Bromhexine 8 - instructions for use, dose, side effects, contraindications

For 100 g of the preparation:
Active substance:
Bromhexine hydrochloride	0,800 g
Excipients:
Anise star fruit butter	0.025 g
Fennel bitter fruit oil	0.075 g
Levomenthol	0.150 g
Thyme herb butter	0.025 g
Peppermint oil	0.025 g
Eucalyptus oil	0.025 g
Sucrose	10,000 grams
Polysorbate 80	0.400 g
Ethanol 96%	36,000 g
Hydrochloric acid conc. 36%	0.039 g
Potassium phosphate dihydrate	0.600 g
Sodium hydrophosphate dodecahydrate	0.031 g
Purified water	51.805 grams

Description:

Transparent, slightly yellowish solution with a fragrant smell.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

R.05.C.B Mucolytics

R.05.C.B.02 Bromhexine

Pharmacodynamics:Bromhexine 8 has mucolytic (secretolitic), expectorant and weak antitussive effect. Reduces the viscosity of sputum (depolymerizes mukoproteinovye and mucopolysaccharide fibers, increases the serous component of the bronchial secretion); activates ciliated epithelium, increases volume and improves sputum discharge.

Pharmacokinetics:Ingestion bromohexine almost completely (99%) is absorbed into the digestive tract within 30 minutes. Bioavailability is 80% due to the effect of "first passage through the liver." Bromhexine in the plasma binds to proteins, penetrates through the blood-brain and placental barriers. In the liver bromohexine is subjected to demethylation and oxidation, part of the metabolites formed (ambroxol) remains active. The half-life is 15 hours due to slow back diffusion from the tissues. The maximum concentration in the blood is reached about 1 hour after admission. Excreted by the kidneys. In chronic renal failure, the release of metabolites of bromhexine is disrupted. With repeated use bromohexine can cumulate.

Indications:

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

Contraindications:

hypersensitivity to the components of the drug;
pregnancy and lactation;
children under 12 years (due to alcohol)
peptic ulcer (at the stage of exacerbation);

Carefully:With caution should be used in patients with bronchial diseases, accompanied by excessive accumulation of secretions; gastric hemorrhage in history, renal and / or hepatic insufficiency; hereditary intolerance to fructose, glucose-galactose malabsorption or insufficiency of sucrose-isomaltase; with bronchial asthma, tk. accidental inhalation of levomenthol, eucalyptus and peppermint oil in the drug may lead to laryngospasm or may cause an attack of bronchial asthma.

Dosing and Administration:

If the doctor does not prescribe a different dosage, Bromhexine 8 is taken orally 3 times a day.

With renal failure, the required dose of the drug reduces or increases the intervals between doses of the drug.

During the treatment it is recommended to use a sufficient amount of liquid that supports the secretolitic action of bromhexine.

If the picture deteriorates, or if there is no improvement after 4-5 days, you should consult your doctor.

Side effects:Nausea, abdominal pain, vomiting, diarrhea. Sometimes heat, hypersensitivity (skin rashes, angioedema, choking, itching, urticaria). Very rarely - anaphylactic reaction, up to a shock. Exacerbation of gastric ulcer and duodenal ulcer, dizziness, headache, increased activity of "liver" transaminases (extremely rare).

Overdose:

Dangerous for life overdoses with the use of Bromhexine 8 in humans are not known.

In case of an overdose, as a rule, there are no signs of the disease that go beyond the usual side effects.

Treatment for acute overdose: artificial vomiting, gastric lavage, symptomatic therapy.

Interaction:

Bromhexine 8 can be administered simultaneously with other drugs used in the treatment of bronchopulmonary diseases.

Bromhexine 8 is not prescribed concomitantly with antitussive agents (including those containing codeine), t. they can make it difficult to cough up Bromhexin's liquefied 8 sputum.

Bromhexine 8 promotes the penetration of antibiotics (amoxicillin, erythromycin, cephalexin, oxytetracycline), sulfonamide drugs in the bronchial secret in the first 4-5 days of antimicrobial therapy.

Special instructions:

The preparation contains 41% vol. Alcohol. When the dosage is met, the patient takes up to 0.36 g of alcohol per ml (23 drops). It poses a danger to people with liver diseases, alcoholism, epilepsy, brain diseases, as well as for pregnant women and children.

Very rarely reported on the occurrence of the syndromes of Stephen-Johnson and Lyell, in a temporary connection with the administration of the drug Bromhexine 8. If there are changes on the skin or mucous membrane, stop taking the drug and consult a doctor.

Form release / dosage:Drops for ingestion 8 mg / ml.

Packaging:For 20 ml, 50 ml and 100 ml of the drug are placed in bottles of brown glass with a vertical built-in dropper. On the bottle Paste the label and place it together with the instructions for use in a cardboard box.

Storage conditions:

Store at room temperature between 15 ° C and 25 ° C.

Keep out of the reach of children!

Shelf life:

5 years.

Do not use the drug after the expiration date!

Terms of leave from pharmacies:Without recipe

Registration number:П N014444 / 01

Date of registration:17.03.2008

Expiration Date:Unlimited

The owner of the registration certificate:Crevel Moiselbach GmbHCrevel Moiselbach GmbH Germany

Manufacturer: & nbsp

KREWEL MEUSELBACH, GmbH Germany

Information update date: & nbsp25.02.2017

Illustrated instructions

Instructions

Bromhexine 8 (Bromhexine 8)