1. WHAT IS NICORETTE MENTHE 2 mg sugar-free, medicated chewing gum sweetened with xylitol AND WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE TAKING NICORETTE MENTHE 2 mg sugar-free, medicated chewing gum sweetened with xylitol?

3. HOW TO TAKE NICORETTE MENTHE 2 mg without sugar, medicated chewing gum sweetened with xylitol?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO CONSERVE NICORETTE MENTHE 2 mg sugar-free, medicated chewing gum sweetened with xylitol?

6. ADDITIONAL INFORMATION

1. WHAT IS NICORETTE MENTHE 2 mg sugar-free, medicated chewing gum sweetened with xylitol AND WHAT IS IT USED FOR?

MEDICINES USED IN NICOTINE DEPENDENCE.

This medication is indicated for the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in subjects who wish 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 NICORETTE MENTHE 2 mg sugar-free, medicated chewing gum sweetened with xylitol?

Not applicable.

Never take NICORETTE MENTHE 2 mg sugar-free, medicated chewing gum sweetened with xylitol:

– if you do not smoke or if you are an occasional smoker,

– if you are allergic to any of the ingredients.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE

Take care with NICORETTE MENTHE 2 mg sugar-free, medicated chewing gum sweetened with xylitol:

Warnings

– · Some diseases require medical examination and monitoring before using this medicine. For example, in case of:

o severe liver and/or kidney failure,

o ulcer of the stomach or duodenum in progress,

it is essential to consult your doctor before using this medicine.

– Itis imperative to keep chewing gum 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 “lack” such as

o urge to smoke,

o irritability, sleep disorders,

o agitation or impatience,

o difficulty concentrating,

consult your doctor or pharmacist. It may be necessary to change the dosage of the medicine.

– 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.

In case of association of NICORETTE 2 mg chewing gums with NICORETTE transdermal device, refer to the leaflet of each of these medicines.

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

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.

Not applicable.

Not applicable.

Pregnancy and breastfeeding

Pregnancy

It is very important to stop smoking during your pregnancy for you and your child.

Treatment with nicotine replacement products during pregnancy requires medical advice and monitoring. You should therefore consult the health professional who is following your pregnancy or your usual doctor or a doctor at a centre specialising in smoking cessation.

Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding

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

The use of this medicine should be avoided while breastfeeding.

However, if you wish to stop smoking and breastfeed your child, seek the advice of your doctor or a doctor at a centre specialising in smoking cessation.

Ask your doctor or pharmacist for advice before taking any medication.

Not applicable.

Not applicable.

List of excipients with a known effect: xylitol.

3. HOW TO TAKE NICORETTE MENTHE 2 mg sugar-free, medicated chewing gum sweetened with xylitol?

Not applicable.

For adults only (15 years and older).

Dosage

Chewing gums containing 2 mg are not suitable for smokers who are strongly or very strongly dependent on nicotine (Fagerström test score of 7 to 10 or smoking more than 20 cigarettes per day: see Health education advice).

Quitting smoking completely

The treatment of nicotine dependence is usually done in 2 phases.

^1st phase

Chew gum every time you feel like smoking.

The number of chewing gums dosed at 2 mg is generally 8 to 12 gums per day and should never exceed 30 gums per day.

The duration of this phase is approximately 3 months, but may vary according to individual response.

^2nd phase

When the urge to smoke is completely overcome, gradually reduce the number of gums chewed per day.

Treatment should be stopped when consumption is reduced to 1 to 2 gums per day.

It is recommended not to use the gums beyond 12 months.

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

Your doctor may advise you to combine NICORETTE Chewing Gum with a form that delivers nicotine throughout the day: NICORETTE Transdermal Devices.

Temporary abstinence from smoking

Chew one gum every time you feel like smoking.

The number of chewing gums containing 2 mg is generally 8 to 12 gums per day and should never exceed 30 gums per day.

Reducing tobacco consumption

If possible, alternate nicotine gums and cigarettes.

Chew gum as soon as the urge to smoke arises in order to reduce cigarette consumption as much as possible and remain smoke-free for as long as possible.

The number of gums to chew per day varies and depends on your needs.

However, it should not exceed 30 gums 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 of tobacco consumption should lead you gradually 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 that you seek advice from a health professional.

It is recommended to n