NICOTINELL MINT Compressed lozenge Ref.[6426] Active ingredients: Nicotine

Nicotinell Mint lozenge 1 mg may be used alone or in combination with Nicotinell transdermal patch.

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

Treatment with Nicotinell Lozenges only.

Nicotinell Mint 1 mg lozenge 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.

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

Treatment with Nicotinell Lozenge in combination with Nicotinell transdermal patch

Smoking cessation

People who have failed when treated with only Nicotinell Lozenge can use Nicotinell patches together with Nicotinell 1 mg lozenge.

Users should stop smoking completely during treatment with Nicotinell lozenge in combination with Nicotinell transdermal patch.

The use of Nicotinell patches together with Nicotinell 1 mg lozenge is recommended for smokers with moderate to very strong dependency, i.e. over 20 cigarettes per day. It is strongly recommended that the combination therapy is used in conjunction with the advice and support from a health care professional.

The maximum total treatment duration is 9 months (for the initial treatment and reduction of nicotine dose)

Initial combination therapy:

Treatment should begin with one patch 21 mg/24 hours in combination with Nicotinell 1mg lozenge. At least 4 pieces of lozenge (1 mg) per day should be used. In most cases, 5-6 lozenges are enough. Not more than 15 pieces of lozenge a day should be used. In normal cases, the treatment may last for 6-12 weeks. Thereafter, the nicotine dose is reduced gradually.

The patch is applied on a clean, dry, hairless, intact area of skin on the trunk, arms or hips. The patch is pressed against the skin for 10-20 seconds.

To minimize the risk of local irritation the placement of Nicotinell patches should be alternated between different application sites.

Hands should be washed thoroughly after application of transdermal patches to avoid irritation of the eyes with nicotine from the fingers.

Reduction of nicotine dose:

This can be done in two ways.

Alternative 1: Use of the patches of a lower strength, i.e. 14 mg/24 hours patches for 3-6 weeks followed by 7 mg/24 hours for another 3-6 weeks together with the initial dose of Nicotinell 1 mg lozenge. Thereafter, the number of lozenges is reduced gradually. It is generally not recommended to use Nicotinell Mint lozenge for longer than 6 months. However, some ex-smokers may need treatment for longer to avoid returning to smoking but it should not be more than9 months.

Alternative 2: Discontinuation of the use of the patches and gradual reduction of the number of 1 mg lozenges. It is generally not recommended to use Nicotinell Mint lozenge for longer than 6 months. However, some ex-smokers may need treatment for longer to avoid returning to smoking but it should not be more than9 months.

Recommended dosage:

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.

In overdose, symptoms corresponding to heavy smoking may be seen.

The acute lethal oral dose of nicotine is about 0.5–0.75 mg per kg body weight, corresponding in an adult to 40–60 mg. Even small quantities of nicotine are dangerous in children, and may result in severe symptoms of poisoning which may prove fatal. If poisoning is suspected in a child, a doctor must be consulted immediately.

Overdose with Nicotinell Mint 1 mg lozenge may only occur if many pieces are sucked simultaneously. Nicotine toxicity after ingestion will most likely be minimised as a result of early nausea and vomiting that occur following excessive nicotine exposure.

General symptoms of nicotine poisoning include: weakness, perspiration, salivation, throat burn, nausea, vomiting, diarrhoea, abdominal pain, hearing and visual disturbances, headache, tachycardia and cardiac arrhythmia, dyspnoea, prostration, circulatory collapse, coma and terminal convulsions.

Treatment of overdose

Treatment of overdose should be immediate as symptoms may develop rapidly. Emesis is usually spontaneous. Administration of oral activated charcoal and gastric lavage should be considered as soon as possible and within 1 hour of ingestion. Monitor vital signs and treat symptomatically.

Shelf life: 2 years.

Do not store above 25°C. Store in the original package.

12, 36, 72, 96, 144 or 204 lozenges in opaque blisters consisting of aluminium foil and PVC/PE/PVDC/PE/PVC-film.

or

24, 72, 96 or 144 lozenges in polypropylene tube with an attached closure cap and an integrated desiccant sleeve of molecular sieve along the inner wall of the tube. Each tube contains 24 lozenges. Packs may contain 1, 3, 4 or 6 tubes.

Not all pack sizes may be marketed.

No special requirements.