Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Nicotine
PCO Manufacturing Ltd.
N07BA; N07BA01
Nicotine
2 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 ® 2 mg 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. Nicorette 2mg Gum can sometimes be used in combination with Nicorette Invisi 10mg and 15mg Patch for the treatment of tobacco dependence as part of a stop smoking programme. 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 are a non-smoker or are under 18 years of age. 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 Läs hela dokumentet
Health Products Regulatory Authority 17 December 2020 CRN00C1F2 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette 2mg Medicated Chewing-gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each piece of medicated chewing gum contains 2 mg nicotine as a resin complex. Excipient(s) 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, beige medicated chewing-gum 4 CLINICAL PARTICULARS As per PA0330/037/014 5 PHARMACOLOGICAL PROPERTIES As per PA0330/037/014 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Chewing gum base (contains Butylhydroxytoluene (E321)) Sorbitol (E420) Sodium carbonate Sodium bicarbonate Flavourings Polacrilin Glycerol Talc 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The she lf lif e e xpir y da t e of this pr oduc t sha l l be t h e da te s how n on thec onta i ne r a nd oute r p ac ka ge of the pr oduc t on t he mar ke t in the c ountr y of or i gin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 °C. Health Products Regulatory Authority 17 December 2020 CRN00C1F2 Page 2 of 2 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 Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/187/005 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 th October 2017 10 DATE OF REVISION OF THE TEXT December 2020 Läs hela dokumentet