Niquitin Minis 4MG Mint 20 Smoking Cessation* tablets

NOTICE

ANSM - Updated on : 11/10/2021

Name of medicinal product

NIQUITINMINIS MENTHE FRAICHE 4 mg SUGAR-FREE, sucking tablet sweetened with lacésulfame potassique

Nicotine

Box

Please read this leaflet carefully before taking this medicine, as it contains important information for you.

You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist for advice and information.

- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

- You should contact your doctor if you do not feel any improvement or if you feel less well.

What does this leaflet contain?

1. What is NIQUITINMINIS MENTHE FRAICHE 4 mg SWEETENING TABLET, sweetened with lacésulfame potassique, and what is it used for?

2. What do I need to know before taking NIQUITINMINIS MENTHE FRAICHE 4 mg SWEETENER TABLET, sweetened with lacésulfame potassium?

3. How do I take NIQUITINMINIS MENTHE FRAICHE 4 mg SUGAR-FREE, lacésulfame potassium-sweetened tablets?

4. What are the possible side effects?

5. How do I keep NIQUITINMINIS MENTHE FRAICHE 4 mg SUGAR-FREE, sweetened with potassium sulfate?

6. Package contents and other information.

1. WHAT IS NIQUITINMINIS MENTHE FRAICHE 4 mg SWEETENING TABLET SWEETENED WITH LACESULFAME POTASSIQUE AND WHAT IS IT USED FOR?

Drugs used in nicotine dependence - ATC code: N07BA01.

This drug is indicated in the treatment of tobacco dependence, to relieve nicotine withdrawal symptoms in subjects wishing to stop smoking.

Although it is preferable to stop smoking altogether, this drug can be used in :

- when a smoker is temporarily abstaining from smoking,

- a smoking reduction strategy as a step towards permanent cessation.

You should consult your doctor if you do not feel any improvement or if you feel less well.

2. WHAT DO I HAVE TO KNOW BEFORE TAKING NIQUITINMINIS MENTHE FRAICHE 4 mg SUGAR-FREE, sweet tooth tablet sweetened with potassium sulfate?

Never take NIQUITINMINIS MENTHE FRAICHE 4 mg SUGAR-FREE, lacésulfame potassium-sweetened tablets:

- if you are allergic to the active substance or to any of the other ingredients of this medicine, as listed in section 6,

- if you do not smoke or if you are an occasional smoker.

If in doubt, ask your doctor or pharmacist.

Warnings and precautions

Certain diseases require medical examination and follow-up before using this medicine. For example, in the case of :

- cardiovascular disease, severe hypertension or heart failure

- cerebrovascular disorder or arteritis of the lower limbs

- diabetes

- uncontrolled hyperthyroidism

- a tumor of the adrenal gland (pheochromocytoma )

- severe hepatic and/or renal insufficiency,

- ulcer of the stomach or duodenum,

- convulsions or a history of convulsions.

Talk to your doctor or pharmacist before taking NIQUITINMINIS MENTHE FRAICHE 4 mg SWEETENING TABLET, sweetened with potassium desulfame.

- If you have ulcers of the stomach or duodenum or inflammation of the sophagus or throat (the passage between the mouth and stomach), nicotine replacement therapy may aggravate your symptoms.

- if you are diabetic, you should check your blood sugar levels more regularly than usual when you start using NIQUITIN MENTHE. NIQUITIN MENTHE DOUCE 2 mg SANS SUCRE, comprimé à sucer édulcoré à laspartam car ce médicament peut avoir un incidence sur vos besoins en insuline ou sur votre traitement.

- if you are hospitalized following a heart attack, severe heart rhythm disturbance or stroke, it is recommended that you stop smoking without using nicotine substitutes, unless your doctor advises otherwise.

- If you have heart problems, you should consult a healthcare professional before using nicotine replacement therapy for gradual cessation or in combination.

If in doubt, ask your doctor or pharmacist.

Taking this medication may lead to dependence.

Certain signs indicate underdosing. If, despite treatment, you feel a sensation of "withdrawal", such as

- urge to smoke

- irritability, sleep disturbances

- restlessness or impatience,

- difficulty concentrating.

Consult your doctor or pharmacist. It may be necessary to adjust the dosage.

Certain signs may indicate overdosage: if signs of overdosage appear, i.e. :

- nausea, abdominal pain, diarrhea,

- hypersalivation,

- sweating, headache, dizziness, hearing loss,

- general weakness,

It is imperative to adapt the treatment with the help of your doctor's or pharmacist's advice.

If NIQUITIN 2 mg chewable tablets are used in combination with NIQUITIN transdermal system, please refer to the respective package leaflet.

Children and adolescents

Sucking tablets must be kept out of the reach of children. The therapeutic dose intended for adults could cause serious or even fatal poisoning in children.

Other medicinal products and NIQUITINMINIS MENTHE FRAICHE 4 mg SUGAR-FREE, sweetened tablets with lacésulfame potassique

Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

Stopping smoking, with or without this medicine, may alter the action of certain medicines taken at the same time. This is particularly important if you are taking clozapine, methadone, ropinirole or theophylline. Dose adjustments by your physician may be necessary.

NIQUITINMINIS MENTHE FRAICHE 4 mg SWEETENING TABLET sweetened with lacésulfame potassique with food and drink

Not applicable.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

It is very important to stop smoking during pregnancy, as it may affect the course of your pregnancy. Delayed fetal growth, premature delivery and late fetal death have been observed in pregnant smokers.

Smoking cessation during pregnancy requires medical advice and follow-up. You should therefore consult the doctor who is monitoring your pregnancy, or your usual doctor, or a doctor at a center specializing in smoking cessation. If you are unable to stop smoking without nicotine replacement therapy, this medicine may be recommended by your doctor.

Breast-feeding

If you are a heavy smoker and do not intend to stop smoking, you should not breast-feed your baby, but use artificial milk.

Use of this drug should be avoided while breast-feeding, as nicotine passes into breast milk and may affect your child. However, if you wish to stop smoking and breastfeed your child, consult your doctor or a doctor at a center specializing in smoking cessation. If your doctor has recommended that you use this medicine, the dose should be taken just after the next feed or more than 2 hours before the next feed .

The use of intermittent doses of nicotine replacement therapy may minimize the amount of nicotine present in breast milk, compared with patches, since the time interval between taking the substitute and breast-feeding can be extended as much as possible.

Because terpene derivatives (peppermint flavoring, menthol flavoring) contained in this medication can pass into milk, and because of potential neurological toxicity in infants, you should consider using another flavoring.

Fertility

Smoking can affect fertility in both men and women. However, the specific contribution of nicotine to these effects in humans is not known.

Driving and use of machinery

Not applicable.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

3. HOW TO TAKE NIQUITINMINIS MENTHE FRAICHE 4 mg SWEETENER TABLET, sweetened with lacesulfame potassium?

Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Dosage

For adults only

The number of tablets to be used each day depends on your nicotine dependence, which can be assessed using the Fagerström test.

The 4 mg sucking tablet is indicated for smokers who are strongly or very strongly dependent on nicotine.

Complete cessation

Advice and follow-up can increase your chances of success.

Nicotine dependence is usually treated in 3 stages.

During weeks 1 to 6, the dosage should be at least 9 sucking tablets a day.

In no case should the number of tablets sucked exceed 11 per day.

If you continue to experience cravings during treatment, or if your treatment has failed, CONSULT YOUR DOCTOR.

Temporary abstinence from smoking

Advice and follow-up can increase your chances of success.

Suck one tablet each time you feel the urge to smoke.

The number of 4 mg tablets should not exceed 11 per day.

It is recommended that you seek the help and advice of a healthcare professional at every stage of your smoking cessation journey.

Reducing tobacco consumption

As far as possible, alternate nicotine tablets with cigarettes.

Suck on a tablet as soon as the urge to smoke arises, to reduce cigarette consumption as much as possible and remain smoke-free for as long as possible.

The number of tablets to be sucked per day is variable and depends on the patient's needs.

However, it should not exceed 11 per day.

If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, advice should be sought from a healthcare professional.

Reduction in tobacco consumption should gradually lead to complete cessation of smoking. This should be attempted as soon as possible within 6 months of starting treatment. If, more than 9 months after the start of treatment, the attempt to stop smoking completely has failed, it is advisable to seek advice from a healthcare professional.

Sucking tablets should not be used beyond 6 months.

Duration of treatment

In the event of persistent craving, or if you find it difficult to stop taking the drug, consult your doctor.

Method and route of administration

Oral route.

Sucking tablets should be placed in the mouth, where they will dissolve. It should be regularly placed from one side of the mouth to the other, until complete dissolution (about 10 minutes). The tablet must not be chewed or swallowed, as the gradually released nicotine must be absorbed by the oral mucosa.

Do not eat or drink while the tablet is in your mouth.

Use in children and adolescents

In subjects under 18 years of age, this medicine must not be used without a doctor's prescription.

If you have taken more NIQUITINMINIS MENTHE FRAICHE 4 mg SWEETENING TABLET SWEETENED WITH LACESULFAME POTASSIQUE than you should have

In case of accidental overdose, or if a child has swallowed one or more tablets, CONTACT A PHYSICIAN OR EMERGENCY SERVICE.

Severe intoxication may occur, manifested by hypotension, weak and irregular pulse, respiratory distress, prostration, cardiovascular collapse and convulsions.

If you forget to take NIQUITINMINIS MENTHE FRAICHE 4 mg SWEETENING TABLET, sweetened with lacésulfame potassique

Not applicable.

If you stop taking NIQUITINMINIS MENTHE FRAICHE 4 mg SWEETENING TABLET, sweetened with lacésulfame potassique

Not applicable.

If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.

Most of the side effects reported appear within the first 3 or 4 weeks after the start of treatment.

- Very common (affecting more than 1 in 10 people): nausea.

- Common (affecting between 1 in 10 and 1 in 100 people): malaise, headache*, dizziness, digestive disorders, diarrhea, indigestion/stomachburn, flatulence, constipation, hiccups, sore throat, mouth irritation, dry mouth, feeling of nausea.mouth irritation, dry mouth, burning mouth, insomnia*, cough*, rhinitis, palpitations (unusual sensation in your heartbeat), dizziness*,Rare (affects 1 to 10 people in 10,000): heart rhythm disorder

- Unknown frequency: vomiting, difficulty swallowing, eructation dysgeusia (disturbance of the sense of taste), tremor, paresthesiaparesthesia of the mouth (decreased sensitivity in the mouth), abnormal dreams, nervousness, excessive sweating, reddening of the skin (erythema), swelling (angioedema), urticaria, erythema.Itching, rapid heart rate (tachycardia), malaise*, fatigue*, flu-like syndrome*, dyspnea (difficult breathing), severe allergic reactions such as wheezing or tightness of the chest and a feeling of weakness.

*These side effects may be related to smoking cessation.

Mouth ulcers may be related to smoking cessation and not to your treatment.

Reporting side effects

If you experience any side effects, please tell <,> . This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance.

By reporting adverse reactions, you are helping to provide more information on drug safety.

5. HOW TO CONSERVE NIQUITINMINIS MENTHE FRAICHE 4 mg SWEETENING TABLET, sweetened with lacésulfame potassique?

Keep out of sight and reach of children.

Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.

Store at a temperature not exceeding 30°C.

Store in original carton, protected from moisture.

Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.

6. CONTENTS AND OTHER INFORMATION

What NIQUITINMINIS MENTHE FRAICHE 4 mg SWEETENING TABLET, sweetened with lacésulfame potassique, contains

The active substance is :

Nicotine............................................................................................................................. 4,000 mg

As nicotine resinate........................................................................................ 20,000 mg

Other ingredients are: mannitol, sodium alginate, calcium polycarbophil, sodium carbonate anhydrous, xanthan gum, magnesium stearate, acesulfame potassium, potassium bicarbonate, takasago flavoring, peppermint flavoring, menthol flavoring.

What NIQUITINMINIS MENTHE FRAICHE 4 mg SUGAR-FREE is, and what it contains

This medicine comes in the form of a sucking tablet.

Boxes of 1, 2 or 5 tubes of 20 tablets or 1 or 2 tubes of 30 tablets.

Not all presentations may be marketed.

Marketing authorization holder

LABORATOIRES OMEGA PHARMA FRANCE

20 RUE ANDRE GIDE

92320 CHATILLON

Marketing authorization holder

LABORATOIRES OMEGA PHARMA FRANCE

20 RUE ANDRE GIDE

92320 CHATILLON

Manufacturer

OMEGA PHARMA INTERNATIONAL NV

VENECOWEG 26,

NAZARETH, 9810

BELGIUM

Product names in member states of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is :

To be completed subsequently by the holder.

Other

Detailed information on this drug is available on the ANSM (France) website.

Health education advice :

As soon as you stop smoking :

- you will no longer absorb the irritating and toxic substances of cigarettes,

- you'll notice certain improvements: gradual disappearance of headaches, coughing, throat irritation and shortness of breath,

- you'll often enjoy the satisfaction of better sleep, food flavors and smells, and improved physical performance,

- reduce your risk of developing lung cancer or cardiovascular disease. In the case of heart or arterial disease (angina pectoris, arteritis of the lower limbs), it is particularly important to succeed in quitting smoking.

What is tobacco dependence?

Tobacco addiction is twofold:

Psychological dependence:

Smoking a cigarette involves a ritual of automatic, 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 behavioral dependence.

Physical dependence:

The body's need for nicotine is due to the effects of this substance on the nervous system. This is physical dependence. Failure to satisfy this need leads to a sensation of craving (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?

- To increase your chances of success, you need to stop smoking completely:

o choose a day when you feel most confident about quitting.

o Throw away your last pack of cigarettes, your lighter and put away your ashtrays.

o In the case of a smoking couple, it's best for both partners to quit at the same time.

- Let your family and colleagues know that you're quitting smoking. Ask them to respect your decision (not to smoke near you, not to offer you any more cigarettes).

- Be prepared for the urge to smoke. It may come on suddenly and intensely, especially in the first few weeks after you've stopped smoking, but it shouldn't last more than 3 or 4 minutes.

- You need to plan what you will do in this case and act very quickly to avoid "cracking", for example

o drinking a large glass of water

o chew gum,

o count to 100,

o take a few deep breaths,

o leave the room,

o change activity.

- Avoid situations associated with smoking (coffee, aperitifs, etc.), avoid temptations (sit with non-smokers). Find ways to compensate for smoking (hobbies, sports, cultural activities).

How can you overcome your physical dependence?

If you're addicted to nicotine, you may need to use nicotine substitutes to succeed.

To assess your level of dependence, we suggest you take the Fagerström test.

FAGERSTROM TEST

score from 0 to 2: you are not addicted to nicotine. You can stop smoking without needing a nicotine replacement. However, if you're worried about quitting, ask your pharmacist or doctor for advice.

score of 3 to 4: you are mildly dependent on nicotine.

score 5 to 6: you are moderately dependent on nicotine. The use of nicotine substitutes will increase your chances of success. Ask your pharmacist or doctor for advice on the best treatment for you.

score from 7 to 10: you are strongly or very strongly dependent on nicotine. The use of nicotine substitutes is recommended to help you overcome this nicotine dependence. This treatment must be used in sufficient and appropriate doses.

Ask your pharmacist or doctor for advice, possibly in the context of a specialized smoking cessation consultation.

Withdrawal symptoms may persist for a long time, and treatment should be of sufficient duration, usually one to three months.

If, despite treatment, you experience a persistent "craving" sensation, such as

- the urge to smoke

- irritability, sleep disturbances

- restlessness or impatience,

- difficulty concentrating,

Ask your doctor or pharmacist for advice, as dose adjustments may be necessary.

How can we help you?

Support from healthcare professionals

The support, advice and follow-up provided by your doctor or pharmacist will be invaluable during the first six months of quitting smoking. You can also turn to a specialized smoking cessation consultation, especially if you've already failed.

Psychological support

Quitting smoking requires a supportive family and social environment. If you're worried that the difficulties are too great, psychological support or temporary treatment can help.

Diet

In the months following smoking cessation, you may notice a moderate weight gain. If you have any concerns in this area, you can speak to a health professional who will be able to advise you.

Why have you started smoking again?

Consider this relapse as an accident along the way, as a normal learning event: a relapse is not a failure.

Analyze the reasons why you started smoking again.

Physical dependence

This may not have been properly taken into account, or it may have reappeared after several months, for example, during prolonged stays in smoky atmospheres.

Excessive weight gain

You may need to modify your eating habits before your next attempt to stop smoking.

Because of a drop in motivation, because of a painful event or a difficult period, because of psychological difficulties that have arisen during the quitting process (depression, anxiety...), because of a lack of energy, because of a lack of energy or because of a lack of energy..), or because of a very tempting situation. Understand the reason for the relapse, so you can prevent it if possible the next time you try.

In all cases, don't hesitate to ask a healthcare professional for advice, or seek out a specialized smoking cessation consultation.