Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
NICOTINE
Ayrton Saunders (Ireland) Limited 8a Sandyford Business Centre Blackthorn Avenue, Sandyford Dublin 18, , Ireland
N07BA01
NICOTINE 0.45 mg
PRESSURISED INHALATION, SOLUTION
NICOTINE 0.45 mg
OTC
OTHER NERVOUS SYSTEM DRUGS
Authorised
2019-03-26
NICOTINE 0.45 MG INHALER nicotine WHAT YOU SHOULD KNOW ABOUT THE NICOTINE INHALER PLEASE READ THIS LEAFLET CAREFULLY before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again. If you think you are having side-effects, have any questions or are not sure about anything, please ask your doctor, nurse, pharmacist. IN THIS LEAFLET: 1. What Nicotine Inhaler is and what it is used for 2. Before using Nicotine Inhaler 3. How and when to use Nicotine Inhaler 4. Possible side-effects 5. How to clean, store and dispose of Nicotine Inhaler 6. Further information 1 WHAT NICOTINE INHALER IS AND WHAT IT IS USED FOR Nicotine Inhaler is a nicotine inhalation device that is used in a similar way to smoking and substitutes the nicotine that you normally get from cigarettes. Nicotine Inhaler is an alternative to smoking. IT IS THE TOXINS IN CIGARETTE SMOKE SUCH AS TAR, LEAD, CYANIDE AND AMMONIA THAT CAUSE SMOKING RELATED DISEASE AND DEATH, NOT THE NICOTINE . By using this Nicotine Replacement Therapy, you and those around you will not be exposed to the serious health risk associated with smoking. For the full health benefits you should use Nicotine Inhaler to help you stop smoking completely. If you’re not ready to do this, it can also help you cut down. Alternatively you can use Nicotine Inhaler when you are unable to smoke or want to avoid causing harm to others e.g. children, friends or family. When you use Nicotine Inhaler, nicotine is released and passes into your body, just like a cigarette but without the harmful chemicals in the smoke. You can use Nicotine Inhaler as you would a cigarette and inhale as much as desired. For the best effect, ensure that you use your Nicotine Inhaler correctly – see “ _How and when to use _ _Nicotine Inhaler_ ”. THE BENEFITS OF STOPPING SMOKING FAR OUTWEIGH ANY POTENTIAL RISK FROM USING NICOTINE FROM NICOTINE INHALER. THERE ARE NO CIRCUMSTANCES IN WHICH IT IS SAFER TO SMOKE THAN TO USE NICOTINE INHALER. Since Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicotine 0.45 mg Inhaler 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pack contains 9 mg nicotine and provides approximately 20 charges of the stick device. Each charge contains approximately 0.45 mg nicotine, equivalent to a delivered dose of 0.43 mg nicotine, except for the first charge, which delivers less than 0.43 mg (range 0.10 – 0.30 mg) due to stick design. Excipient: ethanol (contains less than 10 mg of ethanol per charged stick). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicotine 0.45 mg Inhaler relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. Nicotine 0.45 mg Inhaler is indicated in pregnant and lactating women making a quit attempt. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nicotine 0.45 mg Inhaler is for oral inhalation use only. _Posology _ ADULTS OVER 18 YEARS OF AGE: Nicotine 0.45 mg Inhaler should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur. Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Inhaler and as soon as they are able, reduce the number of charges used until they have stopped completely. Smokers aiming to reduce cigarettes should use the Inhaler, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. As soon as they are ready, smokers should aim to quit smoking completely. Maximum daily dose: 2 packs When making a quit attempt, behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficult Baca dokumen lengkap