Composition

Active substance:

Ambroxol Hydrochloride

Each Uncoated tablet contains Ambroxol Hydrochloride BP 30 mg;

Additional ingredients:

Colloidal silicon dioxide, Crosscarmellose sodium, Microcrystalline

cellulose, Magnesium stearate

Indications

Ambroxol is indicated for secretory therapy of acute and chronic bronchopulmonary

diseases, associated with bronchial secretion disturbance and abatement of mucus discharge.

Administration and Dosage

Adults and children over 12 years of age: 1 tablet 3 times a day.

Therapeutic effect can be achieved while taking 2 tablets 2 times a day.

Take tablets after meal with some water. The duration of treatment is 4-14 days depending

on symptoms.

Side effects

As a rule, patients tolerate Ambroxol well. But the following gastrointestinal adverse

reactions may occur: nausea, vomiting, dyspepsia; rarely there are Possible allergic

reactions, for example, skin rash.

Single cases of acute anaphylactic reaction may occur, but their connection with Ambroxol

was not proved.

Adverse Drug reaction*:

“Inform doctors about unexpected reactions after using drugs”

Drug Interactions

Ambroxol in combination with antibiotics (amoxicillin, cefuroxime, erythromycin,

doxycycline) leads to high antibiotic concentration in lungs tissues.

There are no data relatively clinically undesirable interactions with other medicines.

It is not recommended to combine Ambroxol with medicines with antitussive effect such as

codeine-contained agents for cough.

Precautions

Pregnancy and lactation

Preclinical and clinical studies after 28th week of pregnancy didn’t show the harmful effect

during it. But you should consult the doctor about usage of this preparation during

pregnancy, especially 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 data relatively negative influence of the preparation on reactions velocity in

driving motor transport and operating other machines.

Children

Ambroxol is contraindicated for use in children under 12 years

Contraindications

Ambroxol is contradicted in people who have shown hypersensivity to Ambroxol and other

components of tablets. Children age less than 12 years old.

Overdosage

There are no data relatively symptoms of overdose in human. In case of therapeutic

overdose it is necessary the symptomatic treatment.

Pharmaceutical Form

Uncoated Tablets

Pharmacotherapeutic group

Mucolytic Agent, ATC code R05CB06

Pharmacologic properties

Pharmacodynamics

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 mucosae. 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.

Pharmacokinetic properties

The absorption of all oral forms of Ambroxol goes fast and quite completely, with linear

dependence in therapeutic guidelines. The peak levels are reached 0.5-3 hours after the

dose. In plasma in therapeutic guidelines approximately 90% of the preparation binds with

proteins. While taking per oral the distribution from the blood into tissues goes fast and full blown,

with high concentration of acting substance in lungs. 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%.

Storage conditions

Store at below 30°C in dry place

Shelf-life

3 years.

Package

Mukex tablets are supplied in PVC blister pack with aluminium foil. Each blister contains

10 tablets and 2 such blisters are packed in a carton along with pack insert.

Manufacturer

Kusum Healthcare Pvt. Ltd.

Address

SP 289 (A), RIICO INDL. AREA, CHOPANKI, BHIWADI (Raj.), (INDIA).