French pharmacy
0
French pharmacy
Adult: Max 15 lozenges per day
For warnings, precautions for use and contraindications, please consult the instructions for use.
This medication is indicated for the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in subjects addicted to nicotine and wishing to stop their smoking.
Although stopping smoking altogether is preferable, this medication can be used in:
2.5 mg lozenges are suitable for smokers who are highly or very strongly addicted to nicotine
The active substance is :
Nicotine. 2.50 mg
In the form of nicotine resinate. 13.88 mg
The other ingredients are : Isomalt, hypromellose, aspartame, acesulfame potassium, peppermint flavor, long-lasting fresh mint flavor (including soybean oil), permaseal masking flavor, sodium bicarbonate, anhydrous sodium carbonate.
Excipients with known effect : aspartame (source of phenylalanine) (E951), soybean oil.
Adults and children over 15 years of age.
Complete smoking cessation: Treatment of nicotine addiction is usually done in 2 phases:
If after 6 months after the start of treatment, the attempt to quit smoking completely has failed, it is recommended to consult a doctor. Without results after 9 months of treatment, it is recommended to consider another strategy.
Temporary abstinence from smoking: Suck a lozenge whenever the urge to smoke appears. The number of 2.5 mg lozenges to be used is generally 8 to 12 per day and should in no case exceed 15 lozenges per day.
Tobacco reduction: If possible, alternate nicotine lozenges and cigarettes. Suck on a lozenge when the urge to smoke appears, to stay as long as possible without smoking. Use a sufficient number of lozenges daily without exceeding 15 lozenges per day.
Gradually continue to try to decrease your cigarette consumption, if possible until you stop completely. When you have not smoked for a few weeks, gradually reduce the number of lozenges sucked per day. Treatment will be stopped when consumption is reduced to 1 to 2 lozenges per day.
Contraindications:
Warnings :
In the context of a "complete cessation of smoking", the use of this drug must be accompanied by a total cessation of tobacco consumption.
Certain illnesses require examination and medical follow-up before using this medication. Thus, in the event of :
It is essential to consult your doctor before using this medication.
It is imperative to keep the lozenges out of the reach of children.
In fact, the therapeutic dose intended for adults could cause serious or even fatal intoxication in children.
Precautions for use:
Certain signs indicate an under-dosage . If you feel, despite the treatment, a feeling of "lack", such as:
Certain signs may indicate an overdose : in the event of the appearance of signs of overdose, that is to say:
It is imperative to adapt the treatment using the advice of your doctor or pharmacist.
Driving and using machines:
Quitting smoking can cause behavioral changes. At the recommended doses, there is no particular risk associated with Nicopass fresh mint 2.5 mg sugar-free, lozenge sweetened with aspartame and acesulfame potassium.
Storage:
Duration of treatment :
The duration of treatment should not exceed 6 months.
In case of persistence of the feeling of withdrawal or in case of difficulties to stop this drug, consult your doctor.
Method of administration: Oral route.
The lozenge should be placed in the mouth where it will gradually dissolve. It must be regularly moved from one side of the mouth to the other, until complete dissolution. The matrix structure of the lozenge has been designed to dissolve in approximately 30 minutes, thus allowing a gradual release of nicotine and therefore a slow absorption of it in the oral mucosa.
Consequently, it should not be chewed or swallowed. Do not eat or drink while the lozenge is in the mouth.
Read the instructions before use.
To increase your chances of success, read the instructions carefully and in particular the health education advice at the end.
3 6 lozenges to suck.
By composition, Nicorelay does not cause dependence or addiction.
Suck 6 to 10 lozenges per day each time you want to decompress as part of a balanced diet.
Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 11/05/2017
NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, sweetened with aspartame and with potassic acesulfame
Nicotine
You should always take this medication by strictly following the information provided in this leaflet or by your doctor or pharmacist
AT· Keep this leaflet. You might need to read it again.
AT· Contact your pharmacist for advice or information.
AT· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. See section 4.
AT· If you experience difficulty or if you do not manage to quit smoking within 6 months, consult your doctor or pharmacist
Do not allow this medication to reach children.
1. What is NICOPASS MINT FRESHENER 2.5 mg SUGAR-free , aspartame-sweetened and potassium-acesulfame tablet and in which cases is it used?
2. What information should I take before taking NICOPASS MENTHE FRESHNESS 2.5 mg WITHOUT SUGAR, aspartame-sweetened tablet and potassium-sulphate?
3. How to take NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, sweetened with aspartame and potassium acesulfame?
4. What are the possible undesirable effects?
5. How to store NICOPASS FRESHNESS MINT 2.5 mg SUGAR-free, aspartame-sweetened tablet and potassium-sulphate?
6. Contents of the package and other information.
Pharmacotherapeutic group: Medicines used in nicotine addiction.
ATC code: N07BA01
Reserved for adults and teenagers over 15 years old.
This drug is indicated in the treatment of tobacco dependence in order to alleviate the symptoms of nicotine withdrawal desiring to stop their tobacco consumption.
Although the definitive cessation of tobacco consumption is preferable, this medication can be used in:
AT· the cases where a smoker temporarily abstains from smoking,
AT· a smoking reduction strategy as a step towards the definitive stop.
Appropriate management improves the chances of success in stopping smoking.
Read the health advice at the end of this leaflet carefully.
Never take NICOPASS FRESHNESS 2.5 MG WITHOUT SUGAR, aspartame and potassium-acesulfame tablets in the following cases :
AT· if you do not smoke or if you are an occasional smoker
AT· if you are allergic (hypersensitive) to nicotine or any of the other ingredients of this medication mentioned in section 6.
AT· if you have Phenylketonuria (a hereditary disease diagnosed at birth), due to the presence of aspartame.
AT· if you are allergic (hypersensitive) to peanut or soybean, due to the presence of soybean oil (present in the fresh mint fragrance).
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Warnings and Precautions
As part of a "complete smoking cessation", you must stop smoking completely when you use this medication. Read the health advice at the end of this leaflet carefully.
Some diseases require examination and medical follow-up before using this medication.
Thus, in case of:
AT· severe hepatic and / or renal failure,
AT· ulcer of the stomach or duodenum in evolution
It is essential to consult your doctor before using this medication.
AT· Some signs indicate an under-dosage. If you feel, despite the treatment, a feeling of "lack", like in particular:
o need to smoke,
o irritability, sleep disturbances,
o agitation or impatience,
o difficulty of concentration,
consult your doctor or pharmacist. It may be necessary to change the dosage of the medication.
AT· Some signs may indicate an overdose: if there are signs of overdose, ie:
o nausea, abdominal pain, diarrhea,
o hypersalivation,
o sweating, headache, dizziness, loss of hearing,
o general weakness,
it is imperative that you adjust your treatment with the advice of your physician or pharmacist.
This medication contains isomalt (E953). It is used in patients with fructose intolerance (rare hereditary disease).
If your doctor has informed you of an intolerance to certain sugars, contact him / her before taking this medication.
Talk to your doctor or pharmacist before taking NICOPASS.
children
It is imperative to keep the pellets out of the reach of children.
Indeed, the therapeutic dose intended for the adult could cause a serious intoxication or even death in the child.
Other medicines and NICOPASS FRESHNESS MINT 2.5 mg SUGAR-free, aspartame-sweetened tablet with potassic acesulfame
Tobacco cessation, with or without this medication, may affect the action of certain other medicines taken at the same time.
Dose adjustments by your doctor may be required if you are taking the following medications:
AT· treatment of asthma (theophylline),
AT· treatment of schizophrenia (clozapine),
AT· treatment of Parkinson's disease (ropinirole),
AT· treatment of diabetes (insulin),
AT· substitution therapy for opiate dependence (methadone)
Inform your doctor or pharmacist if you are taking, have recently taken any other medicines.
NICOPASS FRESHNESS MINT 2.5 mg SUGAR-FREE, aspartame and potassium sulfate-containing tablet with food and beverages
Not applicable.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medication.
Pregnancy
It is important to stop smoking during your pregnancy as this can harm your baby. Besides a small birth weight, smoking can also cause a premature birth or the birth of a stillborn babe.
The idea would be to stop smoking without the use of a medication. If you do not get it, this medication can be recommended to help you because the risk to your baby is much less than that related to the pursuit of smoking. Nicotine, whatever its form, can harm your child to be born.
Therefore, this medication should only be used after consulting the health care professional who is following your pregnancy, or your general practitioner or a physician. within a center specializing in smoking cessation.
feeding
This medication, just like smoking during breast-feeding, should be avoided because nicotine passes into breast milk, which can harm your child.
If you smoke a lot and do not plan to stop smoking, you must use artificial breastfeeding.
If you have not been able to stop smoking and are breast-feeding, use this pellet only on medical advice.
Sport
Not applicable.
Driving and using machines
This medication has no known effect on the ability to drive and use machines when used at the recommended dosage.
NICOPASS MENTHE FRESHNESS 2.5 mg SUGAR-free, aspartame and acesulfame potassium-containing tablet contains : aspartam (source of phenylalanine) (E951), isomalt (E953), soya oil (partially hydrogenated) .
Reserved for adults and teenagers over 15 years of age
NICOPASS should not be used by smokers under the age of 18 without the recommendation of a health professional.
Pellets dosed at 2.5 mg are suitable for smokers who are highly or highly dependent on nicotine (Fagerström test score from 7 to 10: see chapter "Advice Health education ").
Dosage
Complete smoking cessation
The treatment of nicotine dependence is usually done in 2 phases for weaning.
1st phase:
Slowly toss a pellet whenever the urge to smoke appears.
The number of pellets dosed at 2.5 mg is usually 8 to 12 per day and should under no circumstances exceed 15 pellets per day.
The duration of this phase is about 3 months, but may vary depending on the individual response.
2nd phase:
When the urge to smoke is completely overcome, gradually reduce the number of tablets sucked per day. Treatment will be stopped when consumption is reduced to 1 to 2 tablets per day.
If more than 6 months after the start of treatment, the attempt to completely stop the tobacco has failed, it is recommended to consult a physician. Without results after 9 months of treatment, it is recommended to consider another strategy.
Temporary abstinence from tobacco
Slowly toss a pellet whenever the urge to smoke appears.
The number of pellets dosed at 2.5 mg is usually 8 to 12 per day and should under no circumstances exceed 15 pellets per day.
Tobacco Reduction
As much as possible, alternate nicotine pellets and cigarettes. Slowly suck a tablet when the urge to smoke appears to stay as long as possible without smoking.
Use a sufficient number of pellets each day without exceeding 15 pellets per day.
Gradually continue to try to decrease your consumption of cigarettes, if possible until the complete stop.
When you do not smoke for a few weeks, gradually reduce the number of tablets sucked per day.
Treatment will be stopped when consumption will be reduced to 1 to 2 tablets per day.
Method of Administration
ORAL WAY.
The pellet should be placed in the mouth where it will dissolve gradually. It must be regularly moved from one side of mouth to the other, until it is completely dissolved. The matrix structure of the pellet was designed to ensure its dissolution in about 30 minutes, thus allowing a gradual release of the nicotine and therefore a slow absorption of it at the level of the buccal mucosa.
Consequently, it should not be crunched or swallowed.
You should refrain from eating or eating when the pellet is in your mouth.
Duration of treatment
The duration of treatment should not exceed 6 months.
If you experience a persistent feeling of shortage or if you have difficulty in stopping this medication, consult your doctor.
If you take more NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, aspartame and potassium sulfate tablet that you should not have :
In case of accidental overdose or if a child swallows one or more lozenges, contact a physician or an emergency department.
In fact, small quantities of nicotine are dangerous in the child.
Severe intoxication may occur and may include hypotension, weak and irregular heartbeat, respiratory distress, prostration, cardiovascular collapse, and convulsions, leading to a fatal outcome.
Immediately consult your doctor or pharmacist.
If you forget to take NICOPASS MENTHE FRESHNESS 2.5 mg WITHOUT SUGAR, aspartame and potassium acesulfame tablet:
If you stop taking NICOPASS FRESHNESS 2.5 mg WITHOUT SUGAR, aspartame and potassium sulfate tablet:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Severe allergic reactions that cause swollen face and throat rarely occur (affecting 1 to 10 people in 10,000).
If you experience symptoms of severe allergic reactions you should stop taking NICOPASS and consult your doctor immediately.
At the beginning of treatment , irritations of the mouth can be felt.
As with other nicotine substitutes, gastritis (inflammation of the stomach) may appear during treatment.
Other undesirable effects listed below are classified according to the likelihood that they may occur.
Frequent (affecting 1 in 10 people): headache, dizziness, hiccups, sore throat, irritation of the mouth, dry mouth feeling, nausea, vomiting, digestive disorders, oesophagitis esophagus), stomatitis (inflammation of the mouth), flatulence.
Uncommon (affecting 1 in 100 people): palpitations (irregular heartbeat and rapid heart rate), urticaria or redness of the skin.
Rare (affecting 1 person in 1000): heart rhythm disorders (uncontrolled, rapid and reversible).
Dizziness, headaches, sleep disorders, mouth ulcers may be related to smoking cessation and not your treatment.
Declaration of side effects
If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Pharmacovigilance Regional Centers - Website: www.ansm.sante.fr
By reporting adverse effects, you are helping to provide more information about the safety of the drug.
Keep this medication out of the reach and sight of children.
Do not use this medication after the expiration date stated on the carton. The redemption date refers to the last day of that month.
Keep at a temperature not higher than + 30 ° C.
Store in the original package in a dry place away from moisture.
Do not throw any medicines into the sewer or with the household garbage. Ask your pharmacist to discontinue the medications you are no longer using. These measures will help to protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
AT· The active substance is:
Nicotine................................................. .................................................. ...................... 2.50 mg
In the form of nicotine resinate .......................................... 13.88 mg
For a pellet.
AT· The other components are:
Isomalt (E953), hypromellose (E464), aspartam (E951), potassic acesulfame, peppermint arsenium, long-lasting fresh mint flavor (containing partially hydrogenated soybean oil (See section 2 "NICOPASS MENTHE FRAICHEUR 2.5 mg WITHOUT SUGAR, aspartame-sweetened tablet and aspartame-free"), sodium bicarbonate, anhydrous sodium carbonate the potassium acesulfame contains ").
This medication is in the form of a square patch, opaque, beige.
Boxes of 12, 24, 36, 48, 60, 72, 84, 96 or 204 tablets.
Not all presentations may be marketed.
Holder of the marketing authorization
45, PLACE ABEL GANCE
92100 BOULOGNE
Operator of the marketing authorization
PIERRE FABRE MEDICAMENT (head office)
45, PLACE ABEL GANCE
92100 BOULOGNE
PIERRE FABRE MEDICAMENT PRODUCTION (head office)
45, PLACE ABEL GANCE
92100 BOULOGNE
Names of medicines in the Member States of the European Economic Area
Not applicable.
The last date on which this notice was revised is as follows:
{MM / YYYY}
Detailed information on this medicinal product is available on the website of the ANSM (France).
ADVICE / HEALTH EDUCATION
Stopping smoking as soon as possible results in immediate health benefits. It's never too late to quit smoking even if you smoke a long time and a lot.
As soon as you stop smoking:
AT· You will not absorb the irritating and toxic substances of cigarettes,
AT· You will notice some improvements: progressive disappearance of headaches, cough, irritation of the throat, shortness of breath,
AT· You will often have the satisfaction of regaining better sleep, food flavor, odor and improving your physical performance,
AT· You will reduce your risk of developing lung cancer or cardiovascular disease.
AT· Moreover, in cardiac or arterial diseases (angina pectoris, arteritis of the lower limbs ...), it is especially imperative to succeed in quitting smoking.
What is tobacco dependence?
Dependence on tobacco is twofold:
Psychological dependence:
Smoking a cigarette involves a ritual of automatic and rehearsal gestures associated with particular circumstances (pleasure, response to stress, intellectual stimulation, support for morale, need for a gesture of conviviality). This is psychological and behavioral dependence.
Physical Dependency:
The need for the nicotine body is due to the effects of this substance on the nervous system. This is physical dependence. Failure to satisfy this need results in a sense of lack. Nicotinic substitutes are intended to treat this dependence.
How to overcome your psychological dependency?
AT· The complete cessation of tobacco is necessary to increase your chances of success, but in addition:
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 stop is made at the same time by both spouses.
AT· Keep your family and colleagues working as you quit smoking. Ask them to respect your decision (do not smoke near you, stop offering you cigarettes).
AT· Prepare to cope with the desire to smoke. It can occur abruptly and intensely especially during the first few weeks after stopping smoking, but does not last more than 3 or 4 minutes.
You have to predict what you will do in this case there and act very fast not to "crack", as for example:
o drink a large glass of water,
o chewing gum,
o counting up to 100,
o do some deep breaths,
o out of the room,
o change activity ...
AT· Avoid situations associated with taking cigarettes (coffee, aperitif, ...), avoid temptations (settle with non-smokers).
Find cigarette compensation (leisure, sport, cultural activity ...).
How to overcome your physical dependency?
If you are addicted to nicotine, the success of your procedure may require the use of nicotine replacements.
In order to assess your level of dependency, the Fagerström test is available.
TEST OF FAGERSTRÃ-M
How long after your waking do you smoke your first cigarette? AT· within 5 minutes: 3 AT· from 6 to 30 minutes: 2 AT· from 31 to 60 minutes: 1 AT· after 60 minutes: 0 |
|
Do you find it difficult not to smoke in places where it is forbidden? AT· yes: 1 AT· no: 0 |
|
What cigarette of the day would you be the hardest to give up? AT· the first: 1 AT· another: 0 |
|
How many cigarettes do you smoke per day? AT· 10 or less: 0 AT· 11 to 20: 1 AT· 21 to 30: 2 AT· 31 or more: 3 |
|
Do you smoke at a more sustained pace in the morning than in the afternoon? AT· yes: 1 AT· no: 0 |
|
Do you smoke when you're so sick that you have to stay in bed almost all day? AT· yes: 1 AT· no: 0 |
|
TOTAL POINTS |
|
AT· Score from 0 to 2 : you are not dependent on nicotine.
You can quit smoking without the need for nicotine replacement. However, if you are concerned about this decision, consult your pharmacist or doctor.
AT· Score from 3 to 4: You are weakly dependent on nicotine.
AT· Score 5 to 6 : You are moderately dependent on nicotine.
The use of nicotinic substitutes will increase your chances of success.
Consult with your pharmacist or doctor to help you choose the treatment best suited to your situation.
AT· Score of 7 to 10 : you are strongly or very heavily dependent on nicotine.
The use of nicotine substitutes is recommended to help you overcome this addiction to nicotine. This treatment should be used in sufficient and appropriate dosage. Consult with your pharmacist or physician, if necessary, as part of a specialized smoking cessation counseling.
Weaning-related disorders may persist for a long time and the duration of treatment should be sufficient, usually one to three months.
If you feel, despite treatment, a feeling of persistent "lack", such as:
o need to smoke,
o irritability, sleep disturbances,
o agitation or impatience,
o difficulty of concentration,
Take the advice of your doctor or pharmacist as a dose adjustment may be required.
How do you get help?
AT· Support from health professionals
The support, advice and follow-up that your doctor or pharmacist can provide will be valuable during the first six months of your cessation of smoking. You can also use a special smoking cessation counseling service, especially if you have already been unsuccessful.
AT· Psychological support
Stopping smoking requires a supportive family and social environment. If you are concerned that the difficulties are too great, psychological support or temporary treatment can help.
AT· The diet
In the months following the cessation of smoking, you may experience moderate weight gain.
If you have any concerns in this area, you can contact a health professional who will be able to advise you.
You started smoking again, why?
Consider this relapse as an accident of course, as a normal event that allows to learn: the relapse is not a failure.
Analyze the reasons why you took back the tobacco.
AT· Because of physical dependence
This may have been poorly taken into account or reappeared after several months, occasionally, for example, of prolonged periods of time in smoky atmospheres.
AT· Because of excessive weight gain
It may be necessary to change your diet somewhat before your next attempt to stop smoking.
AT· Because of a decreased motivation, because of a painful event or a difficult period, because of psychological difficulties appeared to the cessation of the tobacco (depression, anxiety tà © ...), because of a very tempting situation. Understand the reason for this relapse to prevent it if possible during the next attempt.
In all cases, do not hesitate to ask for advice from a health professional or to use a specialized counseling for smoking cessation help.
If you have started smoking again, do not be discouraged, the experience shows that your chances of success increase after one or more attempts to stop.
Medication for smoking cessation
nicotine
. Presentations . Composition . Indications . Contraindications . Warning . Drug interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
NICOPASS 1.5 mg Eucalyptus: lozenge (beige); box of 12.
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NICOPASS 1.5 mg Eucalyptus: lozenge (beige); box of 36.
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NICOPASS 1.5 mg Eucalyptus: lozenge (beige); box of 96.
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NICOPASS 1.5 mg Mint Fragrance: lozenge (beige); box of 12.
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NICOPASS 1.5 mg Mint Fragrance: lozenge (beige); box of 36.
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NICOPASS 1.5 mg Mint Fragrance: lozenge (beige); box of 96.
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NICOPASS 1.5 mg Mint Fragrance: lozenge (beige); box of 144.
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NICOPASS 1.5 mg Regenerate Mint: lozenge (brown); box of 12.
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NICOPASS 1.5 mg Regenerate Mint: lozenge (brown); box of 36.
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NICOPASS 1.5 mg Regenerate Mint: lozenge (brown); box of 96.
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NICOPASS 2.5 mg Mint Fragrance: sucking tablet (beige); box of 12.
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NICOPASS 2.5 mg Mint Fragrance: sucking tablet (beige); box of 36.
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NICOPASS 2.5 mg Mint Fragrance: sucking tablet (beige); box of 96.
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NICOPASS 2.5 mg Regenerate Mint: lozenge (brown); box of 12.
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NICOPASS 2.5 mg Regenerate Mint: lozenge (brown); box of 36.
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NICOPASS 2.5 mg Regenerate Mint: lozenge (brown); box of 96.
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Laboratory Pierre Fabre Medicine
| AT | p pastille | p pastille |
| Nicotine | 1.5 mg | 2.5 mg |
| Aspartam |  + |  + |
Usual dosage:
KIT FOR HOMEOPATHIC STOP SMOKING TOBACCO Boiron
