NIQERO MINT 2 Milligram Medicated Chewing Gum
Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Lastnosti izdelka
(SPC)
20-05-2024
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Aktivna sestavina:
NICOTINE RESINATE
Dostopno od:
Stasisport Pharma N.V.
Koda artikla:
N07BA01
INN (mednarodno ime):
NICOTINE RESINATE
Odmerek:
2 Milligram
Farmacevtska oblika:
Medicated Chewing Gum
Tip zastaranja:
Product not subject to medical prescription
Terapevtsko območje:
Drugs used in nicotine dependence
Status dovoljenje:
Authorised
Datum dovoljenje:
2012-10-12
Lastnosti izdelka
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Niqero Mint 2 mg medicated chewing gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewing-gum contains 2 mg nicotine as nicotine resinate.
Excipients with known effect:
Butylated hydroxytoluene up to 0.5 mg
Maltitol 181 mg
Sorbitol 223 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated chewing-gum
White to yellowish chewing-gum, slightly convex, rectangular with an approximate size of 18×12×5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nicotine is indicated for the treatment of tobacco dependence by relieving nicotine withdrawal symptoms including
cravings (see section 5.1), thereby facilitating smoking cessation or temporary smoking reduction in smokers motivated
to quit smoking. Permanent cessation of tobacco use is the eventual objective.
Niqero Mint is indicated in adults.
Advice and support normally improve the success rate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The strength of the chewing-gum should be selected based on the user’s dependence on nicotine. For low nicotine
dependence a 2 mg chewing-gum is indicated. For high nicotine dependence (FTND
6 or smoking of 20 cigarettes or
more per day) or previous failure with 2 mg, a 4 mg chewing-gum is indicated.
Initially one piece of gum can be taken every 1-2 hours. In most cases 8-12 chewing-gums a day will be sufficient. For
smoking cessation the maximum daily dose is 24 chewing-gums. For smoking reduction when used in between periods
of smoking the maximum daily dose is 24 chewing-gums of 2 mg or 12 chewing-gums of 4 mg.
_Paediatric population_
Niqero Mint chewing-gum should not be used in children below 18 years of age unless prescribed by the physician.
The safety and efficacy of
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