Vietnam Product

Mukex Tablets

Mukex Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Ambroxol is indicated for secretory therapy of acute and chronic bronchopulmonary diseases, associated with bronchial secretion disturbance and abatement of mucus discharge.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

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"

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Ambroxol is contradicted in people who have shown hypersensivity to Ambroxol and other components of tablets. Children age less than 12 years old.

What to do if you accidentally take too much (overdose) of the medicine?

There are no data relatively symptoms of overdose in human. In case of therapeutic overdose it is necessary the symptomatic treatment.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store at below 30°C in dry place

Drug Description

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 and dosage.

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 and drug interactions.

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.

Warnings and precautions

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 old.

Overdosage and Contraindications

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.

Clinical pharmacology.

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).

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780