Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
AMBROXOL HYDROCHLORIDE
Teva Pharma B.V.
R05CB06
AMBROXOL HYDROCHLORIDE
3 Mg/Ml
Oral Solution
Product not subject to medical prescription
ambroxol
Not Marketed
2013-05-03
1 PACKAGE LEAFLET: INFORMATION FOR THE USER AMBROBENE 3 MG/ML ORAL SOLUTION Ambroxol hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 5 days (within 3 days in children aged less than 6 years). WHAT IS IN THIS LEAFLET: 1. What Ambrobene 3 mg/ml Oral Solution is and what it is used for 2. What you need to know before you take Ambrobene 3 mg/ml Oral Solution 3. How to take Ambrobene 3 mg/ml Oral Solution 4. Possible side effects 5. How to store Ambrobene 3 mg/ml Oral Solution 6. Contents of the pack and other information 1. WHAT AMBROBENE 3 MG/ML ORAL SOLUTION IS AND WHAT IT IS USED FOR Ambrobene 3 mg/ml Oral Solution contains the active ingredient ambroxol hydrochloride. This belongs to a group of medicines called mucolytics that help clear airways from mucus. Ambrobene 3 mg/ml Oral Solution is used to treat airway conditions that require the elimination of mucus (phlegm) in adults and children older than 2 years of age. It works by making mucus thinner so that it can be cleared more easily. You must talk to a doctor if you do not feel better or if you feel worse after 5 days (within 3 days in children aged less than 6 years). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMBROBENE 3 MG/ML ORAL SOLUTION DO NOT TAKE AMBROBENE 3 MG/ML ORAL SOLUTION: - If you are allergic to ambroxol hydrochloride or any other ingredients of this medicine (listed in section 6). - Children up to 2 years. - If you have rare hereditary problems of fructose intolerance. WARNINGS AND PRECAUTIONS Talk to your doc Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ambrobene 3 mg/ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains: 3 mg of ambroxol hydrochloride. Excipient(s) with known effect: Sorbitol liquid (E420): 245 mg of sorbitol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. Clear, colourless oral solution with raspberry odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A mucolytic therapy for the treatment of airway diseases associated with abnormal mucous secretion and transport disturbances affecting mucous secretion and clearance in adults and children older than 2 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The following dosages are recommended for Ambrobene 3 mg/ml Oral Solution (5 ml dose = one syringe): _PAEDIATRIC POPULATION:_ Children under 2 years: Ambrobene is contraindicated. Children from 2 to 5 years: Take 2.5 ml (half a syringe) of Ambrobene 3 mg/ml 3 times a day (every 8 hours) (equivalent to 22.5 mg of ambroxol hydrochloride per day). Children from 6 to 12 years: Take 5 ml (one syringe) of Ambrobene 3 mg/ml 2 to 3 times a day (every 12 or 8 hours) (equivalent to 30-45 mg of ambroxol hydrochloride per day). _ADULTS AND CHILDREN OVER 12 YEARS:_ Typically, during the first 2 to 3 days 10 ml (two syringes) of Ambrobene 3 mg/ml should be taken 3 times daily (every 8 hours) (corresponding to 90 mg of ambroxol hydrochloride per day). After that, take 10 ml (two syringes) of Ambrobene 3 mg/ml twice a day (every 12 hours) (equivalent to 60 mg ambroxol hydrochloride per day). At the dosage for adults and children over 12 years, an increased effectiveness is possible with the dosage of 10 ml 6 mg/ml Ambrobene two times a day (every 12 hours) (corresponding to 120 mg of ambroxol hydrochloride per day). H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Læs hele dokumentet