Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
AMBROXOL HYDROCHLORIDE
Sanofi-Aventis Ireland Limited T/A SANOFI
R05CB; R05CB06
AMBROXOL HYDROCHLORIDE
20 milligram(s)
Lozenge
Product not subject to medical prescription
Mucolytics; ambroxol
Not marketed
2004-02-10
2 PACKAGE LEAFLE T: INFORMATION FOR THE USER LYSOPADOL® MINT 20 MG LOZENGES ambroxol hydrochloride RE AD ALL OF THIS LEAFLE T CARE FULLY BE FORE YOU S TART TAKING THIS ME DICINE BECAUS E 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 3 days. WHAT IS IN THIS LEAFLET : 1. What Lysopadol Mint is and what it is used for 2. What you need to know before you take Lysopadol Mint 3. How to take Lysopadol Mint 4. Possible side effects 5. How to store Lysopadol Mint 6. Contents of the pack and other information 1. WHAT LYSOPADOL MINT IS AND WHAT IT IS USE D FOR Lysopadol Mint contains the active substance ambroxol hydrochloride. The active substance is the part of the lozenges that gives the therapeutic effect you need. Lysopadol Mint has a local anaesthetic effect which relieves the pain in acute sore throat. Within 20 minutes, the main clinical study showed a positive onset of action in 73% of the patients. The duration of effect will last for at least 3 hours. Lysopadol Mint is used to: - relieve the pain in mild to moderate symptoms of acute sore throat 2. WHAT YOU NEE D TO KNOW BE FORE YOU TAKE LYSOPADOL MINT DO NOT TAKE LYSOPADOL MINT - If you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6). - WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Lysopadol Mint. - You should not use Lysopadol Mint for more than 3 days. If you still have symptoms after 3 days or if you have a high fever, please consult a doctor. - If you have been told by your doctor that you have an intolerance to some types of su Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 10 December 2020 CRN009QDN Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lysopadol Mint 20mg Lozenges 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One lozenge contains 20 mg of ambroxol hydrochloride. Excipient(s) with known effect: sorbitol (1.37 g per lozenge), lactose monohydrate (less than 1 mg per lozenge) (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lozenge Round, white tablet, both sides flat with bevelled edges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pain relief of mild to moderate symptoms of acute sore throat. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and children over 12 years of age: up to 6 lozenges to be sucked per day. Lysopadol Mint 20 mg Lozenges should not be used for more than 3 days. In case of persistent symptoms or high fever, the patient should consult a doctor. _Paediatric population_ Lysopadol Mint 20 mg Lozenges should not be used in children under 12 years of age. Method of administration Oromucosal use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated with the administration of ambroxol hydrochloride. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, ambroxol hydrochloride treatment should be discontinued immediately and medical advice should be sought. Dyspnoea may be observed in the context of an underlying disease e.g. swollen throat. Local allergic reactions (see section 4.8: angioneurotic oedema) may also cause dyspnoea. The local anaesthetic properties of ambroxol may contribute to an altered perception in the pharyngeal space (see section 4.8: oral and pharyngeal Διαβάστε το πλήρες έγγραφο