Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
NICOTINE
Novartis Consumer Health UK Limited
1mg Milligram
Lozenges
1999-06-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicotinell Mint 1 mg compressed lozenge 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each piece of lozenge contains: Active substance: 1 mg nicotine (corresponding to 3.072 mg nicotine bitartrate dihydrate). Excipient(s): aspartame (0.01 g), maltitol (0.9 g) and sodium (9.8 mg). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Compressed lozenge White, mint flavoured, round biconvex lozenge 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation. Patient counselling and support normally improve the success rate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND ELDERLY Users should stop smoking completely during treatment with Nicotinell lozenge. Nicotinell Mint 1 mg lozenge is recommended in smokers with a low to moderate nicotine dependency. Nicotinell Mint 1 mg lozenge is not recommended in the case of smokers with a strong or very strong nicotine dependency. The optimal dosage form is selected according to the following table: If an adverse event occurs with the use of the high dose form (2 mg lozenge), use of the low dose form (1 mg lozenge) should be considered. The initial dosage should be individualised on the basis of the patients nicotine dependence. One piece of lozenge to suck when the user feels the urge to smoke. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/02/2011_ _CRN 2095865_ _page number: 1_ Initially, 1 lozenge should be taken every 1-2 hours. The usual dosage is 8-12 lozenges per day. The maximum daily dose is 30 lozenges. Directions for use: 1. One lozenge to be sucked until the tas Read the complete document