מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Bromhexine HCl
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
Bromhexine HCl
60 ml; 60 ml; 90 ml; 90 ml; 100 ml; 100 ml; 120 ml; 120 ml
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ REXOM TM BROMHEXINE ELIXIR Bromhexine Hydrochloride (4mg/5ml) 1 WHAT IS IN THIS LEAFLET 1. What REXOM TM Bromhexine is used for 2. How REXOM TM Bromhexine works 3. Before you use REXOM TM Bromhexine 4. How to use REXOM TM Bromhexine 5. While you are using REXOM TM Bromhexine 6. Side effects 7. Storage and disposal of REXOM TM Bromhexine 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT REXOM TM BROMHEXINE IS USED FOR It is used to loosen the mucus, making it easier to cough up the mucus for airway diseases, accompanied by excessive mucus and impaired mucus clearance. HOW REXOM TM BROMHEXINE WORKS REXOM TM Bromhexine helps to clear the chest by thinning the mucus in your air passages. BEFORE YOU USE REXOM TM BROMHEXINE _-When you must not use it _ It should not be used if you had known to be hypersensitive to Bromhexine or other components of the formulation. _-Before you start to use it _ There will be an expected increase in the flow of secretions. Should be used with care in people with a history of ulcer in digestive tract and asthma. _Pregnancy and lactation_ Talk to you doctor before taking this medicine if you are pregnant, might become pregnant or are breastfeeding. Bromhexine should only be used if the maternal condition justifies the potential risk to the fetus or baby. _-Taking other medicines _ Inform your doctor or pharmacist before taking this medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. Some medicines and REXOM TM Bromhexine may interfere with each other. They may be affected by REXOM TM Bromhexine or may affect how well it works. It may increase the concentration of concurrently used antibiotics. HOW TO USE REXOM TM BROMHEXINE _-How much to use _ Always use REXOM TM Bromhexine exactly as your doctor has prescribed. You should check with your doctor or pharmacist if in doubt. The usual dose: Under 2 years: 1.25 ml 2 to קרא את המסמך השלם
REXOM TM BROMHEXINE ELIXIR 4MG/5ML NAME AND STRENGTH OF ACTIVE INGREDIENT(S) Each 5ml contains: Bromhexine HCl BP ...................................... 4 mg Preservative: Sodium Benzoate ........................................ 0.2% w/v PRODUCT DESCRIPTION Colourless liquid with strawberry flavour. PHARMACODYNAMICS Bromhexine is an expectorant/mucolytic agent. Following oral administration, Bromhexine has increased sputum volume and reduced the viscosity of bronchial secretions in chronic bronchitis patients. PHARMACOKINETICS Bromhexine HCl is rapidly absorbed from the gastrointestinal tract and undergoes extensive first-pass metabolism in the liver. It is widely distributed to body tissues. About 85 to 90% of a dose is excreted in the urine mainly as metabolites. Ambroxol is a metabolite of bromhexine. Peak plasma concentrations occur after about 1 hour following oral administration. INDICATIONS Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport. RECOMMENDED DOSE Under 2 years: 1.25 ml, 3 times a day 2 to 6 years: 2.5 ml, 3 times a day 6 to 12 years: 5 ml, 3 times a day ROUTE OF ADMINISTRATION Oral CONTRAINDICATIONS Bromhexine Elixir 4mg/5ml should not be used in patients known to be hypersensitive to Bromhexine or other components of the formulation. WARNING AND PRECAUTIONS Patients being treated with Bromhexine should be notified of an expected increase in the flow of secretions. Bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Very rare cases of chronically associated severe skin impairments such as Stevens Johnson Syndrome, Toxic Epidermal Necrolysis (TEN), Erythema Multiforme (EM) and Acute Generalized ExanthematousPustulosis (AGEP) have been reported. In most cases, these could be explained by the severity of the underlying disease or concomitant administration of another drug. In the early stages of such severe skin reactions, initiall קרא את המסמך השלם