Nicorette 15 mg inhalator - to quit smoking 20 filters

Product Description

Inhalation Solution

Active ingredients

NICORETTE 15 mg inhalation solution Each container contains the active ingredient: nicotine 15 mg.

Excipients: Levomenthol, porous filter.

Therapeutic indications: Treatment for smoking cessation. Relieves withdrawal symptoms. Helps reduce smoking addiction and, consequently, the number of cigarettes smoked.

Contraindications: Hypersensitivity to nicotine or to any of the excipients. NICORETTE should not be administered in the following cases: recent myocardial infarction (within 3 months); unstable or worsening angina pectoris; 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 ad libitum, that is, to be defined on an individual basis, depending on the patient's need to reduce withdrawal symptoms associated with smoking cessation. NICORETTE should be used when the patient feels the urge to smoke a cigarette or when other withdrawal symptoms appear. To effectively control withdrawal symptoms associated with smoking cessation, no fewer than 3 containers per day and no more than 6 containers per day are recommended. NICORETTE should be used like a cigarette to mimic the gestures associated with the habit of smoking. Studies show that different inhalation techniques produce similar effects, deep inhalation (cigarette smoker's style) or shallow inhalation (pipe smoker's style). The amount of nicotine released from one inhalation is less than that from cigarette smoke. If craving relief is not sufficient, increase the frequency and/or size of puffs. Each 15 mg cartridge replaces approximately 7–8 cigarettes. The number, frequency, inhalation/aspiration time, and technique vary individually. The amount of nicotine released by NICORETTE can be reduced in a cold environment. Therefore, it should not be used 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 medicine should not be used for more than 6 months. Paediatric population: Safety and efficacy in children and adolescents under 18 years of age have not yet been established. Method of administration: Inhalation.

Warnings and precautions

Nicotine administration should be temporarily discontinued if any symptoms of overdose occur. If symptoms of nicotine overdose persist, nicotine intake should be reduced, both by reducing the frequency of administration and by lowering the dosage. When starting treatment, the patient should stop smoking immediately. It is important that therapy be supported by other activities to facilitate smoking cessation. Patients who continue to smoke despite treatment with NICORETTE may experience side effects due to higher nicotine concentrations than those obtained with the drug alone. A risk-benefit assessment by a competent physician is necessary for patients with the following conditions: moderate and severe hepatic impairment and/or severe renal impairment. Use with caution in these patients as the clearance of nicotine or its metabolites may be reduced, potentially increasing adverse effects; renal disease and dialysis. Use with caution in such patients who smoke and are undergoing hemodialysis as elevated nicotine levels have been observed; esophagitis and/or gastric or peptic ulcers. Use with caution in these patients as nicotine may worsen the symptoms of these conditions; severe cardiovascular disease (e.g., peripheral occlusive arterial disease, cerebrovascular disease, heart failure), vasospasm, and uncontrolled hypertension or peripheral vascular disease. These patients should be encouraged to quit smoking with non-pharmacological interventions (such as counseling); if this is insufficient, NICORETTE may be considered. Since safety data in this patient group are limited, treatment should only be initiated with caution; uncontrolled hyperthyroidism or pheochromocytoma. Use with caution in these patients as nicotine causes the release of catecholamines; diabetes mellitus. These patients should be advised to monitor blood sugar levels more frequently than usual since, when smoking is stopped and nicotine replacement therapy (NRT) is initiated, nicotine-induced catecholamine release is reduced, which may affect carbohydrate metabolism; chronic throat disease and bronchospasm. Use NICORETTE with caution in such patients. Smoking cessation, with or without nicotine replacement, may alter the pharmacokinetics of some concomitantly administered drugs.

Paediatric population: If a child swallows, chews, or inhales the nicotine cartridge (whether used or unused), there is a risk of poisoning.

Interactions

Clinically relevant interactions between nicotine replacement therapy and other medicinal products have not been definitively established. However, nicotine can potentially enhance the haemodynamic effects of adenosine, such as increased blood pressure, heart rate, and even increased pain response (such as chest pain, angina pectoris) caused by adenosine administration. acetaminophen, caffeine, imipramine, oxazepam, pentazocine, propranolol, theophylline, due to the inhibition of hepatic enzymes; insulin, to increase subcutaneous insulin absorption; adrenergic antagonists (prazosin, labetalol) and adrenergic agonists (isoprenaline, phenylephrine), due to the decrease in circulating catecholamines caused by smoking cessation. In such cases, a dose reduction may be necessary upon cessation of smoking.

Side effects

NICORETTE may cause side effects similar to those associated with nicotine administered by other routes. Most side effects experienced by subjects occur during the initial phase of treatment and are primarily dose-dependent. Mouth and throat irritation may occur, however, most subjects adapt with continued use. Adverse reactions reported in clinical studies The safety of nicotine from clinical studies is based on data from a meta-analysis of randomized clinical trials for smoking cessation treatment.