Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

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 nonpharmacological 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 lozenges dose should be reduced or discontinued.

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.
Diabetes mellitus:blood glucose levels may be more varible dusring smoking cerssation, with or without nicotine replacement therapy. So, it is important for diabetics to closely monitor their blood glucose levels while using this product.

Renal and hepatic impairment: moderate to severe hepatic and/or severe renal impairment.

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.

Patients should initially be encouraged to stop smoking with nonpharmacological interventions (such as counselling).
Gastrointestinal disease: Swallowed nicotine may exacerbate symptoms in subjects suffering from active oesophagitis, oral and pharyngeal inflammation, gastritis or peptic ulcer.

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).

Special warnings about excipients
Nicotinell lozenges contains:aspartame and maltitol and Sodium.
Each Nicotinell lozenge contains 10 mg aspartame, a source of phenylalanine and may be harmful for people with phenylketonuria.

Because Nicotinell lozenges contains maltitol, 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 lozenges contains 9.8 mg of sodium per piece.

Effects on Driving