In the event of an overdose (e.g. too many lozenges ingested) medical attention should be sought immediately. All nicotine intake should cease immediately, and the patient be treated symptomatically, and vital signs monitored.

People who have failed when treated with only Nicotinell Lozenge can use Nicotinell Patches together with Nicotinell 1 mg Lozenge.

The maximum total treatment duration is 9 months (for the initial treatment and reduction of nicotine dose) Use with caution in patients with moderate to severe renal impairment and/or moderate to severe hepatic impairment as the clearance of nicotine or its metabolites maybe decreased with the potential for increased adverse effects. Initially, 1 lozenge should be taken every 1-2 hours. The usual dosage is 8-12 lozenges per day. For smoking cessation and smoking reduction with Nicotinell Lozenge, the maximum daily dose is 24 lozenges. Do not use more than one lozenge per hour. 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.

Danger in small children: 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).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. Treatment should begin with one patch 21 mg/24 hours in combination with Nicotinell 1mg Lozenge. At least 4 pieces of lozenge (1 mg) per day should be used. In most cases, 5-6 lozenges are enough. Not more than 15 pieces of lozenge a day should be used. In normal cases, the treatment may last for 6-12 weeks. Thereafter, the nicotine dose is reduced gradually. Nicotinell Lozenge should not be used by adolescents 12-17 years of age without prescription from a healthcare professional. There is no experience in treating adolescents under the age of 18 with Nicotinell Lozenge. Nicotinell Lozenges should be used with caution in patients with: hypertension, stable angina pectoris, cerebrovascular disease, occlusive peripheral arterial disease, heart failure, hyperthyroidism or pheochromocytoma.

The treatment duration is individual. Normally, treatment should continue for at least 3 months. After 3 months, the user should gradually reduce the number of lozenges. Treatment should be discontinued when the dose has been reduced to 1-2 lozenges per day. Use of nicotine medicinal products like Nicotinell Mint 1 mg Lozenge beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the lozenge longer to avoid returning to smoking. 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. Users should stop smoking completely during treatment with Nicotinell Lozenge in combination with Nicotinell Transdermal Patch.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.