COMPOSITION:
Each uncoated tablet contains: Ambroxol Hydrochloride BP ….. 30 mg
DESCRIPTION:
White, round, flat bevelled edged, uncoated tablet plain on one side & break line on other side.

INDICATIONS:
Mukex is indicated as secretory therapy for liquefaction of tenacious sputum in acute and chronic bronchopulmonary diseases, associated with difficult to expectorate, viscous and tenacious sputum and mucus.
RECOMMENDED DOSE:
Recommended treatment regimen with Mukex is as follows:
Adults and children over 12 years of age: 1 tablet 3 times a day
MODE OF ADMINISTRATION:
Therapeutic effect can also be achieved with 2 tablets 2 times a day.
Take tablets after meals with some water. The duration of treatment is 4 to14 days depending on symptoms.

UNDESIRABLE EFFECTS:
As a rule, Mukex is tolerated well, but sometimes some gastrointestinal adverse reactions such as nausea, vomiting, dyspepsia may occur. Allergic reactions, like skin rash are rare.
Single case of acute anaphylactic reaction has been reported but the connection with Mukex was not proved.

INTERACTIONS WITH OTHER MEDICAMENTS:
Mukex in combination with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) leads to high antibiotic concentration in lungs tissues.
There is no comparative data regarding clinically significant undesirable interactions with other medicines.
Mukex should not be recommended with antitussive medications (for example, codeine-containing preparations for cough).

WARNINGS AND PRECAUTIONS:
Pregnancy and lactation
It is not recommended to use of this preparation during pregnancy, especially the first trimester. Mukex is secreted in the breast milk, therefore you should stop lactation while being treated with Mukex.
Influence on alertness while driving and operating other machines
There are no data indicating negative influence on the response time while driving and operating other machines.
Children
Mukex is not recommended in this dosage form for use in children under 12 years old.

OVERDOSE AND TREATMENTS:
As of now there is no available data regarding overdose in human. In case of therapeutic overdose it is necessary to give symptomatic treatment.
CONTRAINDICATIONS:
Mukex is contradicted in people who are hypersensitive to Mukex and other components of tablets.

PHARMACOKINETICS:
All oral forms of Mukex are absorbed quickly and almost completely, with linear dependence in therapeutic guidelines. The peak levels are reached 0.5 to 3 hours after the oral administration. In plasma approximately 90% of the drug is protein bound with proteins. With oral administration the distribution from the blood into tissues is fast and volume of distribution is high. It achieves high concentration in lungs.
The effective half-life is 7-12 hours; accumulation is not found. While taking per oral approximately 30% of the preparation is excreted in stools. Generally, Mukex is metabolized in liver by conjugation. Approximately 90% of the drug is excreted in urine.

STORAGE CONDITION:
Store below 30°С.
SHELF LIFE:
3 years
DOSAGE FORMS AND PACKAGING AVAILABLE:
PVC blister of 10 tablets, 2 or 10 blisters in a carton.
NAME AND ADDRESS OF MANUFACTURER :
Kusum Healthcare Pvt. Ltd.
SP 289(A), RIICO Indl. Area,
Chopanki, Bhiwadi (Rajasthan), India
DATE OF REVISION OF PACKAGE INSERT:
Not Applicable MM Reg. No.: 1709AA 4708