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Nicotine sublingual tablets

Application and dosage

Area of application
Support in smoking cessation by alleviating nicotine withdrawal symptoms.

Dosage options and recommended dosage
The nicotine sublingual tablet contains 2mg of ingredient. The initial dosage required is initially based on the individual need to relieve withdrawal symptoms. 1 nicotine sublingual tablet can be used every 1-2 hours. Heavy smokers may also use up to 2 nicotine sublingual tablets per hour, but not more than 40 tablets per day .

The sublingual tablets are placed under the tongue where they slowly dissolve, releasing nicotine. They should not be chewed or swallowed. After 4-6 weeks, it is advisable to reduce the daily number of tablets, e.g. by using them at increasingly longer intervals. The first discontinuation attempt should be made when the average consumption during the previous week was 1-2 tablets per day. After 10-12 weeks, the consumption of nicotine sublingual tablets should have been stopped. In exceptional cases, nicotine sublingual tablets may still be used after this time in situations where there is a strong desire to smoke. Treatment lasting longer than six months is generally not recommended.

General information

Nicotine sublingual tablets should not be used in diseases and circumstances where the generally expected benefit is not in favourable proportion to any possible harm.

When using nicotine sublingual tablets, this applies to the following conditions: Heart attack within the last three months, severe cardiac arrhythmia, Prinzmetal's angina (spastic, seizure-like narrowing of the coronary arteries), recent stroke, worsening narrowing of the coronary arteries. In addition, hypersensitivity to nicotine or any other ingredient in Niktoin Sublingual Tablets. Non-smokers or occasional smokers who smoke one cigarette per day or less must not use Nicotine Sublingual Tablets

In the presence of the following diseases, nicotine sublingual tablets should be used with particular caution and in consultation with the doctor: stable constriction of the coronary arteries (angina pectoris), severely elevated blood pressure, cerebrovascular disease, circulatory disorders of the arms and legs, severe heart weaknesshyperthyroidism, diabetes mellitus, acute stomach or intestinal ulcers, severe liver or kidney damage, tumours of the adrenal medulla (pheochromocytoma). Nicotine sublingual tablets should also only be used in persons under 18 years of age in consultation with the doctor.

Smoking is harmful to the health of the mother and the unborn child. The consequences can be: low birth weight, increased risk of miscarriage and increased infant mortality. Nicotine also passes into breast milk and is absorbed by the baby. In general, therefore, smoking should be avoided during pregnancy and nicotine should be avoided.

Pregnant smokers should therefore definitely try to give up smoking without the support of nicotine-containing medication. Only if this is unsuccessful and there is a risk of continued smoking should the use of nicotine substitutes be considered in consultation with the doctor.

There may be basically similar nicotine side effects to smoking (headache, dizziness, nausea, increase in heart rate, transient mild increase in blood pressure). The following side effects have been reported:

Affected siteFrequencySide effects
Nervous System
Common (>1/100)
Headache, dizziness, occasionally anxiety.
Gastrointestinal tract
Common (>1/100)

Constipation, diarrhea, abdominal pain, hiccups, nausea, vomiting.

Local side effects
Common (>1/100)
Irritation in the mouth and throat area, aphthae in the oral mucosa.
Circulatory system
Rare (1/100 -1/1000)
Palpitations.
Very rarely (<1/1000)
Cardiac arrhythmias.
Skin
Rarely (1/100 -1/1000)
Hives.
Other
Very rare (<1/1000)
Allergic reactions such as swelling.

Tobacco smoking causes an increase in the activity of a certain metabolic protein in the liver (cytochrome CYP1A2). After cessation of smoking, the breakdown of other substances that are also metabolised via this pathway may slow down. This can lead to an increase in blood concentrations of various drugs, which is clinically significant for agents with a narrow therapeutic range (e.g. theophylline, tacrine, cloazapine). If you are taking any medicines, always consult your doctor to see whether they may interact with nicotine replacement therapy and whether a dose adjustment may be necessary.

Nicotine overdose may occur if nicotine sublingual tablets have been used in excessive amounts or if nicotine is supplied by other means during use. In addition, overdoses may occur more rapidly in nonsmokers and in smokers who are only mildly addicted to tobacco (less than 10 cigarettes per day).

The symptoms of overdoses are similar to those seen with excessive smoking: Dizziness, faintness, nausea, cold sweats, vomiting, and diarrhea. In cases of poisoning from an overdose or from use in children, other symptoms may include a drop in blood pressure and temperature, shortness of breath, hearing and vision problems, weak and irregular pulse, and convulsions. If there are signs of overdose, the use of nicotine sublingual tablets should be discontinued immediately. The symptoms disappear within a few hours as the level of nicotine in the blood decreases. In case of severe poisoning, emergency measures must be taken immediately and a doctor must be consulted.

Nicotine is a highly toxic substance for non-smokers and children. Even a dosage that is well tolerated by adults can lead to severe symptoms of poisoning in young children, i.e. the ingestion of nicotine sublingual tablets, if not noticed in time, can be life-threatening for children. Therefore, nicotine sublingual tablets must be kept out of reach of children at all times.

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