The gum Quitt nicotine gum is a new chewing gum devel-oped for nicotine replacement therapy (NRT) by Fer-tin Pharma, the worlds leading B2B manufacturer of NRT chewing gum. The gum is available in mint and lemon flavors, 2mg and 4mg strengths, in a wide va-riety of pack count formats. Quitt comes in a coat-ed, extruded form, the formula is based on Nico- tine Polacrilex, and it is bioequivalent to Nicorette.

Tobacco consumptionCited as a major public health threat by the WHO, smoking is the cause of several serious health con-ditions such as: cardiovascular disease, cancer and respiratory diseases. Put into perspective, tobacco accounts for one in every ten deaths worldwide and one fatality every six seconds1.

Nicotine replacement therapyNRT is a treatment that uses small steady doses of nicotine to help stop nicotine cravings and symp-toms that occur while a person is attempting to quit smoking. Thus it is a treatment that allows the smoker to abstain from tobacco use and thereby avoid the dangerous carcinogens and toxic gases from smoke. NRT helps overcome the addiction of nicotine at a gradual rate, which makes quitting easier.

Studies have concluded that NRT increases the chances of stopping smoking by 50-70%3,4,5.

In addition NRT is recommended by doctors and supported by the WHO in fighting the global tobac-co epidemic.

Nicotine chewing gumCurrently, several dosage forms are available for NRT apart from gum such as; lozenges, patches, inhalers and sprays. So why choose gum?

From a consumer perspective, chewing gum is a discrete dosage form that tastes good, is widely ac-cepted and consumed routinely in its confectionery form. From a technical perspective, local delivery in the mouth enables fast uptake of nicotine by buc-cal absorption. From a market perspective, chew-ing gum is the most preferred delivery system within the NRT category with approximately half of the cat-egory share2, growing annually at a rate of 3.1%7 (3-year CAGR).

Nicotine substitutionIn some instances smokers require alternative sources of nicotine other than cigarettes (e.g., due to non-smoking environments or if smoking is not tolerated). In these situations the smoker does not intend to quit, but merely needs a substitute to aid in suppressing nicotine cravings. Nicotine-contain-ing products like chewing gum can be used occa-sionally to hinder such cravings.

References1. World Health Organisation (http://www.who.int/tobacco/mpower/tobacco_facts/en/) 2. IMS Health NRT data (which year) 3. Cohcrane review: Can nicotine replacement therapy (NRT) help people quit smoking? First published: November 14, 2012; This version published: 2012; Review content assessed as up-to-date: September 19, 2012. 4. C. Silagy et al (1994): Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation. The Lancet, Volume 343, Issue 8890, Pages 139 - 142, 15 January 1994 5. Murray, R.P. (1996): Safety of nicotine polacrilex gum used by 3,094 participants in the Lung Health Study. Lung Health Study Research Group. Chest. 1996 Feb;109(2):438-45. 6. Nicorette (http://nicorette.

co.uk/help-and-support/smoking-facts) 7. IMS Health NRT data.

Fact sheet

Nicotine

Peppermintmedicated chewing gum

SafetyThe safety of Nicotine polacrilex chewing gum has been assessed thoroughly and results show that it is safe if used as instructed and unrelated to any car-diovascular illnesses or other serious side effects5.

PotentialsCurrently, NRT is well-established in many parts of the world including the United States, Scandinavia and the United Kingdom, but a sizeable untapped global market still remains.

As local authorities continue to grasp the econo-mic and societal burden caused by tobacco-rela-ted illness and disease, their commitment to anti- smoking initiatives increases.

Recommended dose for cessation1 piece of Quitt 2mg/4mg chewing gum every hour, maximum 16 pieces per day. 8-12 pieces per day are regarded as standard. After 4-6 weeks the dose should be gradually reduced by increasing the in-terval length between each dose or switching from Quitt 4mg to Quitt 2mg.

The first attempt at discontinuing use of Quitt 2mg/4mg chewing gum should be made when the average daily use in the previous week has been 1-2 pieces. The chewing gum should, however, always be within reach for a certain period of time after discontinuing treatment in order to counteract any craving recurrences. Treatment with Quitt 2mg/4mg chewing gum for more than 6 months is generally not recommended.

Recommended dose for substitutionA piece of Quitt 2mg/4mg chewing gum can be chewed whenever the desire to smoke occurs. The number of pieces per day is generally 8-12 and must not under any circumstance exceed 30/15 pieces of gum daily.

If the smoker subsequently wishes to stop smoking completely, the smoker should stop smoking as he/she feels able, and no later than 6 months after ini-tiation of treatment. However, if unsuccessful after 9 months upon initiation of treatment, the doctor must be consulted.

Method of administration1 piece of Quitt 2mg/4mg chewing gum is chewed for approximately 30 minutes with breaks, in order to release all the available nicotine from the chewing gum base.

Product informationIt is particularly important to chew Quitt 2mg/4mg chewing gum slowly. In this way the nicotine is ab-sorbed mainly through the oral mucosa into the body. This results in a nicotine concentration in the blood which switches off the craving for nicotine for a prolonged period. Chewing the gum rapidly and/or intensively should be avoided, so that the nicotine is not released too rapidly from the chewing gum base, making it unavailable for absorption.

Packaging detailsAvailable pack counts: 12, 20, 24, 30, 36, 48, 50, 80, 96 and 108. The chewing gum is packed in 10 or 12 count blisters. The blister pack is made of PVC/PVdC thermoformed blister cards, sealed with alu-minum foil. Availability of pack sizes is subject to lo-cal regulations.

Other product informationShelf life: 24 monthsStorage conditions: Keep below 25C

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Phone: +45 7215 1300

Fertin Pharma A/SDandyvej 19DK-7100 Vejle

API content 1 piece of Quitt 2mg/4mg chewing gum contains 13.2mg/26.5mg nicotine resinate corresponding to 2mg/4mg nicotine.

Therapeutic indicationsDeveloped for the treatment of tobacco depend-ence by relieving nicotine withdrawal symptoms, Quitt 2mg/4mg chewing gum functions as an aid to smoking cessation. Although complete cessation of tobacco use is preferred, this medicinal product may be used in: (1) cases where a smoker temporar-ily abstains from smoking (2) a strategy for reducing nicotine consumption (smoking reduction) as a step towards complete cessation.

Quitt 2mg chewing gum is intended for smokers who were smoking up to a maximum of 20 cigarettes per day before treatment. Quitt 4mg chewing gum is intended for heavily addicted smokers (who were smoking more than 20 cigarettes per day before treatment). The rate of success can be increased by additional advice and supportive measures. Quitt 2mg/4mg chewing gum is also suitable for diabetics.

Quick facts Bioequivalent to Nicorette Available in mint and lemon flavors Two strengths (2mg and 4mg) Extruded chewing gum technology Coated Marketing Authorization Holder is Fertin Pharma