Land: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
60 ml; 90 ml; 100 ml
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ COLDNIL DRY COUGH & CONGESTION RELIEF SYRUP Pseudoephedrine Hydrochloride/ Dextromethorphan Hydrobromide (30mg/10mg per 5ml) 1 WHAT IS IN THIS LEAFLET 1. What COLDNIL Dry Cough & Congestion Relief is used for 2. How COLDNIL Dry Cough & Congestion Relief works 3. Before you use COLDNIL Dry Cough & Congestion Relief 4. How to use COLDNIL Dry Cough & Congestion Relief 5. While you are using COLDNIL Dry Cough & Congestion Relief 6. Side effects 7. Storage and disposal 8. Product description 9. Manufactured by and Product Registration Holder 10. Date of revision 11. Serial number WHAT COLDNIL DRY COUGH & CONGESTION RELIEF IS USED FOR It is used for the relief of cough and nasal congestion associated with common cold, allergy and and other respiratory infections. HOW COLDNIL DRY COUGH & CONGESTION RELIEF WORKS Dextromethorphan Hydrobromide is a cough suppressant which acts centrally to raise the threshold for coughing. Pseudoephedrine Hydrochloride is used to relieve nose congestion by narrowing of the blood vessel in the nasal passages. BEFORE YOU USE COLDNIL DRY COUGH & CONGESTION RELIEF _-When you must not use it _ Tell your doctor before using COLDNIL Dry Cough & Congestion Relief if you have hypersensitivity to pseudoephedrine, dextromethorphan or to any of the excipients. _-Pregnancy and breastfeeding _ Tell your doctor or pharmacist if you are pregnant, planning to get pregnant or are breastfeeding. Use of pseudoephedrine during pregnancy is not recommended. Pseudoephedrine has been detected in human milk and thus use of pseudoephedrine should be avoided during breast feeding. It is not known whether dextromethorphan or its metabolites are excreted in breast milk and therefore use of this product during lactation should be avoided. _-Before you start to use it_ Use with caution if you: have severe heart disease have high blood pressure are taking medicines for antidepressant, e.g. MAOIs (monoamine oxidase inhibitors) or within 2 weeks from stoppi Lestu allt skjalið
Font: 6 COLDNIL DRY COUGH & CONGESTION RELIEF SYRUP NAME AND STRENGTH OF ACTIVE SUBSTANCES Each 5ml contains: Pseudoephedrine HCl ……………………..30mg Dextromethorphan HBr ……..…………….10mg Preservatives: Sodium Benzoate ………………………….0.1% w/v Potassium Sorbate …………………………0.1% w/v PRODUCT DESCRIPTION Reddish pink colour syrup with cherry flavour and raspberry flavour. PHARMACODYNAMICS Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta-adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion. Dextromethorphan is a cough suppressant. _ _ PHARMACOKINETICS Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract and is largely excreted in the urine unchanged. It has an elimination half-life of 5 to 8 hours but its urinary elimination and hence half-life is pH dependent. Pseudoephedrine is rapidly distributed throughout the body, its volume of distribution being 2 to 3 L/kg bodyweight. Dextromethorphan is well absorbed from the gastrointestinal tract, metabolized in the liver and excreted as both unchanged drug and demethylated metabolites. Dextromethorphan undergoes rapid and extensive first-pass metabolism in the liver after oral administration. Genetically controlled O-demethylation (CYD2D6) is the main determinant of dextromethorphan pharmacokinetics in human volunteers. It appears that there are distinct phenotypes for this oxidation process resulting in highly variable pharmacokinetics between subjects. Unmetabolised dextromethorphan, together with the three demethylated morphinan metabolites dextrorphan (also known as 3-hydroxy-N-methylmorphinan), 3-hydroxymorphinan and 3-methoxymorphinan have been identified as conjugated products in the urine. Dextrorphan, which also has antitussive action, is the main metabolite. In some indiv Lestu allt skjalið