País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
FLURBIPROFEN
Reckitt Benckiser Ireland Ltd
FLURBIPROFEN
8.75 Milligram
Granules
Product not subject to medical prescription
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER STREPSILS INTENSIVE MINT 8.75MG GRANULES FLURBIPROFEN 8.75MG READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take this medicine carefully to get the best results from it. ● Keep this leaflet. You may need to read it again. ● Ask your doctor or pharmacist if you need more information or advice. ● You must contact a doctor if your symptoms worsen or do not improve after 3 days. ● If any side effects get serious, or if you notice any side effects not listed, stop taking this medicine and tell your doctor or pharmacist. IN THIS LEAFLET 1 WHAT STREPSILS INTENSIVE MINT 8.75MG GRANULES ARE AND WHAT THEY ARE USED FOR 2 BEFORE YOU TAKE STREPSILS INTENSIVE MINT 8.75MG GRANULES 3 HOW TO TAKE STREPSILS INTENSIVE MINT 8.75MG GRANULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE STREPSILS INTENSIVE MINT 8.75MG GRANULES 6 FURTHER INFORMATION 1 WHAT STREPSILS INTENSIVE MINT 8.75MG GRANULES ARE AND WHAT THEY ARE USED FOR Strepsils Intensive Mint 8.75mg granules contain flurbiprofen. Flurbiprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing how the body responds to pain, swelling and high temperature. Strepsils Intensive Mint 8.75mg granules are used to relieve the symptoms of sore throats such as throat soreness, pain and swelling. 2 BEFORE YOU TAKE STREPSILS INTENSIVE MINT 8.75MG GRANULES DO NOT TAKE STREPSILS INTENSIVE MINT 8.75MG GRANULES IF YOU HAVE OR EVER HAVE SUFFERED FROM: ● allergic (hypersensitive) reactions to flurbiprofen or to any of the other ingredients (see Section 6) ● allergic Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strepsils Intensive Mint 8.75 mg Granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet with 850 mg granules contains 8.75 mg of flurbiprofen Excipient: 4.25 mg of aspartame/sachet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granule White to cream-coloured, free-flowing granule with a characteristic mint odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Strepsils Intensive Mint 8.75mg Granules are indicated for the short term symptomatic relief of sore throat. Strepsils Intensive Mint 8.75mg Granules are indicated in adults and children over the age 12 years 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of Administration: For oral use only. Indicated for adults and children over the age of 12 years: One sachet of granules to be dissolved in the mouth, then swallowed. Strepsils Intensive Mint 8.75mg Granules can be taken every 3-6 hours as required, up to a maximum of 5 sachets of granules in a 24 hour period. The product should not be used for more than 3 days. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). There are no specific requirements in relation to food and drink. PAEDIATRIC POPULATION The safety and efficacy of Strepsils Intensive Mint 8.75mg Granules in children under 12 years has not been established. ELDERLY POPULATION 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. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regular Llegiu el document complet