Land: Malta
Språk: engelsk
Kilde: Medicines Authority
AMBROXOL HYDROCHLORIDE
Medochemie Iberia S.A Rua Jose Maria Nicolau, no 6, 7oB, São Domingos de Benfica, Lisbon, Portugal
R05CB06
AMBROXOL HYDROCHLORIDE
ORAL SOLUTION
AMBROXOL HYDROCHLORIDE 6 milligram(s)/millilitre
OTC
COUGH AND COLD PREPARATIONS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-08-16
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER BROXIVAN 6 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 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. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. WHAT IS IN THIS LEAFLET 1. What Broxivan is and what it is used for 2. What you need to know before you take Broxivan 3. How to take Broxivan 4. Possible side effects 5. How to store Broxivan 6. Contents of the pack and other information 1. WHAT BROXIVAN IS AND WHAT IT IS USED FOR Ambroxol, the active ingredient of this medicine, belongs to a group of medicines called mucolytics, which reduces the viscosity of mucus, fluidizing it and facilitating its elimination. This medicine is indicated for mucous-dissolving treatment in diseases of the bronchi and the lungs with thick mucus, in adults. 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 BROXIVAN DO NOT TAKE BROXIVAN - If you are allergic to ambroxol hydrochloride or any Les hele dokumentet
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Broxivan 6 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of oral solution contains 6 mg ambroxol hydrochloride. Each 5 ml of oral solution contains 30 mg ambroxol hydrochloride. Excipients with known effect: benzoic acid. This medicine contains 0.51 mg benzoic acid in each ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Colourless to slightly yellowish, clear, vanilla and cherry flavoured liquid. 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, in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should not be exceeded for more than 5 days without the advice of a doctor. Posology _Adults _ 10 ml (60 mg of ambroxol hydrochloride), 2 times a day (every 12 hours), which means a daily maximum of 120 mg of ambroxol hydrochloride. Once the patient improves, the dose can be cut in half. _Paediatric population _ _Adolescents and children over 2 years old _ Broxivan 3 mg/ml oral solution is available for children and adolescents. _Children under 2 years _ This medicine is contraindicated in children younger than 2 years. _Patients with renal or hepatic impairment _ In case of moderate to severe renal/hepatic impairment the dosage of ambroxol hydrochloride should be adjusted (see sections 4.4). Method of administration Broxivan is for oral use. Broxivan can be taken with or without food. Page 2 of 6 To facilitate administration of the oral solution the package contains a volume-measuring device. The duration of treatment should not exceed 5 days without medical advice. In the case of acute respiratory conditions, medical advice should be sought if symptoms do not improve or get worse after 5 days of treatment. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in Les hele dokumentet