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

Excipients: levomenthol 0.068 mg; hydrochloric acid 2 mol / l to pH 3.0; methylparahydroxybenzoate 1.64 mg; ethanol 96% 30.0 mg; sorbitol 300.0 mg; purified water 762.0 mg.

Description:

Colorless, transparent, slightly opalescent liquid.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

R.05.C.B Mucolytics

R.05.C.B.02 Bromhexine

Pharmacodynamics:

Bromhexine Nycomed has mucolytic (secretolitic), expectorant and weak antitussive effect. The mucolytic effect is associated with the depolymerization of mucoprotein and mucopolysaccharide fibers and an increase in the serous component of the bronchial secretion.

Pharmacokinetics:

Ingestion bromohexine almost completely (99%) is absorbed in the gastrointestinal tract for 30 minutes. Bioavailability depends on the individual characteristics of the organism, the activity of renal enzymes during the primary passage of the active substance through the liver and is approximately 20%. Bromhexine in plasma binds to proteins, penetrates through blood-brain and placental barriers in the liver bromohexine is subjected to demethylation and oxidation, part of the metabolites formed (ambroxol) remains active. The limiting half-life is 15 hours due to slow reverse diffusion from the tissues. The maximum concentration in the blood is reached approximately 1 hour after administration. Excreted by the kidneys. In chronic renal failure, the release of bromhexine Metabolites is impaired. With repeated use bromohexine can cumulate.

Indications:

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

Sanitation of the bronchial tree in the preoperative period and during the medical and diagnostic intrabronchial manipulation, prevention of congestion in the bronchi of thick viscous sputum after the operation.

Contraindications:

hypersensitivity to the components of the drug;
pregnancy and lactation;
peptic ulcer (at the stage of exacerbation);
children's age up to 3 years.

Carefully:

Use in patients with gastric bleeding in history, with bronchial diseases accompanied by excessive accumulation of secret, with history of episodes of hemoptysis, kidney and / or liver failure. The presence of alcohol in the preparation (3%) can have an adverse effect on children, pregnant women, people with brain diseases, with craniocerebral trauma, alcoholism.

Dosing and Administration:

Inside.

Adults and children over 10 years: 10-20 ml 3 times a day.

Children from 6 to 10 years - 5-10 ml 3 times a day.

Children from 3 to 6 years - 2.5-5 ml 3 times a day.

For the convenience of dosing the preparation, use the attached measuring beaker.

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

Side effects:

Rarely with prolonged use of the drug, dyspepsia is possible, incl. nausea, vomiting, exacerbation of gastric ulcer and duodenal ulcer, allergic reactions, dizziness, headache, increased activity of "hepatic" transaminases in the blood serum.

Overdose:

Dangerous for life overdose in the use of Bromgexin Nycomed in humans are not known.

The following symptoms are possible: nausea, vomiting, diarrhea 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 for 1-2 hours after taking the drug.

Interaction:

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

Bromhexine Nycomed facilitates the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline, ampicillin, amoxicillin), sulfonamide drugs in the bronchial secret.

The drug is incompatible with alkaline solutions

Special instructions:

For patients with diabetes mellitus; in 5 ml of the solution contains 1.5 g of sorbitol, which corresponds to 0.12 bread units.

The composition of the drug includes alcohol at a concentration of 3%, which is one dose of the drug for adults (20 ml) - 0.6 g, respectively for children (2.5 ml) - 0.075 g.

Effect on the ability to drive transp. cf. and fur:

Admission of recommended therapeutic doses (20 ml 3 times a day) does not affect the speed of the patient's psychomotor reactions.

A significant excess of the recommended doses of a drug containing 3% alcohol can affect the speed of psychomotor reactions and be dangerous when driving a car or working with equipment.

Form release / dosage:

Solution for oral administration 0.8 mg / ml.

Packaging:

For 150 ml of the drug in a vial of dark glass with screw plastic cover, connected with a detachment ring, providing control of the first autopsy. The plastic cover is put on bezel with fissions.

Each label is labeled. One bottle with instruction for the application is placed in a cardboard box.

Storage conditions:

Store at temperatures from 15 FROM up to 25 ° С.

Keep out of the reach of children.

Shelf life:

3 years.Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N014477 / 01

Date of registration:03.11.2009 / 08.07.2015

Expiration Date:Unlimited

The owner of the registration certificate:Takeda Pharma A / STakeda Pharma A / S Denmark

Manufacturer: & nbsp

Takeda Pharma A / S Denmark

Representation: & nbspTakeda Pharmaceuticals Ltd.Takeda Pharmaceuticals Ltd.

Information update date: & nbsp25.02.2017

Illustrated instructions

Instructions

Bromgexin Nycomed (Bromhexine Nycomed)