Land: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE
Noripharma Sdn. Bhd.
DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE
100 ml; 90 ml; 60 ml; 120 ml; 60 ml; 90 ml; 100 ml; 120 ml
Noripharma Sdn. Bhd.
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ BENATUSSIL FORTE EXPECTORANT Diphenhydramine hydrochloride/Ammonium chloride (14mg/135mg per 5ml) What is in this leaflet? 1. What Benatussil Forte Expectorant is used for 2. How Benatussil Forte Expectorant works 3. Before you use Benatussil Forte Expectorant 4. How to use Benatussil Forte Expectorant 5. While you are using Benatussil Forte Expectorant 6. Side effects 7. Storage and Disposal of Benatussil Forte Expectorant 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT BENATUSSIL FORTE EXPECTORANT IS USED FOR It is used as an expectorant for control of cough due to cold or allergy HOW BENATUSSIL FORTE EXPECTORANT WORKS Diphenhydramine Hydrochloride is an antihistamine that works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects are caused by blocking another natural substance made by your body (acetylcholine). Ammonium Chloride is an expectorant that helps to liquefy and loosen stubborn phlegm in airways. BEFORE YOU USE BENATUSSIL FORTE EXPECTORANT _When you must not take it _ Do not take Benatussil Forte Expectorant • are allergic to any ingredients in this medicine. • not to be used in children less than 2 years of age. • to be used with caution and on doctor’s or pharmacist’s advice in children 2 to 6 years of age. _Before you start to take it _ Tell your doctor or pharmacist before using Benatussil Forte Expectorant if you: • are pregnant or plan to get pregnant. • are breast-feeding or plan to start breast-feeding. • have liver and/or kidney problems _ _ _Taking other medicines _ Tell your doctor or pharmacist if you are taking alcohol, tranquilizers, sedativehypnotics and CNS depressant which will increase CNS depression and MAO inhibitors which will increase anticholinergic effects. This includes any medicines which you have bought without a prescription. HOW TO USE BENATUSSIL FORTE EXPECTORANT - _How much to use_ Adul Lestu allt skjalið
BENATUSSIL FORTE EXPECTORANT COMPOSITION Each 5ml syrup contains: Diphenhydramine HCL 14.0mg Ammonium Chloride 135.0mg Methylparaben (as preservative) 10.0mg PRODUCT DESCRIPTION A brown colour liquid having raspberry flavour. PHARMACODYNAMICS The combination of Diphenhydramine Hydrochloride, an antihistamine and Ammonium Chloride, an expectorant, will provide rapid relief for cough which is associated with common cold influenza or allergic conditions. PHARMACOKINETICS Diphenhydramine hydrochloride is well absorbed from the gastrointestinal tract. Peak plasma concentrations are achieved about 1 to 4 hours after oral doses. Diphenhydramine is widely distributed throughout the body including the CNS. Diphenhydramine is highly bound to plasma proteins. Metabolism is extensive. Diphenhydramine is excreted mainly in the urine as metabolites; little is excreted as unchanged drug. The elimination half-life has been reported to range from 2.4 to 9.3 hours. Ammonium chloride is absorbed from the gastrointestinal tract. The ammonium ion is converted into urea in the liver, the anion thus liberated into the blood and extracellular fluid causes a metabolic acidosis and decreases the pH of the urine; this is followed by transient diuresis. INDICATION It is indicated as an expectorant for control of coughs due to colds or allergy. RECOMMENDED DOSAGE Unless otherwise prescribed by the physician Adults and children over 12 years: 5 to 10 ml every 4 or 6 hours (not to exceed 60 ml in 24 hours). Children 6 to 12 years: 2.5 to 5 ml every 4 to 6 hours (not to exceed 30 ml in 24 hours). Children 2 to 5 years: 2.5 ml every 4 to 6 hours (not to exceed 20 ml in 24 hours). Do not exceed the stated dose. ROUTE OF ADMINISTRATION Oral administration CONTRAINDICATIONS Hypersensitivity to antihistamines or to any of the ingredients and Patients who are receiving Monoamine Oxidase Inhibitors (MAOIs) therapy. WARNINGS AND PRECAUTIONS Benatussil Forte Expectorant may enhance the sedative effect of central depressants including alcohol, barbiturat Lestu allt skjalið