for medical use of the preparation
Active substance: Ambroxol;
1 tablet contains 75 mg of Ambroxol Hydrochloride;
Other ingredients: Silicacolloidal anhydrous, Hypromellose, microcrystalline cellulose, magnesium stearate.
Medicine form: Sustained Release Tablets.
White, circular, biconvex tablets, smooth on both sides.
Name and address of manufacturer:
“KUSUM PHARM” LTD.
54, Skryabina Str., Sumy, 40030, Ukraine.
Medicines, which are used in cough and colds. Mucolytics. Code ATC R05C B06.
Ambroxol increases the secretion of mucus in respiratory tract, 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. A number of cytokines, mononuclears and polymorphic cells related to the tissue is reduced under an influence of the preparation.
Ambroxol absorption is quick and almost complete, with a linear dependence in therapeutic dosage range. Maximal plasma levels are reached in 6.5±2.2 hours. Ambroxol bioavailability is 95%. In plasma in therapeutic diapason approximately 90% of the preparation is protein bound with proteins.
In oral administration Ambroxol distribution from the blood into tissues is quick and with a high concentration of active substance in lungs.
While taking per oral approximately 30% of the preparation are excreted with faeces. Clinical studies showed that CYP3A4 is a dominant enzyme responsible for Ambroxol metabolism. Ambroxol is predominantly metabolized in liver via conjugation.
Half-life from plasma is 10 hours. Total clearance is within the limits of 660 ml/min, kidney clearance is 8% of total clearance.
Any evidence of age and sex influence on Ambroxol pharmacokinetics in clinically meaningful limits was not found, therefore, any conclusion concerning dosage adjustment was not made.
Secretolytic therapy in acute and chronic diseases of respiratory tract associated with bronchial secretion disorders and reducing of mucus evacuation.
Hypersensitivity to any component of the preparation. Gastric and duodenal ulcer, convulsions of any etiology. I trimester of pregnancy and lactation period. Children age.
Appropriate safety precautions:
It is not recommended to combine this preparation with antitussive medicines, which obstruct sputum excretion.
It is administered with caution in hepatic and renal insufficiency.
Pregnancy and lactation:
Ambroxol penetrates through placental barrier.
It is not recommended to use this preparation during I trimester of pregnancy. During II and III trimester of pregnancy Abrol® SR is administered only when the expected benefit to the mother outweighs the potential risk to the foetus.
Ambroxol penetrates into breast milk, therefore, it is not recommended to use this preparation during lactation. Nevertheless, a harmful influence on sucking babies is not expected.
Influence on velocity rate while driving a car or operating other machines:
It does not influence.
It is not used.
Administration and Dosage:
For adults it is administered 1 tablet per day orally, in the morning and in the evening, after meal.
The duration of the treatment course is 14 days. It is necessary to consult a doctor if the symptoms of disease last more than 14 days and/or they become more severe regardless of Abrol® SR use.
As of nowthere are no reports of overdose symptoms.
In case of overdose symptoms occurrence in significant exceeding of therapeutical dose a symptomatic treatment is necessary.
As a rule, this preparation is well tolerated by patients.
Gastrointestinal tract: heartburn, dyspepsia, nausea, vomiting, diarrhea.
Immune system, skin and subcutaneous tissue: rash, urticaria, angioneurotic edema, anaphylactic reactions (including anaphylactic shock) and allergic reactions.
If skin or mucous tunic lesions progress, then it is necessary to discontinue immediately the preparation use and consult a doctor.
Weakness, headache, dry mouth and respiratory tract, rhinorrhea and dysuria sometimes can be observed.
Very rare – severe skin lesions, such as Stevens-Johnson’s syndrome and Lyell's syndrome. Generally, it may be a result of the severity of the treatment course of underlying disease or simultaneous use of medicines.
Drugs interaction and other types of interaction:
Due to Ambroxol use the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretion and sputum is increased.
There are no reports on clinical interactions with other drugs.
Storeat a temperature not more than 25°С in a dry, protected from light place.
Keep it out of reach of children.
10 tablets are in a blister; 1 or 2 blisters are in a carton pack.
Conditions of supply: