Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
NICOTINE
McNeil Products Limited
N07BA01
NICOTINE
TRANSDERMAL PATCH
NICOTINE 10 milligram(s)
OTC
OTHER NERVOUS SYSTEM DRUGS
Authorised
2012-12-03
PRODUCT BRAND COMPONENT CODE VERSION DESIGN REPLACED COMP CODE MARKET DIELINE / TECH DRAWING REFERENCE COLOR ADDITIONAL INFORMATION 130x700 GB 6511558 6511721 Invisipatch Leaflet NICORETTE SPRUCE LKL-h 9 pt BLACK PMS 355 PDD McNeil, HBG, SWE June 9, 2017 12:06:42 Brand: Nicorette Product: Invisipatch leaflet Component code: 6511721 Version number: LKL-h Dimension: 130 x 700mm Text font: 9 pt INVISI PATCH NICOTINE TRANSDERMAL PATCH WHAT SHOULD YOU KNOW ABOUT NICORETTE ® INVISI 25 MG PATCH STEP 1 NICORETTE ® INVISI 15 MG PATCH STEP 2 NICORETTE ® INVISI 10 MG PATCH STEP 3 Please read this leaflet carefully before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again. If you think you are having side-effects, have any questions or are not sure about anything please ask your doctor, nurse or pharmacist. 1 WHAT THIS MEDICINE IS FOR NICORETTE ® invisi patch is a nicotine replacement therapy (NRT). It is used to relieve and /or prevent withdrawal symptoms and reduce the cravings you get when you try to stop smoking or when cutting down the number of cigarettes you smoke. Ideally you should always aim to stop smoking. You can use NICORETTE ® invisi patch to achieve this by using it to completely replace all your cigarettes. However, NICORETTE ® invisi patch can also be used in other ways, Q if you feel unable to stop smoking completely, or wish to increase the time to your next cigarette with the intention of cutting down the number of cigarettes you smoke, Q at those times when you can’t or do not want to smoke. For example, - where you don’t want to smoke and avoid harm to others e.g children or family - for prolonged periods (greater than 16 hours) where smoking cigarettes is not allowed e.g aeroplanes, work, social occasions It may also help increase your motivation to quit. When making a quit attempt a behavioural support programme will increase your chances of success. nicorette ® invisi 25 mg patch: Each patch releases 25 milli Lesen Sie das vollständige Dokument
Version No: 9.0 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette invisi 10 mg patch/ NicAssist Translucent 10 mg Patch. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _‘Each patch is 9 sq.cm, containing nicotine 1.75 mg/sq.cm, releasing a nominal 10 _ _mg of nicotine per 16 hours’. _ For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. Semi-transparent, beige, imprinted 9 cm 2 rectangular TTS with rounded corners. Centrally located on a rectangular, aluminized and siliconised release liner. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicorette Invisi Patch relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. _ _ Nicorette Invisi Patch is indicated in pregnant and lactating women making a quit attempt (see section 4.6). If possible, Nicorette Invisi Patch should be used in conjunction with a behavioural support programme. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. It is intended that the patch is worn through the waking hours (approximately 16 hours) being applied on waking and removed at bedtime. _SMOKING CESSATION _ _ADULTS (OVER 18 YEARS OF AGE)_ For best results, most smokers are recommended to start on 25 mg / 16 hours patch (Step 1) and use one patch daily for 8 weeks. Gradual weaning from the patch should then be initiated. One 15 mg/16 hours patch (Step 2) should be used daily for 2 weeks followed by one 10 mg/16 hours patch (Step 3) daily for 2 weeks. Version No: 9.0 Dose Duration Step 1 Nicorette invisi 25mg patch First 8 weeks Step 2 Nicorette invisi 15mg patch Next 2 weeks Step 3 Nicorette invisi 10mg patch Last 2 weeks Lighter smokers (i.e. those who smoke less than 10 cigarette Lesen Sie das vollständige Dokument