Nicotinell Mint 2mg Lozenge 36 pack

Children and adolescents (< 18 years)

Nicotinell lozenge 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 with Nicotinell lozenge.

Adults and elderly

Posology:

Nicotinell Mint 2 mg lozenge 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 (2 mg lozenge), use of the low dose form (1 mg lozenge) should be considered.

The initial dosage should be individualised on the basis of the patients nicotine dependence. One piece of lozenge to suck when the user feels the urge to smoke.

Initially, 1 lozenge should be taken every 1-2 hours. The usual dosage is 8-12 lozenges per day. For smoking cessation and smoking reduction with Nicotinell lozenge, the maximum daily dose is 15 lozenges.

Nicotinell lozenge should primarly be used for smoking cessation.

Smoking cessation:

Users should stop smoking completely during treatment with Nicotinell lozenge.

The treatment duration is individual. Normally, treatment should continue for at least 3 months. After 3 months, the user should gradually reduce the number of lozenges or alternatively the user should switch to nicotine 1 mg lozenges and then gradually reduce the number of lozenges per day. Treatment should be discontinued when the dose has been reduced to 1-2 lozenges per day. Use of nicotine medicinal products like Nicotinell Mint 2 mg lozenge beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the lozenge 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.

Smoking reduction:

Nicotinell lozenge should be used between periods of smoking in order to prolong smoke-free intervals and with the intention of reducing smoking as much as possible. The number of cigarettes should be gradually replaced by Nicotinell lozenge. If a reduction of at least 50 % in the number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought. A quit attempt should be made as soon as the smoker feels ready, but not later than 4 months after start of treatment. After that the number of lozenges should be gradually reduced, for example by quitting one lozenge every 2-5 days. If a quit attempt cannot be made within 6 months after starting treatment, professional advice should be sought. Regular use of Nicotinell lozenge beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the lozenges for longer to avoid returning to smoking.

Counselling may improve the chance for smokers to quit.

Method of administration:

1. One lozenge to be sucked until the taste becomes strong.

2. The lozenge should then be lodged between the gum and cheek.

3. When the taste fades, sucking of the lozenge should commence again

4. The sucking routine will be adapted individually and should be repeated until the lozenge dissolves completely (about 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 sucking the lozenge.

Always read the instructions before use