NICOTINELL MINT
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-06-2024
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Active ingredient:
NICOTINE
Available from:
Novartis Consumer Health UK Limited
Dosage:
2 Milligram
Pharmaceutical form:
Lozenges
Authorization date:
2003-06-30
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicotinell Mint 2 mg compressed Lozenge
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each piece of lozenge contains:
Active substance: 2 mg nicotine (corresponding to 6.144 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.
The 2 mg strength is used when severe withdrawal symptoms are experienced.
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 2 mg lozenge is intended to be used by smokers with a strong or very strong nicotine dependency and
those who have previously failed to stop smoking with the aid of nicotine replacement therapy.
The optimal dosage form is selected according to the following table:
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/02/2011_
_CRN 2095865_
_page number: 1_
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.
Initially, 1 lozenge should be taken every 1-2 hours. The usual dosage is 8-12 lozenges per day. The maximum daily
dose is 15 loz
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