Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
AMBROXOL HYDROCHLORIDE
Sanofi-Aventis Ireland Limited T/A SANOFI
R02AD
AMBROXOL HYDROCHLORIDE
17.86 milligram(s)/millilitre
Oromucosal spray, solution
Product not subject to medical prescription
Anesthetics, local
Marketed
2014-02-14
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LYSOPADOL ® 17.86 MG/ML OROMUCOSAL SPRAY, 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 3 days. WHAT IS IN THIS LEAFLET 1. What Lysopadol Spray is and what it is used for 2. What you need to know before you take Lysopadol Spray 3. How to take Lysopadol Spray 4. Possible side effects 5. How to store Lysopadol Spray 6. Contents of the pack and other information 1. WHAT LYSOPADOL SPRAY IS AND WHAT IT IS USED FOR • Lysopadol Spray contains the active substance Ambroxol hydrochloride. The active substance is the part of the spray that gives the therapeutic effect you need. • Lysopadol Spray has a local anaesthetic effect which relieves the pain in acute sore throat. • Lysopadol Spray is used to relieve the pain in acute sore throat for adults and children over 12 years of age. • You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LYSOPADOL SPRAY DO NOT TAKE LYSOPADOL SPRAY 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 Spray. • You should not use Lysopadol Spray 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 liver or kidney problems, ask your doctor before using Lysopadol Spray. • Lysopad Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lysopadol 17.86 mg/ml oromucosal spray, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One actuation of the spray contains 2.5 mg of ambroxol hydrochloride. One ml of the spray contains 17.86 mg of ambroxol hydrochloride. Excipient(s) with known effect: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose (4 actuations) and very small amounts of propylene glycol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal spray, solution Clear and almost colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pain relief in acute sore throat for adults and children over 12 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and children over 12 years of age: one dose of 10 mg (4 actuations) to be sprayed into the back of the throat up to 6 times per day. Lysopadol 17.86 mg/ml Oromucosal Spray can be used for up to 3 days. In case of persistent symptoms or high fever, the patient should consult a doctor. _Paediatric population_ Lysopadol 17.86 mg/ml Oromucosal Spray should not be used in children under 12 years of age (see section 4.4). Method of administration Oromucosal use Prior to use, the pump should be actuated 5 times so that an even spray mist is released. After not having used the spray for a long time, the pump should be actuated once before applying the product again. For application the spray bottle should be used in an upright position with the nozzle targeted at the back of the throat whilst pushing down the pump head completely. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance (ambroxol) or to any of the excipients listed in section 6.1. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Baca dokumen lengkap