País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Nicotine
JNTL Consumer Health I (Ireland) Limited
N07BA; N07BA01
Nicotine
Oromucosal spray, solution
Drugs used in nicotine dependence; nicotine
Marketed
2017-07-14
QuickMist Cool Berry 1mg/spray oromucosal spray, solution Nicotine PACKAGE LEAFLET: INFORMATION FOR THE USER d e e f a b b c button spray nozzle Package leaflet: information for the user Nicorette QuickMist Cool Berry 1 mg/spray oromucosal spray, solution Nicotine Read all of this leaflet carefully before you start using 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. - Ask your pharmacist if you need more infor- mation 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 have not been able to stop smoking after 6 months of treatment with Nicorette QuickMist Cool Berry. What is in this leaflet 1. What Nicorette QuickMist Cool Berry is and what it is used for 2. What you need to know before you use Nicorette QuickMist Cool Berry 3. How to use Nicorette QuickMist Cool Berry 4. Possible side effects 5. How to store Nicorette QuickMist Cool Berry 6. Contents of the pack and other information 1 WHAT NICORETTE QUICKMIST COOL BERRY IS AND WHAT IT IS USED FOR Nicorette QuickMist Cool Berry is used to help you stop smoking when you want to quit or cut down smoking before stopping completely. This is a type of treatment called Nicotine Replace- ment Therapy (NRT). Nicorette QuickMist Cool Berry relieves nicotine withdrawal symptoms including cravings, symptoms you get when stopping smoking. When you suddenly stop providing nicotine from tobacco to your body, you get hit by different kinds of unpleasant feelings called withdrawal symptoms. By using Nicorette QuickMist Cool Berry you can prevent or reduce these unpleasant feelings and cravings for smoking. This is because you continue to provide a small amount of nicotine to your body for a short period of time. Nicorette QuickMist Cool Berry does not contain th Leer el documento completo
Health Products Regulatory Authority 21 December 2023 CRN00DGZZ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette QuickMist Cool Berry 1 mg/spray, oromucosal spray, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One spray delivers 1 mg nicotine in 0.07 ml solution.1 ml solution contains 13.6 mg nicotine. Excipient with known effect: Ethanol (less than 100 mg of ethanol/spray). Propylene glycol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal spray, solution A clear to weakly opalescent, colourless to yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicorette QuickMist Cool Berry is to be used for the treatment of tobacco dependence in adults by relief of nicotine withdrawal symptoms, including cravings, during a quit attempt or to cut down smoking before stopping completely. Permanent cessation of tobacco use is the final objective. Nicorette QuickMist Cool Berry should preferably be used in conjunction with a behavioral support program. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Behavioural therapy advice and support will normally improve the success rate. _Adults and Elderly _ Up to 4 sprays per hour may be used. Do not exceed 2 sprays per dosing episode and do not exceed 64 sprays (4 sprays per hour, over 16 hours) in any 24-hour period. _Abrupt Smoking Cessation_ For smokers willing and ready to stop smoking immediately. Subjects should stop smoking completely during the course of treatment with Nicorette QuickMist Cool Berry. The following chart lists the recommended usage schedule for the oromucosal spray during full treatment (Step I) and during tapering (Step II and Step III). STEP I: WEEKS 1-6 Use 1 or 2 sprays when cigarettes normally would have been smoked or if cravings emerge. If after a single spray cravings are not controlled within a few minutes, a second spray should be used. If 2 sprays are required, future doses may be delivered as 2 consecutive sprays. Most smokers will require 1-2 sprays e Leer el documento completo