国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Flurbiprofen
Reckitt Benckiser Ireland Ltd
R02AX01
Flurbiprofen
Lozenge
flurbiprofen
2022-07-08
PACKAGE LEAFLET: INFORMATION FOR THE USER STREPSILS INTENSIVE SUGAR-FREE 8.75 MG LOZENGES flurbiprofen 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 you 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 lozenges are and what they are used for 2 What you need to know before you take Strepsils Intensive lozenges 3 How to take Strepsils Intensive lozenges 4 Possible side effects 5 How to store Strepsils Intensive lozenges 6 Contents of the pack and other information 1. WHAT STREPSILS INTENSIVE LOZENGES ARE AND WHAT THEY ARE USED FOR Strepsils Intensive lozenges contains flurbiprofen. Flurbiprofen is a non-steroidal anti-inflammatory drug (NSAID) which has analgesic, antipyretic and anti-inflammatory properties. Flurbiprofen 8.75 mg lozenges are used for the short- term relief of symptoms of sore throat such as throat pain, soreness and swelling, and difficulty in swallowing in adults and adolescents over the age of 12 years. 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 USE STREPSILS INTENSIVE LOZENGES DO NOT TAKE THESE LOZENGES IF YOU: • are allergic (hypersensitive) to Flurbiprofen or to any of the other ingredients of this medicine (listed in section 6) • have ever had asthma, unexpected wheezing or shortness of breath, a runny nose, facial swelling or itchy rash (hives) after taking acetylsalicylic acid (aspirin) or any other NSAID medicine • currently have or have ever had two or more episodes of a 阅读完整的文件
Health Products Regulatory Authority 25 March 2024 CRN00DY17 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strepsils Intensive Sugar-Free 8.75 mg Lozenges 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One lozenge contains 8.75 mg of Flurbiprofen Excipients with known effect: Isomalt (E953) 2033.29 mg/lozenge Liquid Maltitol (E965) 509.31 mg/lozenge Fragrances containing allergens* * in the Orange Flavour For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lozenge A round, white to pale yellow lozenge of 19mm diameter with an icon intagliated on both sides of the lozenge. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Strepsils Intensive lozenges are indicated for the short term symptomatic relief of sore throat in adults and adolescents over the age of 12 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The lowest effective dose should be administered for the shortest duration necessary to control symptoms (see section 4.4). Adults and adolescents over the age of 12 years: One lozenge sucked/dissolved slowly in the mouth every 3-6 hours as required. Maximum 5 lozenges in a 24 hour period. It is recommended that this product should be used for a maximum of three days. Children: Not indicated for children under 12 years. Elderly: 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. Impaired hepatic: In patients with mild to moderate impairment of hepatic function no dose reduction is required. In patients with severe hepatic insufficiency flurbiprofen is contraindicated (see section 4.3). Impaired renal: In patients with mild to moderate impairment of renal function no dose reduction is required. In patients with severe renal insufficiency flurbiprofen is contraindicated (see section 4.3). Method of administration For oromucosal administration and short-term use only. As with all lozenges, to avoid local irritation, flurbiprofen 8. 阅读完整的文件