“Active ingredients
NICORETT 15 mg inhalation solution. Each container contains the active substance: nicotine 15 mg.
Excipients: levomenthol, porous filter.
Contraindications: Hypersensitivity to nicotine or to any of the excipients. NICORETT should not be prescribed in the following cases: recent myocardial infarction (within 3 months); unstable or exacerbated angina; Prinzmetal’s angina; severe cardiac arrhythmia; acute stroke; children and adolescents under 18 years of age; pregnancy and breastfeeding; non-smokers.
Dosage
Adults and the elderly. The dose is prescribed ad libitum, i.e. determined individually depending on the patient’s need to reduce the withdrawal syndrome associated with quitting smoking. NICORETTE should be used whenever the patient feels the urge to smoke a cigarette or when other withdrawal symptoms occur. For effective control of withdrawal symptoms associated with smoking cessation, at least 3 and no more than 6 containers should be used per day. NICORETTE should be used like a cigarette to imitate the gestures associated with smoking. Research shows that different inhalation techniques produce the same effect: deep inhalation (cigarette smoker’s technique) or shallow inhalation (pipe smoker’s technique). The amount of nicotine released by inhalation is lower than with cigarettes. If craving relief is not sufficient, increase the frequency and/or size of puffs. Each 15 mg cartridge replaces approximately 7-8 cigarettes. The amount, frequency, inhalation/aspiration time and technique vary individually. The amount of nicotine released by NICORETTE may be reduced in a cold environment. Therefore, it should not be used at temperatures below 15°C. The recommended duration of treatment is 3 months. After this period, the daily dose should be gradually reduced over the next 6-8 weeks. The drug should not be used for more than 6 months. Children. Safety and efficacy in children and adolescents under 18 years of age have not been established. Method of administration: Inhalation route.
Warnings and precautions
Nicotine intake should be temporarily discontinued if any symptoms of overdose occur. If symptoms of nicotine overdose persist, nicotine intake should be reduced either by frequency of intake or by reducing the dosage. When starting treatment, the patient should immediately quit smoking. It is important that therapy is supported by other activities that promote smoking cessation. Patients who continue to smoke despite NICORETTE therapy may experience side effects due to higher nicotine concentrations than those taking this drug alone. Benefit-risk assessment by a competent physician is necessary for patients with the following conditions: moderate to severe liver failure and/or severe renal failure. Use with caution in these patients as clearance of nicotine or its metabolites may be reduced with potential for increased adverse effects; renal disease and dialysis. Use with caution in these patients who are smokers and undergoing haemodialysis as high nicotine levels have been observed. esophagitis and/or gastric ulcer or peptic ulcer. Use with caution in these patients as nicotine may worsen symptoms of these conditions; serious cardiovascular disease (e.g. peripheral arterial occlusive disease, cerebrovascular disease, heart failure), vasospasm and uncontrolled hypertension or peripheral vascular disease. These patients should be encouraged to quit smoking using non-pharmacological interventions (e.g. counselling); if this is insufficient, NICORETTE may be considered. As safety data in this patient group are limited, treatment should be initiated with caution; uncontrolled hyperthyroidism or pheochromocytoma. Use with caution in these patients, since nicotine causes the release of catecholamines; diabetes mellitus. These patients should be advised to monitor their blood sugar levels more often than usual, since when smoking is stopped and nicotine replacement therapy (NRT) is started, nicotine-induced catecholamine release is reduced and this may affect carbohydrate metabolism. chronic throat diseases and bronchospasms. NICORETTE should be used with caution in these patients. Smoking cessation, with or without nicotine replacement, may alter the pharmacokinetics of some concomitantly administered drugs.
Children If a child swallows, chews or aspirates a nicotine cartridge (used or unused), there is a risk of poisoning.”
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