NICOTINELL MINT Compressed lozenge Ref.[6426] Active ingredients: Nicotine

Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe cardiac arrhythmias, uncontrolled hypertensions or recent cerebrovascular accident should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicotinell lozenges may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision.

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

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 and pharyngeal inflammation, gastritis or peptic ulcer.

Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small children and may prove fatal (please see Section 4.9).

Special warnings about excipients

Nicotinell lozenges contain sweeteners, including aspartame and maltitol.

Each Nicotinell Mint 1 mg lozenge contains aspartame (E951), a source of phenylalanine equivalent to 5 mg/dose and may be harmful for people with phenylketonuria.

Because Nicotinell Mint 1 mg lozenge contains maltitol (E965), a source of fructose:

• patients with rare hereditary conditions of fructose intolerance should not take this medicine,
• patients may experience a mild laxative effect.

Calorific value 2.3 kcal/g maltitol.

Nicotinell Mint 1 mg lozenge contains 9.8 mg of sodium per piece.

For special warnings and precautions for the Nicotinell patch, see the Summary of Product Characteristics for the specific product.

Drug Interactions: No information is available on interactions between Nicotinell lozenge and other medicinal products.

Smoking Cessation: Smoking but not nicotine is associated with increased CYP1A2 activity. After stopping smoking there may be reduced clearance of substrates for this enzyme and increased plasma levels of some medicinal products of potential clinical importance because of their narrow therapeutic window e.g. theophylline, tacrine, olanzapine and clozapine.

The plasma concentrations of other active substances metabolised by CYP1A2 e.g. caffeine, paracetamol, phenazone, phenylbutazone, pentazocine, lidocaine, benzodiazepines, warfarin, oestrogen and vitamin B12 may also increase. However the clinical significance of this effect for these active substances is unknown.

Smoking may lead to reduced analgesic effects of propoxyphene, reduced diuretic response to furosemide (frusemide), reduced effect of propranolol on blood pressure and heart rate and reduced responder rates in ulcer healing with H2-antagonists.

Smoking and nicotine may raise the blood levels of cortisol and catecholamines, i.e. may lead to a reduced effect of nifedipine or adrenergic antagonists and to an increased effect of adrenergic agonists.

Increased subcutaneous absorption of insulin which occurs upon smoking cessation may necessitate a reduction in insulin dose.

For interactions for the Nicotinell patch, see the Summary of Product Characteristics for the specific product.

Pregnancy

In pregnant women, complete cessation of tobacco smoking should always be recommended without nicotine replacement therapy.

Nevertheless, in the case of failure in highly dependent pregnant smokers, tobacco withdrawal via nicotine replacement therapy may be recommended. Indeed, foetal risk is probably lower than that expected with tobacco smoking, due to:

• lower maximal plasma nicotine concentration than with inhaled nicotine
• no additional exposure to polycyclic hydrocarbons and carbon monoxide
• improved chances of quitting smoking by the third trimester.

Smoking continued during the third trimester may lead to intra-uterine growth retardation or even premature birth or stillbirth, depending on the daily amount of tobacco.

Tobacco withdrawal with or without nicotine replacement therapy should not be undertaken alone but as part of a medically supervised smoking cessation program.

In the third trimester nicotine has haemodynamic effects (e.g. changes in foetal heart rate) which could affect the foetus close to delivery. Therefore, after the sixth month of pregnancy, the lozenge should only be used under medical supervision in pregnant smokers who have failed to stop smoking by the third trimester.

Lactation

Nicotine is excreted in breast milk in quantities that may affect the child even in therapeutic doses. The lozenge, like smoking itself, should therefore be avoided during breast-feeding. Should smoking withdrawal not be achieved, use of the lozenge by breast feeding smokers should only be initiated after advice from a physician. Where nicotine replacement therapy is used whilst breast-feeding, the lozenge should be taken just after breast-feeding and not during the two hours before breast-feeding.

There is no evidence of any risks associated with driving or operating machinery when the lozenge is used following the recommended dose. Nevertheless one should take into consideration that smoking cessation can cause behavioural changes.

Nicotinell lozenge 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: hypersensitivity, angioneurotic oedema and anaphylactic reactions.

Most of the adverse reactions which are reported by patients occur generally during the first 3-4 weeks after initiation of therapy.

Nicotine from lozenges may sometimes cause a slight irritation of the throat and increased 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 sucking will usually overcome this problem.

Excessive consumption of lozenges 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.

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).

Nervous system disorders

Common: dizziness, headache

Gastrointestinal disorders

Common: nausea, flatulence, hiccups, gastritis, dry mouth, stomatitis and oesophagitis.

Cardiac disorders

Uncommon: Palpitations

Rare: atrial arrhythmia

Immune system disorders

Rare: hypersensitivity, angioneurotic oedema and anaphylactic reactions.

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.

For undesirable effects for the Nicotinell patch, see the Summary of Product Characteristics for the specific product.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuedmonitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report anysuspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.ukyellowcard.

Not applicable.