Bromhexine 8

General characteristics. Structure:

Active ingredient: Bromhexine a hydrochloride - 8,000 mg.

Excipients: lactoses monohydrate, starch corn, gelatin, silicon dioxide colloid, magnesium stearate;

Cover: sucrose, calcium carbonate, magnesium carbonate, talc, macrogoal 6000, K 25 povidone, glucosic syrup, wax of karnaubskiya, titanium dioxide (Е 171), quinolinic yellow (Е 104).

Pharmacological properties:

Pharmacodynamics. Bromhexine 8 Berlin-Hemi render mucolytic (sekretolitichesky) and expectorant (sekretomotorny) action, and also weak antibechic action. Reduces viscosity of a phlegm, activates a ciliary epithelium, increases the volume of a phlegm and improves its otkhozhdeniye. Stimulates production of the endogenous surfactant providing stability of alveolar cells in the course of breath. The effect is shown in 2-5 days from an initiation of treatment.

Pharmacokinetics. At intake almost completely (99%) it is soaked up in digestive tract within 30 min. Bioavailability - about 80%. Contacts proteins of plasma for 99%. Gets through placental and hematoencephalic barriers. Gets into breast milk. In a liver is exposed to demethylation and oxidation, it is metabolized to Ambroxol. The elimination half-life (T 1/2) is equal to 16 h (owing to slow return diffusion from fabrics). It is removed by kidneys in the form of metabolites. At a heavy renal failure of T 1/2 can increase.

Indications to use:

The acute and chronic bronchopulmonary diseases which are followed by formation of a phlegm of the increased viscosity (a tracheobronchitis, pneumonia, obstructive bronchitis, bronchiectasias, bronchial asthma, emphysema of lungs, a mucoviscidosis, tuberculosis, a pneumoconiosis).

Route of administration and doses:

Drug is appointed inside, after food, without chewing, washing down with enough liquid.

For adults and teenagers 14 years are more senior: 3 times a day on 1-2 dragees (24-48 mg/days). Children from 6 to 14 years, and also patients with body weight less than 50 kg: accept 3 times a day 1 dragee (24 mg/days).

At a renal failure and/or a liver it is necessary to increase intervals between receptions, or to reduce a dose. On the matter it is necessary to consult with the attending physician.

Duration of use is established in an individual order and depends on indications and disease. In need of reception more than 4-5 days consultation of the doctor is required.

Side effects:

Frequency is classified by headings, depending on occurrence of a case: very often (> 1/10), it is frequent (<1/10-<1/100), infrequently (<1/100-<1/1000), is rare (<1/1000-<1/10000), is very rare (<1/10000), including separate messages.

Usually Bromgeksin 8 Berlin-Hemi is had well.

Nausea, vomiting, the dispepsichesky phenomena, aggravation of a peptic ulcer of a stomach and duodenum, allergic reactions (skin rash, rhinitis, hypostases), asthma, fervescence and fever are in rare instances possible.
• Extremely seldom (<0,01%) - a heavy acute anaphylaxis.
• Headache, dizziness.
• Increase in activity of "hepatic" transaminases (extremely seldom).

At all forms of allergic reactions it is necessary to stop reception of this medicine and to inform on it the doctor.

Interaction with other medicines:

Bromhexine 8 Berlin-Hemi do not appoint along with the medicines suppressing the tussive center (including containing codeine) since it complicates evacuation of the liquefied phlegm.

Bromhexine 8 Berlin-Hemi promotes penetration of antibiotics (erythromycin, cefalexin, Oxytetracyclinum, ampicillin, amoxicillin) into a bronchial secret in the first 4-5 days of antimicrobic therapy.

It is not compatible to alkaline solutions.

Contraindications:

• hypersensitivity to Bromhexine and other components of drug;
• a peptic ulcer of a stomach and duodenum (in an aggravation stage);
• pregnancy (I trimester);
• deficit of lactase, lactose intolerance, glyukozo-galaktozny malabsorption;
• children's age up to 6 years.

With care
• renal and/or liver failure;
• at the disturbance of motility of bronchial tubes which is followed by excessive accumulation of a secret;
• at tendency to gastric bleedings in the anamnesis.

Bromhexine 8 Berlin-Hemi

At children treatment should be combined with postural drenazhy or the vibration massage of a thorax facilitating removal of a secret from bronchial tubes.

Influence of drug on ability to driving of motor transport and to control of mechanisms

During treatment by the drug Bromhexine 8 Berlin-Hemi it is necessary to be careful at control of vehicles and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Overdose:

Life-threatening effects of overdose, at use of the drug Bromhexine 8 Berlin-Hemi, are unknown.

The following symptoms are possible: nausea, vomiting, diarrhea, dispepsichesky frustration. Treatment: artificial vomiting, a gastric lavage in the first 1 - 2 hour after administration of drug.

Because of high extent of linkng with proteins and high volume of distribution elimination of Bromhexine at a hemodialysis or an artificial diuresis does not happen.

Storage conditions:

At a temperature not above 25 °C. To store medicine in the place, unavailable to children. Period of validity of 5 years. Not to use after the period of validity specified on packaging!

Issue conditions:

Without recipe

Packaging:

Dragee of 8 mg. On 25 dragees in a blister strip packaging (the blister aluminum PVC/foil). On 1 blister together with the application instruction in a cardboard pack.