Nicorette Cools 2mg Lozenge

Nicorette Cools 2 mg Lozenges should only be used by adolescents (12-17 years inclusive) with advice from a doctor. Nicorette Cools Lozenges are not recommended for use in children below the age of 12.

The safety and efficacy of Nicorette Cools 2 mg Lozenges in children and adolescents has not been investigated.

Method of administration

Oromucosal use.

One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately 16-19 minutes). The lozenge should not be chewed or swallowed whole.

Users should not eat or drink while a lozenge is in the mouth. Liquids which lower pH in the mouth such as coffee, juice and soft drinks, can decrease the absorption of nicotine in the mouth. To obtain maximum absorption of nicotine these liquids should be avoided for up to15 minutes before the lozenge is used.

Nicorette Cools 2 mg Lozenges should only be used by adolescents (12-17 years inclusive) with advice from a healthcare professional. Nicorette Cools Lozenges are not recommended for use in children below the age of 12.

The safety and efficacy of Nicorette Cools 2 mg Lozenges in children and adolescents has not been investigated.

Method of administration

Oromucosal use.

One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately 16-19 minutes). The lozenge should not be chewed or swallowed whole.

Users should not eat or drink while a lozenge is in the mouth.

Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby. The earlier abstinence is achieved the better.

Nicotine passes to the foetus and affects its breathing movements and circulation. The effect on the circulation is dose-dependent. Therefore the pregnant smoker should always be advised to stop smoking completely without use of nicotine replacement therapy. The risk of continued smoking may pose greater hazard to the foetus as compared with the use of nicotine replacement products in a supervised smoking cessation programme. Use of Nicorette Cools Lozenge by the pregnant smoker should only be initiated after advice from a healthcare professional. The harmful effects of tobacco smoking on the health of the mother and foetus or child have been clearly demonstrated. These include low birth weight, increased risk of miscarriage, and increased perinatal mortality. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby, and the earlier abstinence is achieved the better. Nicotine passes into the foetus and may cause dose-dependent changes in placental/foetal circulation and breathing movements. Pregnant women or those wishing to conceive should be advised to stop smoking without the use of Nicorette Cools Lozenge nicotine replacement therapy. Use of Nicorette Cools Lozenge by the pregnant highly dependent smoker should only be under the guidance of a doctor, following their assessment of the risk/benefit ratio. The decision to use NRT should be made as early on in the pregnancy as possible. The aim should be to use NRT for only 2-3 months.

Intermittent dosing products may be preferable as these usually provide a lower daily dose of nicotine than patches. However, patches may be preferred if the woman is suffering from nausea during pregnancy.

Breast-feedingLactation

Smoking increases the risk for infertility in women and men. In vitro studies have shown that nicotine can adversely affect human sperm quality. In rats, impaired sperm quality and reduced fertility have been shown. In females tobacco smoking delays time to conception, decreases in-vitro fertilization success rates, and significantly increases the risk of infertility.

In males tobacco smoking reduces sperm production, increases oxidative stress, and DNA damage. Spermatozoa from smokers have reduced fertilizing capacity.

The specific contribution of nicotine to these effects in humans is unknown.

Effects of smoking cessation

Regardless of the means used, a variety of symptoms are known to be associated with quitting habitual tobacco use. These include emotional or cognitive effects such as dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty concentrating, and restlessness or impatience. There may also be physical effects such as decreased heart rate; increased appetite or weight gain, dizziness or presyncopal symptoms, cough, constipation, gingival bleeding or apthous ulceration, or nasopharyngitis. In addition, and of clinical significance, nicotine cravings may result in profound urges to smoke.

The Nicorette Cools Lozenge may cause adverse reactions similar to those associated with nicotine given by other means. NRT can cause adverse reactions similar to those associatated with nicotine administered in other ways, including smoking. These may be attributed to the pharmacological effect of nicotine, some of which are dose dependent. At recommended doses Nicorette Cools 2 mg Lozenges have not been found to cause any serious adverse effects. Excessive consumption of Nicorette Cools 2 mg Lozenges by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Certain symptoms which have been reported such as depression, , irritability, anxiety, increased appetite and insomnia may be related to withdrawal symptoms associated with smoking cessation. Subjects quitting smoking by any means could expect to suffer from headache, dizziness, sleep disturbance, increased coughing or a cold.

Most of the undesirable effects reported by the subjects occur during the early phase of treatment and are mainly dose dependent.

Irritation in the mouth and throat may be experienced, however most subjects adapt to this with ongoing use.

Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of Nicorette Cools Lozenge.

Adverse reactions with oromucosal nicotine formulations identified from clinical trials and during post-marketing experience are presented below. The frequency category has been estimated from clinical trials for the adverse reactions identified during post-marketing experience.