for medical use
Bromhexine 4 Berlin-Hemi
the Trade name
Bromhexine 4 Berlin-Hemi
the International unlicensed
name Bromhexine Dosage Form Solution for intake of 4 mg / 5 ml
In 100 ml of solution contains
active agent – Bromhexine of a hydrochloride of 0.080 g
excipients: propylene glycol, sorbite, Acidum hydrochloricum 0.1M, fragrance concentrated with an apricot smell, the water purified.
Transparent, colourless, slightly viscous liquid with an apricot smell
Expectorant drugs. Mucolytics.
The ATX R05CB02 code
Pharmacokinetics Later properties of intake Bromhexine is almost completely soaked up, at the same time elimination half-life makes about 0.4 hours, and Tmax — is exposed to Presistemny metabolism about 80% of substance 1 hour. At the same time biologically active metabolites are formed. Linking with proteins of blood plasma makes 99%.
Decrease in level of substance in plasma is characterized by multiphase.
The period of semi-distribution is about 1 hour. Elimination half-life makes about 16 hours. It is caused by redistribution of a small amount of Bromhexine from fabrics. The volume of distribution is about 7 l on 1 kg of body weight. Bromhexine does not kumulirutsya.
Bromhexine passes through a placenta, gets into cerebrospinal fluid and breast milk.
It is removed mainly by kidneys in the form of the metabolites which are formed in a liver. In view of high extent of linking with proteins, the considerable volume of distribution and slow redistribution from fabrics in blood, significant influence of dialysis and an artificial diuresis on elimination it is improbable.
In serious illnesses of a liver the decrease in clearance of the main substance is probable. In a heavy renal failure the increase in elimination half-life of metabolites of Bromhexine is not excluded. At the high content of nitrates in a diet, in physiological conditions perhaps nitrozirovany Bromhexine in a stomach.
Bromhexine — synthetic derivative a vazitsina, biologically active agent of plant origin. Drug renders the mucolytic (sekretolitichesky) and expectorating actions in bronchial tubes. It means that drug reduces viscosity of a phlegm and increases physical activity of cilia of a ciliary epithelium that promotes improvement of an otkhozhdeniye of a phlegm. Bromhexine also stimulates production of endogenous surfactant.
Bromhexina leads use to increase in concentration of antibiotics of amoxicillin, erythromycin and Oxytetracyclinum in a phlegm and a bronchial secret.
– sekretolitichesky therapy in acute and chronic diseases of the bronchial tubes and lungs which are followed by disturbance of education and an otkhozhdeniya of a phlegm
the Route of administration and doses
contains In 1 measured spoon (5 ml) of solution active ingredient – Bromhexine of a hydrochloride of 4 mg
Berlin-Hemi is recommended to accept Bromhexine 4 in the following doses:
to adults and teenagers 14 years are more senior: on 2–4 measured spoons of the drug Bromhexine 4 Berlin-Hemi 3 times a day (there correspond 24–48 mg of Bromhexine of a hydrochloride a day),
to adults, children are from 6 to 14 years and the patient with body weight less than 50 kg: on 2 measured spoons of the drug Bromhexine 4 Berlin-Hemi 3 times a day (there correspond 24 mg of Bromhexine of a hydrochloride a day),
to children up to 6 years: on 1 measured spoon of the drug Bromhexine 4 Berlin-Hemi 3 times a day (there correspond 12 mg of Bromhexine of a hydrochloride a day).
Duration of use depends on indications and the course of the disease and is established individually.
Berlin-Hemi it is not necessary to accept Bromhexine 4 more than 4-5 days without consultation with the doctor.
It is recommended to accept enough liquid.
In a renal failure and serious illnesses of a liver the dose needs to be reduced respectively.
Sometimes ³ 1/1000 to & lt, 1/100
– temperature increase, reactions of hypersensitivity (skin rash, a Quincke’s disease, respiratory insufficiency, an itching, a small tortoiseshell)
– nausea, an abdominal pain, vomiting, diarrhea
Very seldom & lt, 1/10000
– anaphylactic reactions up to shock, emergence of heavy skin reactions, for example Stephens-Johnson’s syndrome and a Lyell’s disease, against the background of Bromhexine use (see also Section 4.4).
– hypersensitivity to active ingredient or to any of excipients
– the period of a lactation (breastfeeding)
– children’s age up to 2 years
of the Indication for the combined prescribing of Bromhexine 4 Berlin-Hemi and antibechics should be weighed carefully that is connected with opposite effects of these drugs. Berlin-Hemi along with suppression of a tussive reflex can lead mucolytic effect of Bromhexine 4 to dangerous accumulation of a secret in airways.
At a concomitant use with the substances causing irritation of digestive tract strengthening of their irritant action on mucous a stomach is possible.
At use of Bromhexine the development of heavy skin reactions, for example Stephens-Johnson’s syndrome and a Lyell’s disease is very seldom noted. At emergence of changes on skin and a mucous membrane it is necessary to see immediately a doctor, and to stop intake of Bromhexine.
At children under 2 years Bromhexine 4 Berlin-Hemi should be applied only under observation of the doctor.
Bromhexine 4 Berlin-Hemi influences a mucous barrier of a stomach and intestines therefore its use for patients with ulcer of stomach or duodenum is not recommended.
Owing to possible stagnation of a secret, Bromhexine 4 Berlin-Hemi should be applied with extra care at disturbance of motility of bronchial tubes and formation of a large amount of secretion (for example, at seldom found malignant syndrome of cilia).
Bromhexine 4 Berlin-Hemi should be applied with extra care (i.e. through longer intervals or in lower dose) in a renal failure or serious illnesses of a liver.
In a heavy renal failure the accumulation of the metabolites of Bromhexine formed in a liver is probable.
Control of function of a liver is recommended, especially at prolonged use.
The propylene glycol which is a part of the drug Bromhexine 4 Berlin-Hemi can cause in children symptoms, as after alcohol intake.
Bromhexine 4 Berlin-Hemi is contraindicated to patients with intolerance of fructose. Caloric content is 2.6 kcal on 1 g of sorbite.
1 measured spoon contains 2 g of sorbite (there correspond 0.5 g of fructose) that there correspond about 0.17 grain G (GG).
Sorbite can have easy laxative effect.
Pregnancy and a lactation
So far Bromhexine at pregnancy in clinical practice was not applied. Therefore it is necessary to appoint drug only after careful assessment of a ratio of advantage and risk.
As active ingredient passes into maternal milk, use of the drug Bromhexine 4 Berlin-Hemi during breastfeeding is contraindicated.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
it is not described
Symptoms: aggravation of side effects.
Treatment: symptomatic treatment
the Form of release and packing
Bottles from brown glass on 60 ml, with the plastic or aluminum screwing-up cover.
On 1 bottle together with a measured spoon and the instruction for medical use in the state and Russian languages put in a pack.
To Store storage conditions at a temperature not over 25 ºС.
To store out of children’s reach!
The period of storage
After the storage expiration medicine cannot be used 3 years.
the Name and the country
of the Berlin-Hemi AG manufacturing organization (Menarini Group), Germany
the Name and the country the owner of the registration certificate
BERLIN-HEMI AG (MENARINI GROUP) Glinikker Weg 125 12489 Berlin, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): Representative office of JSC Berlin-Hemi AG in RKNomer of phone number: +7 727 2446183, 2446184, 2446185 fax number: +7 727 2446180 the e-mail address:
To develop Kazakhstan@berlin-chemie.com