Nazione: Svezia
Lingua: svedese
Fonte: Läkemedelsverket (Medical Products Agency)
nikotin
Fertin Pharma A/S
N07BA01
nicotine
2 mg
Munhålepulver i portionspåse
nikotin 2 mg Aktiv substans
Receptfritt
Förpacknings: Burk, 20 portionspåsar (i aluminiumpåse)
Godkänd
2017-09-06
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Ryze Mint 2 mg oromucosal powder in pouch Ryze Mint 4 mg oromucosal powder in pouch 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 doctor, pharmacist or nurse has told you. - Keep this leaflet. You may need to read it again. - Ask you pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor or pharmacist if you have usedfor more than 6 months. WHAT IS IN THIS LEAFLET 1. What Leggi il documento completois and what it is used for 2. What you need to know before you use 3. How to use 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IS IT USED FOR contains the active substance nicotine. It relieves craving for nicotine and withdrawal symptoms when you stop smoking and thereby counteracts relapse to smoking in smokers who are motivated to stop. facilitates smoking reduction in smokers who cannot or are unwilling to stop smoking completely. It is indicated for adults aged 18 years and above. When you suddenly stop providing nicotine in the form of tobacco to your body, you experience different kinds of discomfort, called withdrawal symptoms. When using you can prevent or reduce this discomfort, by continuing to provide a small amount of nicotine to your body during a transitional period. Advice and support may help you to improve the success rate. You must talk to a doctor or pharmacist if you have used for more than 6 months. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DO NOT USE : - if you are ALLERGIC to nicotine or any of the o
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ryze Mint 2 mg oromucosal powder in pouch. Ryze Mint 4 mg oromucosal powder in pouch. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION2 mg: One pouch contains 2 mg nicotine. Leggi il documento completo4 mg: One pouch contains 4 mg nicotine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oromucosal powder in pouch Rectangular pouch filled with powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS oromucosal powder in pouch is indicated in adults for the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms. facilitates smoking cessation in smokers who are motivated to quit and facilitates smoking reduction in smokers who are not able or willing to quit smoking. oromucosal powder in pouch should preferably be used in conjunction with a behavioural support program. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly_ Initially, one pouch may be administered every 1-2 hours. The usual dosage is 8-12 pouches a day. The maximum daily dose is 24 pouches. _Smoking cessation_ The duration of treatment is individual. Normally, the treatment should continue for at least 3 months. The nicotine dose should then be gradually reduced. Treatment should be discontinued when the dose has been reduced to 1-2 pouches per day. Regular use of for more than one year is generally not recommended. In some cases a longer treatment period might be necessary in order to avoid relapse. Any spare pouches should be retained, as craving may suddenly occur. Counselling and support may increase the probability to succeed in quitting smoking. _Smoking reduction_ is used between periods of smoking in order to extend the non-smoking intervals and with the objective to reduce smoking as much as possible. Professional help should be sought if a decrease in number of cigarettes per day has not been achieved after 6 weeks of