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.

The maximum total treatment duration is 9 months (for the initial treatment and reduction of nicotine dose)Alternative 1: Use of the patches of a lower strength, i.e. 14 mg/24 hours patches for 3-6 weeks followed by 7 mg/24 hours for another 3-6 weeks together with the initial dose of Nicotinell 1 mg Lozenge. Thereafter, the number of lozenges is reduced gradually. It is generally not recommended to use Nicotinell Mint Lozenge for longer than 6 months. However, some ex-smokers may need treatment for longer to avoid returning to smoking but it should not be more than9 months. 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). Distribution volume after intravenous administration of nicotine is approximately 2-3 1/kg and the half-life is 2 hours. Nicotine is metabolised principally in the liver and the plasma clearance is approximately 1.2 l/min; nicotine also metabolises in the kidney and lungs. Nicotine crosses the blood-brain barrier. Nicotinell Mint Lozenge 1 mg may be used alone (a) or in combination with Nicotinell Transdermal Patch (b).

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. Hypersensitivity, angioedema, urticaria, ulcerative stomatitis, and very rare anaphylactic reactions. Users should stop smoking completely during treatment with Nicotinell Lozenge in combination with Nicotinell Transdermal Patch.More than 20 metabolites have been identified, all believed to be less active than nicotine. The main metabolite is cotinine which has a half-life of 15-20 hours and with approximately 10 times higher plasma concentration than nicotine. Nicotine's plasma-protein binding is less than 5%. Changes in nicotine binding from the use of concomitant medicinal products or due to altered disease state are not expected to have significant effect on nicotine kinetics. The main metabolite in urine is cotinine (15% of the dose) and trans-3-hydroxy cotinine (45% of the dose).

Patients who have been using oral nicotine replacement therapy beyond 9 months are advised to seek additional help and information from health care professionals. 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.Most of the adverse reactions which are reported by patients occur generally during the first 3-4 weeks after initiation of therapy. Signs and symptoms of an overdose from nicotine lozenge would be expected to be the same as those of acute nicotine poisoning, including: weakness, perspiration, pallor, hyperhidrosis, salivation, throat burn, nausea, vomiting, diarrhoea, abdominal pain, hearing and visual disturbances (sensory disturbance), headache, tachycardia and cardiac arrhythmia, dyspnoea, dizziness, tremor, confusional state and asthenia. Prostration, hypotension, circulatory collapse, coma, respiratory failure and terminal convulsions may ensue with large overdoses. 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. 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. 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.