Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Bromhexine HCl
DUOPHARMA (M) SDN. BHD.
Bromhexine HCl
1000 Tablets
DUOPHARMA (M) SDN. BHD.
_Consumer Medication Information Leaflet (RIMUP)_ 1 MUCOXIN TABLET 8MG Bromhexine hydrochloride (8mg) WHAT IS IN THE LEAFLET? 1. What MUCOXIN is used for 2. How MUCOXIN works 3. Before you use MUCOXIN 4. How to use MUCOXIN 5. While you are using it 6. Side effects 7. Storage and Disposal of MUCOXIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT MUCOXIN IS USED FOR MUCOXIN is used in conditions where there are a lot of thick secretions or phlegm in your air passages. HOW MUCOXIN WORKS MUCOXIN contains bromhexine hydrochloride as an active ingredient. Helps to clear the chest by thinning the phlegm in your air passages. If you are not sure whether you should start taking this medicine, talk to your doctor. - _ Before you start to use it_ Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breastfeeding. Tell your doctor if you have: - Liver problem - Kidney problem - Gastric ulcer - _ Taking other medicines_ Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without prescription from your pharmacy, supermarket or health food shop. avoid while taking this medicine. HOW TO USE MUCOXIN Follow all directions given to you by your doctor and pharmacist carefully. These directions may differ from the information contained in this leaflet. If you do not understand the instructions on the pack, ask your doctor or pharmacist for help. - _ How much to use_ Adult: Initially, take two tablets three times a day for first seven days. For maintenance, one tablet three times a day. Children over the age of three years: Take one tablet three times a day. BEFORE YOU USE MUCOXIN - _ When you must not take it_ Do not take this medicine if you have an allergy to: - bromhexine hydrochloride - any of the other ingredients listed at the end of this leaflet Do not take this medicine after the expiry date printed on Прочетете целия документ
[DUOPHARMA (M) SDN BHD] [Page 1/2] _ _ (Revision Date: 26.03.2019) MUCOXIN DESCRIPTION: MUCOXIN ELIXIR 4 MG/ ML: A clear, green syrup. MUCOXIN TABLET 8 MG: A round scored tablet, blue in colour, 7 mm diameter with marking ‘duo’ COMPOSITION: MUCOXIN ELIXIR 4 MG/ ML: Each 5 ml syrup contains Bromhexine Hydrochloride 4 mg. PRESERVATIVES: Methyl Paraben 0.1%; Propyl Paraben 0.033% MUCOXIN TABLET 8 MG: Each tablet contains Bromhexine Hydrochloride 8 mg. PHARMACODYNAMICS: Bromhexine hydrochloride is a mucolytic. It has been shown to enhance the transport of mucus by reducing its viscosity and by activating the ciliated epithelium (mucociliary clearance). Preclinical studies show that there is an increase in the amount of thin watery bronchial secretion. PHARMACOKINETICS: Enteric absorption of bromhexine in man is relatively rapid, with an absorption half-life of 0.4 hours. Peak blood levels are reached within approximately 1 hour after oral administration. Bromhexine undergoes extensive first-pass metabolism with at least ten metabolites identified. Food eaten before administration of bromhexine enhances bioavailability. Following oral administration, bromhexine shows dose-linearity in the dose range 8-32 mg. There is a high level of protein binding and a large distribution volume. Bromhexine accumulates in the lung rather than in the plasma. The dominant elimination half-life is 1 hour; the terminal elimination half-life is 13-40 hours. Following oral administration of 8 mg, the plasma levels fell after 8-12 hours to 1.5 ng/mL and 0.2 ng/mL, respectively. For the most part, bromhexine is excreted in the urine as metabolites that pass through the kidneys while only minor amounts of parent compound are found in unchanged form in the urine. After 24 hours and 5 days, 70 and 88% of the oral dose respectively is recovered in the urine, 4% is excreted with the faeces. Bromhexine does not accumulate, as the long terminal elimination half-life is not dominant. Steady state levels are reached after three days at the latest Прочетете целия документ