Nicorette MOUTH SPRAY 1 * 150

Nicorette : patch Nicorette, gum Nicorette - Anti-tabac Nicorette : patch Nicorette, gum Nicorette - Anti-tabac

Nicorette MOUTH SPRAY: Nicorettespray solution for oral spray Mint is a drug indicated for the relief of nicotine cravings and withdrawal symptoms of nicotine associated with stopping smoking.

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Nicorette MOUTH SPRAY 1 * 150


For warnings, precautions for use and cons-indications, see the instructions for use.

 

Nicorette MOUTH SPRAY DESCRIPTION


Nicorette Fresh Mint Buccal Spray is a drug indicated for the relief of nicotine cravings and withdrawal symptoms of nicotine associated with stopping smoking. It helps in curbing the consumption of tobacco one to two doses when necessary to control his cravings.

Dialing a distributor (13.2 ml):

Active substance   :   Nicotine.
A spray delivers a dose of 1 mg nicotine.
Other components   :   Propylene glycol, anhydrous ethanol, trometamol, poloxamer 407, glycerol, sodium bicarbonate, levomenthol, peppermint aroma, refreshing flavor, sucralose, acesulfame potassium, hydrochloric acid, purified water.

Instructions :


-Press The upper part of the dispenser to release a dose in your mouth.
-Do Not breath when spraying so the product does not fit into your airways.
-For Best results, avoid swallowing for a few seconds after spraying.


 

HOW TO USE Nicorette MOUTH SPRAY

 

 

At baseline, use 1 or 2 sprays spray nicorette the usual times tobacco use or when the urge. Start by spraying, and if the urge to smoke does not disappear after a few minutes, use a second spray. If 2 sprays are required, the subsequent doses can contain two consecutive sprays. Many smokers have to use about 1 to 2 sprays every 30 minutes to 1 hour.

For example if average consumption of 15 cigarettes a day, you should use 1-2 sprays at least 15 times a day.
After 6 weeks, start to reduce the daily number of sprays.
Maximum dose of 2 sprays per dose, 4 sprays per hour and 64 sprays per day.
The subjects under 18 years old should not use Nicorettespray, unless prescribed by a doctor.

The dispenser opening, release the spray nozzle   :
-A Using the thumb slide the button down until you can bring him with light pressure. Do not press too hard.
-Any By pushing the button inward, please let slide up to unlock the upper distributor. Then release the button.

Loading Machine   :
When first using the oral spray, start by booting the vaporizer. Hold the sprayer tip away from yourself and adults, children and animals are nearby. With the index finger, press 3 times the upper portion of the dispenser until appearance of a fine mist. After 2 days without use, it may be necessary to repeat this sprayer loading procedure.

The dispenser closure, blockage of spray nozzle   :
-Make Slide the button down until you can push it inward.
-Any By pushing the button inward, slide the upper part of the dispenser down.
Release the button. The valve is closed.

To take another dose, repeat the steps above.

Cons-indications:


-If You are allergic (hypersensitive) to nicotine or any other ingredients in Nicorettespray.

Precautions:


Contact your doctor if you experience any of these symptoms. You can take Nicorettespray but you should discuss beforehand with your doctor if you have:
-Of a recent history (
-a chest pain (unstable angina) or stable angina,
-a problem affecting your heart rate or heart rate,
-a hypertension that is not controlled by drugs,
-the history of allergic reactions are manifested by swelling of the lips, face and throat (angioedema) or rashes associated with itching (hives). Sometimes the use of NRT triggers this type of reaction,
-a moderate or severe hepatic impairment,
-a severe renal impairment,
-a diabetes,
-a hyperthyroidism,
-a tumor of the adrenal gland (pheochromocytoma)
-a stomach ulcer,
-a esophagitis.
-Nicorettespray Should not be used by non-smokers.
-S'abstenir Eating and drinking during the oral spray.
-take Care not to spray the content of the oral spray towards the eyes. If spray in the eyes, rinse thoroughly with water.
-Keep Out of the reach and sight of children.
-A Keep at temperatures below 25 ° C.
-A Best before the date indicated on the package.
-Refermer Distributor after each use to prevent children from using the sprayer and to prevent accidental spraying.
-Read the instructions before use.
-Keep Out of reach of children.
-A Keep at temperatures below 25 ° C.

Taking other medicines   :
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist. This is especially important if you are taking medicines containing:
-from theophylline for asthma,
-from tacrine for treating Alzheimer's disease,
-In clozapine to treat schizophrenia,
-du ropinirole to treat Parkinson's disease.

Route of administration:   Mouth.

To increase your chances of success, read the instructions carefully and particularly health education boards located at the end of the leaflet.

Packaging :   1 x 150 or 2 x 150 doses sprays.

 

Warnings on drugs


Warning, the drug Nicorette sprayer is not a product like any other. Read the package leaflet before ordering. Do not leave medicines within reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please tell your online pharmacist of current treatments to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the manual of this drug on the website of the National Agency of Drug Safety and health products.

Pharmacovigilance Reporting an or effect (s) Adverse (s) bound (s) use of a medicament

VIDAL OF THE FAMILY

NICORETTESPRAY

Medication for smoking cessation

nicotine

. Presentations . Composition . Indications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

NICORETTESPRAY 1 mg / dose: buccal spraying solution (mint flavoring); 1 spray bottle (150 doses).
-

NICORETTESPRAY 1 mg / dose: buccal spraying solution (mint flavoring); box of 2 spray bottles (150 doses).
-

Laboratory

COMPOSITION (summary)
p pulv
Nicotine 1 mg
Alcohol +
Propylene glycol +

INDICATIONS (summary)
This medication helps smokers detoxify tobacco. The solution brings into the blood via the oral mucosa , nicotine, the main active substance in tobacco, responsible for addiction.
WARNING (Contents)
With a view to definitive detoxification, cessation of smoking is a necessary condition for successful treatment.
Precautions are necessary in case of severe heart disease (recent myocardial infarction, recent angina pectoris , Printzmetal angina, severe heart rhythm disorders , stroke ), stomach ulcer or duodenal ulcer , hyperthyroidism , pheochromocytoma , diabetes , renal insufficiency or liver failure . In these situations, a prior medical consultation is essential before using this medication; a cessation of smoking without substitution treatment may be necessary.
Nicotine is a toxic substance. Do not leave the vial within reach of children. The use of this medication is reserved for adults over 18 years (in the absence of studies).
DRUG INTERACTIONS (summary)
The products contained in tobacco smoke can accelerate the rate of elimination of certain drugs, especially theophylline. When smoking cessation, these drugs can see their effect strengthened and signs of overdose may appear. Contact your doctor in case of any doubt.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
Smoking in pregnant women may cause fetal growth retardation. Stopping tobacco is always desirable. In women who are highly dependent on nicotine, the use of this medication may be an aid, but the effects of nicotine alone on the fetus are poorly understood. This drug has the advantage of not exposing the fetus to other toxic substances present in tobacco smoke. In summary: if the ideal is not to smoke and not to expose the fetus to nicotine intake, the use of this drug is a lesser evil compared to tobacco.

Breastfeeding:
Nicotine passes into breast milk, and breast-feeding is not recommended during treatment.
DIRECTIONS FOR USE AND DOSAGE (summary)
The solution should be sprayed into the mouth avoiding the lips. For better effectiveness, it is important to avoid swallowing saliva within seconds of spraying.
In practice, it is useful to know the signs of under or overdose to adapt the dosage after a few days of treatment:
  • the overdose results in the condition of the smoker who has smoked too much and is mainly reflected in a nauseous condition and headaches. Difficulty in sight or hearing, trembling, dizziness are also possible;
  • an under-dosage causes symptoms of lack: irritability, nervousness, stomach cramps (kind of painful hunger), difficulty concentrating.

Usual dosage:

  • Adult: in a first phase of 6 weeks, do a spray whenever the need for smoking is felt, usually 1 or 2 times per hour. If the urge persists after a few minutes, repeat the spray. Do not exceed 2 sprays per intake and 64 sprays per day.
    A second phase, which usually lasts 3 weeks, corresponds to a halving of the number of sprays per day.
    Then, for a few weeks, we must continue to reduce the number of sprays until complete cessation.
Do not exceed 6 months of continuous treatment.
TIPS (summary)
This medication can be used by smokers without medical advice. It is available without a prescription and can be accessed directly in certain pharmacies. Nevertheless, do not hesitate to have your choice chosen by your pharmacist. His advice is precious. He can help you determine the best time to quit and explain the causes of failure.
Nicotine taken by way oral replacing the cigarette has the same cardiovascular harmful than that in tobacco. Only the risk of lung cancer disappears. When smoking cessation is motivated by urgent medical reasons: recent infarction , arteritis , gastritis or ulcer , it is preferable to stop the absorption of nicotine in all its forms.
like all smoke-free methods used to help smokers, this drug can only be effective when the will to quit is personal and accompanied by strong motivation. it is this motivation that will make it possible to fight against the desire to smoke, without being forced to make constant appeal to the will that dulls over time. A cessation of lasting tobacco in the smoker assumes that the smoker considers tobacco to be a poison, an unacceptable addiction. It must be done to the idea that it will never smoke, from the beginning of weaning. Every day without tobacco must be experienced as a release, not as a calvary. The smoker who is in this state of mind is a good candidate for definitive weaning.
Stopping smoking, which is a real drug, causes many problems: weight gain is frequent, concentration disorders can last several weeks. A mild depressive condition is possible. Weight gain should be fought by a diet, and if possible by a sports program that has the advantage of reconciling the smoker with his body.
Do not hesitate to consult your doctor in case of difficulty; his advice and experience will be invaluable in the fight against relapses.
POSSIBLE ADVERSE EFFECTS (summary)
During the first few days of treatment, irritation of the mouth or throat and hiccups are particularly common. These effects usually decrease with continued treatment.
Very common: nausea, difficult digestion, excessive salivation or, on the contrary, dry mouth, burning sensation of the lips, headaches, disorders of taste, inflammation of the oral mucosa.
Frequent: vomiting, diarrhea, bloating, tight throat, tiredness.
Uncommon: tingling, watery eyes, palpitations , flushing, shortness of breath, stuffy or runny nose, sneezing, gingivitis, tongue inflammation, sweating, rash, itching, hoarseness, hoarse voice.
Rarely: blurred vision, heart rhythm disorders , allergic reaction .


GLOSSARY (summary)


stroke
Brain injury due to haemorrhage or abrupt obstruction of an artery. Depending on the size of the lesion, the consequences are more or less serious: temporary discomfort, paralysis, coma.
Abbreviation: AVC.


angina pectoris
Oppressive pain due to partial obstruction of the coronary arteries that irrigate the heart muscle. It can manifest in the chest, arms or jaw.
Synonym: angor.


arteritis
Arterial disease favored by smoking and most often localized to the legs. It is characterized by a thickening of the arterial walls which interferes with blood circulation and causes pain during walking (intermittent claudication). Lower limb arteritis increases the risk of myocardial infarction and requires medication. At an advanced stage, it can be treated surgically.
Synonym: Occlusive arteriopathy of the lower limbs.


diabetes
A general term for diseases that result in the emission of abundant urine and intense thirst. The word diabetes, used alone, is generally related to diabetes mellitus, which corresponds to a disruption in the regulation of the body's sugars by insulin. It results in increased sugar (glucose) in the blood and its possible presence in the urine. There are two types of diabetes mellitus: Type 1 or insulin-dependent diabetes, which requires insulin injections, and type 2 or non-insulin dependent diabetes, which can initially be treated with oral antidiabetics.


duodenum
A part of the intestine into which food from the stomach penetrates.


depressed state
State of moral suffering associating a demotivation, a fatigue, a feeling of uselessness, of self-depreciation. In the absence of treatment, the depressive state may develop into a serious depression with a feeling of incurability, guilt, and a suicidal risk.


gastritis
Inflammation of the stomach favored by stress, tobacco, alcohol and certain drugs such as aspirin or anti-inflammatory drugs.


hyperthyroidism
Excessive thyroid hormones, including heart failure, poor heat tolerance, weight loss and chronic fatigue.


myocardial infarction
Destruction of part of the cardiac muscle (myocardium), deprived of blood by obstruction of its arteries.


Hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


mucous
Tissue (membrane) that lines the cavities and ducts of the body communicating with the outside (digestive tract, respiratory tract, urinary tract, etc.).


palpitations
Abnormal perception of irregular heartbeat.


pheochromocytoma
Very rare tumor of the adrenal glands, manifested mainly by seizures of hypertension.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


Printzmetal
angina pectoris a particular form of angina pectoris due to spasm of the coronary arteries.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


overdose
Excessive intake of a drug may result in an increase in the intensity of adverse effects or even in the development of specific adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.


symptoms
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.


heart rhythm disorders
Severe or benign anomaly of the frequency of contractions of the heart. Extrasystole is contraction occurring just before or after a normal contraction, often perceived as a slight shock in the chest. Fibrillation is an irregular and disorderly contraction. Other disorders include torsades de pointes, Wolf-Parkinson-White syndrome, Bouveret's disease, tachysystolia, flutter and atrioventricular block, etc.


ulcer
Injury of skin, mucous membranes or cornea.
  • Leg ulcer: chronic wound due to poor circulation of blood.
  • Gastroduodenal ulcer: a localized wound in the mucosa of the stomach or duodenum due to excess acidity and very often to the presence of a bacterium (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and certain medications (aspirin, NSAIDs, etc.).


way
  • Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
  • Set of hollow organs allowing the passage of air (airways), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 13/09/2016

Name of the medicinal product

NICORETTESPRAY 1 mg / dose, buccal spray solution

Nicotine

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

You should always use this medication exactly as prescribed 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.

· Contact your doctor or pharmacist if you have difficulty quitting or have not been successful after 6 months of treatment with NICORETTESPRAY.

Review summary

What this leaflet contains:

1. What is NICORETTESPRAY 1 mg / dose, buccal spray solution and in which cases is it used?

2. What should I know before using NICORETTESPRAY 1 mg / dose, mouth spray solution ?

3. How to use NICORETTESPRAY 1 mg / dose, solution for oral spraying ?

4. What are the possible side effects?

5. How to store NICORETTESPRAY 1 mg / dose, oral spray solution ?

6. Additional information.

1. WHAT NICORETTESPRAY 1 mg / dose, oral spraying solution AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

Not applicable.

Therapeutic indications

NICORETTESPRAY is used to help smokers quit smoking. This is a Nicotine Replacement Therapy (NRT) therapy.

NICORETTESPRAY relieves the symptoms of nicotinic weaning that you feel when you stop smoking, including the irresistible cravings to smoke. When the body is brutally deprived of nicotine brought by tobacco, it feels different types of unpleasant sensations, called withdrawal symptoms. The use of NICORETTESPRAY helps to prevent or reduce these unpleasant sensations and irresistible cravings for smoking. These effects are achieved through the small amount of nicotine that the body continues to receive for a short period of time. NICORETTESPRAY is less harmful than smoking. It contains no tar, carbon monoxide or other toxins in cigarette smoke.

In order to increase your chances of quitting smoking, get advice and support if possible.

2. BEFORE YOU USE NICORETTESPRAY 1 mg / dose, oral spray solution?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never use NICORETTESPRAY 1 mg / dose, oral spray solution in the following cases:

· If you are allergic to nicotine or to any of the other ingredients of this medication (mentioned in section 6).

· If you are under 18 years of age.

· If you have never smoked.

Precautions for use; special warnings

Take special care with NICORETTESPRAY 1 mg / dose, oral spray solution:

Contact your doctor if you experience any of the following symptoms. You can take NICORETTESPRAY, but you should discuss this with your doctor beforehand if you present:

· recent history (<3 months) of heart attack or stroke ,

· chest pain (unstable angina pectoris), or stable angina pectoris,

· a heart problem affecting your heart rate or heart rate,

· an arterial hypertension that is not controlled by drugs,

· a history of allergic reactions that have manifested as swelling of the lips, face and throat (angioedema) or rash associated with itching (urticaria). It may happen that the use of a NRT triggers this type of reaction,

· severe or moderate hepatic impairment,

· severe renal insufficiency,

· diabetes ,

· hyperthyroidism ,

· a tumor of the adrenal gland (pheochromocytoma),

· an ulcer of the stomach ,

· an esophagitis .

NICORETTESPRAY should not be used by non-smokers .

Interaction with other medicines

Taking or using other medicines:

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist. This is especially important if you are taking medicines containing:

· of theophylline to treat asthma,

· tacrine for treating Alzheimer's disease,

· clozapine to treat schizophrenia,

· of ropinirole to treat Parkinson's disease.

Interactions with food and beverages

Food and drinks

Refrain from eating and drinking when spraying the mouth.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy, breast-feeding and fertility

It is very important to stop smoking during pregnancy as this can slow down the growth of your baby. This can also lead to premature delivery or late fetal deaths. It is advisable to stop smoking without using medicines containing nicotine.

If you are unable to stop smoking without nicotine replacement therapy, NICORETTESPRAY may be used after consulting the health care provider who is following your pregnancy, your family doctor, or a doctor at a center specializing in helping people wishing to stop smoking.

The use of NICORETTESPRAY should be avoided during breast-feeding because nicotine passes into breast milk and can affect your child. If your doctor has recommended that you use NICORETTESPRAY, the dose should be taken immediately after breastfeeding and a 2-hour interval should be followed between oral spraying and the next breastfeeding.

Smoking increases the risk of infertility in women and in humans. The effects of nicotine on fertility are unknown.

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using machines

No effects were observed on the ability to drive and use machines.

List of excipients with known effect

Important information about some of the ingredients of NICORETTESPRAY 1 mg / dose, oral spray solution

This medication contains small amounts of ethanol (alcohol), less than 100 mg per spray.

3. HOW TO USE NICORETTESPRAY 1 mg / dose, oral spray solution?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Always use NICORETTESPRAY following the instructions in this leaflet or your doctor or pharmacist . If in doubt, consult your doctor or pharmacist.

Subjects under 18 years of age should not use NICORETTESPRAY unless prescribed by a physician.

During treatment with NICORETTESPRAY, you must abstain from smoking.

The following table shows the recommended detailed schedule for NICORETTESPRAY.

Step 1 : Weeks 1 to 6

Use 1 or 2 sprays at the usual times of tobacco consumption or in case of an irrepressible urge to smoke. Start with a spray, and if the urge to smoke does not disappear after a few minutes, use a second spray. If two sprays are required, subsequent doses may consist of 2 consecutive sprays. Most smokers should use about 1 or 2 sprays every 30 minutes to 1 hour.

For example, with an average consumption of 15 cigarettes per day, 1 to 2 sprays should be used at least 15 times per day.

The maximum dose is 2 sprays per intake, 4 sprays per hour and 64 sprays per day.

Step 2 : Weeks 7 to 9

Start reducing the daily number of sprays.

At the end of Week 9, the average number of sprays you use per day should be equal to the HALF of the one in Step 1.

Step 3 : Weeks 10 to 12

Continue to reduce the daily number of sprays to a maximum of 4 sprays per day at Week 12. When using only 2-4 sprays per day, you can stop using NICORETTESPRAY.

When the treatment stops, you may be tempted to smoke again. Keep a sprayer in reserve as the urge to smoke can suddenly reappear. If you have an irresistible urge to smoke, use one or two sprays if the effects of a single spray are insufficient after a few minutes.

Normally, you can take NICORETTESPRAY for 3 months, but not for more than 6 months.

Ask your doctor or pharmacist for advice if you need to use NICORETTESPRAY for more than 6 months.

Follow these instructions carefully using the diagrams

Unblocking of the vaporization orifice

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Opening of the distributor

1. Using the thumb, slide the knob ( a ) down until it can be pressed in with a slight pressure ( b ). Do not press too hard.

2. While pushing the knob inward, slide it upward ( c ) to unlock the top of the dispenser. Then release the button.

Loading dispenser

The first time you use the buccal sprayer, you first need to prime the vaporizer. Hold the sprayer by removing the tip from yourself and from adults, children and pets that are nearby. With the index finger, press 3 times on the top of the dispenser until a fine mist appears. After 2 days without use, it may be necessary to repeat this sprayer loading procedure.

Use of the dispenser

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3. Open your mouth and place the sprayer tip as close to the sprayer as possible.

4. Press down firmly on the top of the sprayer to release a dose into your mouth, avoiding the lips. Do not inhale during spraying so that the product does not enter your respiratory tract. For best results, avoid swallowing for a few seconds after spraying.

Blocking of the vaporization orifice

678

Closure of dispenser

5. Slide the knob (d) down until it can be pushed inward.

6. While pushing the knob inward, slide the top of the dispenser down (f). Release the button. The dispenser is closed.

To take another dose, repeat the steps above.

Close the dispenser after each use to prevent children from using the sprayer and to avoid accidental spraying.

Be careful not to spray the contents of the buccal sprayer into the eyes. In case of vaporization in the eyes, rinse thoroughly with water.

Symptoms and Instructions for Overdose

If you used more NICORETTESPRAY 1 mg / dose, oral spray solution you should:

A nicotine overdose can occur if you smoke while using NICORETTESPRAY.

If a child uses NICORETTESPRAY or if you have used more NICORETTESPRAY than you should, contact your doctor or go immediately to the nearest hospital. The doses of nicotine tolerated by adult smokers during treatment can cause severe or even fatal poisoning in children .

Symptoms of overdose include vomiting (nausea), vomiting, excess saliva, stomach pain, diarrhea, sweating, headache, dizziness, decreased acuity hearing and general weakness. In high doses, these symptoms may be accompanied by low blood pressure, low and irregular pulse, respiratory discomfort, extreme fatigue, cardiovascular collapse and convulsions.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

Instructions for omission of one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, NICORETTESPRAY 1 mg / dose, oral spraying solution is likely to have side effects, although not everyone is affected.

NICORETTESPRAY can produce the same adverse effects as other forms of nicotine. In general, side effects are related to the dose you are taking.

Effects of smoking cessation (nicotine withdrawal)

Some of the side effects you experience when quitting smoking can be withdrawal symptoms due to reduced nicotine intake.

These effects include:

· Irritability, aggressiveness, impatience or frustration,

· Anxiety, restlessness or difficulty concentrating,

· Insomnia or sleep disorders,

· Increased appetite or weight gain,

· Depressed mood,

· Urgent need for smoking (irresistible cravings),

· Reduced heart rate,

· Bleeding from the gums, or ulcers of the mouth

· Dizziness or feelings of intoxication,

· Cough, sore throat, stuffy nose or runny nose.

· Constipation

If you notice one of these rare but serious side effects, stop taking NICORETTESPRAY and contact a doctor immediately (signs of angioedema):

· Swelling of the face, tongue or pharynx,

· Difficulty swallowing,

· Urticaria and difficulty breathing.

Very common: affects more than one user in 10

· Hiccups (particularly frequent),

· Headaches, nausea (vomiting),

· Irritation of the throat

Common: affects 1 to 10 users

· Localized effects such as burning sensation, inflammation in the mouth, taste impairment

· Dry mouth or increased amounts of saliva

· Dyspepsia

· Pain or discomfort in the abdomen (abdomen),

· Vomiting, flatulence or diarrhea,

· Feeling tired.

· Hypersensitivity (allergy)

· tingling

Uncommon: affects up to 1 user in 100:

· Effects at the nose such stuffy nose, sneezing

· Wheezing (bronchospasm), or impression that breathing requires more effort than usual (dyspnea), throat tightness

· Hot flushes (redness of the face), or excessive sweating,

· Effects on the mouth such as tingling in the mouth, inflammation of the tongue, mouth ulcers, lesions of the oral mucosa, or changes in the sound of your voice, pain in the mouth and throat, eructation

· Palpitations (unusual sensitivity to your heartbeat), increased heart rate, high blood pressure

· Heart rhythm disorders

· Eruptions and / or itching (pruritus, urticaria) of the skin.

· nightmares

· Chest discomfort and pain

· Weakness, feeling unwell

· Bleeding from the gums

· Runny nose

Rare: Affects up to 1 user in 1,000

· Difficulty swallowing, decreased sensation in the mouth

· The green-heart

Unknown frequency: frequency can not be estimated on the basis of available data

· Blurred vision, increased tear production (tearing)

· Dryness of the throat, discomfort in the stomach, pain in the lips

· Redness of the skin

· Allergic reactions including swelling of face and mouth (angioedema or anaphylaxis).

If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, talk to your doctor or pharmacist.

Declaration of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 drug safety

5. HOW TO STORE NICORETTESPRAY 1 mg / dose, oral spray solution?

Keep this medicine out of the reach and sight of children.

Expiration date

Do not use NICORETTESPRAY after the expiration date which is stated on the dispenser and on the outer packaging. The expiry date refers to the last day of the month.

Storage conditions

Store at a temperature not exceeding 25 ° C.

If necessary, warnings against visible signs of deterioration

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. ADDITIONAL INFORMATION

Full list of active substances and excipients

What NICORETTESPRAY contains 1 mg / dose, buccal spray solution

The active substance is : nicotine.

A spray gives a dose of 1 mg of nicotine.

The other components are:

Propylene glycol, anhydrous ethanol, trometamol, poloxamer 407, glycerol, sodium bicarbonate, levomenthol, mint flavor, refreshing aroma, sucralose, acesulfame potassium, hydrochloric acid (pH adjustment) and purified water.

Pharmaceutical form and content

Aspect of NICORETTESPRAY 1 mg / dose, spraying solution and contents of container

This medication is in the form of a buccal solution in a plastic bottle contained in a dispenser equipped with a pump for mechanical spraying. The dispenser is equipped with a child safety system.

Each vial contains 13.2 ml of solution to provide 150 doses, each containing 1 mg of nicotine.

NICORETTESPRAY comes in a box of 1 or 2 dispensers.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Marketing Authorization Holder and Manufacturer

Holder

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1 RUE CAMILLE DESMOULINS

92130 ISSY-LES-MOULINEAUX

exploiting

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1 RUE CAMILLE DESMOULINS

92130 ISSY-LES-MOULINEAUX

Maker

MCNEIL AB

PO BOX 941

NORRBROPLATSEN 2,

SE-251 09 HELSINGBORG,

SWEDEN

Names of the medicinal product in the Member States of the European Economic Area

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

In accordance with the regulations.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

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

Information for health professionals only

Not applicable.

Other

SANITARY EDUCATION COUNCILS

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 no longer absorb the irritating and toxic substances of the cigarette,

· you can 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 reduce 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 (see description in the chapter "How to overcome your physical dependence?").

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 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 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 can 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 anticipate 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.

FAGERSTROM 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:

· compelling need to smoke,

· irritability, sleep disturbances,

· agitation or impatience,

· 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 very tempting situation . Understand the reason for this relapse to prevent it if possible during your 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.

Get all Nicorette products to help you stop smoking: Nicorette patch, Nicorette gum, inhaler

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All smokers know, quitting smoking is not an easy task! The lack of nicotine leads to withdrawal syndrome which causes irritability, anxiety, sadness. For a stress-free withdrawal, you will find here the suitable products for stop smoking: patch, gum, lozenges, tablets, inhleur and homeopathy anti tobacco ... We are available via chat, do not hesitate to Contact to get personalized advice.

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