Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
NICOTINE
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
NICOTINE
7 mg/24 hours
Transdermal Patch
Product not subject to medical prescription
Authorised
0000-00-00
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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NiQuitin 7mg/24hrs transdermal patches 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 7 cm 2 transdermal patch contains 36 mg nicotine, equivalent to 5.1 mg/cm 2 of nicotine and delivers 7 mg over 24 hours. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. Each patch is rectangular and is comprised of an outer matt pinkish tan-coloured layer, a middle silver layer and an outer clear layer which is removed prior to use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NiQuitin is indicated for the relief of nicotine withdrawal symptoms including cravings as an aid to smoking cessation. If possible, when stopping smoking, NiQutin should be used in conjunction with a behavioural support programme. NiQuitin patch is indicated in adults and adolescents aged 12 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (18 years and over)_ The patches should be used as directed below. Prior to initiation of therapy users should be committed to stopping smoking. During a quit attempt, every effort should be made to stop smoking during treatment with NiQuitin. Concurrent behavioural support is recommended, as such programmes have been shown to be beneficial for smoking cessation. NiQuitin patches should be applied once a day, at the same time each day and preferably soon after waking and worn continuously for 24 hours. NiQuitin therapy should usually begin with NiQuitin 21 mg/24 hrs and be reduced according to the following dosing schedule: Light smokers (e.g. those who smoke less than 10 cigarettes per day) are recommended to start at Step 2 (14 mg) for 6 weeks and decrease the dose to NiQuitin 7 mg/24 hrs for the final 2 weeks. Dose Duration Step Läs hela dokumentet