Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Nicotine
PCO Manufacturing Ltd.
N07BA; N07BA01
Nicotine
4 milligram(s)
Medicated chewing-gum
Product not subject to medical prescription
Drugs used in nicotine dependence; nicotine
Authorised
2017-10-27
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER NICORETTE ® 4mg medicated chewing gum nicotine 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 have 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. WHAT IS IN THIS LEAFLET 1. What Nicorette Gum is and what it is used for 2. What you need to know before you use Nicorette Gum 3. How to use Nicorette Gum 4. Possible side effects 5. How to store Nicorette Gum 6. Contents of the pack and other information 1. WHAT NICORETTE GUM IS AND WHAT IT IS USED FOR Nicorette Gum is a nicotine replacement therapy (NRT). It is used to relieve withdrawal symptoms and reduce the cravings for nicotine that you get when you try to stop smoking, or when you are cutting down the number of cigarettes you smoke while trying to stop smoking. Nicorette Gum can also be used to relieve cravings and withdrawal symptoms when you cannot smoke, e.g. in smoke free areas such as on a plane or at the cinema. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NICORETTE GUM X DO NOT USE NICORETTE GUM: IF YOU ARE ALLERGIC to nicotine or any of the other ingredients of this medicine (listed in section 6). IF YOU ARE PREGNANT OR BREAST FEEDING, unless advised by your doctor. IF YOU DO NOT SMOKE IN CHILDREN ! WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR, NURSE OR PHARMACIST BEFORE USING NICORETTE GUM... IF YOU ARE IN HOSPITAL BECAUSE OF HEART DISEASE (including heart attack, disorders of heart rate or rhythm, or stroke). IF YOU HAVE HIGH BLOOD PRESSURE, BAD CIRCULATION. IF YOU HAVE PERSISTENT INDIGESTION OR PAINS IN THE CHEST. IF YOU HAVE A STOMACH ULCER, duodenal ulcer, inflammation of the stomac Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette 4mg Medicated Chewing-gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each piece of medicated chewing gum contains 4 mg nicotine as a resin complex. Excipients with known effect: Each piece contains Sorbitol (E420) and Butylhydroxytoluene (E321). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Medicated Chewing-gum _Product imported from the UK:_ A square, yellow medicated chewing-gum 4 CLINICAL PARTICULARS As per PA0823/049/004 5 PHARMACOLOGICAL PROPERTIES As per PA0823/049/004 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Chewing gum base (contains Butylhydroxytoluene (E321)) Sorbitol (E420) Sodium carbonate Quinoline yellow (E104) Flavourings Polacrilin Glycerol Talc 6.2 INCOMPATIBILITIES None known. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 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_ _ _ _1_ _8_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _5_ _6_ _5_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. 6.5 NATURE AND CONTENTS OF CONTAINER Blister packed strips each containing 15 pieces supplied in packs of 30 or 210 pieces. Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Przeczytaj cały dokument