Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
NICOTINE RESINATE
Stasisport Pharma N.V.
N07BA01
NICOTINE RESINATE
4 Milligram
Medicated Chewing Gum
Product not subject to medical prescription
Drugs used in nicotine dependence
Authorised
2012-10-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Niqero mint 4 mg medicated chewing gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewing-gum contains 4 mg nicotine as nicotine resinate. Butylated hydroxytoluene up to 0.5 mg Maltitol 181 mg Sorbitol 208 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 Niqero Mint chewing-gum in ch Izlasiet visu dokumentu