Adults and elderly
Users should stop smoking completely during treatment with Nicotinell medicated chewing-gum.
The 4 mg medicated chewing-gum is intended to be used by smokers with a strong or very strong nicotine dependency and those who have previously failed to stop smoking with the aid of nicotine replacement therapy.
The optimal dosage form is selected according to the following table:
If an adverse event occurs with the use of the high dose form (4 mg medicated chewing-gum), use of the low dose form (2 mg medicated chewing-gum) should be considered.
The initial dosage should be individualised on the basis of the patient's nicotine dependence.
One piece of Nicotinell medicated chewing-gum to be chewed when the user feels the urge to smoke.
If Nicotinell 4 mg medicated chewing-gum is selected, normally use 8-12 pieces per day, up to a maximum of 15 pieces per day.
The characteristics of medicated chewing-gum as a pharmaceutical form are such that individually different nicotine levels can result in the blood. Therefore, dosage frequency should be adjusted according to individual requirements within the stated maximum limit.
The treatment duration is individual. Normally, treatment should continue for at least 3 months.
After 3 months, the users should gradually reduce the number of pieces chewed each day until they have stopped using the product.
Treatment should be discontinued when the dose has been reduced to 1-2 pieces of medicated chewing-gum per day. Use of nicotine medicinal products like Nicotinell medicated chewing-gum beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the medicated chewing-gum for longer to avoid returning to smoking. Patients who have been using oral nicotine replacement therapy beyond 9 months are advised to seek additional help and information from health care professionals.
Counselling may help smokers to quit.
Nicotinell medicated chewing-gum should not be used by people under 18 years of age without recommendation from a physician. There is no experience in treating adolescents under the age of 18 years with Nicotinell medicated chewing-gum.
Method of administration
1. One piece of medicated chewing-gum should be chewed until the taste becomes strong.
2. The medicated chewing-gum should be rested between the gum and cheek.
3. When the taste fades, chewing should commence again.
4. The chewing routine should be repeated for 30 minutes.
Concomitant use of acidic beverages such as coffee or soda may decrease the buccal absorption of nicotine. Acidic beverages should be avoided for 15 minutes prior to chewing the medicated chewing-gum.