Ülke: Malta
Dil: İngilizce
Kaynak: Malta 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 3 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 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 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 (within 3 days in children aged less than 6 years). 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 and children from 2 years old. 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 ye Belgenin tamamını okuyun
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Broxivan 3 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of oral solution contains 3 mg ambroxol hydrochloride. Each 5 ml of oral solution contains 15 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 and children aged over 2 years old. 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 (30 mg of ambroxol hydrochloride), 3 times a day (every 8 hours), which means a daily maximum of 90 mg of ambroxol hydrochloride. _Paediatric population _ _Adolescents over 12 years old _ 10 ml (30 mg of ambroxol hydrochloride), 3 times a day (every 8 hours), which means a daily maximum of 90 mg of ambroxol hydrochloride. _Children from 6 to 12 years old _ 5 ml (15 mg of ambroxol hydrochloride), 2-3 times a day, which means a daily maximum of 45 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosage regimen can be reduced to 2 times a day every 12 hours. _Children from 2 to 5 years old _ 2.5 ml (7.5 mg of ambroxol hydrochloride), 3 times a day (every 8 hours), which means a daily maximum of 22.5 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosage regimen can be reduced to 2 times a day every 12 hours. In this population, a doctor should be consulted. Page 2 of 7 _Children under 2 years _ This medicine is contraindicated in children younger than 2 years. _Patients with renal or hepatic impairment _ In case of moder Belgenin tamamını okuyun