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72076 Tübingen


Person profile: 07071 29-82311


Fax number: 07071 29-4141


Nicotine gum

Application and dosage

Field of application
Treatment of tobacco dependence by alleviating nicotine withdrawal symptoms.

Dosage options and recommended dosage
Nicotine gum is available in two different dosages, as 2 mg or as 4 mg gum. The initial dosage required is initially based on the individual need to relieve withdrawal symptoms. The recommended dosage is one 4 mg gum per hour, with a maximum of 16 pieces per day. This is especially true for smokers who are more addicted to nicotine (a smoker can be considered more addicted to nicotine if he or she smokes the first cigarette within 20 minutes of getting up and more than 20 cigarettes a day) and for smokers who continued to suffer withdrawal symptoms with a 2 mg gum.

A nicotine gum should be chewed slowly over about 30 minutes to release all the nicotine from the chewing mass. In this process, the nicotine is absorbed into the body primarily through the oral mucosa. It should be avoided to chew the gum quickly or intensively, so that the nicotine is not released too quickly from the chewing mass.

After 4-6 weeks, it is advisable to gradually reduce the daily number of chewing gums, e.g. by chewing the gum at increasingly longer intervals. The first discontinuation attempt should be made when the average daily consumption during the preceding week was 1-2 chewing gums. A treatment lasting longer than 6 months is generally not recommended.

General information

Nicotine chewing gum 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 gum, this applies to the following conditions: recent heart attack, severe cardiac arrhythmia, Prinzmetal's angina (spastic and seizure-like narrowing of the coronary arteries), recent stroke, worsening narrowing of the coronary arteries. Also in case of hypersensitivity to nicotine or any other ingredient of the chewing gum. Non-smokers or occasional smokers who smoke one cigarette per day or less must not use nicotine gum.

In the presence of the following diseases, nicotine gum 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 cardiac insufficiency, hyperthyroidismDiabetes mellitus, acute stomach and intestinal ulcers, hyperthyroidism, severe liver or kidney damage, tumours of the adrenal medulla (pheochromocytoma). Nicotine gum should also only be used in persons under the age of 18 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 infant. In general, therefore, smoking should be avoided during pregnancy and nicotine should be abstained from.

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 treatment with 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
Gastrointestinal tract
Common (>1/100)

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

Local side effects
Common (>1/100)
Irritation of the mouth and throat, pain in the muscles of mastication, aphthae in the mucous membrane of the mouth. Chewing gum may adhere to and damage dentures.
Circulatory system
Rarely (1/100 -1/1000)
Palpitations
Very rare (<1/1000)
Cardiac arrhythmia
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, clozapine). If you are taking any medicines, always ask your doctor whether they may interact with nicotine replacement therapy and whether a dose adjustment may be necessary.

Nicotine overdose may occur if nicotine gum is used in excessive amounts or if nicotine is supplied by other means during use. In addition, overdoses are more likely to occur in non-smokers and in smokers who are only mildly addicted to tobacco (more than 10 cigarettes per day).

The symptoms of overdoses are similar to those that occur 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 the chewing gum should be discontinued immediately. The symptoms disappear within a few minutes as the nicotine level in the blood decreases. In case of severe poisoning, emergency measures must be taken immediately and a doctor must be consulted.

Denture wearers may have difficulty chewing the nicotine gum because of its adhesive properties, making it impossible to use in some cases. Dental fillings or inlays that are not properly fixed may become further loose when the gum is chewed. 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 gum can be life-threatening for children if it is not noticed in time. Therefore, nicotine gum must be kept out of reach of children at all times.

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