Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Dextromethorphan hydrobromide monohydrate 10.5mg
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Dextromethorphan hydrobromide monohydrate 10.5 mg
10.5 mg
Pastille
Active: Dextromethorphan hydrobromide monohydrate 10.5mg Excipient: Acacia Betadex Citric acid Limette flavour 18635/02 Honey Flavour 8366/001 Levomenthol Light liquid paraffin Maltitol Purified water Quinoline yellow Saccharin sodium Sodium cyclamate White beeswax
Restricted
Divi's Laboratories Limited
Bisolvon Dry Pastilles are used for the symptomatic treatment of dry, irritant, unproductive coughs.
Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al - 20 pastilles - 36 months from date of manufacture stored below 25°C
2015-02-23
BISOLVON®DRY PASTILLES ® 1 BISOLVON® DRY PASTILLES ACTIVE INGREDIENT: Dextromethorphan hydrobromide monohydrate CONSUMER MEDICINE INFORMATION (CMI) This leaflet provides important information about using Bisolvon Dry Pastilles. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS ABOUT USING BISOLVON DRY PASTILLES. WHERE TO FIND INFORMATION IN THIS LEAFLET: 1. Why am I using Bisolvon Dry Pastilles? 2. What should I know before I use Bisolvon Dry Pastilles? 3. What if I am taking other medicines? 4. How do I use Bisolvon Dry Pastilles? 5. What should I know while using Bisolvon Dry Pastilles? 6. Are there any side effects? 7. Product details 1. WHY AM I USING BISOLVON DRY PASTILLES? BISOLVON DRY PASTILLES CONTAINS THE ACTIVE INGREDIENT DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE. Bisolvon Dry Pastilles are a cough suppressant that acts on the cough centre in the brain to suppress a dry cough. BISOLVON DRY PASTILLES ARE USED FOR THE TREATMENT OF DRY, IRRITATING COUGHS. Bisolvon Dry Pastilles also helps soothe sore throats. Bisolvon Dry Pastilles does not have any pain-relieving (analgesic) properties. 2. WHAT SHOULD I KNOW BEFORE I USE BISOLVON DRY PASTILLES? WARNINGS This medicine can lead to dependence. Therefore, the treatment should be of short duration. DO NOT USE BISOLVON DRY PASTILLES IF: • You are allergic to dextromethorphan hydrobromide monohydrate (active ingredient), or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: o shortness of breath o wheezing or difficulty breathing o swelling of the face, lips, tongue or other parts of the body o rash, itching or hives on the skin • you have the following medical conditions: o asthma o a lung condition called chronic obstructive airways disease (COAD or COPD) o respiratory failure o pneumonia o shallow breathing (respiratory depression) o fructose intolerance o mastocytosis • you are taking, or have taken in the Belgenin tamamını okuyun
bisoldryliq-ccds- 05- ds 4-21jun21 Page 1 NEW ZEALAND DATA SHEET 1 BISOLVON DRY BISOLVON DRY Oral Liquid BISOLVON DRY Pastilles 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL of BISOLVON DRY Oral Liquid contains dextromethorphan hydrobromide monohydrate 10 mg. Excipients with known effect: methyl hydroxybenzoate, maltitol, saccharin sodium Each BISOLVON DRY Pastille contains dextromethorphan hydrobromide monohydrate 10.5 mg (equivalent to dextromethorphan hydrobromide anhydrous 10 mg). Excipients with known effect: maltitol, saccharin sodium For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM Oral solution BISOLVON DRY Oral Liquid is a clear, colourless, syrupy liquid with an aroma of apricot and vanilla. Pastille BISOLVON DRY Pastille is a yellow, round pastille with a honey lime flavor. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BISOLVON DRY Oral Liquid and BISOLVON DRY Pastilles are used for the symptomatic treatment of dry, irritant, unproductive coughs. BISOLVON DRY Pastilles also helps soothe the throat. bisoldryliq-ccds- 05- ds 4-21jun21 Page 2 4.2 DOSE AND METHOD OF ADMINISTRATION Bisolvon Dry Oral Liquid and Bisolvon Dry Pastilles are preparations for oral administration. The following dosage regimen is recommended: In the case of self treatment, the maximum duration of treatment is 5 days. BISOLVON DRY Oral Liquid: Adults and children 12 years and over: 5 – 15 mL of BISOLVON DRY Oral Liquid, every 4 – 6 hours when necessary. The maximum total daily dose is 60 mL of BISOLVON DRY (equivalent to 120 mg dextromethorphan hydrobromide monohydrate). Do not exceed 4 doses in a 24 hour period. Children 6 – 11 years: 2.5 – 7.5 mL of BISOLVON DRY Oral Liquid, every 4 – 6 hours when necessary. The maximum total daily dose is 30 mL of BISOLVON DRY Oral Liquid (equivalent to 60 mg of dextromethorphan hydrobromide monohydrate). Do not exceed 4 doses in a 24 hour period. BISOLVON DRY Pastilles: Adults and children 12 years and over: Slowly suck 1 - 3 pastill Belgenin tamamını okuyun