País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
dextromethorphan hydrobromide monohydrate, Quantity: 10.5 mg
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare
dextromethorphan hydrobromide monohydrate
Pastille
Excipient Ingredients: menthol; Acacia; saccharin sodium; white beeswax; betadex; quinoline yellow; sodium cyclamate; light liquid paraffin; maltitol solution; citric acid; Flavour
Oral
30, 10, 40, 20
(S2) Pharmacy Medicine
BISOLVON DRY Pastilles are used for the symptomatic treatment of dry, irritant, unproductive coughs and helps soothe the throat.
Visual Identification: Yellow, round pastilles with a citrus like flavour.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-11-03
BISOLVON ® DRY PASTILLES B i s o l v o n ® D r y P a s t i l l e s 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 are used for the treatment of dry, irritating coughs. Bisolvon Dry Pastilles contains the active ingredient dextromethorphan hydrobromide, a cough suppressant that acts on the cough centre in the brain to suppress a dry cough. 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 DO NOT USE BISOLVON DRY PASTILLES IF: YOU ARE ALLERGIC TO DEXTROMETHORPHAN HYDROBROMIDE (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 • DO NOT TAKE BISOLVON DRY PASTILLES IF 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 • DO NOT TAKE THIS MEDICINE IF YOU ARE TAKING, OR HAVE TAKEN IN THE PREVIOUS 14 DAYS A MONOAMINE OXIDASE INHIBITOR (MAOI) USED TO Leia o documento completo
bis-ccdsv5-piv10-25mar21 1 AUSTRALIAN PRODUCT INFORMATION – BISOLVON ® DRY (DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE) 1 NAME OF THE MEDICINE Dextromethorphan hydrobromide monohydrate 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 Bisolvon Dry Oral Liquid is a clear, colourless, syrupy liquid with an aroma of apricot and vanilla. Bisolvon Dry Pastille is a yellow, round pastilles with a honey lime flavour. 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. 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. bis-ccdsv5-piv10-25mar21 2 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 Oral Liquid (equivalent to 120 mg dextromethorphan hydrobromide). 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). Do not exceed 4 doses in a 24 hour period. BISOLVON DRY PASTILLES _ADULTS AND CHILDREN 12 YEARS AND OVER: _ Slowly Leia o documento completo