Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
AMBROXOL HYDROCHLORIDE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
R05CB06
AMBROXOL HYDROCHLORIDE 30 mg/5ml
ORAL SOLUTION
AMBROXOL HYDROCHLORIDE 30 mg/5ml
OTC
COUGH AND COLD PREPARATIONS
Withdrawn
2015-05-14
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER ABROLIN 15 MG/5 ML ORAL SOLUTION ABROLIN 30 MG/5 ML ORAL SOLUTION Ambroxol hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has 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. WHAT IS IN THIS LEAFLET 1. What Abrolin is and what it is used for 2. What you need to know before you take Abrolin 3. How to use Abrolin 4. Possible side effects 5. How to store Abrolin 6. Contents of the pack and other information 1. WHAT ABROLIN IS AND WHAT IT IS USED FOR Abrolin contains the active ingredient ambroxol hydrochloride. This belongs to a group of medicines called mucolytics (cough and cold preparations) that help clear airways from mucus. Abrolin 15 mg/5 ml is used to treat wet (productive) cough in children from 6 to 12 years of age. Abrolin 30 mg/5 ml is used to treat wet (productive) cough in adults and adolescents over 12 years of age. Wet (productive) cough is associated with disorders of the lungs and bronchial tubes when excess mucus is produced. Abrolin works by making mucus thinner and loosens it, so that it can be coughed up more easily. You must talk to a doctor if you do not feel better or if you feel worse after 5 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ABROLIN DO NOT USE ABROLIN - if you are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6). - in children under six years of age. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Abrolin: - if you have or have had liver or kidney problems There Citiți documentul complet
1 SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 2 SUMMARY OF PRODUCT CHARACTERISTICS 3 1. NAME OF THE MEDICINAL PRODUCT Abrolin 15 mg/5 ml oral solution Abrolin 30 mg/5 ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Abrolin 15 mg/5 ml oral solution: One ml contains 3 mg ambroxol hydrochloride. Abrolin 30 mg/5 ml oral solution: One ml contains 6 mg ambroxol hydrochloride. Excipient with known effect: Each ml of Abrolin contains 0.35 g of sorbitol (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Colourless or pale yellow liquid, with odour of strawberry 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mucolytic therapy of productive cough in acute or chronic bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport. Abrolin 15 mg/5 ml oral solution is indicated in children from 6 to 12 years of age. Abrolin 30 mg/5 ml oral solution is indicated in adults and adolescents over 12 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The following dosages are recommended for Abrolin: _[Abrolin 15 mg/5 ml:]_ _Children from 6 to 12 years of age _ 5 ml oral solution (15 mg ambroxol hydrochloride) administered 2 to 3 times daily (equivalent to 30–45 mg ambroxol hydrochloride per day). _Children under 6 years of age _ Abrolin is contraindicated in children under 6 years of age (see section 4.3). _[Abrolin 30 mg/5 ml:]_ _Adults and adolescents over 12 _ _years of age_ 5 ml oral solution (30 mg ambroxol hydrochloride) administered 3 times daily (equivalent to 90 mg ambroxol hydrochloride per day) during the first 2 to 3 days. After that, 5 ml oral solution is administered twice daily (equivalent to 60 mg ambroxol hydrochloride per day). For adults, the dose may be increased up to 60 mg ambroxol hydrochloride (10 ml of Abrolin 30 mg/5ml) twice daily (equivalent to 120 mg ambroxol hydrochloride per day) if needed. 4 _Paediatric population _ _Children from 6 to 12 years of age _ Other Citiți documentul complet