Страна: Нидерланды
Язык: голландский
Источник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
NICOTINERESINAAT SAMENSTELLING overeenkomend met ; NICOTINE
Omega Pharma Nederland B.V. Kralingseweg 201 3062 CE ROTTERDAM
NICOTINERESINAAT COMPOSITION corresponding to ; NICOTINE
Zuigtablet
ACACIA SENEGAL ; ACESULFAAM KALIUM (E 950) ; CALCIUMCARBONAAT (E 170) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MENTHOL, RACEMISCH (DL-Vorm) ; MUNTSMAAKSTOF ; NATRIUMALGINAAT (E 401) ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; PEPERMUNTOLIE ; POLYCARBOFIL CALCIUM ; SUCRALOSE (E 955) ; XANTHAANGOM (E 415), ACACIA SENEGAL ; ACESULFAAM KALIUM (E 950) ; CALCIUMCARBONAAT (E 170) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MENTHOL, RACEMISCH (DL-Vorm) ; MINTSMAAKSTOF ; NATRIUMALGINAAT (E 401) ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; PEPERMUNTOLIE ; POLYCARBOFIL CALCIUM ; SUCRALOSE (E 955) ; XANTHAANGOM (E 415)
Oromucosaal gebruik
2021-06-10
PACKAGE LEAFLET: INFORMATION FOR THE USER NIQUITIN MINT MINIZUIGTABLET 4 MG, ZUIGTABLETTEN NICOTINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your healthcare professional has told you. • Keep this leaflet. You may need to read it again. • Ask a healthcare professional e.g. doctor, nurse, smoking cessation adviser or pharmacist if you need more information or advice. • If you get any side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you have not achieved a reduction in cigarette consumption or in the number of compressed lozenges after 9 months of treatment with Nikotin Perrigo. Throughout this leaflet Nikotin Perrigo 4 mg compressed lozenge is referred to as Nikotin Perrigo. WHAT IS IN THIS LEAFLET: 1. What Nikotin Perrigo is and what it is used for 2. What you need to know before you take Nikotin Perrigo 3. How to use Nikotin Perrigo 4. Possible side effects 5. How to store Nikotin Perrigo 6. Content of the pack and other information 1. WHAT NIKOTIN PERRIGO IS AND WHAT IT IS USED FOR Nikotin Perrigo are used to help people stop smoking. This type of treatment is called Nicotine Replacement Therapy or NRT. Nikotin Perrigo is indicated in adults and adolescents (12-17 years). Nikotin Perrigo are intended for smokers who smoke _more than 20 cigarettes _ a day. Nikotin Perrigo can also be used for gradual cessation for smokers who are unwilling or unable to quit abruptly. Nikotin Perrigo should preferably be used in conjunction with a behavioral support programme. See Section 3 “How to use Nikotin Perrigo” for further details. It is the nicotine in cigarettes that can make you physically addicted to them. • Nikotin Perrigo help you to give up smoking by replacing some of the nicotine you get from cigarettes. • This nicotine relieves some of Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NiQuitin Mint minizuigtablet 4 mg, zuigtabletten 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains nicotine resinate equivalent to 4 mg nicotine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Compressed Lozenge (lozenge) Size to the nearest mm: L: 10 mm × W: 5 mm White to off white oval lozenge with convex surfaces; one surface bearing a debossed “NIC4” logo. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nikotin Perrigo are to be used for the treatment of tobacco dependence by relief of nicotine withdrawal symptoms and cravings. Permanent cessation of tobacco use is the eventual objective. Nikotin Perrigo can also be used for gradual cessation for smokers who are unwilling or unable to quit abruptly. Nikotin Perrigo should preferably be used in conjunction with a behavioral support programme. Nikotin Perrigo is indicated in adults and adolescents (12-17 years). In adolescents this product should be used only after advice from a healthcare professional. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY :_ _ Users should make every effort to stop smoking completely during treatment with Nikotin Perrigo. The strength of lozenge to be used will depend on the smoking habits of the individual. 4 mg Nikotin Perrigo are suitable for smokers who smoke more than 20 cigarettes a day. Behavioral therapy advice and support will normally improve the success rate PAEDIATRIC POPULATION :_ _ _ _ Adolescents (12-17 years) should follow the schedule of treatment for abrupt cessation of smoking as given above, but as data are limited, duration of use of NRT in this age group is restricted to 10 weeks. In adolescents this product should be used only after advice from a healthcare professional. Nikotin Perrigo must not be used in children below the age of 12 due to a lack of data on safety and efficacy, please see section 4.3. ADULTS (18 YEARS AND OVER)_ _ _Abrupt cessation of smoking: _ Use the lozenges whenever there Прочитать полный документ