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

Composition:Each tablet contains 30 mg of active substance ambroxol hydrochloride; auxiliary substances: lactose monohydrate 84 mg, microcrystalline cellulose 30 mg, sodium carboxymethyl starch (type A) 10 mg, povidone (K-30) 5 mg, magnesium stearate 1 mg.

Description:White or almost white flat round tablets with bevel, with a risk on one side and engraved on E 231 - on the other side, without or almost no smell.

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 (first trimester).

Intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption (the preparation contains lactose monohydrate).

This dosage form is not intended for use in children under 5 years of age (see section "route of administration and dose").

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:

Tablets should be taken orally, after eating and washed down with plenty of liquid. Abundant fluid intake helps to liquefy mucus when treated with ambroxol.

Adults and children over 12 years of age: the usual daily dose in the first 2-3 days of treatment: 1 tablet 3 times a day, and on the following days - 1 tablet 2 times a day or 1/2 tablet 3 times a day. In severe cases, the dose is not reduced throughout the course of treatment.

Children under the age of 5 are recommended to take Halixol syrup.

Children aged 5-12 years: 1/2 tablet 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. The following side effects can occur: weakness, headache, diarrhea, constipation, dry mouth and respiratory tract, rhinorrhea, dysuria, gastralgia, nausea, vomiting, exanthema, urticaria.

There have been reports of severe acute anaphylactic reactions, but their causal relationship with the use of ambroxol has not been established.

Overdose:

Symptoms: nausea, vomiting, diarrhea, indigestion.

Treatment: cause vomiting, then appoint a drink (milk or tea), the intake of fat-containing foods. 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:

Do not prescribe simultaneously 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.

Form release / dosage:Tablets 30 mg.

Packaging:

For 10 tablets in a PVC / alfolgi blister or PVC / PVDC / alfolgi; 2 blisters together with instructions for use are packed in cardboardpack.

In the case of packaging and packaging of the drug in Russia additionally indicated:

Packaging of the product after packaging or packaging at OOO SERDIKS, Russia:

For 10 tablets in a PVC / alfolgi blister or PVC / PVDC / alfolgi; 2 blisters together with instructions for use are packed in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C, in a place protected from light. 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 N016005 / 01

Date of registration:26.08.2009

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®)