Bromhexine 8 Berlin-Chemie, drags 8mg, 25pcs

Composition

Composition for 1 tablet:

Core:

Active ingredient: Bromhexinee hydrochloride-8,000 mg.

Auxiliary substances: lactose monohydrate, corn starch, gelatin, colloidal anhydrous silicon dioxide, magnesium stearate;

Shell: sucrose, calcium carbonate, magnesium carbonate, talc, macrogol 6000, povidone K 25, glucose syrup, Carnauba wax, titanium dioxide (E 171), quinoline yellow dye (E 104).

Pharmacological action

Pharmacotherapy group:  expectorant mucolytic agent

ATX: R05 SV 02

Pharmacological properties

Pharmacodynamics

Bromhexinee has mucolytic (secretolytic) and expectorant (secretomotor) effects.

Reduces the viscosity of sputum, activates the ciliated epithelium, increases the volume of sputum and improves its discharge. It stimulates the production of endogenous surfactant, which ensures the stability of alveolar cells during respiration. The effect manifests itself in 2-5 days from the start of treatment.

Pharmacokinetics

Suction.  After oral use, Bromhexinee is rapidly and almost completely absorbed from the gastrointestinal tract. The half-absorption period is about 0.4 h. The maximum concentration in blood plasma after oral use is reached after 1 h.

Distribution. The volume of distribution is approximately 7 l / kg of body weight. The degree of binding to plasma proteins is 99%. Bromhexinee penetrates the blood-brain barrier and placental barrier. Penetrates into breast milk and cerebrospinal fluid. Bromhexinee is not cumulated.

Metabolism. 80% of Bromhexinee undergoes a “first pass” effect through the liver with the formation of biologically active metabolites. In severe liver diseases, there is a decrease in the clearance of Bromhexinee.

Output. Bromhexinee is mainly eliminated from the body as metabolites. The half-life of reaching the minimum effective concentration after reaching equilibrium between the processes of absorption and elimination is approximately 1 h. The final half-life is about 16 h due to the reverse distribution of small amounts of Bromhexinee from tissues.

It is mainly excreted by the kidneys in the form of metabolites formed in the liver. Due to the high degree of binding to plasma proteins and high volume of distribution, as well as slow re-distribution from tissues to blood, significant elimination of Bromhexinee by dialysis or forced diuresis should not be expected.

In severe renal insufficiency, an increase in the half-life of Bromhexinee metabolites cannot be excluded. Possible nitrosation of Bromhexinee under physiological conditions in the stomach.

Indications

Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with impaired sputum secretion and transport (for example, acute and chronic bronchitis, bronchiectasis, etc. ).

Use during pregnancy and lactation

The use of the drug during pregnancy is possible in the 2nd and 3rd trimester only if the intended benefit to the mother exceeds the possible risk to the fetus. The use of Bromhexinee during breastfeeding is contraindicated.

Contraindications

• hypersensitivity to Bromhexinee and other components of the drug;
• lactase deficiency, rare hereditary intolerance to galactose or fructose, glucose-galactose malabsorption syndrome, sucrose-isomaltase insufficiency;
• peptic ulcer of the stomach and duodenum (including in the anamnesis);
• pregnancy (I trimester);
• children under 6 years of age.

With caution

• in case of impaired renal function and / or liver diseases;
• in case of impaired bronchial motility, accompanied by excessive accumulation of secretions;

Side effects

Usually, the drug Bromhexinee 8 Berlin-Chemi is well tolerated.

Possible side effects are listed below by descending frequency of occurrence:  very often (>1/10), often (>>1/100, >><1/10), infrequently (>1/1000, <1/10), infrequently (><1/100), rarely (>1/10000, <1/100), rarely (><1/1000), very rarely, including individual messages ( 

From the immune system

Rarely:  hypersensitivity reactions;

Frequency unknown: anaphylactic reactions, up to anaphylactic shock; angioedema, pruritus of the skin.

Skin and subcutaneous tissue disorders

Rarely: skin rash, urticaria;

Frequency unknown: severe skin reactions, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), acute generalized exanthematous pustulosis (see section “Special instructions”).

From the gastrointestinal tract

Infrequently: nausea, vomiting, abdominal pain, diarrhea.

General violations

Infrequently: fever.

In all forms of allergic reactions (hypersensitivity, anaphylaxis) or in the event of any skin and/or mucosal damage, it is necessary to stop taking this medicine and immediately inform the attending physician.

Interaction

Bromhexinee is not prescribed simultaneously with antitussive agents (including those containing codeine), because due to the suppression of the reflex, it is difficult to evacuate liquefied sputum, which can lead to accumulation of secretions in the respiratory tract.

Bromhexinee promotes the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline, ampicillin, amoxicillin) into the bronchial secretions in the first 4-5 days of antimicrobial therapy. The clinical significance of this possible interaction has not been proven.

When used concomitantly with drugs that have an irritating effect on the gastrointestinal tract (for example, some nonsteroidal anti-inflammatory drugs), it is possible to increase the irritating effect of the latter on the gastric mucosa.

How to take, course of use and dosage

The drug is taken orally, after a meal, without chewing, with a sufficient amount of liquid.

Adults and adolescents over 14 yearsof age: 1-2 tablets 3 times a day (24-48 mg / day).

Children from 6 to 14 years of age, as well as patients with a body weight of less than 50 kg: 1 tablet 3 times a day (24 mg/day).

If renal and/or hepatic function is impaired, the intervals between doses should be increased or the dose should be reduced. Please consult your doctor on this issue.

Bromhexinee should not be taken for more than 4-5 days without consulting your doctor.

The duration of use is determined individually and depends on the indications and course of the disease.

Overdose

Life – threatening overdose symptoms with Bromhexinee 8 Berlin-Chemi are unknown.

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

Published a study of overdose cases, according to which 4 out of 25 overdose cases were observed vomiting. Three of the children experienced vomiting, deafness, ataxia, diplopia, mild metabolic acidosis, and tachypnea. In children, symptoms did not occur when taking Bromhexinee at a dose of up to 40 mg, even if left untreated.

There is no evidence of chronic human toxicity of Bromhexinee.

Treatment: in case of severe overdose, blood circulation monitoring and, if necessary, symptomatic treatment are indicated. Due to the low toxicity of Bromhexinee, as a rule, there is no need for invasive measures aimed at reducing its absorption (forced vomiting, gastric lavage) or speeding up excretion. In addition, due to pharmacokinetic features (high volume of distribution, slow redistribution processes, and high protein binding), effective removal of Bromhexinee from the body by dialysis or forced diuresis should not be expected.

Since only mild symptoms are expected in children from 2 years of age, even after taking large doses of Bromhexinee, detoxification can be avoided with a dose of Bromhexinee hydrochloride up to 80 mg (for example,10 tablets of 8 mg). In younger children, the appropriate dose limit is 60 mg Bromhexinee hydrochloride (6 mg / kg body weight).

In case of overdose, it is also possible to develop side effects caused by excipients.

Description

yellow to greenish-yellow coated tablets slightly biconvex with an almost white core.

Special instructions

In cases of impaired bronchial motility (for example, with a rare syndrome of primary ciliary dyskinesia) or with a significant volume of sputum secreted, the use of Bromhexinee 8 Berlin-Chemi requires caution, due to the increased risk of airway obstruction.

In patients with impaired renal function and severe liver diseases, Bromhexinee 8 Berlin-Chemi should be used with extreme caution (for example, reduce the dose or increase the interval between doses). In severe renal insufficiency, it is necessary to consider the possibility of accumulation of metabolites formed in the liver.

Periodic monitoring of liver function is recommended, especially during long-term treatment.

There are data on the occurrence in very rare cases of severe skin reactions (such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis) while taking Bromhexinee. If you experience allergic reactions and / or signs of progressive skin rash (sometimes in combination with blistering and mucosal damage), you should immediately stop using the drug and consult a doctor.

Effect of the drug on the ability to drive vehicles and mechanisms When taken at the recommended doses, Bromhexinee does not affect the speed of psychomotor reactions.

Form of production

Coated tablets,8 mg.

25 tablets in a contour cell package (blister) made of PVC/aluminum foil.

1 blister along with the instructions for use of the drug in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 ° C. Keep the medicine out of the reach of children!

Shelf

life 3 years Do not use after the expiration date indicated on the package.

Active ingredient

Bromhexinee

Dosage form

dragees

Purpose

Pregnant women in the second and third trimester as prescribed by a doctor, Children over 6 years of age, For adults

Indications

Chronic obstructive pulmonary disease, Cough, Bronchial asthma, Bronchitis, pneumonia