NICOTINELL 1mg Nicotine 204 Tablets to suck Mint

NOTICE

ANSM - Updated: 21/08/2017

Name of the drug

NICOTINELL MINT 1 mg, sucking tablet

Nicotine

framed

Read this leaflet carefully before taking this medicine. It contains important information for your treatment.

If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.

· Keep this leaflet, you may need to read it again.

· If you need more information and advice, talk to your pharmacist.

· If you always use NICOTINELL MENTHE 1 mg, tablet to suck after 9 months, consult a doctor.

· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Summary notice

In this notice :

1. WHAT IS NICOTINELL MINT 1 mg tablet to suck AND WHAT IT IS USED FOR?

2. BEFORE YOU TAKE NICOTINELL MINT 1 mg, tablet to suck?

3. HOW TO TAKE NICOTINELL MINT 1 mg, tablet to suck?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE NICOTINELL MINT 1 mg, tablet to suck?

6. ADDITIONAL INFORMATION

1. WHAT IS NICOTINELL MINT 1 mg tablet to suck AND WHAT IT IS USED FOR?

Pharmacotherapeutic class

NICOTINELL MENTH 1 mg, sucking tablet contains nicotine, one of the substances of tobacco.

NICOTINELL MINT 1 mg sucking tablet belongs to the range of drugs to help you stop smoking.

Nicotine is released slowly and then absorbed through the oral mucosa each time a tablet is sucked.

Therapeutic indications

This medicine is indicated in the smoking cessation aid. The nicotine in NICOTINELL MENTHE 1 mg, a sucking tablet, relieves the symptoms of nicotine withdrawal when you quit smoking or temporarily reduce, in order to facilitate a complete cessation. By relieving the symptoms of lack at work and the irresistible cravings of smoking, NICOTINELL MENTHE 1 mg, a tablet to suck, prevents relapses in smokers motivated to quit.

Appropriate management increases the chances of success at stopping smoking.

NICOTINELL is indicated for smokers over the age of 18 years.

2. BEFORE YOU TAKE NICOTINELL MINT 1 mg, tablet to suck?

List of information needed before taking the medication

Not applicable.

Cons-indications

Do not take NICOTINELL MENTHE 1 mg, tablet to suck:

· If you are not usually a smoker,

· If you are allergic to nicotine or any of the excipients,

If in doubt, it is essential to seek the advice of your doctor or pharmacist.

Precautions for use; special warnings

Take special care with NICOTINELL MENTHE 1 mg, tablet to suck:

Take advice from your doctor or pharmacist if you:

· cardiovascular disease (myocardial infarction, heart failure, angina pectoris, Prinzmetal's angina, cardiac arrhythmia),

· history of stroke,

· high blood pressure,

· circulatory problems,

· diabetes,

· thyroid disease (hyperthyroidism),

· pheochromocytoma (adrenal gland disease leading to severe hypertension),

· hepatic or renal failure,

· inflammation of the mouth or throat, esophagitis, gastritis, ulcer of the stomach or duodenum.

Nicotine in small amounts is dangerous in children and can cause severe symptoms or death. This is why it is imperative to take NICOTINELL MENTHE 1 mg tablet to suck out of the reach and sight of children.

Children and adolescents under 18 years

In patients under 18 years of age, this drug should not be used without medical advice.

Interactions with other drugs

Other medicines and NICOTINELL MINT 1mg, tablet to suck:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. If you stop smoking and take other medications, your doctor may want to adjust the dosage.

There are no data on possible interactions between NICOTINELL MENTHE 1 mg, sucking tablet and other medicines. However, substances in the cigarette, other than nicotine, can affect certain drugs.

Smoking cessation can alter the action of certain drugs, for example:

· theophylline (a medicine used in the treatment of asthma),

· tacrine (a drug used in the treatment of Alzheimer's disease),

· olanzapine and clozapine (medicines used in the treatment of schizophrenia),

· doses of insulin (a drug used in the treatment of diabetes) may require dosage adjustment.

Interactions with food and drinks

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy

It is very important to stop smoking during your pregnancy as this can lead to stunting of your baby or even prematurity or fetal death. Ideally, you should try to stop smoking without taking any medicine. In case of failure, NICOTINELL MINT 1 mg, sucking tablet may be advisable to help you. Indeed, the risk to the fetus is probably lower than that related to smoking. Nicotine in all its forms can harm your baby. NICOTINELL MINT 1 mg, sucking tablet can be taken only after consulting the doctor who is following your pregnancy or a doctor specializing in smoking cessation help.

feeding

NICOTINELL MENTHE 1 mg, tablet to suck as smoking, should be avoided during breastfeeding, as nicotine passes into breast milk.

If your doctor recommends the use of NICOTINELL MENTHE 1 mg, a sucking tablet during breastfeeding, the tablet should be sucked just after feeding and not within two hours of the next feeding.

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

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using machines

Stopping smoking can cause changes in behavior. At the recommended doses, there is no particular risk associated with NICOTINELL MENTHE 1 mg, tablet to suck.

List of excipients with known effect

Important information about some of the ingredients of NICOTINELL MENTHE 1 mg, tablet to suck:

The NICOTINELL MENTHE sucking tablet contains sweeteners namely aspartame and maltitol.

Each tablet of NICOTINELL MENTHE 1 mg, contains aspartame (E951) source of phenylalanine in an amount equivalent to 5 mg per tablet; this can be dangerous in subjects with phenylketonuria.

NICOTINELL MENTHE 1 mg sucking tablet contains maltitol (E965), a source of fructose:

· if you know you are intolerant to some sugars, consult your doctor before taking this medicine,

· a slight laxative effect is sometimes observed.

The calorific value of maltitol is 2.3 kcal / g. The constituents of NICOTINELL MENTHE 1 mg, sucking tablet may be suitable for diabetics.

Each NICOTINELL MENTHE 1 mg sucking tablet contains 9.8 mg of sodium, which should be taken into consideration by people on a low salt diet.

3. HOW TO TAKE NICOTINELL MINT 1 mg, tablet to suck?

Instructions for a good use

Use NICOTINELL MENTHE 1 mg, sucking tablet as indicated in the package leaflet. Ask your doctor or pharmacist for advice if in doubt.

NICOTINELL MENTHE 1 mg sucking tablets are available in 2 strengths (1 mg and 2 mg).

NICOTINELL MENTHE 1 mg sucking tablet is recommended for low to medium nicotine-dependent smokers. This drug is not recommended for smokers who are highly or highly dependent on nicotine.

NICOTINELL MENTHE 1 mg, sucking tablet can be used alone or in combination with NICOTINELL TTS, transdermal patch.

Adults over 18 years old:

Treatment with NICOTINELL MINT 1 mg, tablet to suck.

The table below shows the dosage that is suitable for you:

If any adverse effects are observed when using the 2 mg tablets, use the 1 mg tablets.

Administration mode

ORAL PATH.

Do not swallow the tablet.

· Suck a tablet until the taste becomes strong.

· Then place the tablet between the gum and the cheek.

· Start again to suck the tablet when the taste has faded

· Continue this process until the tablet is completely dissolved (about 30 minutes)

Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment

Dosage in adults over 18 years

Frequency of administration

Suck a tablet whenever you feel the need to smoke. The initial dose should be 1 tablet every 1 to 2 hours. The usual dose is 8 to 12 tablets a day. If you still feel an urge to smoke, you can take an extra tablet. The maximum dose is 30 tablets per day (this applies both in the complete judgment and in the reduction of tobacco consumption).

NICOTINELL MENTHE 1 mg tablet should be used primarily for complete cessation of smoking.

Duration of treatment

Complete cessation of tobacco

At the beginning and throughout the treatment, complete cessation of smoking is necessary to increase your chances of success.

The duration of the treatment is to be adapted individually. Normally, treatment should be continued for at least 3 months. After this time, gradually reduce the number of tablets; stop the treatment when the dose is reduced to 1-2 tablets a day. It is generally not recommended to continue treatment beyond 6 months. However, some "ex-smokers" may need longer treatment to prevent relapses.

In case of difficulty to stop this drug beyond 9 months, ask for advice from a health professional.

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

Reduction of tobacco consumption

NICOTINELL MENTHE 1 mg tablet should be used between 2 cigarettes for the purpose of prolonging periods without smoking and with the intention of minimizing cigarette consumption. Cigarettes should be replaced as and when NICOTINELL MINT 1 mg tablet to suck.

If after 6 weeks you have not been able to reduce the number of cigarettes smoked per day by at least half, it is recommended that you seek medical advice.

You should try to stop smoking as soon as you feel ready, but not more than 4 months after initiation of treatment. After this period, the number of tablets should be reduced gradually, for example by stopping one tablet every 2-5 days. If more than 6 months after the start of treatment, the attempt to stop smoking has failed, it is recommended to seek advice from a health professional. Regular use of NICOTINELL MENTHE 1 mg, tablet to be sucked after 6 months is not generally recommended. Some former smokers may need longer treatment to avoid resumption of smoking.

Counseling can improve your chances of stopping.

Treatment with NICOTINELL 1 mg, sucking tablet in combination with NICOTINELL TTS, transdermal patch

Complete cessation of tobacco

If your treatment has failed with NICOTINELL 1mg, Suction Tablet alone, you can use it in combination with NICOTINELL TTS transdermal patch.

Note: Read the leaflet for NICOTINELL TTS transdermal patch before use.

In order to increase your chances of quitting smoking, it is advisable to stop smoking completely when you start taking these tablets in combination with NICOTINELL TTS, a transdermal patch, for the duration of the treatment.

The use of NICOTINELL TTS transdermal patch with NICOTINELL 1 mg sucking tablet is recommended for moderately to highly nicotine-dependent smokers, ie more than 20 cigarettes per day. It is strongly recommended to conduct this therapy in association with the advice and support of a health professional.

Combination therapy should only be used when smoking is complete.

Initial treatment under association:

Start the treatment with a patch of 21 mg / 24 hours in combination with NICOTINELL 1 mg, tablet to suck. Use at least 4 tablets to suck (1 mg) daily. In most cases, 5 to 6 tablets a day are sufficient. Do not use more than 15 tablets a day. In normal situation, the treatment should not last more than 6 to 12 weeks. Thereafter, you must reduce the nicotine dose gradually.

Apply the patch to clean, dry, uninjured skin where hair is scarce (trunk, upper arms, hips) and press the patch on the skin with your hands for 10 to 20 seconds.

To minimize the risk of local irritation, it is advisable to apply NICOTINELL TTS transdermal patch to an application site different from the previous site.

It is advisable to wash your hands thoroughly after handling the transdermal patches to avoid irritation of the eyes by nicotine deposited on the fingers.

Nicotine dose reduction after the initial 6 to 12 weeks:

This can be done in 2 ways.

Option 1: Use of the patches at a lower dose, ie NICOTINELL TTS 14 mg / 24 hours, transdermal patch for 3 to 6 weeks followed by NICOTINELL TTS 7 mg / 24 hours, transdermal patch for another 3 to 6 weeks with the initial dose of NICOTINELL 1 mg, tablet to suck. Subsequently, the number of tablets should be reduced gradually. It is not generally recommended to use NICOTINELL 1mg, tablet to be sucked for more than 6 months. However, some ex-smokers may need treatment for a longer period of time to avoid smoking, but this should not exceed 9 months.

Option 2: Discontinuous use of patches and gradual decrease in the number of tablets in 1 mg. It is not generally recommended to use NICOTINELL 1 mg, tablet to be sucked for more than 6 months. However, some ex-smokers may need treatment for a longer period of time to avoid smoking, but should not exceed 9 months.

Recommended dosage

If you continue to use sucking tablets and patches after 9 months, it is advisable to consult a doctor or pharmacist.

Symptoms and instructions in case of overdose

If you take more NICOTINELL MINT 1 mg tablet to suck than you should:

If you suck too many tablets you will feel the same signs as if you had smoked too much. These general signs of nicotine overdose are: general weakness, sweating, hypersalivation, throat irritation, nausea, vomiting, diarrhea, abdominal pain, hearing and visual disturbances, headache, palpitations, shortness of breath and circulatory problems.

In this case, inform your pharmacist or doctor.

If you suspect poisoning in a child, contact a doctor or emergency department. In fact, nicotine in small amounts is dangerous in children and can cause severe symptoms or death.

Instructions for omitting one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

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

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of adverse effects

Like all medicines, NICOTINELL MENTHE 1 mg, sucking tablet can have side effects, although not everybody gets them.

Some side effects such as dizziness, headache and insomnia can occur early in treatment and may be due to withdrawal symptoms related to stopping smoking or nicotine under-dosing.

Common side effects (affecting 1 to 10 people in 100)

· Headache, dizziness.

· Dry mouth, hiccups, digestive disorders, nausea, flatulence, heartburn, hypersalivation, irritation of the mouth and throat may occur, especially if you suck the tablets too quickly.

These signs can be diminished by sucking the tablet more slowly.

Uncommon side effects (affecting 1 to 10 people in 1000)

· Palpitations.

Rare side effects (affecting 1 to 10 people in 10,000)

· Heart rhythm disorders and allergic reactions. These reactions can be in very rare cases serious. You should immediately consult your doctor if you experience symptoms such as edema (swelling) of the face, mouth and / or pharynx and / or difficulty swallowing or if you have hives associated with difficulty breathing (edema from Quincke).

Mouth ulceration may occur during smoking cessation, but its relationship to nicotine treatment is not established.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

By reporting side effects, you can help provide more information about the safety of the medicine.

5. HOW TO STORE NICOTINELL MINT 1 mg, tablet to suck?

Keep out of the reach and sight of children.

Expiration date

Do not use after the expiry date stated on the box after "EXP".

The expiry date refers to the last day of the month.

Storage conditions

Store at a temperature not exceeding 25 ° C.

If necessary, warn against some visible signs of deterioration

Medicines should not be thrown away with sewage or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Complete list of active substances and excipients

What does NICOTINELL MINT contain 1 mg, tablet to suck?

The active substance is :

Nicotine ................................................. .................................................. ..................................... 1,000 mg

In the form of nicotine bitartrate dihydrate ........................................... ....................................... 3.072 mg

For a tablet to suck.

The other components are :

Maltitol (E965), anhydrous sodium carbonate, sodium bicarbonate, 30% polyacrylate dispersion, xanthan gum, anhydrous colloidal silica, levomenthol, peppermint essential oil, aspartame (E951), magnesium stearate.

This medicine does not contain sugar.

Pharmaceutical form and content

What is NICOTINELL MENTHE 1 mg, tablet to suck and contents of the pack?

NICOTINELL MINT 1 mg, sucking tablet is a white, mint flavored, round and biconvex tablet.

NICOTINELL MENTHE, tablet to suck exists in two dosages (1 and 2 mg).

This medicine is available as a sucking tablet in packs of 12, 36, 72, 96, 144 or 204 tablets.

Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different

Holder

GLAXOSMITHKLINE CONSUMER HEALTH

23 RUE FRANCOIS JACOB

92500 RUEIL MALMAISON

exploiting

GLAXOSMITHKLINE CONSUMER HEALTH

23 RUE FRANCOIS JACOB

92500 RUEIL MALMAISON

Maker

NOVARTIS CONSUMER HEALTH GMBH

ZIELSTATTSTRASSE 40

81379 MUNICH

GERMANY

Names of the drug in the member states of the European Economic Area

This medicine is authorized in the member states of the European Economic Area under the following names:

[to be completed by the holder]

Date of approval of the notice

The last date this notice was posted is [MM / YYYY].

AMM under exceptional circumstances

Not applicable.

Internet information

Detailed information on this medicine is available on the Ansm (France) website.

Information reserved for health professionals

Not applicable.

Other

COUNCIL / HEALTH EDUCATION

As soon as you stop smoking:

· You will no longer absorb the irritating and toxic substances of cigarettes,

· You will see some improvements: progressive disappearance of headaches, coughing, irritation of the throat, shortness of breath,

· You will often have the satisfaction of getting better sleep, flavor of food, smells and improving your physical performance,

· You will reduce your risk of developing lung cancer or cardiovascular disease.

What is smoking addiction?

Tobacco addiction is twofold:

· Psychological dependence:
Smoking a cigarette entails a ritual of automatic and repetitive gestures associated with particular circumstances (pleasure, stress response, intellectual stimulation, support for morale, need for the gesture of conviviality). This is the psychological and behavioral dependence.

· Physical dependence:
The body's need for nicotine is due to the effects of this substance on the nervous system. It's about physical dependence. The non-satisfaction of this need leads to a feeling of lack (see description in the chapter "How to overcome your physical dependence?").

Nicotine substitutes aim to treat this dependence.

How to overcome your psychological dependence?

· Complete smoking cessation is necessary to increase your chances of success, but more:

o Choose a day J 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 arrest attempt be made at the same time by both spouses.

· Tell your family and coworkers that you are quitting. Ask them to respect your decision (do not smoke near you, do not offer cigarettes).

· Prepare to deal 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 must anticipate what you will do in this case and act very quickly not to "crack" like for example:

o drink a big glass of water,

o to chew gum,

o count to 100,

o to make some deep breaths,

o to leave the room,

o change of activity ...

· Avoid situations associated with taking cigarettes (coffee, aperitif, ...), avoid temptations (settle with non-smokers).

Find compensation for cigarettes (leisure, sport, cultural activity ...).

How to overcome your physical dependence?

If you are addicted to nicotine, the success of your approach may require the use of nicotine substitutes.

To assess your level of dependence, the Fagerström test is offered.

TEST OF FAGERSTROM

· score from 0 to 2 : you are not addicted to nicotine.
You can stop smoking without the need for a nicotine replacement.
However, if you are dreading 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.
Take advice from your pharmacist or doctor to help you choose the most appropriate treatment for you.

· score 7 to 10 : you are strongly or very strongly dependent on nicotine.
The use of nicotine replacement is recommended to help you overcome this addiction to nicotine. This treatment must be used in sufficient and appropriate doses.
Take advice from your pharmacist or doctor, possibly as part of a specialized quit smoking consultation.
Withdrawal disorders can 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 craving to smoke,

o irritability, sleep disorders,

o agitation or impatience,

o difficulty concentrating,

Take advice from your doctor or pharmacist as dose adjustment may be necessary.

How to help you?

· The support of health professionals
The accompaniment, the advice, the follow-up that can bring you your doctor or your pharmacist will be precious during the first six months of your stop of the tobacco. You can also use a specialized smoking cessation counseling, especially if you have already failed.

· Psychological support
Quitting 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 you.

· Dietetics
In the months after stopping smoking, you may notice moderate weight gain.
If you have concerns in this area, you can contact a health professional who will advise you.

You started smoking again, why?

Consider this relapse as an accident of course, as a normal event that allows you to learn: relapse is not a failure.

Analyze why you started smoking again.

· Because of physical dependence
This may have been poorly taken into account or may reappear after several months, for example, prolonged stays in smoky atmospheres.

· Because of weight gain deemed excessive.
It may be necessary to change your eating habits a little before your next quit attempt.

· Because of a decrease in motivation , because of a painful event or a difficult period, because of psychological difficulties appeared at the stop of the tobacco (depression, anxiety ...), because of a situation very tempting. Understand the reason for this relapse to prevent it if possible during the next attempt.
In any case, do not hesitate to seek advice from a health professional or to resort to a specialized consultation of help with smoking cessation.

VIDAL OF THE FAMILY

NICOTINELL sucking tablet