Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE
Noripharma Sdn. Bhd.
DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE
60 ml; 90 ml; 90 ml; 100 ml; 120 ml; 60 ml; 100 ml; 120 ml
Noripharma Sdn. Bhd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ BENATUSSIL PAEDIATRIC EXPECTORANT Diphenhydramine HCl /Ammonium Chloride 7mg/67.5mg per 5ml WHAT IS IN THIS LEAFLET? 1. What Benatussil Pediatric Expectorant is used for. 2. How Benatussil Pediatric Expectorant works. 3. Before use Benatussil Pediatric Expectorant 4. How to use Benatussil Pediatric Expectorant 5. While you are using it. 6. Side effects. 7. Storage and disposal of Benatussil Pediatric Expectorant 8. Product Description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. WHAT BENATUSSIL PEDIATRIC EXPECTORANT IS USED FOR It is used as an expectorant for control of cough due to cold or allergy. HOW BENATUSSIL PEDIATRIC EXPECTORANT WORKS Diphenhydramine hydrochloride is an antihistamine that suppresses the urge to cough and dries up secretions in the nose and chest. Ammonium chloride is an expectorant that helps loosen phlegm. BEFORE YOU USE BENATUSSIL PEDIATRIC EXPECTORANT _-_ _ _ _When you must not use it_ Do not use Benatussil Paediatric Expectorant if your child is allergic to Diphenhydramine Hydrochloride or Ammonium Chloride or any of the other ingredients listed at the end of the leaflet. Do not use Benatussil Paediatric Expectorant if your child is taking monoamine oxidase inhibitors (MAOI) (a treatment for depression). _-_ _ _ _Before you start to use it _ Before taking Benatussil Paediatric Expectorant you must tell your doctor or pharmacist if your child have, or have had, any of the medical conditions. If you are not sure if your child have, or have had, any of these conditions, you should raise those concerns with your doctor or pha r m aci st . _Taking other medicines _ Inform your doctor or pharmacist before taking Benatussil Pediatric Expectorant. Before using Benatussil Pediatric Expectorant, it is important to tell your doctor or pharmacist if your child is taking any other medicines, obtained with or without a doctor’s prescription. Benatussil Pediatric Expectorant may enhance alcohol and medicines used to help Đọc toàn bộ tài liệu
BENATUSSIL PAEDIATRIC EXPECTORANT COMPOSITION Each 5ml syrup contains : Diphenhydramine HCL 7.0mg Ammonium Chloride 67.5mg Methylparaben (as preservative) 9.0mg Propylparaben (as preservative) 0.1mg PRODUCT DESCRIPTION A clear, red 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 gastro-intestinal tract, though high first- pass metabolism appears to affect systematic availability. Peak plasma concentrations are achieved about 1 to 4 hours after administration by mouth. A mean peak plasma-diphenhydramine concentration of 110 ng per mL has been reported after administration of 50 mg four times daily by mouth. Diphenhydramine is widely distributed throughout the body including the CNS. It crosses the placenta and has been detected in breast milk. 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. Excretion is almost complete within 24 hours of administration. Ammonium chloride is absorbed from the gastro-intestinal tract. The ammonium ion is converted into urea in the liver; the anion thus liberated into the blood stream and extracellular fluid causes a metabolic acidosis and decreases the pH of the urine; this is followed 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: To be taken 4-6 hourly. Children 2-5 years : 5ml, not to exceed 40 ml in 24 hours. Children 6-12 years : 5-10 ml, not to exceed 60 ml in 24 hours. Children above 12 years : 10 - 20 ml, not to exceed 120 ml in 24 hours. ROUTE OF ADMINISTRATION Oral administration CONTRAINDICATIONS Hypersensitivity to antihistamines or Đọc toàn bộ tài liệu