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72076 Tübingen


Person profile: 07071 29-82311


Fax number: 07071 29-4141


Nicotine lozenges

Application and dosage

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

Dosage options and recommended dosage
Nicotine lozenges are available in two different dosages (2mg and 4mg ingredient).The required initial dosage is initially based on the individual need to relieve withdrawal symptoms. Heavy smokers should use 4mg tablets and less heavy smokers should use the 2mg version. The maximum dosage should not exceed 15 lozenges per day.

The tablets dissolve slowly in the mouth. They should not be chewed or swallowed. After 4-6 weeks, it is advisable to reduce the daily number of nicotine lozenges, e.g. by using them at increasingly longer intervals. The first discontinuation attempt should be made when the average consumption during the preceding week was 1-2 lozenges per day. After 10-12 weeks the consumption of nicotine lozenges should have been stopped. In exceptional cases, nicotine lozenges 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 lozenges 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 lozenges, 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. Also, hypersensitivity to nicotine or any other ingredient in Niktoin lozenges. Non-smokers or occasional smokers who smoke one cigarette per day or less should not use Nicotine Lozenges.

In the presence of the following diseases, nicotine lozenges should be used with special 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 lozenges should also only be used in persons under 18 years of age in consultation with a 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 lozenges 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 an overdose, the use of nicotine lozenges 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 lozenges, if not noticed in time, can be life-threatening for children. Therefore, nicotine lozenges must be kept out of reach of children at all times.

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