NICOTINELL ICE MINT

Posology Adults over 18-years old and elderly Users should stop smoking completely during treatment with Nicotinell medicated chewing-gum. The 2 mg medicated chewing-gum is not recommended for smokers with a strong or very strong nicotine dependency.

The optimal dosage form is selected according to the following table:

Low to moderate dependency Moderate to strong dependency Strong to very strong dependency Less than 20 cigarettes / day From 20 to 30 cigarettes / day Over 30 cigarettes / day Low dose forms are preferable (2 mg gum) Low (2 mg gum) or high (4 mg gum) dose forms are acceptable depending on patient characteristics and preference.

High dose forms are preferable (4 mg gum) If an adverse event occurs with the use of the high dose form (4 mg medicated chewing-gum), use of the low dose form (2 mg medicated chewing-gum) should be considered. The initial dosage should be individualised on the basis of the patients nicotine dependence.

One piece of Nicotinell medicated chewing-gum to be chewed when the user feels the urge to smoke. If Nicotinell 2 mg medicated chewing-gum is selected, normally use 8-12 pieces per day, up to a maximum of 24 pieces per day. Do not use more than 1 gum per hour.

The characteristics of medicated chewing-gum as a pharmaceutical form are such that individually different nicotine levels can result in the blood. Therefore, dosage frequency should be adjusted according to individual requirements within the stated maximum limit.

The treatment duration is individual. Normally, treatment should continue for at least 3 months. Low dosage forms acceptable High dosage forms acceptable After 3 months, the users should gradually reduce the number of pieces chewed each day until they have stopped using the product.

Treatment should be discontinued when the dose has been reduced to 1-2 pieces of medicated chewing-gum per day. Use of nicotine medicinal products like Nicotinell medicated chewing-gum beyond 6 months is generally not recommended. Some ex- smokers may need treatment with the medicated chewing-gum for longer to avoid returning to smoking.

Patients who have been using oral nicotine replacement therapy beyond 9 months are advised to seek additional help and information from health care professionals. Counselling may help smokers to quit. Paediatric Population Nicotinell medicated chewing-gum should not be used by people under 18 years of age without recommendation from a physician.

There is no experience in treating adolescents under the age of 18 years with Nicotinell medicated chewing-gum. Renal impairment Use with caution in patients with moderate to severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

Hepatic impairment Use with caution in patients with moderate to severe hepatic impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects. Method of administration 1.

One piece of medicated chewing-gum should be chewed until the taste becomes strong. 2. The medicated chewing-gum should be rested between the gum and cheek. 3. When the taste fades, chewing should commence again. 4. The chewing routine should be repeated for 30 minutes.

Concomitant use of acidic beverages such as coffee or soda may decrease the buccal absorption of nicotine. Acidic beverages should be avoided for 15 minutes prior to chewing the medicated chewing-gum.

Nicotinell medicated chewing-gum can cause adverse reactions similar to those associated with nicotine administered by smoking. These can be attributed to the pharmacological effects of nicotine, which are dose- dependent. Non dose-dependent adverse reactions are as follows: jaw muscle ache, urticaria, hypersensitivity, angioneurotic oedema and anaphylactic reactions.

Most of the side effects which are reported by patients occur generally during the first 3-4 weeks after initiation of therapy. Nicotine from gums may sometimes cause a slight irritation of the throat and increase salivation at the start of the treatment.

Excessive swallowing of nicotine which is released in the saliva may, at first, cause hiccups. Those who are prone to indigestion may suffer initially from minor degrees of dyspepsia or heartburn; slower chewing will usually overcome this problem.

Excessive consumption of nicotine gums by subjects who have not been in the habit of inhaling tobacco smoke, could possibly lead to nausea, faintness and headache. Increased frequency of aphthous ulcer may occur after abstinence from smoking.

The medicated chewing-gum may stick to and in rare cases damage dentures and dental appliances. The following undesirable effects detailed in Table 1 are nicotine related adverse events for all oral dosage forms. Adverse reactions are listed below, by system organ class and frequency.

Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000, <1/1,000) or very rare (<1/10,000). Table 1 shows events which were identified from a double-blind, randomised, placebo-controlled lozenge clinical study involving 1818 patients.

Adverse events reported in this study have been considered for inclusion, where the incidence in the 2 mg or 4 mg nicotine arm was higher than the corresponding placebo arm. Frequencies are calculated from safety data of the study. g.

flatulence, vomiting, dyspepsia♦, stomatitis, oral discomfort. abdominal pain upper, diarrhoea, dry mouth, constipation. - - Respiratory, Thoracic and Mediastinal Disorders - Pharyngitis, cough*, pharyngolaryngeal pain - - * These events may also be due to withdrawal symptoms following smoking cessation.

♦ Individuals with a tendency to experience indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4 mg dose is used - slower chewing in the case of gum or the use of the 2 mg dose (if necessary more frequently) will usually overcome this problem.

Post Marketing Data Table 2 shows events which were identified from post-marketing experience of nicotine oral forms. As these reactions are reported voluntarily from a population of uncertain size, the frequency of these reactions is unknown, but considered likely to be rare or very rare.

Table 2:

Adverse Reactions from post-marketing data System Organ Class Adverse Reactions Immune System Disorders Hypersensitivity, angioedema, urticaria, ulcerative stomatitis, and very rare anaphylactic reactions. Nervous System Disorders Tremor Cardiac Disorders Palpitations, tachycardia, arrhythmias Respiratory, Thoracic and Mediastinal Disorders Dyspnoea Gastrointestinal Disorders Dysphagia, eructation, salivary hypersecretion General Disorders and Administration Site Conditions Asthenia**, fatigue**, malaise**, influenza type illness** ** These events may also be due to withdrawal symptoms following smoking cessation.

Certain symptoms which have been reported such as dizziness, headache and insomnia may be ascribed to withdrawal symptoms in connection with smoking cessation and may be due to insufficient administration of nicotine. Cold sores may develop in connection with smoking cessation, but any relation with the nicotine treatment is unclear.

The patient may still experience nicotine dependence after smoking cessation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Patients with a recent myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe cardiac arrhythmias, uncontrolled hypertensions or recent cerebrovascular accident who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions.

If this fails, Nicotinell medicated chewing-gums may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the Nicotinell Peppermint gum dose should be reduced or discontinued.

Nicotinell medicated chewing-gums should be used with caution in patients with hypertension, stable angina pectoris, cerebrovascular disease, occlusive peripheral arterial disease, heart failure, moderate to severe hepatic and/or moderate to severe renal impairment, hyperthyroidism or pheochromocytoma, and diabetes mellitus.

Blood glucose levels may be more variable during smoking cessation, with or without nicotine replacement therapy so, it is important for diabetics to closely monitor their blood glucose levels while using this product.

Seizures:

Use with caution in subjects taking anti-convulsant therapy or with a history of epilepsy as cases of convulsions have been reported in association with nicotine. Patients should initially be encouraged to stop smoking with non-pharmacological interventions (such as counselling).

Swallowed nicotine may exacerbate symptoms in subjects suffering from active oesophagitis, oral or pharyngeal inflammation, gastritis or peptic ulcer. 9). Nicotine oral products should be kept out of sight and reach of children. People having problems with the joint of the jawbone and denture wearers may experience difficulty in chewing the medicated chewing-gum.

In this case, it is recommended that they use a different pharmaceutical form of nicotine replacement therapy. Nicotine gum may loosen fillings or dental implants. Special warnings about excipients Because Nicotinell Mint medicated chewing-gums contain sorbitol: Patients with rare hereditary conditions of fructose intolerance should not take this medicine.

02 g fructose. 2 kcal/piece of medicated chewing-gum. Nicotinell Mint 2 mg medicated chewing-gum contains less than 1 mmol sodium (23 mg) per chewing gum, that is to say essentially ‘sodium-free’. The gum base contains butylhydroxytoluene (E321) which may cause local irritation to mucous membranes.

1. Nicotinell medicated chewing-gum should not be used by non-smokers.