দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Flurbiprofen
Rowex Ltd
R02AX; R02AX01
Flurbiprofen
8.75 milligram(s)
Lozenge
Product not subject to medical prescription
Other throat preparations; flurbiprofen
Not marketed
2016-10-28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLURSIL RELIEF SUGAR FREE 8.75MG LOZENGES Flurbiprofen_ _ 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 3 days. WHAT IS IN THIS LEAFLET 1. What Flursil Relief Sugar Free is and what it is used for 2. What you need to know before you take Flursil Relief Sugar Free 3. How to take Flursil Relief Sugar Free 4. Possible side effects 5. How to store Flursil Relief Sugar Free 6. Contents of the pack and other information 1. WHAT FLURSIL RELIEF SUGAR FREE IS AND WHAT IT IS USED FOR Flursil Relief Sugar Free contains flurbiprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain, swelling, and high temperature. Flursil Relief Sugar Free lozenges are used for the short-term relief of symptoms of sore throat such as throat pain and soreness in adults and children 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 TAKE FLURSIL RELIEF SUGAR FREE DO NOT TAKE FLURSIL RELIEF SUGAR FREE IF YOU: are allergic to flurbiprofen or to any of the other ingredients of this medicine (listed in section 6) currently have (or have had two or more episodes of) a stomach ulcer, intestinal ulcers, or gastrointestinal bleeding have ever had asthma, unexpected wheezing or shortness of breath, a runny nose, facial swelling or itchy rash (hives) after taking acetylsalicy সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 17 November 2019 CRN0093VH Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flursil Relief Sugar Free 8.75 mg lozenges 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 8.75 mg Flurbiprofen. Excipient(s) with known effect Isomalt 2160 mg/lozenge Maltitol 383 mg/lozenge Butylated hydroxyanisole (E320) 0.013 mg/lozenge For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lozenge Round, orange lozenge with typical line marking and without debossment, orange flavour. Diameter: Approximately 19 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flursil Relief Sugar Free 8.75 mg lozenges are indicated for the short term symptomatic relief of sore throat in adults and children over the age of 12 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults, the elderly and children 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. _Pediatric population_ 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. _Hepatic impairment_ 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). _Renal impairment_ 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 Health Products Regulatory Authority 17 November 2019 CRN0093VH Page 2 of 10 For oromucosal administration and short-term use only. As with all lozenges, to avoid local irritation, Flursil Relief Sugar Free should be moved around সম্পূর্ণ নথি পড়ুন