Formulation:

Each Uncoated tablet contains:

Ambroxol Hydrochloride BP 30 mg

Description:

White, round, flat, beveled edge, uncoated tablet plain on one side & break line on other side.

Indications:

Used in the treatment of respiratory disorders associated with productive cough.

Dosage and Administration:

Adults and children > 12 years of age: One tablet three times a day.

It is best taken with meals.

Adverse Effects: Ambroxol Hydrochloride is generally well tolerated. Mild upper gastro-intestinal side effects (primarily pyrosis, dyspepsia, and

Mukex/PH/F

Mukex/PH/B

occasionally nausea, vomiting) have been reported, principally following parenteral administration. Allergic reactions have occurred rarely, primarily skin rashes. There have been extremely rare case reports of severe acute anaphylactic-type reactions but their relationship to ambroxol is uncertain. Some of these patients have also shown allergic reactions to other substances.

Interactions:

Ambroxol in combination with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) leads to high antibiotic concentration in lungs tissues.

There are no clinical data on the undesirable effects of interaction with other medicines.

It is not recommended to combine Ambroxol with medicines with antitussive effect such as codeine-containing agents for cough.

Warnings:

Ambroxol must be administered with caution to patients affected by peptic ulcer.

Precautions:

Pregnancy and lactation

Preclinical and clinical studies after 28th week of pregnancy did not show any harmful effect. But doctor should be consulted about

usage of this preparation during pregnancy, especially on the first trimester. Ambroxol penetrates into the breast milk, therefore you

should stop lactation while treatment.

Influence on reactions velocity in driving motor transport and operating other machines:

There are no on negative effects of Ambroxol on the ability to drive and use machine.

Overdose:

There are no data regarding symptoms of overdose in human. In case of therapeutic overdose, only supportive treatment is given.

Contraindications:

Ambroxol should not be used in patients known to be hypersensitive to ambroxol or other components of the formulation.

Pharmacokinetics:

The absorption of all oral forms of Ambroxol is fast and relatively complete, with linear dependence in therapeutic guidelines. The

peak levels are reached 0.5-3 hours after the dose. In plasma, approximately 90% of the preparation binds with proteins. Distribution

via oral route is fast and complete with high concentrations reaching the lung tissues. The effective half-life is 7-12 hours; cumulation

is not found. While taking peroral approximately 30% of the preparation egests with stool. Generally, ambroxol metabolized in liver

by conjugation. General renal excretion is approximately 90%.

Pharmacodynamics:

Pharmacotherapeutic group:

Mucolytics, ATC code:

R05CB06

Ambroxol is a product derived from bromhexine biotransformation. Pharmacologic investigations showed that ambroxol has a

higher bronchosecretolytic effect than the compound from which it originates.

It develops a dual activity, on the one side it improved the expectorate rheology with a hydration mechanism, which makes secretions

more fluid, helps expectoration, reduces cough and dyspnea, while on the other side it stimulates the production of surfactant from the

second grade pneumocytes, thus reducing the surface tension of the alveolar mucosa. It increases secretion of the respiratory tracts,

enhances the excretion of pulmonary surfactant and stimulates ciliary activity. It leads to improvement of mucus discharge and its

excretion (mucociliary clearance). Activation of fluid secretion and increasing of mucociliary clearance facilitate mucus discharge

and reduce cough.