NOTICE
ANSM - Updated on : 29/06/2023
Product name
NICORETTESPRAY 1 mg/dose, oral spray solution
Nicotine
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information given in this leaflet or by your doctor.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- If you are unable to stop smoking after 6 months of treatment with NICORETTESPRAY, you should contact your doctor.
What does this leaflet contain?
1. What is NICORETTESPRAY 1 mg/dose, oral spray solution and what is it used for?
2. What do I need to know before using NICORETTESPRAY 1 mg/dose, oral spray solution?
3. How do I use NICORETTESPRAY 1 mg/dose, oral spray solution?
4. What are the possible side effects?
5. How do I keep NICORETTESPRAY 1 mg/dose, solution for mouth spray?
6. Package contents and other information.
1. WHAT IS NICORETTESPRAY 1 mg/dose, oral spray solution AND WHAT IS IT USED FOR?
NICORETTESPRAY is used to help smokers stop or reduce their tobacco consumption before they stop completely. It is a Nicotine Replacement Therapy (NRT) treatment.
NICORETTESPRAY relieves the symptoms of nicotine withdrawal experienced when quitting smoking, notably irresistible cravings. When the body is suddenly deprived of the nicotine provided by tobacco, it experiences various types of unpleasant sensations, known as withdrawal symptoms. NICORETTESPRAY helps prevent or reduce these unpleasant sensations and cravings. These effects are achieved thanks to the small amount of nicotine that the body continues to receive over a short period of time. NICORETTESPRAY is less harmful than smoking. It contains no tar, carbon monoxide or other toxins found in cigarette smoke.
To increase your chances of quitting smoking, take advantage of our advice and support service, if available.
2. WHAT DO I HAVE TO KNOW BEFORE USING NICORETTESPRAY 1 mg/dose, oral spray solution?
Never use NICORETTESPRAY 1 mg/dose, solution for mouth spray:
- if you are allergic to nicotine or to any of the other ingredients of this product, as listed in section 6.
- if you are under 18 years of age
- if you have never smoked
Warnings and precautions
Contact your doctor before taking this medicine if you experience any of the following symptoms. You may take NICORETTESPRAY, but you should discuss this with your doctor beforehand if you have :
- a 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 rhythm,
- high blood pressure not controlled by medication,
- a history of allergic reactions manifested by swelling of the lips, face and throat (angioedema) or an itchy rash (urticaria). The use of NRT may trigger this type of reaction,
- severe or moderate hepatic insufficiency,
- severe renal insufficiency
- diabetes,
- hyperthyroidism,
- a tumor of the adrenal gland (pheochromocytoma),
- stomach or duodenal ulcer,
- sophagitis,
- a history of seizures or convulsions.
NICORETTESPRAY should not be used by non-smokers.
Children and adolescents
Do not use in children or adolescents.
Other medicines and NICORETTESPRAY 1 mg/dose, oral spray solution
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including medicines obtained without a prescription. This is particularly important if you are taking medicines containing :
- theophylline to treat asthma,
- tacrine to treat Alzheimer's disease,
- clozapine to treat schizophrenia,
- ropinirole to treat Parkinson's disease.
NICORETTESPRAY 1 mg/dose, oral spray solution with food and drink
Do not eat or drink while spraying.
Pregnancy, breast-feeding and fertility
It is very important to stop smoking during pregnancy, as it can slow down your baby's growth. It can also lead to premature delivery or late fetal death. It is advisable to stop smoking without using nicotine-containing medication.
If you are unable to stop smoking without nicotine replacement therapy, NICORETTESPRAY may be used in consultation with the healthcare professional monitoring your pregnancy, your paediatrician or your pharmacist. who is monitoring your pregnancy, your family doctor, or a doctor at a center specializing in helping people who want to stop smoking.
The use of NICORETTESPRAY should be avoided while breast-feeding, as nicotine passes into breast milk and may affect your child. If your doctor has recommended that you use NICORETTESPRAY, the dose should be taken immediately after feeding, with a 2-hour interval between a mouth spray and the next feeding.
Smoking increases the risk of fertility in both men and women. The effects of nicotine on fertility are unknown.
Driving vehicles and using machines
No effect has been observed on the ability to drive vehicles and use machines.
NICORETTESPRAY contains 11 mg propylene glycol per spray. NICORETTESPRAY contains approximately 7 mg alcohol (ethanol) per spray, equivalent to 97 mg/ml. The amount in one spray is equivalent to less than 2 ml beer or 1 ml wine. The amount of alcohol contained in this medicine is unlikely to have a significant effect.
It also contains less than 1 mmol (23 mg) sodium per spray, making it essentially "sodium-free". Due to the presence of butylated hydroxytoluene, NICORETTESPRAY may cause local skin reactions (e.g. contact dermatitis), or irritation of the eyes and mucous membranes.
3. HOW DO I USE NICORETTESPRAY 1 mg/dose, solution for mouth spray?
Always use NICORETTESPRAY exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
NICORETTESPRAY should not be used by persons under 18 years of age.
Ask your doctor for advice if you have not succeeded in reducing the number of sprays or your cigarette consumption after 6 weeks of treatment, or if you need to use NICORETTESPRAY for more than 6 months.
Normally, you can take NICORETTESPRAY for 3 months, but not for more than 6 months.
Instructions on how to use NICORETTESPRAY depend on whether you stop immediately or gradually reduce the number of cigarettes you smoke before stopping completely.
Immediate smoking cessation
The aim is to stop smoking immediately, and using the spray will relieve irresistible cravings.
Do not use more than 2 sprays per dose or 4 sprays over 16 hours. The maximum dose is 64 sprays over 16 hours in a 24-hour period.
Step 1: Weeks 1 to 6
Use 1 or 2 sprays at regular smoking times, or when you feel the urge to smoke. Start with one spray, and if the urge to smoke doesn't disappear after a few minutes, use a second spray. If 2 sprays are required, subsequent doses may comprise 2 consecutive sprays. Most smokers should use 1 or 2 sprays every 30 minutes to 1 hour.
For example, if you smoke an average of 15 cigarettes a day, you should use 1 to 2 sprays at least 15 times a day.
Step 2: Weeks 7 to 9
Start reducing the number of sprays per day.
By the end of Week 9, the average number of sprays you use per day should be HALF that of Step 1.
Step 3: Weeks 10 to 12
Continue to reduce the number of sprays per day until you reach a maximum of 4 sprays per day in Week 12. When you're down to 2-4 sprays a day, you can stop using NICORETTESPRAY.
Smoking cessation
The aim is to start by gradually replacing some of your cigarettes with NICORETTESPRAY. After that, you stop smoking cigarettes altogether when you use the spray. Finally, you stop using the spray.
When you feel an irresistible urge to smoke, use 1 to 2 sprays instead of a cigarette to help you manage your cravings. The spray is intended to replace a cigarette, so don't smoke immediately after using the spray. Using the spray without reducing the number of cigarettes you smoke may cause undesirable effects (see "If you have used more NICORETTESPRAY 1 mg/dose, oral spray solution than you should have"). Reduce the number of cigarettes you smoke per day as much as possible and replace them with a spray. If you have not succeeded in reducing your cigarette consumption after 6 weeks of treatment, seek advice from a healthcare professional. As soon as you feel ready, you can stop smoking completely, but no later than 12 weeks after the start of treatment. Once you've stopped smoking, gradually reduce the number of sprays per day. When you've reduced it to 2 to 4 sprays a day, you can stop using NICORETTESPRAY.
Do not use more than 2 sprays per dose or 4 sprays over 16 hours. The maximum dose is 64 sprays over 16 hours in a 24-hour period.
When treatment stops, you may be tempted to smoke again. Keep a spare spray bottle on hand, as the urge to smoke may 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.
Follow these instructions carefully, using the diagrams as a guide.
Releasing the spray orifice
Opening the dispenser
1. Using your thumb, slide the knob (a) downwards until you can push it in with light pressure (b). Do not press too hard.
2. While pushing the knob inwards, slide it upwards (c) to release the top of the dispenser. Then release the knob.
Loading the dispenser
When using the oral sprayer for the first time, start by priming the sprayer. Hold the sprayer away from yourself and nearby adults, children and pets. Using your index finger, press the top of the dispenser 3 times until a fine mist appears. After 2 days without use, it may be necessary to repeat this sprayer loading procedure.
Using the dispenser
3. Open your mouth and place the spray nozzle as close to it as possible.
4. Press firmly on the top of the sprayer to release a dose into your mouth, avoiding the lips. Do not inhale when spraying, to prevent the product from entering your respiratory tract. For best results, avoid swallowing for a few seconds after spraying.
Blocking the spray orifice
Closing the dispenser
5. Slide knob (d) down until it can be pushed in (e).
6. While pushing the knob inwards, slide the top part of the dispenser down (f). Release the button. The dispenser is now closed.
To take another dose, repeat the above steps.
Close the dispenser after each use to prevent children from using the sprayer and to avoid accidental spraying.
Take care not to spray the contents of the mouth spray into the eyes. If sprayed in eyes, rinse thoroughly with water.
If you have used more NICORETTESPRAY 1 mg/dose, oral spray solution than you should have
Nicotine overdose may occur if you smoke while using NICORETTESPRAY.
If a child is using NICORETTESPRAY, or if you have used more NICORETTESPRAY than you should have, contact your doctor or the nearest hospital immediately. The doses of nicotine tolerated by adult smokers during treatment can cause severe, even fatal, intoxication in children.
Symptoms of overdosage include nausea, vomiting, excess saliva, stomach pain, diarrhea, vomiting, diarrhea, nausea and vomiting.stomach pain, diarrhea, sweating, headache, dizziness, hearing loss and general weakness. At high doses, these symptoms may be accompanied by low blood pressure, weak and irregular pulse, difficulty breathing, extreme fatigue, cardiovascular collapse and convulsions.
If you have any further questions about the use of this drug, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, NICORETTESPRAY may cause undesirable effects, but these do not always occur in everyone.
NICORETTESPRAY may produce the same undesirable effects as other forms of nicotine. In general, side effects are related to the dose you take.
Effects related to smoking cessation (nicotine withdrawal)
Some of the side effects you experience when you stop smoking may be withdrawal symptoms due to reduced nicotine intake.
These include :
- irritability, aggressiveness, impatience or frustration,
- anxiety, restlessness or difficulty concentrating,
- insomnia or sleep disorders,
- increased appetite or weight gain,
- depressed mood,
- urge to smoke (cravings),
- reduced heart rate,
- bleeding gums or mouth ulcers
- dizziness or drunkenness,
- cough, sore throat, blocked nose or runny nose.
- constipation
If you notice any 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,
- hives and difficulty breathing.
Very common: affects more than 1 in 10 users
- hiccups (particularly frequent),
- headache, nausea (vomiting),
- throat irritation
Common: affects up to 1 in 10 users
- localized effects such as burning sensation, inflammation of the mouth, alteration of taste
- dry mouth or increased saliva,
- dyspepsia,
- pain or discomfort in the abdomen,
- vomiting, flatulence or diarrhea,
- feeling of tiredness,
- hypersensitivity (allergy)
- tingling
- cough
Uncommon: affects up to 1 in 100 users:
- effects on the nose such as blocked nose, sneezing
- wheezing (bronchospasm), or a feeling that breathing requires more effort than usual (dyspnea), throat tightness
- hot flushes (facial flushing), or excessive sweating,
- effects in 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, belching, bleeding gums
- palpitations (unusual sensitivity to your heartbeat), increased heart rate, high blood pressure
- skin rashes and/or itching (pruritus, urticaria).
- nightmares
- chest discomfort and pain
- weakness, malaise
- runny nose
Rare: affects up to 1 in 1,000 users
- difficulty swallowing, decreased sensation in the mouth
- retching
Unknown frequency: frequency cannot be estimated on the basis of available data
- blurred vision, increased tear production (lacrimation)
- dry throat, stomach discomfort, sore lips
- skin redness
- allergic reactions including swelling of the face and mouth (angioedema or anaphylaxis).
- heart rhythm disorders
- convulsions
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effect 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 - Website: https://signalement.social-sante.gouv.fr.
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE NICORETTESPRAY 1 mg/dose, solution for mouth spray?
Keep out of sight and reach of children.
Do not use NICORETTESPRAY after the expiry date (EXP) indicated on the dispenser and outer packaging. The expiration date refers to the last day of the month.
Store at temperatures not exceeding 30°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment, especially the aquatic environment in the case of nicotine.
6. CONTENTS AND OTHER INFORMATION
What NICORETTESPRAY 1 mg/dose oral spray solution contains
- The active substance is :
Nicotine.................................................................................................................................. 1 mg
for one spray.
- Other ingredients are :
Propylene glycol (E1520), ethanol anhydrous, trometamol, poloxamer 407, glycerol (E422), sodium bicarbonate, levomenthol, mint flavour, refreshing flavour.flavor, sucralose, acesulfame potassium, butylated hydroxytoluene (E321), hydrochloric acid (pH adjustment) and purified water.
What NICORETTESPRAY 1 mg/dose oral spray solution is and what it contains
NICORETTESPRAY is supplied as an oral solution in a plastic bottle contained in a dispenser fitted with a mechanical spray pump. The dispenser is child-resistant.
Each bottle contains 13.2 ml of solution to provide 150 doses, each containing 1 mg of nicotine.
NICORETTESPRAY comes in boxes of 1 or 2 dispensers.
All presentations may not be marketed.
Explanatory note: The 2 sentences between <> above referring to the presentation with the NFC chip will only be printed on the leaflet in countries where this presentation is available.
Marketing authorization holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
43 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX, FRANCE
Marketing authorization holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
43 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Manufacturer
MCNEIL AB
P.O. BOX 941
NORRBROPLATSEN 2,
SE-251 09 HELSINGBORG,
SWEDEN
Product names in member states of the European Economic Area
This product is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
[To be completed subsequently by the holder].
The last date on which this leaflet was revised was :
[to be completed at a later date by the registrant]
Other
Detailed information on this drug is available on the ANSM (France) website.
HEALTH EDUCATION ADVICE :
Quitting smoking as soon as possible has immediate health benefits. It's never too late to quit, even if you've smoked a lot for a long time.
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 its effects on the nervous system. This is physical dependence. Failure to satisfy this need leads to a feeling 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:
- choose a day when you feel most confident about quitting,
- throw away your last pack of cigarettes, your lighter and put away your ashtrays,
- In the case of a smoking couple, it's preferable 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're going to do in that case, and act very quickly to avoid "cracking":
- drink a large glass of water,
- chewing gum,
- count to 100,
- take a few deep breaths,
- leave the room,
- 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
|
How long after waking up do you smoke your first cigarette?
|
|
|
|
- within 5 minutes: 3
- 6 to 30 minutes: 2
- from 31 to 60 minutes: 1
- after 60 minutes: 0
|
|
|
|
Do you find it difficult not to smoke in places where it's forbidden?
|
|
|
|
- yes : 1
- no : 0
|
|
|
|
Which cigarette of the day would be the most difficult for you to give up?
|
|
|
|
- the first: 1
- another : 0
|
|
|
|
How many cigarettes do you smoke a day?
|
|
|
|
- 10 or less: 0
- 11 à 20 : 1
- 21 à 30 : 2
- 31 or more: 3
|
|
|
|
Do you smoke more in the morning than in the afternoon?
|
|
|
|
- yes : 1
- no : 0
|
|
|
|
Do you smoke when you are so ill that you have to stay in bed most of the day?
|
|
|
|
- yes : 1
- no : 0
|
|
|
|
TOTAL POINTS
|
|
|
Score from 0 to 2: you are not addicted to nicotine.
You can stop smoking without needing a nicotine substitute.
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 of 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 usually last one to three months.
If, despite treatment, you experience a persistent sensation of "craving", such as
- the urge to smoke
- irritability, sleep disturbances
- restlessness or impatience,
- difficulty concentrating.
Consult your doctor or pharmacist, 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?
Think of 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 a little before your next attempt to stop smoking.
- Because of a drop in motivation, a painful event or difficult period, or psychological difficulties that have arisen in the course of quitting smoking.psychological difficulties (depression, anxiety), or a very tempting situation. Understand the reason for this 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.
If you've started smoking again, don't be discouraged. Experience shows that your chances of success increase after one or more quit attempts.