Nicotinell Lozenge, 204 x 1mg

Product Information

Seizures: potential risks and benefits of nicotine should be carefully evaluated before use in subjects taking anti-convulsant therapy or with a history of epilepsy as cases of convulsions have been reported in association with nicotine. The maximum total treatment duration is 9 months (for the initial treatment and reduction of nicotine dose) patients with rare hereditary problems of fructose intolerance should not take this medicinal product

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 healthcare professional. 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. The patch is applied on a clean, dry, hairless, intact area of skin on the trunk, arms or hips. The patch is pressed against the skin for 10-20 seconds. 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.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. Cardiovascular disease: 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. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the nicotine lozenge dose should be reduced or discontinued. For undesirable effects for the Nicotinell Patch, see the Summary of Product Characteristics for the specific product. Most of the adverse reactions which are reported by patients occur generally during the first 3-4 weeks after initiation of therapy. Women who are pregnant should first be advised to stop smoking without the assistance of nicotine replacement therapy. If this fails, the use of nicotine replacement therapy should only be used after advice from a health care professional.

If an adverse event occurs with the use of the high dose form (2 mg lozenge), use of the low dose form (1 mg lozenge) should be considered. Hypersensitivity, angioedema, urticaria, ulcerative stomatitis, and very rare anaphylactic reactions.

Each Nicotinell Mint 1 mg Lozenge contains 10 mg aspartame (E951), a source of phenylalanine equivalent to 5 mg/dose and may be harmful for people with phenylketonuria. Patients should initially be encouraged to stop smoking with non-pharmacological interventions (such as counselling).