Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Bromhexine HCl
HOVID BERHAD
Bromhexine HCl
120 ml; 60 ml; 60ml mL; 120ml mL
HOVID BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ Page 1 of 2 HOSOLVON ELIXIR 4 MG/ 5ML (SUGAR FREE) BROMHEXINE HYDROCHLORIDE 4 MG/ 5 ML WHAT IS IN THIS LEAFLET? 1. What Hosolvon is used for 2. How Hosolvon works 3. Before you use Hosolvon 4. How to use Hosolvon 5. While you are using Hosolvon 6. Side effects 7. Storage and Disposal of Hosolvon 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision WHAT HOSOLVON IS USED FOR Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport. HOW HOSOLVON WORKS This medicine contains bromhexine hydrochloride as the active ingredients. Bromhexine acts as an expectorant/ mucolytic agent. It increases sputum volume and reduces the viscosity of bronchial secretions in chronic bronchitis patients. Secondary to this effect, bromhexine also improves pulmonary function in bronchitis patients. Metabolite of bromhexine, ambroxol may also contribute to enhanced secretion from exocrine glands BEFORE YOU USE HOSOLVON _- When you must not use it _ _ _ Do not take this medicine if: • you are allergic to bromhexine, or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin Do not take this medicine after the expiry date printed on the pack or if the packaging is damaged. If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor. _- Before you start to use it _ _ _ Tell your doctor/pharmacist if: • you have allergies to any other medicines, foods, dyes or preservatives • you have gastric ulcer • you have asthma • you have liver problem • you have kidney problems • you are taking antibiotics • you are breastfeeding • you are pregnant, think you are pregnant, or plan to get pregnant. _- Taking o Les hele dokumentet
DESCRIPTION Clear, colourless, aniseed and menthol flavoured liquid. COMPOSITION Bromhexine hydrochloride 4 mg / 5 mL. PHARMACODYNAMICS Bromhexine is an expectorant/mucolytic agent. The drug is a benzylamine derivative (2-amino-3, 5-dibromo-N-cyclohexyl N-methylbenzylamine hydrochloride) and also a derivative of vasicine and adhatodic acid, alkaloids obtained from the plant Adhatoda vasica. Following oral administration, bromhexine has increased sputum volume and reduced the viscosity of bronchial secretions in chronic bronchitis patients. The drug has been reported to induce hydrolytic depolymerization of mucoprotein fibers and stimulate activity of the ciliated epithelium. An increase in lysosomal activity facilitated by bromhexine has been postulated. Improvements in pulmonary function in bronchitis patients appear secondary to easier expectoration. An effect of bromhexine on increasing sputum concentrations of various antibiotics (eg,oxytetracycline, erythromycin, ampicillin, amoxicillin) has also been reported. However, some of these effects (exocrine stimulation, increased sputum concentrations) have not been confirmed in some studies. It has been suggested that a metabolite of bromhexine, ambroxol, may contribute to enhanced secretion from exocrine glands during bromhexine administration. PHARMACOKINETICS • ABSORPTION Oral, well absorbed. Rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations occur after about 1 hour following oral administration. • METABOLISM Bromhexine undergoes extensive first-pass metabolism in the liver: Ambroxol is a metabolite of bromhexine. • DISTRIBUTION It is widely distributed to body tissues. Bromhexine is highly bound to plasma proteins. Bromhexine crosses the blood-brain barrier and small amounts cross the placenta. • EXCRETION Bromhexine is excreted primarily in the urine as metabolites. Only small amounts appear as unchanged drug. About 85 to 90% of a dose is excreted in the urine mainly as metabolites. Approximately 70% of an oral dose of brom Les hele dokumentet