NOTICE
ANSM - Last updated: 11/05/2017
Name of the medicinal product
NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, sweetened with aspartame and acesulfame potassium
Nicotine
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine by following the information provided in this leaflet or by your doctor or pharmacist
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· If you are experiencing difficulties or are unable to stop smoking within 6 months, see your doctor or pharmacist
Do not use this medication for children.
What is in this leaflet?
1. What is NICOPASS FRESH MINT 2.5 mg SUGAR-free , sweetened with aspartame and acesulfame potassium and in which cases it is used?
2. What should I know before taking NICOPASS MENTHE FRAICHEUR 2.5 mg WITHOUT SUGAR, sweetened with aspartame and acesulfame potassium?
3. How to take NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, sweetened with aspartame and acesulfame potassium?
4. What are the possible side effects?
5. How to store NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, sweetened with aspartame and acesulfame potassium?
6. Package contents and other information.
1. WHAT NICOPASS MENTHE FRESHNESS 2.5 mg WITHOUT SUGAR, sweetened with aspartame and acesulfame potassic AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: Drugs used in nicotine addiction.
ATC code: N07BA01
Reserved for adults and adolescents over 15 years of age.
This medication is indicated for the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal wishing to stop their tobacco consumption.
Although definitive cessation of tobacco use is preferable, this drug may be used in:
· the cases where a smoker temporarily abstains from smoking,
· a strategy to reduce smoking as a step towards the final stop.
Tailored management improves the chances of success in stopping smoking.
Read the health education tips carefully at the end of this leaflet.
2. BEFORE YOU TAKE NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, sweetened with aspartame and acesulfame potassium?
Never take NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, sweetened with aspartame and acesulfame potassium in the following cases :
· if you do not smoke or if you are an occasional smoker
· if you are allergic (hypersensitive) to nicotine or any of the other ingredients of this medication mentioned in section 6.
· if you have phenylketonuria (hereditary disease detected at birth), because of the presence of aspartame.
· if you are allergic (hypersensitive) to peanut or soybean, due to the presence of soybean oil (present in the mint freshness long-lasting aroma).
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 quit smoking completely when using this medication. Read the health education tips at the end of this leaflet carefully.
Some diseases require examination and medical follow-up before using this medication.
Thus, in case of:
· severe hepatic and / or renal insufficiency,
· ulcer of the stomach or duodenum
It is essential to consult your doctor before using this medication.
· Some signs indicate an under-dosage. If you feel, despite the treatment, a feeling of "lack", such as:
o compelling need to smoke,
o irritability, sleep disturbances,
o agitation or impatience,
o difficulty of concentration,
consult your doctor or pharmacist. Indeed, it may be necessary to change the dosage of the drug.
· Some signs may reflect 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 to adapt the treatment with the advice of your doctor or pharmacist.
This medicine contains isomalt (E953) It is not recommended for use in patients with fructose intolerance (rare hereditary disease).
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
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 FRESH MINT 2.5 mg WITHOUT SUGAR, sweetened with aspartame and acesulfame potassium
Stopping smoking, 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 necessary if you are taking the following medications:
· treatment of asthma (theophylline),
· treatment of schizophrenia (clozapine),
· treatment of Parkinson's disease (ropinirole),
· treatment of diabetes (insulin),
· substitution treatment for opioid dependence (methadone)
Inform your doctor or pharmacist if you are taking, have recently taken any other medication.
NICOPASS FRESH MINT 2.5 mg SUGAR-FREE, sweetened with aspartame and acesulfame potassium with food and drink
Not applicable.
Pregnancy and breast feeding
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 medicine.
Pregnancy
It is important to quit smoking during your pregnancy as this can harm your baby. Besides a low birth weight, smoking can also cause premature birth or the birth of a stillborn baby.
The ideal would be to quit smoking without using medication. If this does not work, this medication may be recommended to help you because the risk to your baby is much lower than the risk of smoking. Nicotine, whatever its form, can harm your unborn child.
Therefore, this medication should only be used after consulting the healthcare professional who is following your pregnancy, or your general practitioner, or a doctor at a smoking cessation center.
feeding
This medication, just like smoking during breastfeeding should be avoided, as 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 feeding.
If you have not been able to stop smoking and are breastfeeding, use this medicine only on medical advice.
Sport
Not applicable.
Driving and using machines
This medicinal product has no known effect on the ability to drive and use machines when used at the recommended dosage.
NICOPASS FRESH MINT 2.5 mg SUGAR-FREE, sweetened tablet with aspartame and acesulfame potassium contains : aspartam (source of phenylalanine) (E951), isomalt (E953), soybean oil (partially hydrogenated) .
3. HOW TO TAKE NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, sweetened with aspartame and acesulfame potassium?
Reserved for adults and adolescents over 15 years of age
NICOPASS should not be used in smokers under 18 years of age without recommendation from a health care professional.
2.5 mg pellets are suitable for smokers who are highly or highly dependent on nicotine (Fagerström test score from 7 to 10: see chapter "Health education advice").
Dosage
Complete cessation of smoking
Treatment of nicotine dependence is usually done in 2 phases for withdrawal.
1st phase:
Slowly toss a pellet whenever the urge to smoke appears.
The number of pellets dosed at 2.5 mg is generally from 8 to 12 per day and should in no case 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 initiation of treatment, attempted complete cessation of tobacco has failed, 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 generally from 8 to 12 per day and should in no case exceed 15 pellets per day.
Tobacco reduction
As much as possible, alternate pills to nicotine 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 cigarette consumption, if possible until 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 is reduced to 1 to 2 tablets per day.
Administration mode
ORAL WAY.
The pellet should be placed in the mouth where it will dissolve gradually. It must be regularly moved from one side of the mouth to the other, until it is completely dissolved. The matrix structure of the pellet has been designed to ensure its dissolution in about 30 minutes, thus allowing a progressive release of the nicotine and therefore a slow absorption of the latter at the level of the buccal mucosa.
Therefore, it should not be chewed or swallowed.
It is necessary to refrain from drinking or eating when the pellet is in the mouth.
Duration of treatment
The duration of treatment should not exceed 6 months.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist of all prescription and nonprescription / herbal products you may use before using this medication.
If you take more NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, sweetened with aspartame and acesulfame potassium that you should :
In case of accidental overdose or if a child swallows one or more lozenges, contact a doctor or emergency department.
In fact, small amounts of nicotine are dangerous in children.
Severe intoxication may occur and may include hypotension, weak and irregular heartbeat, respiratory discomfort, prostration, cardiovascular collapse, and convulsions, leading to a fatal outcome.
Immediately consult your doctor or pharmacist.
If you forget to take NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, sweetened with aspartame and acesulfame potassium:
Not applicable.
If you stop taking NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, tablet sweetened with aspartame and acesulfame potassium:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Severe allergic reactions that cause swollen face and throat rarely occur (affecting 1 to 10 people in 10,000).
If you notice 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 nicotinic substitutes, gastritis (inflammation of the stomach) may appear during treatment.
Other side effects listed below are classified according to the probability that they may occur.
Common (affecting 1 in 10): headache, dizziness, hiccups, sore throat, irritation of the mouth, dry mouth, nausea, vomiting, digestive disorders, esophagitis (inflammation of the esophagus), stomatitis of the mouth), flatulence.
Uncommon (affecting 1 in 100 people): palpitations (irregular heartbeat and rapid heartbeat), hives or redness of the skin.
Rare (affecting 1 in 1000 people): heart rhythm disorders (uncontrolled, rapid and reversible).
Dizziness, headaches, sleep disorders, mouth ulcers may be related to smoking cessation and not to your treatment.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE NICOPASS FRESH MINT 2.5 mg WITHOUT SUGAR, sweetened with aspartame and acesulfame potassium?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store at a temperature not exceeding + 30 ° C.
Store in the original package in order to protect from moisture.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What NICOPASS MENTHE FRESHNESS contains 2.5 mg SUGAR-free, sweetened with aspartame and acesulfame potassium
· The active substance is:
Nicotine................................................. .................................................. ...................... 2.50 mg
In the form of nicotine resinate ............................................ ..................................... 13.88 mg
For a pellet.
· The other components are:
Isomalt (E953), hypromellose (E464), aspartam (E951), acesulfame potassium, peppermint aroma, long-lasting fresh mint aroma (containing partially hydrogenated soybean oil), Permaseal mashed flavor, sodium bicarbonate, anhydrous sodium (see section 2 "NICOPASS MENTHE FRESHNESS 2.5 mg WITHOUT SUGAR, sweetened tablet with aspartame and acesulfame potassium contains").
What is NICOPASS MENTHE FRAICHEUR 2.5 mg WITHOUT SUGAR, tablet sweetened with aspartame and acesulfame potassic and contents of the pack
This medication is in the form of a square, opaque, beige pellet.
Boxes of 12, 24, 36, 48, 60, 72, 84, 96 or 204 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
Marketing Authorization Operator
PIERRE FABRE MEDICAMENT (head office)
45, PLACE ABEL GANCE
92100 BOULOGNE
Maker
PIERRE FABRE MEDICAMENT PRODUCTION (head office)
45, PLACE ABEL GANCE
92100 BOULOGNE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
{MM / YYYY}
Other
Detailed information on this medicine is available on the ANSM website (France).
ADVICE / HEALTH EDUCATION
Stopping smoking as soon as possible results in immediate health benefits. It's never too late to quit even if you've smoked a long time and a lot.
As soon as you stop smoking:
· You will not absorb the irritating and toxic substances of cigarettes,
· You will see some improvements: progressive disappearance of headaches, cough, irritation of the throat, shortness of breath,
· You will often have the satisfaction of regaining better sleep, food flavor, odor and improve your physical performance,
· You will decrease your risk of developing lung cancer or cardiovascular disease.
· Moreover, in cardiac or arterial diseases (angina pectoris, arteritis of the lower limbs ...), it is particularly imperative to succeed in quitting smoking.
What is tobacco dependence?
Tobacco addiction is twofold:
Psychological dependence:
Smoking a cigarette involves a ritual of automatic and repetitive 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 dependence:
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 aim to treat this dependence.
How to overcome your psychological addiction?
· Stopping smoking is necessary to increase your chances of success, but more:
o choose a D day in the period that you think is the most favorable.
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.
· Tell your family and co-workers that you quit smoking. Ask them to respect your decision (no smoking near you, no longer offering you cigarettes).
· Prepare yourself to cope with the desire to smoke. It may occur suddenly and severely, especially during the first few weeks after the cessation of smoking, but does not last more than 3 or 4 minutes.
You have to foresee what you will do in this case and act very quickly so as not to "crack", as for example:
o drink a large glass of water,
o to chew gum,
o counting up to 100,
o do some deep breaths,
o out of the room,
o change activity ...
· 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 addiction?
If you are addicted to nicotine, the success of your approach may require the use of nicotine substitutes.
In order to assess your level of dependence, the Fagerström test is offered.
FAGERSTRÖM TEST
How long after you wake up do you smoke your first cigarette? · within 5 minutes: 3 · from 6 to 30 minutes: 2 · from 31 to 60 minutes: 1 · after 60 minutes: 0 | |
Do you find it difficult to not smoke in places where it is forbidden? · yes: 1 · no: 0 | |
What cigarette of the day would you be the hardest to give up? · the first: 1 · another: 0 | |
How many cigarettes do you smoke per day? · 10 or less: 0 · 11 to 20: 1 · 21 to 30: 2 · 31 or more: 3 | |
Do you smoke at a more sustained pace in the morning than in the afternoon? · yes: 1 · no: 0 | |
Do you smoke when you are so sick that you have to stay in bed almost all day? · yes: 1 · no: 0 | |
TOTAL POINTS | |
· Score from 0 to 2 : you are not addicted to nicotine.
You can stop smoking without the need for nicotine replacement. If you are concerned about this decision, consult your pharmacist or doctor.
· Score 3 to 4: You are weakly dependent on nicotine.
· Score 5 to 6 : You are moderately addicted to nicotine.
The use of nicotine substitutes will increase your chances of success.
Consult with your pharmacist or doctor to help you choose the treatment best suited to your situation.
· Score 7 to 10 : you are highly or very strongly 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 doctor, possibly 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 the treatment, a feeling of persistent "lack" such as:
o compelling need to smoke,
o irritability, sleep disturbances,
o agitation or impatience,
o difficulty of concentration,
Take the advice of your doctor or pharmacist as doses may need to be adjusted.
How do you get help?
· Support from health professionals
The support, advice and follow-up that your doctor or pharmacist can give you will be valuable during the first six months of your smoking cessation. You can also use a specialized smoking cessation counseling, especially if you have already failed.
· 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.
· Dietetics
In the months following tobacco cessation, you may find 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.
· Because of the physical dependence
This may have been poorly taken into account or reappeared after several months, occasionally, for example, by prolonged stays in smoky atmospheres.
· Because of excessive weight gain
It may be necessary to change your diet somewhat before your next attempt to quit smoking.
· Because of a decline in motivation, because of a painful event or a difficult period, because of psychological difficulties appearing at the cessation of smoking (depression, anxiety ...), because of a situation very tempting. 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 consultation to help with smoking cessation.
If you have started smoking again, do not get discouraged, experience shows that your chances of success increase after one or more attempts to quit.