SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nicorette invisipatch 25 mg/16 h transdermal patch Nicorette invisipatch 15 mg/16 h transdermal patch Nicorette invisipatch 10 mg/16 h transdermal patch 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch contains nicotine 1.75 mg/cm2. Nicorette invisipatch 25 mg/16 h, of 22.5 cm2 size contains nicotine 39.37 mg and releases nicotine 25 mg /16 hours Nicorette invisipatch 15 mg/16 h, of 13.5 cm2 size contains nicotine 23.62 mg and releases nicotine 15 mg /16 hours Nicorette invisipatch 10 mg/16 h, of 9.0 cm2 size contains nicotine 15.75 mg and releases nicotine 10 mg /16 hours For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transdermal patch Beige, semi-transparent, rectangular patch with rounded edges and light-brown “Nicorette” printing, is placed on an easily removable layer coated with aluminium and silicon and is formed by nicotine layer and adhesive acrylate layer. 4. CLINICAL PARTICULARS 4.1. Therapeutic indication Nicorette invisipatch is to be used for the treatment of tobacco dependence in adults by relief of nicotine withdrawal symptoms, including cravings, during a quit attempt. Permanent cessation of tobacco use is the eventual objective. Nicorette invisipatch is indicated in adults. Nicorette invisipatch should preferably be used in conjunction with a behavioral support program. 4.2. Posology and method of administration Posology Subjects should stop smoking completely during the course of treatment with Nicorette invisipatch. Administration of nicotine should be stopped immediately if any symptoms of overdose listed in Section 4.9 occur. Professional advice and support usually improve the success rate. 1/12 Treatment with Nicorette invisipatch simulates variation of plasma nicotine level observed in smokers without nicotine intake during sleep. Nicotine released from Nicorette patches that are used only during the active part of a day (during 16 hours), does not cause sleep disorders that are observed when nicotine is applied during sleep. Monotherapy Adults Treatment with Nicorette invisipatch is usually 12 weeks, 8 weeks treatment with a sufficient therapeutic dose, followed by 4 weeks tapering. Smokers with high nicotine dependence (Fagerström score of nicotine dependence 6 or 20 cigarettes a day) are recommended to start the treatment with Nicorette invisipatch 25 mg/16 h, one patch a day (Step 1 in Table 1) for 8 weeks. After 8 weeks, the nicotine dose should be decreased gradually. Therefore, Nicorette invisipatch 15 mg/16 h should be used for 2 weeks, one patch a day (Step 2 in Table 1) followed by Nicorette invisipatch 10 mg/16 h used for 2 weeks as well, one patch a day (Step 3 in Table 1). Smokers with lower nicotine dependence (Fagerström score of nicotine dependence < 6 or ≤ 20 cigarettes a day) are recommended to start their treatment with Nicorette invisipatch 15 mg/16 h, one patch a day (step 1 in Table 2) for 8 weeks. After 8 weeks, the nicotine dose should be decreased gradually. Therefore, Nicorette invisipatch 10 mg/16 h should be used for 4 weeks, one patch a day (Step 2 in Table 2). Using patches longer than 6 months is generally not recommended. Some ex-smokers may need treatment with the patch longer to avoid returning to smoking. Table 1) Dosage scheme in smokers with high nicotine dependence Dosage Treatment period Step 1 Nicorette invisipatch 25 mg/16 h one patch a day first 8 weeks – initial phase Step 2 Nicorette invisipatch 15 mg/16 h one patch a day following 2 weeks Step 3 Nicorette invisipatch 10 mg/16 h one patch a day last 2 weeks Table 2) Dosage scheme in smokers with lower nicotine dependence Dosage Treatment period Step 1 Nicorette invisipatch 15 mg/16 h one patch a day first 8 weeks – initial phase Step 2 Nicorette invisipatch 10 mg/16 h one patch a day following 4 weeks Combination therapy Smokers who experience `breakthrough' cravings with single nicotine replacement therapy (NRT) or those who have failed with single NRT treatment, can use Nicorette invisipatches in combination with an oromucosal NRT product for fast relief of cravings. The oromucosal format to consider in combination with the Nicorette invisipatches are [to be completed nationally depending on local product names and licences granted amongst: the Nicorette 2mg gums (any flavour) or Nicorette 1mg/spray mouthspray]. 2/12 The user needs to also refer to the product information of the chosen flexible format. Smokers should stop smoking completely during the course of treatment. For combination therapy use of only one flexible format over a 24h period is recommended. Recommended use of transdermal patch in combination with chewing gum 2mg / oromucosal spray 1mg/spray in tabular form: High level of dependence: Smokers with high nicotine dependence (Fagerström score of nicotine dependence 6 or 20 cigarettes a day) who experience `breakthrough' cravings or those who have failed with single NRT treatment Dose Time 2mg Gums Oromucosal spray 1mg/spray period Step 1 1 patch First 8 As needed but not more than 16 As needed but not more than 32mg 25mg/16h weeks gums a day. a day (2 sprays per hour over 16h). Usual dose is 5-6 gums per day Start reducing from week 7. Step 2 1 patch Next 2 As needed but not more than 16 As needed but not more than 32mg 15mg/16h weeks gums a day. a day (2 sprays per hour over 16h). Continue reducing the number of spray per day. By the end of week 9, users should be using half the average of sprays per day that was used until week 6. Step 3 1 patch Last 2 As needed but not more than 16 Continue reducing the number of 10mg/16h weeks gums a day. spray per day so users are not using more than 4 sprays per day during week 12. When users have reduced to 2-4 sprays per day, oromucosal spray should be discontinued. Do not use more than 32 mg a day (2 sprays per hour over 16h). Beyond None After If needed but reduce the If needed but continue reducing the Step 3 Week 12 number of gums. Treatment number of spray per day. When should be stopped when the users have reduced to 2-4 sprays dose is reduced to 1-2 chewing per day, oromucosal spray should gums per day. be discontinued. Do not take more than 16 gums Do not use more than 32 mg a day a day. (2 sprays per hour over 16h). Up to maximum 12 months Up to maximum 6 months Low level of dependence: Smokers with lower nicotine dependence (Fagerström score of nicotine dependence < 6 or ≤ 20 cigarettes a day) who experience `breakthrough' cravings or those who have failed with single NRT treatment Dose Time 2mg Gums Oromucosal spray 1mg/spray 3/12 period Step 1 1 patch First 8 As needed but not more than 16 As needed but not more than 32 mg 15mg/16h weeks gums a day. a day (2 sprays per hour over 16h). Usual dose is 5-6 gums per day Start reducing from week 7. Step 2 1 patch Last 4 As needed but not more than 16 Continue reducing the number of 10mg/16h weeks gums a day. spray per day. By the end of week 9, users should be using half the average of sprays per day that was used until week 6. Users should not be using more than 4 sprays per day during week 12. When users have reduced to 2-4 sprays per day, oromucosal spray should be discontinued. Do not use more than 32mg a day (2 sprays per hour over 16h). Beyond None After If needed but reduce the If needed but continue reducing the Step 2 Week 12 number of gums. Treatment number of spray per day. When should be stopped when the users have reduced to 2-4 sprays dose is reduced to 1-2 chewing per day, oromucosal spray should gums per day. be discontinued. Do not take more than 16 gums Do not use more than 32mg a day a day. (2 sprays per hour over 16h). Up to maximum 12 months Up to maximum 6 months Paediatric population The safety and efficacy of Nicorette invisipatch in children under 18 years of age, have not been established. No data are available. Method of administration: The patch is applied in the morning and taken off when going to bed, so that approximate 16 hour effect is ensured. The patch is applied on a clean, dry, hairless and intact area of skin (for example on the trunk, hip, upper arms or chest). These areas should be varied each day and the same site should not be used on consecutive days. 1. Wash your hands before applying a patch. 2. Cut open the pouch with scissors along the side, as indicated. 3. Remove one part of a silver aluminium layer as far as possible. Avoid touching the sticky surface of the patch with your fingers! 4. Firmly apply the patch by pressing the sticky side of the patch onto your skin and remove the silver aluminium layer. 5. Firmly press the patch onto the skin, with your fingers or palm. 6. Rub firmly round the edge to ensure that the patch sticks firmly. 7. If the patch comes off, replace with a new one. After removal, used patches should be disposed of safely. Do not use patches during night, i.e. not longer than 16 hours. 4.3 Contraindications 4/12 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.