Composition:
Active substance: Ambroxol;
1 tablet contains 30 mg of Ambroxol Hydrochloride;
Other ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.

Medicine form: Tablets. White, circular tablets with break-line on one side.

Pharmacotherapeutic group:
Mucolytics. Code ATC R05C B06.

Pharmacological properties: Ambroxol increases secretion of mucus in the respiratory tracts, enhances the secretion of pulmonary surfactant, and stimulates ciliary activity. It leads to improvement in mucus secretion and expectoration (mucociliary clearance). Activation of fluid secretion and increase in mucociliary clearance facilitates mucus expectoration and reduces cough.
All oral forms of Ambroxol are absorbed quickly and almost completely, with linear dependence in therapeutic guidelines. Maximal plasma levels are reached in 0.5-3 hours. In plasma in therapeutic diapason approximately 90% of the drug is protein bound with proteins.
In oral administration Ambroxol distribution from the blood into tissues is fast and full-blown with a high concentration of active substance in lungs.
Half-life from plasma is 7-12 hours; cumulation is not found. While taking per oral approximately 30% of the preparation is excreted with faeces. Generally, Ambroxol is metabolized in liver via conjugation. Total renal excretion is approximately 90%.

Indications:
Mucolytic activity in acute and chronic bronchopulmonary diseases associated with bronchial secretion disorders and weakening of mucus movement.

Contraindications:
Hypersensitivity to Ambroxol and other preparation components.

Special Precautions / Warnings:
Pregnancy and lactation:
It is not recommended to use this preparation during pregnancy, especially during the first trimester. Ambroxol penetrates into breast milk, therefore it is necessary to stop lactation while being treated with Abrol® medicine.

Influence on velocity rate while driving a car or operating other machines:
There is no data indicating negative influence on psychomotor reaction rate.

Children:
Ambroxol is not recommended in this dosage form for use in children under 12 years old.

Administration and Dosage:
For successful treatment it is recommended the following regimen of Abrol® preparation usage.
Adults and children over 12 years old: 1 tablet 3 times per a day.
Therapeutic effect can also be achieved with 2 tablets 2 times per a day.
Tablets should be taken after meals with some water. The duration of the treatment is from 4 to 14 days depending on treatment course.

Overdose:
As of now there is no available data regarding overdose in human. In case of therapeutic overdose it is necessary to give symptomatic treatment.

Side effects:
As a rule, Abrol® preparation is tolerated well by patients, but sometimes gastrointestinal adverse reactions such as nausea, vomiting, dyspepsia may occur. Allergic reactions like skin rash are rarely observed. Single case of acute anaphylactic reaction has been reported, but the connection with Ambroxol was not proved.

Drugs interaction:
Abrol® preparation administration in combination with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) causes occurrence of high antibiotic concentrations in lungs tissues.
There is no data concerning clinically significant undesirable interactions with other medicines. It is not recommended concurrent administration of Ambroxol with antitussive medications (for example, codeine-containing preparations for cough).

Shelf-life:
3 years.

Storage:
Store in a dry, protected from light place at a temperature not more 25°С.
Keep it out of reach of children.

Package:
10 tablets are in a blister; 2 blisters are in a pack.

Conditions of supply:
Without prescription.