NICOTINELL MINT Compressed lozenge (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Nicotinell Mint 1 mg compressed lozenges.
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 ...
Pharmaceutical form
Compressed lozenge. White, mint flavoured, round biconvex lozenge.
Therapeutic indications
Nicotinell is indicated in adults. Treatment of tobacco dependence by providing relief of nicotine withdrawal symptoms including cravings (see section 5.1), thereby facilitating smoking cessation or temporary ...
Posology and method of administration
Nicotinell Mint lozenge 1 mg may be used alone or in combination with Nicotinell transdermal patch. Children and adolescents (<18 years) Nicotinell lozenge should not be used by people under 18 years of ...
Contraindications
Hypersensitivity to nicotine or to any of the excipients. Nicotinell lozenge should not be used by non-smokers.
Special warnings and precautions for use
Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetals angina, severe cardiac arrhythmias, uncontrolled hypertensions or recent cerebrovascular accident ...
Interaction with other medicinal products and other forms of interaction
Drug Interactions: No information is available on interactions between Nicotinell lozenge and other medicinal products. Smoking Cessation: Smoking but not nicotine is associated with increased CYP1A2 activity. ...
Pregnancy and lactation
Pregnancy In pregnant women, complete cessation of tobacco smoking should always be recommended without nicotine replacement therapy. Nevertheless, in the case of failure in highly dependent pregnant smokers, ...
Effects on ability to drive and use machines
There is no evidence of any risks associated with driving or operating machinery when the lozenge is used following the recommended dose. Nevertheless one should take into consideration that smoking cessation ...
Undesirable effects
Nicotinell lozenge can cause adverse reactions similar to those associated with nicotine administered by smoking. These can be attributed to the pharmacological effects of nicotine, which are dose-dependent. ...
Overdose
In overdose, symptoms corresponding to heavy smoking may be seen. The acute lethal oral dose of nicotine is about 0.5–0.75 mg per kg body weight, corresponding in an adult to 40–60 mg. Even small quantities ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs used in nicotine dependence ATC Code: N07BA01 Nicotine, the primary alkaloid in tobacco products and a naturally occurring autonomous substance, is a nicotine receptor ...
Pharmacokinetic properties
The absorbed amount of nicotine depends on the amount released into the mouth and absorbed through the buccal mucosa. The main part of nicotine in Nicotinell Mint 1 mg lozenge is absorbed through the buccal ...
Preclinical safety data
Nicotine was positive in some in vitro genotoxicity tests but there are also negative results with the same test systems. Nicotine was negative in standard in-vivo tests. Animal experiments have shown ...
List of excipients
Maltitol (E965) Sodium carbonate anhydrous Sodium hydrogen carbonate Polyacrylate dispersion 30 per cent Xanthan gum Colloidal anhydrous silica Levomenthol Peppermint oil Aspartame (E951) Magnesium stearate ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Do not store above 25°C. Store in the original package.
Nature and contents of container
12, 36, 72, 96, 144 or 204 lozenges in opaque blisters consisting of aluminium foil and PVC/PE/PVDC/PE/PVC-film. or 24, 72, 96 or 144 lozenges in polypropylene tube with an attached closure cap and an ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Marketing authorization number(s)
PL 44673/0118
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 July 1999 Date of last renewal: 16 December 2008
Date of revision of the text
15/04/2016
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