Translation of the instruction Mose

Instruction

On medical use of medicine

Ingredients:

Active ingredient: bromhexine;

1 tablet contains Bromhexine of a hydrochloride 8 mg;

excipients: lactose monohydrate, potato starch, calcium stearate.

Dosage form.

Tablet.

Main physical and chemical properties: tablets of white color of a ploskotsilindrichesky form with a facet.

Pharmacotherapeutic group.

Means, applied at cough and catarrhal diseases. mucolytic means. code atkh r05c b02.

Pharmacological properties.

Pharmacodynamics.

Medicine shows mucolytic (sekretolitichesky) and expectorant action. The mucolytic effect is connected with a depolymerization and depression of mucoprotein and mukopolisakharidny fibers. One of important features of effect of Bromhexine is its ability to stimulate formation of surfactant — surfactant lipido - proteinaceous mukopolisakharidnoy the nature, synthesized in cells of alveoluses; biosynthesis of surfactant is broken at various bronchopulmonary diseases which leads to disturbance of stability of alveolar cages, weakening of their reaction to adverse effects.

Pharmacokinetics.

from digestive tract. The bioavailability is about 20%. Healthy volunteers have the maximum concentration (the C _max ) in plasma is defined in 1 hour. Linking of Bromhexine with proteins of plasma high. It is widely distributed in body tissues. Bromhexine gets through a blood-brain barrier. In small amounts gets through a placenta. At prolonged repeated use can kumulirovat. Is exposed to intensive metabolism at the first passing through a liver. In a liver is exposed to demethylation and oxidation. The main metabolite of Bromhexine is Ambroxol. About 85-90% are brought out of an organism with urine, mainly in the form of metabolites. Elimination half-life (T _1/2 ) makes 12–15 hours owing to slow return diffusion of fabrics.

Clinical characteristics.

Indication.

Sekretolitichesky therapy at the sharp and chronic bronkhopulmonalny diseases which are followed by a phlegm otkhozhdeniye complication.

Contraindication.

Hypersensitivity to medicine components; peptic ulcer of a stomach and duodenum; the diseases of a respiratory system proceeding with formation of a plentiful liquid phlegm.

Interaction with other medicines and other types of interactions.

Antibiotics (amoxicillin, tsefuroksy, erythromycin, doxycycline), sulfanamide medicines — at the combined application with Bromhexine raise concentration of antibiotics and streptocides in a bronchopulmonary secret and in a phlegm.

Antibechics — the combined application with Bromhexine leads to accumulation of slime in airways and difficulty of removal of a phlegm from bronchial tubes against the background of reduction of cough. Such combination is not recommended.

Medicines irritating a digestive tract (for example, non-steroidal anti-inflammatory drugs) — at the combined application with Bromhexine perhaps mutual strengthening of effects of irritation of a mucous membrane.

in a combination with bronchodilators, antibacterial and with medicines which apply in cardiology.

Feature of application.

At treatment needs to accept enough liquid that strengthens expectorant effect of Bromhexine. in the presence in the anamnesis of gastric bleedings Bromhexine should be applied under control of the doctor.

With care to apply medicine to the patients having bronchial asthma and to patients with a renal or heavy liver failure (that is to increase intervals between receptions or to reduce a dose).

In an acute renal failure needs to consider a possibility of accumulation of metabolites of Bromhexine in a liver.

At prolonged use of medicine is recommended to control function of a liver from time to time.

Medicine contains lactose therefore to patients with rare hereditary forms of intolerance of a galactose, insufficiency of lactase or a syndrome of glyukozo-galaktozny malabsorption it is impossible to apply medicine.

At the first manifestations of any disturbances from skin or mucous membranes during use of Bromhexine of a hydrochloride should stop immediately medicine use (perhaps, this beginning of development of such heavy complications as Stephens-Johnson's syndrome or a Lyell's disease).

Use during pregnancy or feeding by a breast.

during pregnancy taking into account a ratio the advantage for mother/risk for a fruit.

during feeding owing to its penetration into breast milk.

Ability to influence the speed of reactions at control of motor transport or other mechanisms.

messages that medicine can affect ability to drive the car or to work with other mechanisms.

Route of administration and doses.

inside, irrespective of meal. duration of reception depends on indications and the course of the disease and is established individually.

to Adults and children since 14 years: on 1–2 tablets (8–16 mg) 3 times a day. A course of treatment — 4–5 days.

to Children from 6 to 14 years and also the patient with body weight less than 50 kg: on 1 tablet (4–8 mg) 3 times a day. A course of treatment — 4–5 days.

in case of renal failures or a serious illness of a liver a medicament dose needs to be reduced.

Children.

to children from 6 years. to children up to 6 years to apply in other dosage forms.

Overdose.

Symptoms: dispeptic disorders, nausea, vomiting, diarrhea, dizziness, headache, diplopia, ataxy, slight metabolic acidosis, tachypnea. at use up to 40 mg of Bromhexine for children of early age of symptoms it was not observed even without carrying out decontamination. any chronic toxic action on the person is not revealed.

Treatment: to cause vomiting, to carry out gastric lavage (in the first 1–2 hours after reception), symptomatic therapy. At considerable overdose it is necessary to carry out monitoring of a cardiovascular system. Because of high extent of linking with proteins of plasma, large volume of distribution and slow return distribution of Bromhexine from fabrics in blood it is not necessary to expect acceleration of removal of medicine at a hemodialysis or an artificial diuresis.

Side reactions.

from nervous system: a headache (as migraine), dizziness.

from the respiratory system, bodies of a thorax and mediastinum: strengthening of cough, bronchospasm, breath disorders, respiratory distress.

from digestive tract: the dispeptic phenomena, nausea, vomiting, diarrhea, an abdominal pain, exacerbation of a peptic ulcer of a stomach and duodenum, tranzitorny increase in activity of aminotransferases in blood serum.

from the immune system: reactions of hypersensitivity, including skin rashes, erythematic and urtikarny rashes, the naggers of skin, a small tortoiseshell; very seldom — a Quincke's edema, anaphylactic reactions, including an acute anaphylaxis; it was extremely seldom reported about severe damages of skin: Stephens-Johnson's syndrome and a Lyell's disease connected with application of mucolytic means, such as Bromhexine. Mostly, they could be explained with weight of a course of a basic disease or a concomitant use of other medicine. At emergence of skin reactions or reactions on mucous membranes the patient should stop intake of medicine and to see a doctor.

General violations and changes in the injection site: the strengthened sweating, fever.

Expiration date.

3 years.

Storage conditions.

in original packing at a temperature not above 25 °C. to store out of children's reach.

Packing.

On 10 tablets in blister strip packaging; on 5 blister strip packagings in a pack; on 10 or 20 tablets in blister strip packagings.

Category of a holiday.

Without recipe.

Producer.

"pharmaceutical "darnitsa".

Location of the producer and address of the place of implementation of its activity.

Ukraine, 02093, of cues, st. Boryspil, 13.