NICOPASS 1.5mg SUGAR-FREE EUCALYPTUS lozenge, sweetened with aspartame and acesulfame potassium, is indicated for the treatment of tobacco dependence to relieve nicotine withdrawal symptoms in individuals who wish to quit smoking.
Although permanent cessation of smoking is preferred, this medicine can be used in:
- cases where a smoker is temporarily abstaining from smoking.
- a smoking reduction strategy as a step towards permanent cessation.
The active substance is: nicotine 1.5mg as nicotine catioresin carboxylate 8.33mg.
The other ingredients are: isomalt (E 953), hypromellose (E 464), aspartam (E 951), acesulfame potassium, sodium bicarbonate, anhydrous sodium carbonate, flavouring with natural mint and eucalyptus extracts (trans-anethole, eucalyptol, L-menthol), Permaseal Givaudan masking flavouring (natural flavouring substances, maltodextrin, gum arabic, propylene glycol)
Notable excipient: aspartam.
Dosage
The 1.5 mg lozenges are not suitable for smokers who are strongly or very strongly dependent on nicotine (Fagerström test score of 7 to 10).
For adults over 15 years of age only.
Whatever the method of use, do not exceed 30 lozenges per day. For adults only (15 years and older).
Complete cessation of smoking: the treatment of nicotine dependence is usually done in 2 phases.
1st phase: suck a lozenge each time the desire to smoke appears. The number of lozenges to be sucked at a dose of 1.5 mg is generally 8 to 12 per day and should not exceed 30 lozenges per day. The duration of this phase is about 3 months, but may vary according to individual response.
2nd phase: when the urge to smoke is completely overcome, gradually reduce the number of lozenges sucked per day. The treatment will be stopped when the consumption is reduced by 1 to 2 lozenges per day. It is recommended not to use the lozenges for more than 12 months. If at the end of your treatment you continue to experience cravings or if your treatment has failed, CONSULT YOUR DOCTOR. He may advise you to combine the lozenges with a form that delivers nicotine throughout the day; a transdermal device. Suck a lozenge each time the urge to smoke appears despite treatment with a transdermal device. The number of lozenges to suck per day varies and depends on your needs. Generally, the number of lozenges to suck is 5 to 6 per day. Gradually reduce the number of 1.5 mg lozenges used per day during withdrawal.
Temporary absence from smoking: suck a lozenge each time the desire to smoke appears. The number of 1.5 mg lozenges used per day is usually 8 to 12 mg and should never exceed 30 lozenges per day.
Smoking reduction: If possible, alternate nicotine lozenges with cigarettes. Suck on a lozenge when the urge to smoke arises, to remain smoke-free for as long as possible. The number of lozenges to suck per day varies and depends on your needs. However, it should not exceed 30 lozenges per day. If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, it is recommended to seek advice from a health professional. The reduction in tobacco consumption should lead you progressively to complete cessation of smoking.
This cessation should be attempted as soon as possible within 6 months of the start of treatment. If, after 9 months of treatment, the attempt to stop smoking completely has failed, it is recommended not to use the lozenges beyond 12 months
Method of administration For more information, please contact:
The lozenge must be placed in the mouth where it will dissolve gradually. It should be moved regularly from one side of the mouth to the other until it is completely dissolved. The matrix structure of the lozenges has been designed to ensure that they dissolve in approximately 30 minutes, allowing for a gradual release of nicotine and thus slow absorption of nicotine into the oral mucosa. Therefore, they should not be chewed and swallowed. Do not drink or chew while the lozenge is in your mouth
Duration of treatment The total duration of treatment should not exceed 12 months.
If you experience persistent cravings or have difficulty stopping this medicine, consult a doctor.
If you have taken more NICOPASS 1.5 mg SUGAR-FREE EUCALYPTUS lozenge sweetened with aspartame and acesulfame potassium than you should have: In case of accidental overdose or if a child swallows one or more lozenges, contact a doctor or an emergency service. Indeed, small quantities of nicotine are dangerous for children. Serious intoxication may occur and manifest itself as hypotension, weak and irregular pulse, difficulty breathing, prostration, cardiovascular collapse and convulsions, which may be fatal.
If NICOPASS 1.5 mg Lozenges are used in combination with a transdermal device, refer to the package insert for each medication
Never take NICOPASS 1.5 mg SUGAR-FREE EUCALYPTUS, lozenge sweetened with aspartame and acesulfame potassium:
- if you do not smoke or if you are an occasional smoker,
- in case of allergy to one of the constituents,
- in case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartam.
IN CASE OF DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST
Warnings For more information:
As part of a "complete stop to smoking", the use of this medicine must be accompanied by a total cessation of tobacco consumption. Read the health education advice carefully.
Some diseases require an examination and medical follow-up before using the medicine. For example, in case of :
- severe hepatic and/or renal insufficiency,
- ulcer of the stomach or duodenum in progress.
It is essential to consult your doctor before using this medicine.
It is imperative to keep pastilles to suck out of the reach of children.
Indeed, the therapeutic dose intended for adults could cause intoxication, even fatal in children
Precautions for use :
Some signs indicate an underdose. If you feel, despite the treatment, a sensation of withdrawal, such as:
- urge to smoke,
- irritability, sleep disorders,
- restlessness or impatience,
- difficulty in concentrating.
Consult your doctor or your pharmacy. It may be necessary to change the dosage of the medication.
Certain signs may indicate an overdose; if signs of overdose appear, i.e. nausea, abdominal pain, diarrhea, hypersalivation, sweating, headache, dizziness, hearing loss, general weakness.
It is imperative that you adopt the treatment with the help of your doctor or pharmacist.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE
Pregnancy :
It is very important to stop smoking during your pregnancy for your and your child. Quitting smoking during pregnancy requires medical advice and follow-up and should be attempted first without nicotine replacement.
You should therefore consult the doctor who is following your pregnancy or your usual doctor or a doctor in a centre specialising in smoking cessation
Breastfeeding
If you are a heavy smoker and do not intend to stop smoking, you should not breastfeed your child, but use artificial milk.
The use of this medicine should be avoided while breastfeeding because nicotine passes into breast milk.
However, if you wish to stop smoking and breastfeed your child, take the advice of your doctor or a doctor in a centre specialising in smoking cessation
Driving and use of machines Cessation of smoking may cause changes in behaviour. At the recommended doses, there is no risk associated with NICOPASS.
Notable excipient: aspartam (source of phenylhalanine) (E951), isomalt
Taking or using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, even if it is obtained without a prescription. Quitting smoking may change the way some medications work. Talk to your pharmacist or doctor.
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