Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
BENZYDAMINE HYDROCHLORIDE
PCO Manufacturing Ltd.
A01AD; A01AD02
BENZYDAMINE HYDROCHLORIDE
0.15 percent weight/volume
Oromucosal spray
Product not subject to medical prescription
Other agents for local oral treatment; benzydamine
Authorised
2017-03-01
PACKAGE LEAFLET: INFORMATION FOR THE USER DIFFLAM SPRAY 0.15% W/V, OROMUCOSAL SPRAY Benzydamine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You must talk to a doctor if you do not feel better or if you feel worse. The name of your medicine is Difflam spray 0.15% w/v, oromucosal spray, which will be called Difflam spray throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Difflam spray is and what it is used for 2. What you need to know before you use Difflam spray 3. How to use Difflam spray 4. Possible side effects 5. How to store Difflam spray 6. Contents of the pack and other information 1. WHAT DIFFLAM SPRAY IS AND WHAT IT IS USED FOR Difflam spray contains the active ingredient benzydamine, which belongs to a group of medicines called local analgesics and anti-inflammatories. Difflam spray is used along with other treatments to relieve painful inflammatory conditions of the mouth and throat. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DIFFLAM SPRAY Do not use Difflam spray: if you are allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. WARNINGS OR PRECAUTIONS Talk to your doctor or pharmacist before using Difflam spray. Try not to get Difflam spray in your eyes. If you do, wash them thoroughly with clean water. Stop using if the conditio Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Difflam Spray, 0.15% w/v, Oromucosal Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each puff (175 microlitres) contains 262.5 micrograms of benzydamine hydrochloride (0.15% w/v). Excipients: Each puff contains 0.17mg of Methyl parahydroxybenzoate (E218) and 14mg of Ethanol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal spray. _Product imported from the UK:_ Difflam Spray is a metered dose pump oromucosal spray solution. 4 CLINICAL PARTICULARS As per PA1332/017/003 5 PHARMACOLOGICAL PROPERTIES As per PA1332/017/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Glycerol Saccharin Sodium bicarbonate Ethanol Methyl parahydroxybenzoate (E218) Mouthwash flavour Polysorbate 20 Purified Water 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30°C. Do not refrigerate or freeze. Store in the original package. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _2_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _5_ _8_ _0_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Difflam spray is presented in a box containing a 30 ml plastic bottle with a metering valve spray pump. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHE Les hele dokumentet