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Bromhexine
Release form
Tablets
For children
From 6 years
For pregnant women
Not recommended
For nursing mothers
Contraindicated
For drivers
Does not affect
Storage temperature
to 25 °C
INSTRUCTION
storage
active substance: bromhexine; 1 tablet contains bromhexine hydrochloride 8 mg; excipients: lactose monohydrate, sugar, ruberozum, potato starch, calcium stearate.
Medicinal form
Tablets. Main physico-chemical properties: tablets of pink color, with a flat surface and beveled edges.
Pharmacotherapeutic group
Medications used in cough and catarrhal diseases. Mucolytic agents. ATX code R05C B02.
Pharmacological properties
Pharmacodynamics. Bromhexine is a synthetic derivative of the plant-derived active ingredient vasicin. It has a secretolytic and secretomotor effect in the area of the bronchial tract, as a result of which bronchial secretion increases, the viscosity of mucus (sputum) decreases and the activity of the ciliated epithelium is stimulated, which promotes the promotion of mucus (sputum) through the respiratory tract. Pharmacokinetics. After oral administration, bromhexine is almost completely absorbed, with a half-life of approximately 0.4 hours. The effect of the first passage is approximately 80%, while biologically active metabolites are formed. Binding to blood plasma proteins is 99%. The decrease in the level of concentration in the blood plasma is multiphasic. The half-life, which limits the duration of action, is about 1 hour. The final half-life is about 16 hours. This is caused by the redistribution of small amounts of bromhexine from the tissues. The volume of distribution is about 7 liters per 1 kg of body weight. Bromhexine does not accumulate. Bromhexine penetrates through the placenta, into the cerebrospinal fluid and into breast milk. It is excreted mainly by the kidneys in the form of metabolites. In acute liver diseases, the clearance of the active substance may decrease. In acute renal failure, the possibility of an increase in the half-life of bromhexine metabolites cannot be excluded. Under physiological conditions, nitrosation of bromhexine is possible in the stomach.
Indication
For secretolytic therapy in acute and chronic bronchopulmonary diseases accompanied by impaired sputum formation and promotion.
Contraindication
Hypersensitivity to the active substance or to any auxiliary substance of the medicinal product; peptic ulcer disease of the stomach and duodenum; diseases of the respiratory system, the course of which is accompanied by the formation of a large amount of liquid sputum
Interaction with other medicinal products and other forms of interaction
Bromhexine can be prescribed in combination with bronchodilators, antibacterial drugs, agents used in cardiology. Medicinal products that irritate the digestive tract (for example, non-steroidal anti-inflammatory drugs) - when used in combination with bromhexine, mutual strengthening of the effects of irritation of the mucous membrane is possible. Antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline), sulfonamide drugs - when used in combination with bromhexine, the concentration of antibiotics and sulfonamides in bronchopulmonary secretions and sputum increases. Antitussives - combined use with bromhexine leads to the accumulation of mucus in the respiratory tract and difficulty in removing sputum from the bronchial tubes against the background of a decrease in cough. This combination is not recommended.
Features of use
In case of violation of bronchial motility, which is accompanied by the formation of a large amount of bronchial secretion (for example, in such a rare disease as primary ciliary dyskinesia), bromhexine hydrochloride should be used with extreme caution due to the possible accumulation of secretion. Use with caution in patients suffering from bronchial asthma. During treatment, it is necessary to take a sufficient amount of liquid, which increases the expectorant effect of bromhexine. If there is a history of gastric bleeding, Bromhexine should be used under the supervision of a doctor. In case of impaired kidney function and severe liver diseases, the drug should be used with great caution (extend the time intervals between taking the drugs or reduce their dose). With acute renal failure, the possibility of accumulation of bromhexine metabolites in the liver should be taken into account. With long-term use of the drug, it is recommended to monitor liver function from time to time. If any skin or mucous membrane disorders appear for the first time during the use of bromhexine hydrochloride, the use of the drug should be stopped immediately (perhaps this is the beginning of the development of such serious complications as Stevens-Johnson syndrome or Lyell's syndrome). The medicinal product contains sugar, which should be taken into account by patients with diabetes. The drug contains lactose, so patients with such rare hereditary diseases as galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. If you have an intolerance to some sugars, consult your doctor before taking this medicine. Use during pregnancy or breastfeeding. During pregnancy, the drug should be prescribed taking into account the ratio of benefits for the mother / risk for the fetus, it is not recommended to use it in the first trimester of pregnancy. During breastfeeding, the use of bromhexine is contraindicated due to the fact that it penetrates into breast milk. The ability to influence the speed of reaction when driving vehicles or other mechanisms. There are no reports that the drug can affect the ability to drive a car or work with other mechanisms.
Methods of application
The medicinal product should be used internally after meals, drinking a large amount of liquid (for example, a glass of water). Adults and children over 14 years of age: 8–16 mg (1–2 tablets) 3 times a day, which corresponds to 24–48 mg/day of bromhexine hydrochloride. Children aged 6 to 14 years, as well as patients with a body weight of less than 50 kg: 8 mg (1 tablet) 3 times a day, which corresponds to 24 mg/day of bromhexine hydrochloride. Other special groups of patients: bromhexine hydrochloride should be used with special caution (ie, with longer intervals or in smaller doses) in the presence of impaired renal function or severe liver diseases (see the section "Particulars of use". The duration of treatment should be determined individually, according to indications and dynamics) the development of the disease, but it should not exceed 4-5 days without the appropriate recommendation of a doctor.Children. Do not use the medicine in this dosage form for children under 6 years of age.
Overdose
Symptoms: dyspeptic disorders, nausea, vomiting, diarrhea. Dizziness, headache, ataxia, diplopia, metabolic acidosis, frequent breathing. When using up to 40 mg of bromhexine in young children, symptoms were not observed even without decontamination. No chronic toxic effect on humans was found. Treatment. Induce vomiting, perform gastric lavage (in the first 1–2 hours after administration). In case of a significant overdose, the cardiovascular system should be monitored and, if necessary, symptomatic therapy should be prescribed. Due to the high degree of binding to blood plasma proteins, the large volume of distribution and the slow reverse distribution of bromhexine from tissues to the blood, it is not expected to accelerate the elimination of the drug during hemodialysis or forced diuresis. Reservation. If the amount of bromhexine taken exceeds the above limits, you should also take into account the possible side effects of the auxiliary substances of the drug (see the section "Peculiarities of use".
Side effects
The frequency of adverse reactions is determined as follows: very often (≥ 1/10), often (≥ 1/100 to < 1/10), infrequent (≥ 1/1000 to < 1/100), rarely ( ≥ 1/10000 to < 1/1000), very rare (< 1/10000), unknown (according to the available data, the frequency cannot be established). From the gastrointestinal tract. Infrequently: stomach pain, dyspeptic disorders, nausea, vomiting, diarrhea, exacerbation of peptic ulcer disease of the stomach and duodenum, transient increase in the activity of aminotransferases in blood serum. From the side of the central nervous system. Uncommon: headache (migraine type), dizziness, palpitations. From the side of the skin and subcutaneous tissues. Uncommon: increased sweating. Not known: severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome and acute generalized exanthematous pustulosis). From the side of the respiratory system, organs of the chest and mediastinum. Infrequent: breathing disorders, increased cough, respiratory distress. Rarely: bronchospasm. From the side of the immune system. Rarely: hypersensitivity reactions, including skin rashes, erythematous and urticarial rashes, urticaria. Not known: skin itching, angioedema, anaphylactic reactions, including anaphylactic shock. General disorders. Uncommon: chills. If hypersensitivity reactions, anaphylactic reactions or any skin and mucous membrane disturbances occur, bromhexine should be stopped immediately and a doctor should be consulted.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not higher than 25 ºС. Keep out of the reach of children.
Packaging
20 tablets in a blister.
Leave category
Without a prescription.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.