Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
NICOTINE
McNeil Healthcare (Ireland) Ltd
N07BA01
NICOTINE
25 mg / 16 Milligram
Transdermal Patch
Product not subject to medical prescription
Drugs used in nicotine dependence
Authorised
2008-09-05
PACKAGE LEAFLET: INFORMATION FOR THE USER NICORETTE INVISI EXTRA STRENGTH 25MG/16 HOURS TRANSDERMAL PATCH Nicotine A GUIDE FOR USERS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Invisi Patch is and what it is used for 2. What you need to know before you use Nicorette Invisi Patch 3. How to use Nicorette Invisi Patch 4. Possible side effects 5. How to store Nicorette Invisi Patch 6. Contents of the pack and other information 1. WHAT NICORETTE INVISI PATCH IS AND WHAT IT IS USED FOR Nicorette Invisi Patch 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. Nicorette ® Invisi 25mg Patch: Each patch releases 25 milligrams of nicotine, over 16 hours. When you stop smoking, your body misses the nicotine that you have been absorbing. You may experience unpleasant feelings and a strong desire to smoke (craving). This indicates that you were dependent on nicotine. When you apply a Nicorette Invisi Patch to the skin, nicotine is released and passes into your body through the skin. The nicotine released is sufficient to relieve the unpleasant nicotine withdrawal symptoms and your cravings to smoke. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NICORETTE INVISI PATCH X Do not use Nicorette Invisi Patch: • if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6). • if you are a non-smoker or are under 18 years of age. • if you are pregnant or breast-feeding. ! Warnings and Precautions Ta Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette Invisi Extra Strength 25mg/16 hours Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nicotine, 25mg released over 16 hours use. Each patch is 22.5cm 2 , containing 1.75mg nicotine / cm 2 . For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal Patch Beige semi-transparent patch consisting of pre-coated backing layer, nicotine source layer, a skin contact adhesive layer on a pre-coated, aluminized and siliconised release layer with “nicorette” printed on the top face of the patch. The patch is approximately 4 x 5cm (with rounded corners). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and the Elderly Experience with the treatment of nicotine dependence shows that success rates are improved if patients also receive support therapy and counseling. Nicorette Invisi Patch should not be used concurrently with any other nicotine products and patients must stop smoking completely when starting treatment. The patch should be applied to an intact area of the skin upon waking up in the morning and removed at bedtime. Patch treatment mimics the fluctuations of nicotine over the day in smokers, with no nicotine administration during sleep. Daytime nicotine patch treatment does not give the nicotine induced sleep disturbances seen with nicotine administration during sleep. Heavy smokers are recommended to start at Step 1 with the 25 mg/ 16 hours patch and use one patch daily for 8 weeks. Gradual weaning from the patch should then be initiated. One 15 mg/16 hours patch should be used daily for 2 weeks followed by one 10 mg/16 hours patch daily for 2 weeks. Light smokers are recommended to start at Step 2 (15 mg) for 8 weeks and decrease the dose to Step 3 (10 mg) for the final 4 weeks. H E A L T H Διαβάστε το πλήρες έγγραφο