Bromhexine 4 Berlin-Chemie - instructions for use, dose, side effects, contraindications

Excipients: propylene glycol 25.00 g, sorbitol 40.00 g, aromatic concentrate with apricot smell 0.05 g, hydrochloric acid 0.1 M (3.5 %) solution - 0.156 g, purified water - 49.062 g.

Description:

Transparent colorless slightly viscous liquid with a characteristic apricot smell.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

R.05.C.B Mucolytics

R.05.C.B.02 Bromhexine

Pharmacodynamics:

Bromhexine has mucolytic (secretolitic) and expectorant action. Reduces the viscosity of phlegm; activates the ciliated epithelium, increases the volume of sputum and improves its departure.

Pharmacokinetics:

When ingested almost completely (99%) is absorbed in the gastrointestinal tract for 30 minutes. Bioavailability is about 80%. It binds to plasma proteins by 99%. Penetrates through the placental and blood-brain barrier. Penetrates into breast milk. In the liver it undergoes demethylation and oxidation, it is metabolized to ambroxol. The half-life period (T1/2) is 16 hours (due to slow back diffusion from the tissues). It is excreted by the kidneys in the form of metabolites. In severe renal failure, T 1/2 may increase.

Indications:

Acute and chronic bronchopulmonary diseases accompanied by the formation of sputum of increased viscosity (tracheobronchitis, pneumonia, obstructive bronchitis, bronchiectasis, bronchial asthma, emphysema, cystic fibrosis, tuberculosis, pneumoconiosis).

Contraindications:

hypersensitivity to the components of the drug;
peptic ulcer (at the stage of exacerbation);
pregnancy (I trimester);
lactation period;
congenital intolerance to fructose.

Carefully:

renal and / or liver failure;
bronchial diseases accompanied by excessive accumulation of secretions;
gastric haemorrhage in the anamnesis;
children's age up to 2 years.

Pregnancy and lactation:

The use of the drug in the first trimester of pregnancy is contraindicated. In the II and III trimesters of pregnancy, the drug is only possible if the intended benefit to the mother exceeds the possible risk to the fetus. The use of the drug during lactation is contraindicated.

Dosing and Administration:

Solution for oral administration.

1 measuring spoon contains 5 ml of solution.

Unless otherwise prescribed, the following doses are recommended:

Adults and adolescents over 14 years of age: 3 times a day for 2-4 scoops (24-48 mg bromhexine per day).

Children from 6 to 14 years, as well as patients with a body weight of less than 50 kg: 3 times a day for 2 measuring spoons (24 mg bromhexine per day).

Children from 2 to 6 years: 3 times a day for 1 measuring spoon (12 mg bromhexine per day).

Children under 2 years: 3 times a day for 1/2 measuring spoon (6 mg bromhexine per day).

When limiting kidney function or severe liver damage, the drug should be used with longer intervals between doses or in a reduced dose.

During the treatment it is recommended to use a sufficient amount of liquid for_;maintenance of secretolitic action of bromhexine.

Without consulting a doctor, do not take Bromhexine 4 Berlin-Chemie, more, 4-5 days.

Side effects:

The frequency is classified according to the headings, depending on the occurrence of the case: very often (> 1/10), often (<1 / 10- <1/100), infrequently (<1 / 100- <1/1000), rarely (<1 / 1000- <1/10000), very rarely (<1/10000), including individual messages.

Disorders from the digestive system:

Infrequently: nausea, vomiting, diarrhea, abdominal pain;

Immune system disorders:

Infrequently: fever, hypersensitivity reactions (skin rash, angioedema, respiratory failure, itching, urticaria);

Rarely: anaphylactic reactions up to shock.

Disturbances from the skin and subcutaneous tissues:

Rarely: Stevens-Johnson Syndrome:

If side effects occur, stop taking the drug and consult a doctor.

Overdose:

Symptoms: nausea, vomiting and other gastrointestinal disorders.

Treatment: there is no specific antidote. In case of overdose, it is necessary to induce vomiting, and then to the patient to give a liquid (milk or water). Gastric lavage is recommended within 1-2 hours after taking the drug.

Interaction:

Bromhexine 4 Berlin-Chemie can be administered simultaneously with other drugs used in the treatment of bronchopulmonary diseases.

With combined use of the drug Bromhexine 4 Berlin-Chemie and antitussive agents that suppress the cough reflex (including those containing codeine), due to the weakening of the cough: reflex, there can be a danger of stagnation.

Bromhexine 4 Berlin-Chemie promotes the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline, ampicillin, amoxicillin) into the lung tissue.

Special instructions:

To maintain the secretionolytic action of the drug Bromhexine 4 Berlin-Chemie during the period of taking the drug must ensure the intake of liquid in the body in sufficient quantities.

In cases of violation of bronchial motility or with a significant amount of sputum (for example, with a rare malignant cilia syndrome) preparation Bromhexine 4 Berlin-Chemie requires caution in connection with the risk of delayed discharge in the respiratory tract.

Application of the drug Bromhexine 4 Berlin-Chemie in children under the age of 2 years is possible - only under the supervision of a doctor.

Indication for patients with diabetes: in 5 ml of solution (1 measuring spoon) contains 2 g of sorbitol (equivalent to 0.5 g of fructose), which corresponds to 0.17 bread units.

Form release / dosage:

Solution for oral administration 4 mg / 5 ml.

Packaging:

For 60 or 100 ml solution in dark glass bottles with a screwed plastic or aluminum stopper with a gasket.

For 1 bottle complete with a measuring spoon, along with instructions for use in a cardboard bundle.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep the medicinal product out of the reach of children.

Shelf life:

3 years.

3 months after the first opening of the vial.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N013480 / 01

Date of registration:22.08.2011 / 18.06.2015

Expiration Date:Unlimited

The owner of the registration certificate:Berlin-Chemie, AGBerlin-Chemie, AG Germany

Manufacturer: & nbsp

BERLIN-CHEMIE, AG Germany

Information update date: & nbsp25.02.2017

Illustrated instructions

Instructions

Bromhexine 4 Berlin-Chemie (Bromhexine 4 Berlin-Chemie)