Haliksol - instructions for use, dose, side effects, contraindications

Composition:In 10 ml of syrup contains active substance ambroksol a hydrochloride - 30 mg; auxiliary ingredients: sorbitol, povidone (K-90), citric acid monohydrate, sodium cyclamate, strawberry flavor 22754, banana flavor 270650, sodium benzoate, sodium citrate, purified water.

Description:

Colorless or pale yellow color, clear liquid without sediment, with a characteristic odor.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Ambroxol is an active metabolite of bromhexine, belongs to the benzylamine group of mucolytic substances.

It dilutes sputum by increasing the production and increasing activity of hydrolytic enzymes that break down the bonds between mucopolysaccharides of sputum.

Improves the rheological properties of sputum, reducing its viscosity and adhesive properties, by stimulating serous cells of the glands of the bronchial mucosa and normalizing the ratio of mucous and serous sputum components. Increases mucociliary transport, increasing the motor activity of the ciliated epithelium. Does not cause excessive secretion, reduces spastic hyperreactivity of the bronchi. Contributes to the production of surfactant.

The effect develops 30 minutes after taking the drug.

Pharmacokinetics:

Almost completely absorbed in the gastrointestinal tract. Approximately 80% binds to blood plasma proteins. It is subject to active metabolism of the "first passage" in the liver. Bioavailability after oral administration is approximately 60%. The time to reach the maximum concentration is 2 hours.

Approximately 90% of the dose taken is excreted in the urine in the form of glucuronide conjugate ambroxol or oxidized products of its metabolism.The half-life period is about 7 hours, it increases with severe renal failure, it does not change if liver function is impaired.

Penetrates through the placental barrier. Its concentration in the fetus is 2-4 times higher than that of the mother. It is found in breast milk and cerebrospinal fluid.

Indications:

Acute and chronic diseases of the respiratory system, accompanied by the formation of viscous sputum: bronchitis, bronchial asthma, chronic obstructive pulmonary disease, pneumonia, bronchiectatic disease.

Inflammatory diseases of ENT organs (sinusitis, otitis), in which liquefaction of mucus is necessary.

Contraindications:

Hypersensitivity to ambroxol or bromhexine.

Ulcerative lesion of the gastrointestinal tract.

Pregnancy (I term)

Carefully:Severe kidney failure.

Pregnancy and lactation:The drug is contraindicated for admission in the first trimester of pregnancy; the drug is excreted in breast milk, therefore, when taking the drug during lactation, the question of stopping breastfeeding should be resolved.

Dosing and Administration:

Inside, after eating and squeezed a lot of liquid.The syrup can be taken with the help of a measuring cap, which is supplied with the drug. Abundant fluid intake contributes to liquefaction of mucus during treatment with Chaliixol.

Adults and children over 12 years of age: the usual daily dose in the first 2-3 days of treatment: 10 ml of syrup 3 times a day, and in the following days - 10 ml of syrup 2 times a day or 5 ml of syrup 3 times a day. In severe cases, the dose is not reduced throughout the course of treatment.

Children under 2 years: 2.5 ml of syrup 2 times a day.

2-5 years: 2.5 ml of syrup 3 times a day.

5-12 years old: 5 ml of syrup 2-3 times a day.

In severe renal failure, lower doses should be given or the intervals between doses should be increased.

When taking Chaliksol for more than 4-5 days, a doctor's consultation is recommended.

Side effects:

Halixol, as a rule, is well tolerated. Rarely, the following side effects can be observed: weakness, headache, diarrhea, constipation, dry mouth and respiratory tract, rhinorrhea, dysuria, gastralgia, nausea, vomiting, exanthema, urticaria. Very severe acute anaphylactic reactions were rarely reported, but their causal relationship with ambroxol was not established.

Overdose:

Symptoms: nausea, vomiting, diarrhea, indigestion.

Treatment: cause vomiting, then prescribe a drink (milk or tea), taking fat-containing products. Gastric lavage is recommended within 1-2 hours after taking the drug. You should constantly monitor the function of the cardiovascular system.

Interaction:

Antitussive drugs (incl. codeine) may make it difficult to isolate phlegm diluted with ambroxol.

Halixol promotes the penetration of certain antibiotics into the bronchial secret (amoxicillin, cefuroxime, erythromycin, doxycycline and etc.).

Special instructions:

It should not be prescribed with antitussive drugs - difficulty in sputum production. The use of the drug in patients with impaired bronchial motor function or abundant sputum with low viscosity requires caution because of the danger of stagnation of bronchial secretions.

The syrup contains nonspecific sweeteners, sorbitol and sodium cyclamate, so patients with diabetes can use this drug, but the content of sorbitol (1.2 grams per 5 ml of syrup) should be taken into account by patients suffering from diabetes.

The drug does not contain alcohol.

Form release / dosage:Syrup.

Packaging:

For 100 ml of syrup in a bottle of brown glass with a white aluminum lid with the control of the first autopsy. 1 bottle together with the instruction for use and a measuring cup are packed in a cardboard box.

Storage conditions:

At a temperature of 15-25 ° C, out of reach of children.

Shelf life:

5 years. The open vial is stored for 4 weeks.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N016005 / 02

Date of registration:10.08.2009

The owner of the registration certificate:EGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary

Manufacturer: & nbsp

EGIS PHARMACEUTICALS, Plc Hungary

Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary

Information update date: & nbsp24.09.2015

Illustrated instructions

Instructions

Halixol® (Halixol®)