Posology : מינונים

4.2    Posology and method of administration

Children and adolescents (< 18 years)
Nicotinell lozenges should not be used by people under 18 years of age. There is no experience in treating adolescents under the age of 18 with Nicotinell lozenges.

Renal and hepatic impairment:
Use with caution in patients with moderate to severe renal impairment and/or moderate to severe hepatic impairment as the clearance of nicotine or its metabolites maybe decreased with the potential fr increased adverse effects


Posology:
Adults and elderly
Nicotinell Lozenges 1 mg is recommended in smokers with a low to moderate nicotine dependency. It is not recommended in the case of smokers with a strong or very strong nicotine dependency.

Nicotinell Lozenges 2 mg 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 lozenges, the maximum daily dose is 30 lozenges of the low dose form (1 mg lozenge) and 15 lozenges of the high dose form (2 mg lozenge).

Nicotinell lozenges should primarly be used for smoking cessation.

Smoking cessation:
Nicotinell Lozenges 1 mg :
Users should stop smoking completely during treatment with Nicotinell lozenges.
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.

Nicotinell Lozenges 2 mg :
Users should stop smoking completely during treatment with Nicotinell lozenges.

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.


Nicotinell Lozenges 1 mg, 2 mg :
Treatment should be discontinued when the dose has been reduced to 1-2 lozenges per day. Use of nicotine medicinal products like Nicotinell lozenges 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 lozenges 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 lozenges. 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 lozenges 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 - lozenges:
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.