It is not necessary to accept Berlin Bromhexine 8 of Hemi more than 4-5 days, without having consulted to the doctor.
Sometimes (≥ 1/1000 to & lt, 1/100)
– hypersensitivity reactions (skin rash, a Quincke’s disease, disorders of breath, an itching, urticaria)
– nausea, an abdominal pain, vomiting, diarrhea
Very seldom (& lt, 1/10000)
– anaphylactic reactions, including an acute anaphylaxis
– development of heavy skin reactions, such as Stephens-Johnson’s syndrome and scalded skin syndrome
At reactions of hypersensitivity, anaphylactic reaction or emergence of any unusual changes on skin and mucous membranes immediately stop intake of Bromhexine 8 Berlin-Hemi and see a doctor.
– the known hypersensitivity to Bromhexine or to one of other components of drug
– hereditary intolerance of a galactose or fructose, a glucose galactose sprue, hereditary insufficiency of invertase-isomaltase
– the lactation period
– children’s age up to 18 years
At Bromhexine 8 use Berlin-Hemi in combination with antibechic drugs perhaps dangerous accumulation of a secret because of suppression of a tussive reflex – therefore when assigning such combination of drugs is necessary especially careful inspection.
At simultaneous use of the drugs causing symptoms of irritation of digestive tract strengthening of irritant action on mucous membranes of a GIT is possible.
as a result of use of a bromgegsin in extremely exceptional cases heavy skin reactions, for example, Stephens-Johnson’s syndrome and a Lyell’s disease took place. At emergence of any unusual changes on skin and mucous membranes immediately stop intake of Bromhexine 8 Berlin-Hemi and see a doctor.
Ulcer of stomach and a 12-perstny gut
it is not necessary to apply Bromhexine 8 Berlin-Hemi if you have (or suffered in the past) ulcer of stomach or a 12-perstny gut as Bromhexine can influence barrier function of a mucous membrane of digestive tract.
Lungs and airways
Due to the possible accumulation of a secret, at Bromhexine 8 use Berlin-Hemi by patients (e.g., in such rare disease as primary tsiliarny dyskinesia [dyskinesia of cilia]) it is necessary to be careful with disturbances of bronchial motility and the slime strengthened by secretion.
Disturbances from a liver and kidneys
In an abnormal liver function or serious renal diseases it is necessary to observe extra care (it is necessary to accept Bromhexine in a smaller dose or with longer intervals).
In a renal failure of heavy degree the accumulation of the metabolites of Bromhexine which are formed in a liver is probable.
It is recommended to control periodically function of a liver, especially at long-term treatment.
Lactose, glucose, sucrose
contain In this drug lactose, glucose and sucrose. In this regard, it is contraindicated to patients with such hereditary diseases as intolerance of fructose, a sprue of glucose galactose or to patients with a lack of an invertase-isomaltase organism.
experience of use of Bromhexine at pregnancy is absent So far, therefore, Bromhexine 8 use Berlin-Hemi is allowed by pregnant women only after careful assessment by the doctor of risk and advantage, use in the first trimester of pregnancy is not recommended.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Symptoms: the overdose cases at the person constituting danger are unknown so far.
Data on chronic toxic effect of drug at the person are absent.
Treatment: after considerable overdose the blood circulation control, if necessary, symptomatic treatment is shown. Due to the hypotoxicity of Bromhexine of need for more invasive measures for decrease in absorption or to acceleration of its removal from an organism does not arise. Besides, in connection with pharmacokinetic features (large volume of distribution, slow processes of redistribution and considerable linking with proteins) dialysis and an artificial diuresis have no significant effect on removal of substance from an organism.
The form of release and packing
On 25 tablets place in blister strip packaging from a rigid transparent polyvinylchloride film and solid aluminum foil.
On 1 or 2 planimetric packs together with the instruction for medical use in the state and Russian languages put in a pack cardboard.
To Store storage conditions at a temperature not higher than 25 wasps.
To store out of children’s reach!
The period of storage
of 5 years
After expiry date drug cannot be used!
of Proizvoditel Berlin-Hemi AG (Menarini Group),
Gliniker Weg 125, 12489 Berlin, Germany
the Owner of the registration certificate
of Berlin-Hemi AG (Menarini Group),
Gliniker Weg 125, 12489 Berlin, 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 RK
Ph.: +7 727 2446183, 2446184, 2446185
Fax: +7 727 2446180
To Develop Kazakhstan@berlin-chemie.com