In this manual :
1. WHAT IS NICOPASS 1.5 mg SUGAR-FREE MINT, lozenge sweetened with aspartame and acesulfame potassium AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING NICOPASS 1.5 mg SWEET MINT, lozenge sweetened with aspartame and acesulfame potassium?
3. HOW DO I TAKE NICOPASS 1.5 mg SUGAR-FREE SWEET MINT, lozenge sweetened with aspartame and acesulfame potassium?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE NICOPASS 1.5 mg SUGAR-FREE SWEET LIGHT, lozenge sweetened with aspartame and acesulfame potassium?
6. ADDITIONAL INFORMATION
1. WHAT IS NICOPASS 1.5 mg SUGAR-FREE SWEET LETTER, sweetened with aspartame and acesulfame potassium AND WHEN IS IT USED?
Pharmacotherapeutic class
Not applicable.
This medicine is indicated for the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in subjects wishing to stop smoking.
Although permanent cessation of smoking is preferred, this drug may be used in:
- cases where a smoker is temporarily abstaining from smoking,
- a smoking reduction strategy as a step towards permanent cessation.
2. WHAT YOU SHOULD KNOW BEFORE TAKING NICOPASS 1.5 mg SUGAR-FREE MINT, lozenge sweetened with aspartame and acesulfame potassium
List of information needed before taking the medicine
Not applicable.
Do not take NICOPASS 1.5 mg SWEET MINT, 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), because of the presence of aspartam.
In case of doubt, it is essential to seek the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take care with NICOPASS 1.5 mg SWEET MINT, lozenge sweetened with aspartame and acesulfame potassium
Special Warnings
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As part of a "complete stop smoking", the use of this drug must be accompanied by a total interruption of tobacco consumption Read the health education advice carefully.
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Some diseases require medical examination and monitoring before using this medicine. For example, in case of:
- severe liver and/or kidney failure,
- ulcer of the stomach or duodenum in progress.
It is essential to consult your doctor before using this medicine.
It is imperative that you keep the lozenges out of the reach of children.
Indeed, the therapeutic dose intended for adults could cause serious or even fatal poisoning in children.
Precautions for use
- Certain signs indicate an underdose. If you feel, despite the treatment, a sensation of withdrawal such as
o urge to smoke,
o irritability, sleep disturbances,
o agitation or impatience,
o difficulty in concentrating,
consult your doctor or pharmacist. It may be necessary to change the dosage of the medication.
- Certain signs may indicate an overdose: if signs of overdose appear, i.e:
o nausea, abdominal pain, diarrhea,
o hypersalivation,
o sweating, headache, dizziness, hearing loss,
o general weakness,
it is imperative to adapt the treatment with the help of your doctor or pharmacist.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Quitting smoking may affect the way some medicines work: talk to your pharmacist or doctor.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy
It is very important to stop smoking during your pregnancy for you and your child.
Smoking cessation during pregnancy requires medical advice and monitoring, and should be attempted 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 plan to stop smoking, you should not breastfeed your child but use artificial milk.
The use of this medicine should be avoided while breast-feeding, as 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 at a centre specialising in smoking cessation.
Not applicable.
Effects on ability to drive and use machines
Driving and using machines
Smoking cessation may cause behavioural changes. At the recommended doses, there is no particular risk associated with NICOPASS.
List of excipients with a known effect
Important information about some of the ingredients of NICOPASS 1.5 mg SWEET MINT, lozenge sweetened with aspartame and acesulfame potassium
Notable excipients: aspartam (source of phenylalanine) (E951).
3. HOW TO TAKE NICOPASS 1.5 mg SUGAR-FREE SWEET LETTER, sweetened with aspartame and acesulfame potassium
Instructions for proper use
The 1.5 mg lozenges are not suitable for smokers who are strongly or very strongly dependent on nitonine (Fagerström test score of 7 to 10) see chapter "Health education advice".
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Whatever the method of use, do not exceed 30 tablets per day.
For adults only (15 years and older).
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 see "Health Education Tips" section).
Quitting smoking completely
Treatment of nicotine addiction is usually done in 2 phases.
1st phase
Suck a lozenge each time the urge to smoke arises.
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 desire to smoke is completely overcome, gradually reduce the number of lozenges sucked per day. The treatment will be stopped when the consumption is reduced to 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 abstinence from smoking
Suck a lozenge each time the urge to smoke arises.
The number of 1.5 mg lozenges to be sucked is generally 8 to 12 per day and should not 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 as long as possible.
The number of lozenges to suck is variable 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 a complete stop of smoking.
This cessation should be attempted as soon as possible within 6 months of starting 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
BY MOUTH.
The lozenge should be placed in the mouth where it will gradually dissolve. 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 or swallowed.
Do not eat or drink while the lozenge is in your mouth.
Duration of treatment
The duration of treatment should not exceed 12 months.
In case of persistent craving or difficulty in stopping the drug, consult your doctor.
Symptoms and instructions in case of overdose
If you have taken more NICOPASS 1.5 mg SUGAR-FREE SWEET LETTER 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 PHYSICIAN OR EMERGENCY SERVICE.
Small amounts of nicotine are dangerous for children.
Severe intoxication may occur and manifest itself as hypotension, weak and irregular pulse, difficulty breathing, prostration, cardiovascular collapse and convulsions, which may lead to death.
If NICOPASS 1.5 mg Lozenges are used in combination with a transdermal device, refer to the package insert for each medication.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, NICOPASS 1.5 mg SUGAR-FREE SWEET MINT, lozenge sweetened with aspartame and acesulfame potassium is likely to have undesirable effects, although not everyone is subject to them.
At the beginning of treatment, irritation of the mouth may be experienced.
Other reported side effects are: headache, dizziness, nausea, digestive disorders, hiccups, sore throat, redness of the skin, urticaria, palpitations.
More rarely: heart rhythm disturbances or allergic reactions may occur.
Dizziness, headaches, sleep disorders, mouth ulcers may be related to stopping smoking and not to your treatment.
If NICOPASS 1.5 mg Lozenges are used in combination with a transdermal device, please refer to the package insert for each medication.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE NICOPASS 1.5 mg SUGAR-FREE MINT, lozenge sweetened with aspartame and acesulfame potassium?
Keep out of the reach and sight of children.
Do not use NICOPASS 1.5 mg SUGAR-FREE MINT, lozenge sweetened with aspartame and acesulfame potassium after the expiry date stated on the box.
Store at a temperature not exceeding 30°C.
Store in the outer packaging in a dry place.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does NICOPASS 1.5 mg SUGAR-FREE MINT contain, a lozenge sweetened with aspartame and acesulfame potassium?
The active substance is:
Nicotine .......................................................................................................................................... 1.50 mg
In the form of nicotine catioresin carboxylate ............................................................................. 8.33 mg
For one lozenge.
Other components are:
Isomalt, hypromellose, aspartam, acesulfame potassium, peppermint flavour IFF 13-571-016, long lasting fresh mint flavour IFF 13-627-517, permaseal masking flavour GIVAUDAN 1 1031-31, sodium bicarbonate, anhydrous sodium carbonate.
Pharmaceutical form and content
What is NICOPASS 1.5 mg SUGAR-FREE MINT, lozenge sweetened with aspartame and acesulfame potassium and what does it contain?
This medicine comes in the form of lozenges. Boxes of 12, 24, 36, 48, 60, 72, 84, 96 or 144 tablets.
All presentations may not be marketed.
Name and address of the marketing authorization holder and of the manufacturing authorization holder responsible for batch release, if different
Holder
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92654 BOULOGNE CEDEX
Operator
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
Z.I. DE LA COUDETTE
32290 AIGNAN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
ADVICE / HEALTH EDUCATION
As soon as you stop smoking:
- You will no longer absorb the irritating and toxic substances of cigarettes,
- You may notice some improvements: gradual disappearance of headaches, coughing, throat irritation, shortness of breath,
- You will often have the satisfaction of finding a better sleep, the taste of food, smells and improve your physical performance,
- You will reduce your risk of developing lung cancer or cardiovascular disease.
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It's never too late to quit smoking, even if you've smoked a lot and for a long time.
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What is tobacco addiction?
Tobacco addiction is twofold:
- Psychological dependence:
Smoking a cigarette leads to a ritual of automatic and repetitive gestures associated with particular circumstances (pleasure, response to stress, intellectual stimulation, support for morale, need for the gesture of conviviality). This is psychological and behavioural dependence.
- Physical dependence:
The body's need for nicotine is due to the effects of this substance on the nervous system. This is called physical dependence. Failure to satisfy this need leads to a feeling of withdrawal (see description in the chapter "How to overcome your physical dependence?").
Nicotine substitutes are designed to treat this dependence.
How to overcome your psychological dependence?
- Quitting smoking completely is necessary to increase your chances of success:
o Choose a D-day in the period that seems most favorable to you.
o Throw away your last pack of cigarettes, your lighter and put away your ashtrays.
o In a couple of smokers, it is preferable that the attempt to quit is made at the same time by both spouses.
- Tell your family and co-workers that you are quitting smoking. Ask them to respect your decision (not to smoke near you, not to offer you any more cigarettes).
- Prepare yourself to face the desire to smoke. It can come on suddenly and intensely, especially during the first few weeks after you stop smoking, but it should not last more than 3 or 4 minutes.
You must plan what you will do in this case and act very quickly so as not to "crack", for example
o drink a large glass of water,
o chewing gum,
o count to 100,
o take a few deep breaths,
o leave the room,
o change activity...
- Avoid situations associated with smoking (coffee, aperitif, etc.), avoid temptations (sit with non-smokers).
Find compensations for smoking (leisure, sport, cultural activities...).
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