Bromhexine 4 syrup instructions for use. A cough remedy with a mucolytic effect - Bromhexine Berlin Chemie syrup: instructions for use for children of different ages. Use during pregnancy and lactation

Mucolytic agent with expectorant action.
Drug: BROMHEXINE 4 BERLIN-CHEMIE
Active substance of the drug: bromhexine
ATX coding: R05CB02
CFG: Mucolytic and expectorant
Registration number: P No. 013480/01
Registration date: 03.11.06
Owner reg. cert.: BERLIN-CHEMIE AG (Germany)

Bromhexine 4 Berlin-Chemie release form, drug packaging and composition.

The solution for oral administration is clear, colorless, slightly viscous, with a characteristic apricot odor.

5 ml
Bromhexine hydrochloride
4 mg

Excipients: propylene glycol, sorbitol (2 g/5 ml), apricot flavor No. 521708, hydrochloric acid 0.1 M (3.5% solution), purified water.

60 ml - dark glass bottles (1) complete with a measuring spoon - cardboard packs.
100 ml - dark glass bottles (1) complete with a measuring spoon - cardboard packs.

DESCRIPTION OF THE ACTIVE SUBSTANCE.
All information provided is provided for information only about the drug; you should consult your doctor about the possibility of use.

PHARMACHOLOGIC EFFECT
Mucolytic agent with expectorant action. Reduces the viscosity of bronchial secretions by depolarizing the acidic polysaccharides it contains and stimulating the secretory cells of the bronchial mucosa, which produce secretions containing neutral polysaccharides. It is believed that bromhexine promotes the formation of surfactant.

Pharmacokinetics of the drug.

Bromhexine is rapidly absorbed from the gastrointestinal tract and undergoes intensive metabolism during the “first pass” through the liver. Bioavailability is about 20%. U healthy patients Cmax in plasma is determined after 1 hour.

Widely distributed in body tissues. About 85-90% is excreted in the urine, mainly in the form of metabolites. Ambroxol is a metabolite of bromhexine.

The binding of bromhexine to plasma proteins is high. T1/2 in the terminal phase is about 12 hours.

Bromhexine penetrates the BBB. IN small quantities ah penetrates the placental barrier.

Only small amounts are excreted in urine with a T1/2 of 6.5 hours.

The clearance of bromhexine or its metabolites may be reduced in patients with severe hepatic or renal impairment.

Indications for use:

Diseases of the respiratory tract accompanied by the formation of difficult-to-discharge viscous secretions: tracheobronchitis, Chronical bronchitis with a broncho-obstructive component, bronchial asthma, cystic fibrosis, chronic pneumonia.

Dosage and method of administration of the drug.

Orally for adults and children over 10 years old - 8 mg 3-4 times a day. Children under 2 years of age - 2 mg 3 times a day; at the age of 2 to 6 years - 4 mg 3 times a day; at the age of 6 to 10 years - 6-8 mg 3 times a day. If necessary, the dose can be increased for adults to 16 mg 4 times a day, for children - up to 16 mg 2 times a day.

In the form of inhalations, adults - 8 mg, children over 10 years old - 4 mg, aged 6-10 years - 2 mg. At the age of up to 6 years - used in doses of up to 2 mg. Inhalations are carried out 2 times a day.

Therapeutic effect may appear on days 4-6 of treatment.

Side effects of Bromhexine 4 Berlin-Chemie:

From the outside digestive system: dyspeptic symptoms, transient increase in the activity of liver transaminases in the blood serum.

From the side of the central nervous system: headache, dizziness.

Dermatological reactions: increased sweating, skin rash.

From the outside respiratory system: cough, bronchospasm.

Contraindications to the drug:

Increased sensitivity to bromhexine.

Use during pregnancy and lactation.

During pregnancy and lactation, bromhexine is used in cases where the expected benefit to the mother outweighs the potential risk to the fetus or child.

Special instructions for the use of Bromhexine 4 Berlin-Chemie.

At peptic ulcer stomach, as well as when indicated stomach bleeding history of bromhexine should be used under medical supervision.

Use with caution in patients suffering from bronchial asthma.

Bromhexine is not used simultaneously with medications containing codeine, because this makes it difficult to cough up thin mucus.

Used as part of combination drugs plant origin With essential oils(including eucalyptus oil, anise oil, peppermint oil, menthol).

DRUG INTERACTIONS
Bromhexine is incompatible with alkaline solutions.

oral solution

Owner/Registrar

PHARMSTANDARD-LEKSREDSTVA, OJSC

International Classification of Diseases (ICD-10)

E84 Cystic fibrosis J04 Acute laryngitis and tracheitis J15 Bacterial pneumonia, not elsewhere classified J20 Acute bronchitis J37 Chronic laryngitis and laryngotracheitis J42 Chronic bronchitis, unspecified J45 Asthma R05 Cough

Pharmacological group

Mucolytic and expectorant drug

pharmachologic effect

Mucolytic agent with expectorant action. Reduces the viscosity of bronchial secretions by depolarizing the acidic polysaccharides it contains and stimulating the secretory cells of the bronchial mucosa, which produce secretions containing neutral polysaccharides. It is believed that bromhexine promotes the formation of surfactant.

Pharmacokinetics

Bromhexine is rapidly absorbed from the gastrointestinal tract and undergoes intensive metabolism during the “first pass” through the liver. Bioavailability is about 20%. In healthy patients, Cmax in plasma is determined after 1 hour.

Widely distributed in body tissues. About 85-90% is excreted in the urine, mainly in the form of metabolites. Ambroxol is a metabolite of bromhexine.

The binding of bromhexine to plasma proteins is high. T1/2 in the terminal phase is about 12 hours.

Bromhexine penetrates the BBB. In small quantities it penetrates the placental barrier.

Only small amounts are excreted in urine with T1/2 6.5 hours.

The clearance of bromhexine or its metabolites may be reduced in patients with severe hepatic or renal impairment.

Diseases of the respiratory tract accompanied by the formation of difficult-to-discharge viscous secretions: tracheobronchitis, chronic bronchitis with a broncho-obstructive component, bronchial asthma, cystic fibrosis, chronic pneumonia.

Hypersensitivity to bromhexine.

From the digestive system: dyspeptic symptoms, transient increase in the activity of liver transaminases in the blood serum.

From the side of the central nervous system: headache, dizziness.

Dermatological reactions: increased sweating, skin rash.

From the respiratory system: cough, bronchospasm.

special instructions

For gastric ulcers, as well as when there is a history of gastric bleeding, bromhexine should be used under the supervision of a physician.

Use with caution in patients suffering from bronchial asthma.

Bromhexine is not used simultaneously with medications containing codeine, because this makes it difficult to cough up thin mucus.

Used as part of combination preparations of plant origin with essential oils (including eucalyptus oil, anise oil, peppermint oil, menthol).

Use during pregnancy and breastfeeding

During pregnancy and lactation, bromhexine is used in cases where the expected benefit to the mother outweighs the potential risk to the fetus or child.

Drug interactions

Bromhexine is incompatible with alkaline solutions.

The therapeutic effect may appear on days 4-6 of treatment.

Tradename

Bromhexine 4 Berlin-Chemie

International nonproprietary name

Bromhexine

Dosage form

Oral solution 4mg/5ml

Compound

100 ml of solution contains

active substance - Bromhexine hydrochloride 0.080 g

Excipients:

propylene glycol, sorbitol, concentrated apricot flavor, 0.1 M hydrochloric acid, purified water.

Description

Transparent, colorless, slightly viscous solution with an apricot odor.

Pharmacotherapeutic group

Expectorants. Mucolytics. Bromhexine.

ATX code R05CB02

Pharmacological properties

Pharmacokinetics

After oral administration, bromhexine is absorbed almost completely; its half-life is approximately 0.4 hours. Tmax when taken orally is 1 hour. The effect of the first passage through the liver is about 80%. Biologically active substances are formed during the excretion process. Plasma protein binding - 99%.

The decrease in plasma concentration is multiphasic. The half-life after which the effect ceases is about 1 hour. In addition, the terminal half-life is approximately 16 hours. This is caused by the redistribution of small amounts of bromhexine into tissues. The volume of distribution is approximately 7 liters per kg body weight. Bromhexine does not accumulate in the body.

Bromhexine overcomes the placental barrier and also penetrates into cerebrospinal fluid And breast milk.

Excretion is primarily through the kidneys, since metabolites are formed in the liver. In view of high degree Bromhexine's binding to proteins and its significant volume of distribution, as well as due to its slow redistribution from tissues to the blood, excretion of any significant part of the drug through dialysis or forced diuresis is unlikely.

At serious illnesses liver, a decrease in clearance of the parent substance can be expected. In severe renal failure, the half-life of bromhexine may be prolonged. IN physiological conditions nitrosation of bromhexine is possible in the stomach.

Pharmacodynamics

Bromhexine is a synthetic derivative of the plant active ingredient vasicin. It has a secretolytic effect and promotes the evacuation of secretions from the bronchi. Animal experiments have shown that this drug increases the proportion of the serous component in bronchial secretions. This facilitates the transport of sputum by reducing its viscosity and enhancing the work of the ciliary epithelium.

With the use of bromhexine, there is an increase in the concentration of the antibiotics amoxicillin, erythromycin and oxytetracycline in sputum and bronchial secretions. Clinical significance this effect has not been determined.

Indications for use

As a secretolytic agent for acute and chronic diseases of the bronchi and lungs, accompanied by impaired formation and elimination of mucus.

Directions for use and doses

Oral solution

Adults and adolescents over 14 years of age - 2 - 4 scoops of BROMHEXINE 4 BERLIN-CHEMIE three times a day (equivalent to 24 - 48 mg of bromhexine hydrochloride per day).

Children and adolescents from 6 to 14 years old, as well as patients weighing less than 50 kg, take 2 scoops of BROMHEXINE 4 BERLIN-CHEMIE three times a day (equivalent to 24 mg of bromhexine hydrochloride per day).

The use of BROMHEXINE 4 BERLIN-CHEMI is permitted only in children over 2 years of age and under medical supervision.

Instructions for use in special groups patients:

The use of the drug BROMHEXINE 4 BERLIN-CHEMIE for liver dysfunction or serious renal diseases requires special caution (bromhexine should be used in a lower dose or at longer intervals).

The duration of treatment is determined individually in accordance with the indications and course of the disease. Taking BROMHEXINE 4 BERLIN-CHEMI without a doctor's recommendation is allowed for no more than 4-5 days.

Side effects

By frequency of occurrence, side effects are classified as follows:

Often
	≥ 1/100 to< 1/10
	≥ 1/1000 to< 1/100
	≥ 1/10000 to< 1/1000
Very rarely
Unknown	Based on available data, cannot be assessed

Sometimes:

Fever

Hypersensitivity reactions (skin rash, angioedema, difficulty breathing, itching, urticaria)

- nausea, abdominal pain, vomiting, diarrhea

Very rarely

- anaphylactic reactions, up to the development of shock

Heavy skin reactions, for example, Stevens-Johnson syndrome and Lyell's syndrome (see section " special instructions»).

At the first manifestations of a hypersensitivity reaction, anaphylactic reactions or if any unusual changes occur on the skin or mucous membranes, immediately stop taking BROMHEXINE 4 BERLIN-CHEMIE and consult a doctor.

Reports of possible adverse reactions

Reporting possible side effects after registration medicinal product plays important role. This allows continued monitoring of the benefit/risk ratio for a given medicine. Health care professionals should report any possible adverse reactions.

Contraindications

Hypersensitivity to the active substance or to other excipients

Lactation period

Drug interactions

When using BROMHEXINE 4 BERLIN-CHEMIE in combination with antitussive drugs, a dangerous accumulation of secretions is possible due to suppression of the cough reflex - therefore, when prescribing such a combination of drugs, a particularly thorough examination is necessary.

At simultaneous use drugs, causing symptoms irritation gastrointestinal tract, may increase the irritant effect on the mucous membranes of the gastrointestinal tract.

special instructions

Skin reactions: Severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, have occurred in extremely rare cases as a result of the use of bromhexine. If any unusual changes occur on the skin or mucous membranes, immediately stop taking BROMHEXINE 4 BERLIN-CHEMIE and consult a doctor.

Gastric and duodenal ulcers: You should not use BROMHEXINE 4 BERLIN-CHEMIE if you suffer (or have suffered in the past) from a stomach or duodenal ulcer, since bromhexine may affect the barrier function of the gastrointestinal mucosa.

Lungs and airways: due to the possible accumulation of secretions, when using BROMHEXINE 4 BERLIN-CHEMIE in patients with impaired bronchial motility and increased secretion of mucus (for example, with such rare disease, such as primary ciliary dyskinesia [cilia dyskinesia]) caution should be exercised.

Liver and kidney disorders: in case of impaired liver function or serious renal diseases, special caution must be taken (use bromhexine in a lower dose or at longer intervals).

In severe renal failure, accumulation of bromhexine metabolites produced in the liver is likely.

Children: the use of BROMHEXINE 4 BERLIN-CHEMI is permitted only in children over 2 years of age and under medical supervision.

Propylene glycol, sorbitol: Due to propylene glycol, which is part of the drug, BROMHEXINE 4 BERLIN-CHEMIE can cause in children the same symptoms that occur after drinking alcohol.

In this regard, the drug is contraindicated in rare cases hereditary disease- congenital fructose intolerance.

Caloric content 2.6 kcal/g sorbitol.

One scoop contains 2 g sorbitol (source of 0.5 g fructose), which is equivalent to approximately 0.17 bread units.

The drug may have a slight laxative effect due to the sorbitol it contains.

Pregnancy and lactation

Pregnancy

To date, there is no experience with the use of bromhexine during pregnancy; therefore, the use of BROMHEXINE 4 BERLIN-CHEMIE by pregnant women is allowed only after a thorough assessment by a doctor of the risks and benefits; use in the first trimester of pregnancy is not recommended.

Lactation

Because active substance excreted in breast milk, the use of BROMHEXINE 4 BERLIN-CHEMIE during lactation is not allowed.

Features of the effect of the drug on the ability to drive vehicle or potentially dangerous mechanisms

Unknown

Overdose

Symptoms: Cases of dangerous overdose in humans are still unknown.

A study of overdose cases has been published, according to which vomiting was observed in 4 out of 25 cases of bromhexine overdose, and in three children such phenomena as vomiting were noted, as well as loss and confusion of consciousness, ataxia, double vision, mild metabolic acidosis and increased respiration. Children who took up to 40 mg of bromhexine had no symptoms even without measures to remove this substance from the body. Data on chronic toxic effect There are no drugs available in humans.

Therapeutic measures: after a significant overdose, circulatory control and, if necessary, symptomatic therapeutic measures are indicated. Due to the low toxicity of bromhexine, there is usually no need for more invasive measures to reduce absorption or accelerate elimination. In addition, due to pharmacokinetic characteristics (large volume of distribution, slow redistribution processes and significant protein binding), dialysis and forced diuresis do not have a significant effect on the removal of the substance from the body.

Since children over 2 years of age usually experience only mild symptoms, even after taking a significant dose, there is no need for antidotes when taking up to 80 mg of bromhexine hydrochloride (i.e. 100 ml of BROMHEXINE 4 BERLIN-CHEMIE); for young children this limit is 60 mg bromhexine hydrochloride (6 mg/kg body weight).

Note: when taking more than high doses the impact should also be taken into account excipients(see sections “composition” and “Special instructions” - propylene glycol and sorbitol).

Release form and packaging

60 ml in brown glass bottles with a plastic or aluminum screw cap.

1 bottle each along with a measuring spoon and instructions for medical use in the state and Russian languages they are placed in a pack of cardboard.

Storage conditions

Store at a temperature not exceeding 25°C.

Keep out of the reach of children!

Shelf life

No more than 3 months after the first opening of the bottle.

Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies

Over the counter

Manufacturer

Berlin Chemie AG (Menarini Group),

Glinker Veg 125

12489 Berlin, Germany

Registration Certificate Holder

Berlin Chemie AG (Menarini Group), Germany

Address of the organization that receives claims from consumers regarding the quality of products (goods) on the territory of the Republic of Kazakhstan and is responsible for post-registration monitoring of the safety of the medicinal product:

Representative office of JSC Berlin-Chemie AG in the Republic of Kazakhstan

Tel.: +7 727 2446183, 2446184, 2446185

Fax:+7 727 2446180

Address Email: [email protected]

Attached files

984426251477976208_ru.doc	43 kb
381347421477977459_kz.doc	81.5 kb

dragees, drops for oral administration, solution for injection, solution for oral administration, syrup, syrup [for children], tablets, tablets [for children]

Pharmachologic effect:

Mucolytic (secretolytic) agent, has an expectorant and weak antitussive effect. Reduces the viscosity of sputum (depolymerizes mucoprotein and mucopolysaccharide fibers, increases the serous component of bronchial secretions); activates ciliated epithelium, increases volume and improves sputum discharge. Stimulates the production of endogenous surfactant, which ensures the stability of alveolar cells during respiration. The effect appears within 2-5 days from the start of treatment.

Indications:

Diseases of the respiratory tract, accompanied by difficulty in the discharge of viscous sputum: tracheobronchitis, bronchitis of various etiologies (including complicated by bronchiectasis), bronchial asthma, pulmonary tuberculosis, pneumonia (acute and chronic), cystic fibrosis. Sanitation bronchial tree in the preoperative period and during therapeutic and diagnostic intrabronchial manipulations, prevention of accumulation of thick viscous sputum in the bronchi after surgery.

Contraindications:

Hypersensitivity, peptic ulcer, pregnancy (first trimester); lactation period; childhood(up to 6 years - for tablet forms). With caution. Renal and/or liver failure; diseases of the bronchi, accompanied by excessive accumulation of secretions; a history of gastric bleeding.

Side effects:

Allergic reactions, nausea, vomiting, dyspepsia, exacerbation of gastric ulcer and duodenal ulcer, dizziness, headache, increased activity of “liver” transaminases (extremely rare). Overdose. Symptoms: nausea, vomiting, diarrhea, dyspeptic disorders. Treatment: artificial vomiting, gastric lavage (in the first 1-2 hours after administration).

Directions for use and dosage:

Bromhexine 4 mg for children is taken orally (syrup, tablets and dragees - for children over 6 years old, drops, oral solution), adults and children over 14 years old - 8-16 mg 3-4 times a day. Children under 2 years old - 2 mg 3 times a day, 2-6 years old - 4 mg 3 times a day, 6-14 years old - 8 mg 3 times a day. If necessary, the dose can be increased for adults to 16 mg 4 times a day. In the form of inhalations (inhalation solution): adults - 8 mg, children over 10 years old - 4 mg, 2-10 years old - 2 mg. Inhalations are carried out 2 times a day. The solution is diluted 1:1 with distilled water and heated to body temperature to prevent coughing. In case of bronchial obstruction, a bronchodilator should be prescribed before inhalation. Bromhexine 8 drops: orally, adults and adolescents over 14 years old - 23-47 drops 3 times a day; children 6-14 years old and patients weighing less than 50 kg - 23 drops 3 times a day, up to 6 years - 12 drops 3 times a day. The therapeutic effect may appear on days 4-6 of treatment. Parenterally (i.m., subcutaneously, i.v. slowly, over 2-3 minutes) - 2-4 mg 2-3 times a day. The solution for intravenous administration should be diluted with Ringer's solution or sterile water for injection. Patients with renal failure Prescribe smaller doses or increase the interval between administrations.

Special instructions:

During treatment, it is necessary to take a sufficient amount of fluid, which increases the expectorant effect of bromhexine. In children, treatment should be combined with postural drainage or vibration massage chest, facilitating the removal of secretions from the bronchi. It should be taken into account that the composition of Bromhexine 8-drops includes ethanol (41 vol.%).

Interaction:

Bromhexine 4 mg for children is not prescribed simultaneously with drugs that suppress the cough center (including codeine), since this complicates the passage of liquefied sputum (accumulation of bronchial secretions in the respiratory tract). Incompatible with alkaline solutions. Bromhexine promotes the penetration of antibiotics (amoxicillin, erythromycin, cephalexin, oxytetracycline), sulfonamide drugs into bronchial secretion in the first 4-5 days of antimicrobial therapy.

Before using the drug Bromhexine 4 mg for children consult your doctor!

Bromhexine*

Pharmacological group

Secretolytics and stimulants of motor function of the respiratory tract

Composition and release form

5 ml of mixture (1 measuring spoon) contains bromhexine hydrochloride 4 mg; in dark glass bottles of 60 ml, complete with a measuring spoon, 1 set in a cardboard box.

1 tablet contains bromhexine hydrochloride 8 mg; 25 pcs in a blister, 1 blister in a box.

pharmachologic effect

pharmachologic effect- secretomotor, secretolytic, antitussive, antibacterial.

Causes depolymerization of mucoprotein and mucopolysaccharide polymer molecules (mucolytic effect). Stimulates the production of endogenous surfactant, which ensures the stability of alveolar cells during respiration and their protection from unfavorable factors. Surfactant improves rheological properties bronchopulmonary secretion, its “sliding” along the epithelium and facilitates the release of sputum from the respiratory tract.

Pharmacokinetics

Almost completely absorbed. Plasma protein binding - 99%. The volume of distribution is about 7 l/kg. Penetrates through the BBB and placental barrier, as well as into breast milk. T1/2 - from 1 to 16 hours. Excreted only in urine in the form of metabolites.

Indications of the drug Bromhexine 4 Berlin-Chemie

Spicy and chronic diseases bronchi and lungs with impaired sputum discharge.

Contraindications

Hypersensitivity.

Use during pregnancy and breastfeeding

Use with caution only as prescribed by a doctor.

Side effects

In rare cases, dyspeptic disorders, allergic reactions.

Interaction

Promotes the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline) into the lung tissue.

Directions for use and doses

Orally, adults and children over 14 years old - 8-16 mg 3 times a day; children under 14 years of age and patients weighing less than 50 kg - 8 mg 3 times a day; children under 6 years old - 4 mg 3 times a day.

Precautionary measures

Prescribe with caution for stomach ulcers. It is not allowed to be used in combination with antitussives (codeine), since if the cough reflex is suppressed, stagnation of secretions in the respiratory tract is possible.

Storage conditions for the drug Bromhexine 4 Berlin-Chemie

At a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life of the drug Bromhexine 4 Berlin-Chemie

3 years. After opening - 3 months.

Do not use after the expiration date stated on the package.