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In principle, Nicotinell TTS can cause nicotine side effects similar to those associated with smoking. However, smoking carries additional risks because of the known harmful effects of carbon monoxide, irritant gases, and tar. Since the plasma nicotine concentrations produced by Nicotinell TTS are substantially lower than those produced by smoking, the nicotine side effects during treatment with Nicotinell TTS can be expected to be less marked. However, if the patient continues to smoke while using Nicotinell TTS, the side effects of nicotine may be more frequent and more pronounced.
The following adverse events/withdrawal symptoms were reported in three double-blind clinical trials, irrespective of causal association with Nicotinell TTS (frequency at least 0.5% greater than with placebo).
Skin: Owing to the properties of the active substance, nicotine, Nicotinell TTS may cause mild erythema and pruritus in up to 35% of patients. The incidence of severe erythema, which can be reversed by removing the system, increases from the third week of treatment (up to 8% cases). Allergy, herpes, and rash have been observed in rare cases.
Nicotinell TTS is left on the skin for one day, producing an occlusive effect. This effect can cause skin irritation in the form of dermatitis. As with normal adhesive plasters, reaction may occur as a result of intolerance to the adhesive.
Erythema usually disappears within a few hours of removing the system. To reduce local irritation a different site of application should be chosen each day. Patients with a known history of allergy to adhesive plasters should be carefully monitored for skin reactions during the first few days of treatment.
Central Nervous System: Headache (in about 30% of patients), frequently dizziness, nausea, and sleep disturbances.
Rare: Impaired concentration, abnormal dreaming, fatigue, dry mouth, confusion, migraine, increased sweating, increased appetite.
Cardiovascular system: Rare: Increase in heart rate and blood pressure changes . If the cardiovascular system is already compromised, symptoms of coronary heart disease (e.g. angina pectoris) and/or peripheral arterial occlusive disease (intermittent claudication) could be exacerbated.
Gastrointestinal tract: Rare: Abdominal pain, dyspepsia, vomiting, peptic ulcer, flatulence, dysphagia.
Other organ systems: Frequent: Influenza-like symptoms. Rare: Motor dysfunction, chest pain. Isolated cases of urticaria, angioneurotic oedema, and dyspnoea have been reported.
