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The patient should be urged to stop smoking completely when using Nicotinell TTS. Patients should be informed that if they continue to smoke while using Nicotinell TTS, they may experience increased adverse effects due to the hazards of smoking, including cardiovascular effects.
Given the pharmacological effects of nicotine, the use of Nicotinell TTS calls for careful weighing of the risks and benefit before it can be considered in patients with the following diseases: Stable angina pectoris, status postmyocardial infarction, occlusive peripheral arterial diseases, cerebrovascular diseases, arrhythmias, heart failure, disturbance of renal or hepatic function, diabetes mellitus, hypertension, hyperthyroidism, peptic ulcer.
Allergic reactions: In clinical studies, contact sensitivity occurred in a few patients when using transdermal nicotine. In such cases, it should be noted that contact sensitivity may recur when other nicotine-containing products, including tobacco, are used.
Intermittent Use: There is no insufficient data on the intermittent use of Nicotinell TTS. However, in case of chronic insomnia, the patch can be removed after 16 hours.
Use in Pregnancy and Lactation: No controlled studies in pregnant women are available. Nicotine passes into the breast milk; Nicotinell TTS should not be used during pregnancy and breast feeding without physician or pharmacist advice.
Use in Children: Safety Note Concerning Children: Nicotine is highly toxic substance. Even the dose tolerated by adults during treatment can produce severe symptoms of poisoning in small children. In other words, application of Nicotinell TTS in play can be fatal for children if not noticed on time. Nicotinell TTS must therefore be kept out of the reach of children at all times.
To protect children, Nicotinell TTS is sealed in a child-resistant sachet. This sachet should be opened immediately before use with a pair of scissors, taking care that the patch inside is not damaged.
The patches still contain nicotine after use and must be disposed of so that they do not fall into children's hands.
