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

1 tablet contains: active substance: bromhexine hydrochloride 4 mg; Excipients: sucrose - 60 mg, lactose monohydrate - 30 mg, potato starch - 5 mg, magnesium stearate - 1 mg.

5 ml of syrup (one teaspoon) contain: active substance: bromhexine hydrochloride 4 mg; Excipients: methylparahydroxybenzoate 5 mg, ethanol 96% 0.625 ml, sorbitol solution (stabilized) 2860 mg (in terms of 100% sorbitol 2000 mg), levomentol 0.55 mg, anise oil 0.00025 ml, mint oil - 0.00025 ml, fennel oil - 0.00025 ml, purified water - 2.20 ml.

Description:

Tablets for children. Round flat cylindrical tablets of white color with a bevel.

Syrup. Colorless or slightly colored transparent liquid with a characteristic odor.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

R.05.C.B Mucolytics

R.05.C.B.02 Bromhexine

Pharmacodynamics:

The drug has mucolytic (secretolitic) and expectorant action. Reduces the viscosity of sputum (depolymerizes mucoprotein and mucopolysaccharide fibers, increases the serous component of the bronchial secretion), activates the ciliated epithelium, increases the volume and improves the sputum discharge. Stimulates the production of endogenous surfactant, which ensures the stability of alveolar cells in the process of breathing. The effect manifests itself in 2-5 days from the beginning of treatment.

Pharmacokinetics:

When ingested almost completely (99%) is absorbed in the gastrointestinal tract for 30 minutes. Bioavailability - 20% (the effect of the primary "passage" through the liver). It penetrates the placental barrier and the blood-brain barrier. In the liver it is demethylated and oxidized, metabolized to pharmacologically active ambroxol. The highest concentration in the plasma is achieved 1 h after the administration of bromhexine hydrochloride. The half-life (T1 / 2) is 15 hours (due to a slow reverse diffusion from tissues).It is excreted by the kidneys. Unchanged in the urine, only a small amount of the drug is released. With chronic renal failure, the release of metabolites is disrupted. With repeated use can be cumulated.

Indications:

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

Contraindications:

hypersensitivity to the components of the drug, including sorbitol (syrup), lactose and sucrose (tablets for children)
pregnancy
lactation period
stomach ulcer
children under 1 year for syrup and up to 6 years for tablets.

Carefully:

Renal and / or hepatic insufficiency, bronchial diseases, accompanied by excessive accumulation of secretion of gastric bleeding in history, liver disease, brain disease, epilepsy, alcoholism, childhood, the propensity to develop drug dependence.

Dosing and Administration:

Bromhexine take inside regardless of food intake.During the treatment it is recommended to use a sufficient amount; A liquid that supports the secretolitic action of bromhexine. The course of treatment is from 4 to 28 days.

Tablets for children. Children from 6 to 14 years - 4-8 mg 3 times a day.

Children aged 1 to 6 years are advised to take bromhexine syrup.

Syrup. Take 3 times a day.

Patient's age	Dose; teaspoons
Children
from 1 to 2 years	1/2
from 2 to 6 years	½ - 1
from 6 to 14 years	1-2
Adolescents (starting from age 14) and adults	2-3

The patient should consult a doctor if his condition has not improved during a 6-day treatment with bromhexine.

Side effects:

Rarely with prolonged use of the drug, dizziness, headache, nausea, vomiting, dyspepsia, exacerbation of peptic ulcer and duodenal ulcer, allergic reactions (skin rash, face swelling, rhinitis, etc.) are possible, an increase in the level of transaminases in the serum. In these cases, the drug should be discontinued.

Overdose:

The intoxication of bromhexine in humans has not yet been established.

Acute drug poisoning in experimental animals causes increased salivation, nausea, diarrhea, vomiting and lowering of blood pressure.- In case of an overdose of bromhexine administered orally, it is necessary first of all to wash the stomach, monitor the circulatory parameters, and carry out symptomatic therapy.

Interaction:

Bromhexine can be prescribed concomitantly with other drugs used in the treatment of broncho-pulmonary diseases.

Bromhexine Do not prescribe concomitantly with medicines containing codeineSince suppression of the cough reflex complicates the coughing diluted sputum.

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

Ethanol (alcohol), which is part of the syrup, can change the effect of other medicines.

The combined use of bromhexine with some non-steroidal anti-inflammatory drugs (for example, salicylates, phenylbutazone or butadiene) can cause irritation of the gastric mucosa.

Bromhexine not compatible with alkaline solutions.

Special instructions:

Bromhexine should be used with caution weakened patient.

1 tablet of bromhexine for children contains 30 mg of lactose and 60 mg of sucrose.

5 ml of syrup contains 2 g of sorbitol.

The syrup contains 12.5 vol. % of alcohol. This should be taken into account when using syrup for pregnant women, children and high-risk groups for patients with liver disease, brain diseases, alcoholism, epilepsy and a propensity to develop drug dependence.

When treating, you must 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 of the chest, facilitating the evacuation of secretions from the bronchi.

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

There is no information about the adverse effects of bromhexine on the ability to drive vehicles and service mechanisms that require increased attention and speed of psychomotor reactions.

Form release / dosage:

Tablets for children 4 mg.

Packaging:

Tablets for children 4 mg. For 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil. 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Syrup 4 mg / 5 ml. For 100 ml in dark glass bottles with screw-on plastic caps with safetyrings to control the first opened. One bottle together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

Tablets for children. Keep in dry the dark place at a temperature of no higher than 25 ° C.

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

Shelf life:

5 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:П N016027 / 01

Date of registration:29.06.2011

Expiration Date:Unlimited

The owner of the registration certificate:GRINDEX, JSC GRINDEX, JSC Latvia

Manufacturer: & nbsp

Grindeks, JSC Latvia

Information update date: & nbsp25.02.2017

Illustrated instructions

Instructions

Bromhexine Grindeks (Bromhexine Grindex)