Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Flurbiprofen
Reckitt Benckiser Ireland Ltd
R02AX; R02AX01
Flurbiprofen
8.75 milligram(s)/dose
Oromucosal spray, solution
Product not subject to medical prescription
Other throat preparations; flurbiprofen
Marketed
2014-11-03
PACKAGE LEAFLET: INFORMATION FOR THE USER STREPSILS INTENSIVE CHERRY & MINT 8.75MG/DOSE OROMUCOSAL SPRAY Flurbiprofen For use in adults 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 3 days. WHAT IS IN THIS LEAFLET 1. What STREPSILS INTENSIVE CHERRY & MINT 8.75MG/DOSE OROMUCOSAL SPRAY is and what it is used for 2. What you need to know before you use STREPSILS INTENSIVE CHERRY & MINT 8.75MG/DOSE OROMUCOSAL SPRAY 3. How to use STREPSILS INTENSIVE CHERRY & MINT 8.75MG/DOSE OROMUCOSAL SPRAY 4. Possible side effects 5. How to store STREPSILS INTENSIVE CHERRY & MINT 8.75MG/DOSE OROMUCOSAL SPRAY 6. Contents of the pack and other information 1. WHAT STREPSILS INTENSIVE CHERRY & MINT 8.75MG/DOSE OROMUCOSAL SPRAY AND WHAT IT IS USED FOR? The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines called Non- Steroidal Anti-Inflammatory Drugs (NSAIDs), which work by changing how the body responds to pain, swelling and high temperature. Strepsils Intensive is used for the short-term relief of symptoms of sore throats such as throat soreness, pain, difficulty swallowing and swelling in adults aged 18 and over. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE STREPSILS INTENSIVE CHERRY & MINT 8.75MG/DOSE OROMUCOSAL SPRAY DO NOT USE STREPSILS INTENSIVE CHERRY & MINT 8.75 MG/DOSE OROMUCOSAL SPRAY IF YOU: • Are ALLERGIC to flurbiprofen, other NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs), acetylsalicylic acid or to any of the ingredients listed in section 6 • Have had a PREVIOUS Baca dokumen lengkapnya
Health Products Regulatory Authority 25 March 2024 CRN00DY17 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strepsils Intensive Cherry & Mint 8.75mg/dose Oromucosal Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One actuation contains 2.91 mg of Flurbiprofen, three actuations equal to one dose contains 8.75mg, corresponding to 16.2 mg/ml Flurbiprofen. Excipients with known effect: Methyl parahydroxybenzoate (E218) 1.181 mg/dose Propyl parahydroxybenzoate (E216) 0.2362 mg/dose Fragrances containing allergens (in Cherry flavour and Mint flavour) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal spray, solution Clear, colourless to slightly yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Strepsils Intensive Cherry & Mint 8.75mg/dose Oromucosal Spray is indicated for the short term symptomatic relief of acute sore throat in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY For short-term use only. Adults aged 18 years and over: One dose (3 actuations) administered to the back of the throat every 3‑6 hours as required, up to a maximum of 5 doses in a 24 hour period. Paediatric Population: The safety and efficacy of Strepsils Intensive Cherry & Mint 8.75mg/dose Oromucosal Spray in children or adolescents under 18 years has not yet been established. Elderly patients: A general dose recommendation cannot be given, since to date clinical experience is limited. The elderly are at increased risk of the serious consequences of adverse reactions. The lowest effective dose should be administered for the shortest duration necessary to control symptoms (see section 4.4). METHOD OF ADMINISTRATION For oromucosal administration Do not inhale whilst spraying. It is recommended that this product should be used for a maximum of three days. Health Products Regulatory Authority 25 March 2024 CRN00DY17 Page 2 of 9 Before first use, activate the pump by pointing the nozzle away from you and spraying a minimum of four times until a fine, consist Baca dokumen lengkapnya