NICOTINELL FRUIT

Posology Adults over 18 years of age and the elderly The 2 mg chewing gum is recommended in smokers with a low to moderate nicotine dependency. The 2 mg chewing gum may not be well suited to 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 High dose forms are preferable (4 mg gum) preference.

Low dosage forms acceptable High dosage forms acceptable If an adverse event is noted when high dose forms are initiated, this should be replaced by the lower dosage form. One piece of Nicotinell gum to be chewed when the user feels the urge to smoke.

Do not use more than 1 gum per hour. Normally, 8-12 pieces per day can be used, up to a maximum of 24 pieces per day. Do not use more than 1 gum per hour. The characteristics of 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 time is individual. Normally, treatment should continue for at least 3 months. After three months, the user should gradually cut down 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 gum per day. Nicotine gum should not be used for more than 12 months unless the potential benefit outweighs the potential risk to the smokers. Nicotinell gum is sugar free.

Children and Adolescents (aged 12-17 years of age) The above recommendation can be used for adolescents aged between 12 and 17 years of age. As data are limited in this age group, medical advice should be obtained should it be found necessary to use the gum beyond 12 weeks.

The use of NRT in adolescents should only be used when the benefits of abstinence outweigh the risks of continued smoking. Nicotine gum should preferably be used in conjunction with a behavioural support programme as this normally improves the success rate.

Adolescents should not quit with a combination NRT Regimen. Children below 12 years of age Nicotine gum are not recommended for use in children under 12 years. 4). 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 gum. Method of administration 1. One piece of gum should be chewed until the taste becomes strong. 2. The 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.

Certain symptoms such as dizziness, headache and sleep disturbances may be related 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.

Nicotinell gums can cause adverse reactions similar to those associated with nicotine administered by other means (including smoking). These can be attributed to the pharmacological effects of nicotine, which are dose dependant.

Non dose-dependent adverse reactions are as follows:

Jaw muscle ache, erythema, urticaria, hypersensitivity, angioneurotic oedema and anaphylactic reactions. At recommended doses Nicotinell gum has not been found to cause any serious adverse effects. Excessive consumption of Nicotinell gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. 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.

The 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. 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.

Table 1:

Adverse Reaction from clinical trial data 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 to <1/1,000) or very rare (<1/10,000), System Organ Class Adverse Reaction Frequency Psychiatric Disorders Insomnia* Common Headache*, dizziness* CommonNervous system disorders Seizures Not Known Gastrointestinal disorders Salivary hypersecretion, stomatitis, oral pain, oral discomfort, hiccups, nausea, vomiting, dyspepsia**, abdominal pain upper, diarrhoea, dry mouth, constipation and flatulence.

Common Musculoskeletal, connective and bone disorders Jaw muscle ache*** Common Palpitations UncommonCardiac disorders Atrial arrhythmia Rare Skin and subcutaneous tissue disorders Erythema, urticaria Uncommon Immune system disorders Hypersensitivity, angioneurotic oedema and anaphylactic reactions.

Rare Respiratory, Thoracic and Mediastinal Disorders Pharyngitis, cough*, pharyngolaryngeal pain Common * 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.

*** This adverse event could be due to mechanical stress caused by chewing of the gum rather than due to the direct action of nicotine. 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.

Table 2:

Adverse Reactions from post-marketing data System Organ Class Adverse Reaction Immune system disorders Hypersensitivity, angioedema, urticaria, ulcerative stomatitis, angioneurotic oedema and very rare anaphylactic reactions. Nervous system disorders Tremor Cardiac disorders Palpitations, tachycardia, arrhythmias, atrial fibrillation.

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.

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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Any risks that may be associated with nicotine replacement therapy are substantially outweighed by the well-established dangers of continued smoking. Precautions Users should be informed that if they continue to smoke while using the gums they may experience increased adverse effects due to the hazards of smoking, including cardiovascular effects.

Cardiovascular disease In stable cardiovascular disease Nicotinell gum presents a lesser hazard than continuing to smoke. However dependant smokers currently hospitalised as a result of a recent myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe cardiac arrhythmias, uncontrolled hypertension, or recent cerebrovascular accident who are considered to be haemodynamically unstable should be encouraged to stop smoking with non- pharmacological interventions (such as counselling).

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

Diabetes mellitus Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when nicotine replacement therapy is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Allergic reactions Angioedema and urticaria have been reported. Gastro-intestinal disease Swallowed nicotine may exacerbate symptoms in patients suffering from active oesophagitis, oral or pharyngeal inflammation, gastritis, or peptic ulcers and oral nicotine replacement therapy preparations should be used with caution in these conditions.

Ulcerative stomatitis has been reported. Renal and or hepatic impairment Should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

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. 9). Products containing nicotine should not be left where they may be misused, handled or ingested by children.

Nicotinell gum should be disposed of with care. Nicotine products should be kept out of sight and reach of children. Phaeochromocytoma and uncontrolled hyperthyroidism Nicotinell gum should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma as nicotine causes the release of catecholamines.

Transferred dependence Transferred dependence is rare and is both less harmful and easier to break than smoking dependence. Stopping smoking Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly CYP 1A1).

When a smoker stops, this may result in slower metabolism and a consequential rise in blood levels of drugs such as theophylline, tacrine, olanzaprine and clozaprine. Other warnings People having problems with the joint of the jawbone and denture wearers may experience difficulty in chewing the 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 gum contains sorbitol, xylitol and maltitol: Patients with rare hereditary conditions of fructose intolerance should not take this medicine.

04g fructose. 0 kcal/piece of gum. Nicotinell 2mg gum contains less then 1 mmol sodium (23 mg) per chewing, that is to say essentially ‘sodium-free’. The gum base contains butylhydroxytoluene (E321) which may cause local irritation to mucous.

1. Nicotinell gum should not be used by non-smokers or occasional smokers.