Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
NICOTINE
Novartis Consumer Health UK Limited
21mg Milligram
Transdermal Patch
2000-06-14
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Boots Nicotine Transdermal Patch 21 mg/24 hour 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch contains 52.5mg S (-) nicotine, average absorption rate 21mg in 24 hours. Drug releasing surface area – 30cm 2 . For excipients, see 6.1. 3 PHARMACEUTICAL FORM Transdermal Patch Transdermal therapeutic system, consisting of a round, flat, matrix-type self-adhesive yellowish-ochre coloured patch printed ‘CG EME’ on the patch surface. It is protected by a rectangular metallic release liner backing to be discarded before application. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of nicotine dependence, as an aid to smoking cessation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults Users should stop smoking completely during treatment with the Boots Nicotine Patch 21mg/24 Hour. For individuals smoking 20 cigarettes or more a day, it is recommended that treatment be started with Boots Nicotine Patches 21mg/24 Hour (step 1) daily, applied to a dry non-hairy area of the skin on the trunk or upper arm. Those smoking less than this are recommended to start with Boots Nicotine Patches 14mg/24 Hour (step 2). Sizes of 30cm 2 , 20cm 2 and 10cm 2 are available to permit gradual withdrawal of nicotine replacement, using treatment periods of 3-4 weeks for each size. The size of patch may be adjusted according to individual response, maintaining or increasing the dose if abstinence is not achieved or if withdrawal symptoms are experienced. Total treatment periods of more than 3 months and daily doses above 30cm 2 have not been evaluated. The treatment is designed to be used continuously for 3 months but not beyond. However, if abstinence is not achieved at the end of the 3 month treatment Read the complete document