Nicorette Quick

Package leaflet: Information for the user

Nicorettequick 1 mg/spray, oromucosal spray, solution

Nicotine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your pharmacist or doctor has told you to.

• Keep this leaflet, you may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you have not succeeded in quitting smoking after 6 months of treatment with Nicorettequick.

Contents of this leaflet

1. What Nicorettequick is and what it is used for
2. What you need to know before using Nicorettequick
3. How to use Nicorettequick
4. Possible side effects
5. How to store Nicorettequick
6. Contents of the pack and other information

1. What Nicorettequick is and what it is used for

Nicorettequick is used as an aid when you want to stop smoking or to reduce the number of cigarettes smoked before quitting completely. This treatment is known as nicotine replacement therapy (NRT).
Nicorettequick relieves nicotine withdrawal symptoms, including the urge to smoke and other symptoms that occur when you stop smoking. When you suddenly stop providing your body with nicotine from tobacco, you may experience various unpleasant sensations known as withdrawal symptoms. Nicorettequick helps prevent or reduce these unpleasant sensations and the urge to smoke by continuing to supply your body with a low amount of nicotine for a short period of time. Nicorettequick does not contain tar, carbon monoxide, or other toxins present in cigarette smoke.
To increase your chances of successfully quitting smoking, you should also seek support and advice from appropriate professionals, if possible.

2. What you need to know before using Nicorettequick

Do not use Nicorettequick

• If you are allergic to nicotine or to any of the other ingredients of this medicine (listed in section 6).
• If you are under 18 years of age.
• If you have never smoked.

Warnings and precautions
Consult your doctor before using this medicine if you have any of the following conditions.
You may still be able to use Nicorettequick, but you should speak to your doctor first if:

• you have recently had a heart attack or stroke (within the past 3 months);
• you have experienced chest pain (unstable angina) or angina at rest;
• you have a heart condition affecting your heart rate or rhythm;
• you have uncontrolled high blood pressure;
• you have had allergic reactions including swelling of the lips, face, and throat (angioedema) or itchy skin rash (urticaria). In some cases, nicotine replacement therapy may trigger such reactions.
• Moderate or severe liver disease
• Severe kidney disease
• Diabetes
• Hyperthyroidism
• Tumour of the adrenal glands (pheochromocytoma)
• Gastric or duodenal ulcer
• Oesophagitis

Nicorettequick must not be used by non-smokers.
Children and adolescents
Do not give this medicine to children or adolescents.
Other medicines and Nicorettequick
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is particularly important if you are taking medicines containing:
theophylline for the treatment of asthma;
tacrine for Alzheimer's disease;
clozapine for schizophrenia;
ropinirole for the treatment of Parkinson's disease.
Nicorettequick with food and drink
Do not eat or drink while administering the oromucosal spray.
Pregnancy, breastfeeding and fertility
It is very important to stop smoking during pregnancy, as smoking can lead to reduced fetal growth, premature birth, or stillbirth. It is preferable to stop smoking without using nicotine-containing medicines. If you are unable to manage without medication, Nicorettequick should only be used after consulting the healthcare professional managing your pregnancy, your general practitioner, or a doctor at a specialist smoking cessation clinic.
Page 2 of 18
Nicorettequick should not be taken during breastfeeding, as nicotine present in breast milk may have harmful effects on the infant. If your doctor has advised you to use Nicorettequick, the spray should be taken immediately after breastfeeding and not within the 2 hours preceding breastfeeding.
Smoking increases the risk of infertility in both women and men. The effects of nicotine on fertility are unknown.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Nicorettequick contains 11 mg of propylene glycol per dose. This medicine contains approximately 7 mg of alcohol (ethanol) per dose, equivalent to 97 mg/mL. The amount per dose is equivalent to less than 2 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine will not have any significant effect.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
Due to the presence of butylated hydroxytoluene, Nicorettequick may cause localized skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use NicoretteQuick

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
NicoretteQuick must not be used by individuals under the age of 18.
Consult your doctor if you have not reduced the number of sprays or cigarettes after 6 weeks of treatment, or if you require NicoretteQuick treatment for longer than 6 months.
Typically, NicoretteQuick is used for a period of 3 months. NicoretteQuick must not be used for longer than 6 months.
Instructions for using NicoretteQuick depend on whether you intend to stop smoking immediately or gradually reduce the number of cigarettes before quitting completely.

Stopping smoking immediately
The goal is to stop smoking immediately and use the spray to relieve cigarette cravings.
Do not use more than 2 sprays at a time or 4 sprays per hour for 16 hours. The maximum dose is 64 sprays within 16 hours over a 24-hour period.
The table below details the recommended procedure for using NicoretteQuick.

Phase 1: Weeks 1 to 6
Use 1 or 2 sprays instead of the cigarette you would normally smoke, or when you feel the urge to smoke. First administer only one spray; if the craving does not subside after a few minutes, administer a second spray. If two sprays are needed, you may in the future administer two consecutive sprays. For most smokers, this means 1 or 2 sprays every 30 minutes or 1 hour.
For example, if you usually smoke 15 cigarettes per day, you should administer 1 or 2 sprays at least 15 times during the day.
Do not use more than 2 sprays at a time or 4 sprays per hour over 16 hours. The maximum dose is 64 sprays within 16 hours over a 24-hour period.

Phase 2: Weeks 7 to 9
Begin reducing the number of daily sprays.
By the end of week 9, you must have HALVED the average number of daily sprays used during Phase 1.

Phase 3: Weeks 10 to 12
Continue reducing the number of daily sprays so that by week 12 you use no more than 4 sprays per day. When the number of sprays has been reduced to 2–4 per day, you must stop using NicoretteQuick.

Gradual smoking cessation
The goal is to begin treatment by replacing some cigarettes with NicoretteQuick. Once this is achieved, you must stop smoking completely while continuing to use the spray. Finally, discontinue use of the spray.
When you feel a strong urge to smoke, use 1–2 sprays instead of a cigarette to help manage the craving. The spray is intended to replace a cigarette; do not smoke shortly after using the spray. Using the spray without reducing the number of cigarettes smoked may make you feel unwell (see section "If you use more NicoretteQuick than you should"). Reduce the number of cigarettes smoked per day as much as possible and replace them with the spray. If after 6 weeks of treatment no reduction in cigarette consumption has been achieved, consult a doctor. As soon as you feel ready, you must stop smoking completely, but no later than 12 weeks after starting treatment. After quitting smoking, gradually reduce the number of sprays per day. When you have reduced usage to 2–4 sprays per day, stop using NicoretteQuick.
Do not use more than 2 sprays at a time or 4 sprays per hour for 16 hours. The maximum dose is 64 sprays within 16 hours over a 24-hour period.

After stopping treatment, you may still experience urges to smoke. Keep any remaining spray available, as sudden cravings may occur. If you feel the urge to smoke, use one or two sprays, using a second spray if the first has no effect within a few minutes.

Strictly follow the instructions and use the images as a reference

Unblocking the nozzle

How to open the dispenser

1. Slide the button downwards with your thumb ( a ) until it can be gently pressed inward ( b ). Do not apply excessive pressure.
2. While pressing inward, slide the button upwards ( c ) to unlock the top part of the dispenser. Then release the button.

How to prime the dispenser
When using the oromucosal spray for the first time, the spray pump must first be primed. Point the spray nozzle away from yourself and from any other person, child, or pet nearby. Press the top of the dispenser with your index finger 3 times until a fine mist is observed. If the spray has not been used for 2 days, repeat the priming procedure.

How to use the dispenser

3. Point the spray nozzle towards your open mouth and hold it as close to your mouth as possible.
4. Press firmly on the top of the dispenser to release one spray into your mouth, avoiding the lips. To prevent spraying into the throat, do not inhale during administration. For optimal results, do not swallow for several seconds after spraying.

To retract the nozzle

How to close the dispenser
Page 5 of 18

5. Slide the button downwards ( d ) until it can be pushed inward ( e ).
6. While pushing inward, slide the top part of the dispenser downwards ( f ). Release the button. The dispenser is now closed. To take another dose, repeat the procedure described above.

Always close the dispenser after each use to prevent accidental spraying and access by children.
Be careful to avoid contact of the oromucosal spray with the eyes during administration. If contact occurs, rinse thoroughly with water.

If you use more NicoretteQuick than you should
If you smoke a cigarette while using NicoretteQuick, an overdose of nicotine may occur.
If a child ingests NicoretteQuick or if you have used more than recommended, seek medical advice immediately or go to the nearest hospital. Doses of nicotine tolerated by adult smokers during treatment may cause severe poisoning symptoms, potentially fatal, in children.
Symptoms of overdose include nausea, vomiting, excessive salivation, stomach pain, diarrhea, sweating, headache, dizziness, hearing disturbances, and extreme weakness. At higher doses, the above symptoms may progress to low blood pressure, weak and irregular heartbeat, breathing difficulties, excessive fatigue, circulatory collapse, and generalized seizures.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
NicoretteQuick may cause the same side effects as other forms of nicotine. Generally, side effects depend on the dose taken.

Effects related to smoking cessation (nicotine withdrawal)
Some of the side effects experienced when quitting smoking may be symptoms of withdrawal due to reduced nicotine intake.

These effects include:

• irritability, aggression, impatience, or frustration;
• anxiety, restlessness, or difficulty concentrating;
• nighttime awakenings or sleep disturbances;
• increased appetite or weight gain;
• feeling depressed;
• urge to smoke ( craving );
• reduced heart rate;
• bleeding gums or mouth ulcers;
• dizziness or lightheadedness;
• cough, sore throat, nasal congestion, or runny nose;
• constipation.

If you experience any of the following rare but serious side effects, stop taking NicoretteQuick and contact a doctor immediately (signs of angioedema):

• swelling of the face, tongue, or pharynx;
• difficulty swallowing;
• hives and breathing difficulties.

Very common: may affect more than 1 in 10 people

• hiccups (particularly common);
• headache, nausea;
• throat irritation.

Common: may affect up to 1 in 10 people

• local effects such as burning sensation, mouth inflammation, altered taste;
• dry mouth or increased salivation;
• dyspeptic sensation;
• abdominal pain or discomfort;
• vomiting, flatulence, or diarrhea;
• feeling of fatigue (tiredness);
• hypersensitivity (allergy);
• tingling;
• cough.

Uncommon: may affect up to 1 in 100 people

• nasal effects such as nasal congestion or sneezing;
• wheezing (bronchospasm) or sensation of breathing difficulty (dyspnea), throat tightness;
• skin redness (flushing) or increased sweating;
• oral effects such as mouth tingling, tongue inflammation, mouth ulcers, damage to oral mucosa, voice changes, mouth and throat pain, burping, gum bleeding;
• palpitations (unusual awareness of heartbeat), increased heart rate, hypertension;
• skin rashes and/or itching (urticaria);
• disturbed sleep;
• chest discomfort and pain;
• weakness, feeling unwell;
• runny nose.

Rare: may affect up to 1 in 1000 people

• difficulty swallowing, reduced mouth sensitivity;
• nausea and vomiting urges.

Not known (frequency cannot be estimated from available data):

• blurred vision, increased tearing;
• dry throat, gastrointestinal disturbances, lip pain;
• skin redness;
• allergic reactions, including swelling of the face and mouth (angioedema or anaphylaxis);
• irregular heartbeat.

If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.

Reporting suspected adverse reactions
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nicorettequick

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the dispenser and on the
blister. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Nicorettequick contains

• The active substance is nicotine. One spray delivers 1 mg of nicotine.
• The excipients are: propylene glycol (E1520), anhydrous ethanol, tromethamine, poloxamer 407, glycerol (E422), sodium hydrogen carbonate, levomenthol, peppermint flavour, refreshing flavour, sucralose, acesulfame potassium, butylated hydroxytoluene (E321), hydrochloric acid (for pH adjustment), and purified water.

Description of the appearance of Nicorettequick and package contents
Nicorettequick is contained in a plastic bottle of solution housed in a dispenser with a mechanical spray pump. The dispenser is equipped with a child-resistant mechanism.
Each bottle contains 13.2 ml of solution, equivalent to 150 sprays.
Nicorettequick is supplied in packages containing 1 or 2 dispensers.
Nicorettequick is also available in packages containing 1 or 2 dispensers which include, under the rear label, a Near Field Communication (NFC) chip to enable connection to a smartphone app.
Page 8 of 18

The dispensers display the following symbol
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
McNeil AB
Norrbroplatsen 2
SE-251 09 Helsingborg
Sweden
Local representative in Italy:
Johnson & Johnson S.p.A.,
via Ardeatina km 23.500
00071 Santa Palomba
Pomezia (RM)
Manufacturer:
McNeil AB, Norrbroplatsen 2, SE-251 09 Helsingborg, Sweden
This medicinal product is authorised in the EEA Member States under the following names:

Sweden	Nicorette Peppermint
Belgium	Nicorette Mint Mouth Spray
Netherlands
Luxembourg	Nicorette Mint Buccal Spray
Denmark	Nicorette QuickMist
Iceland
Ireland
Austria	Nicorette Mint Spray
Germany
Czech Republic	Nicorette Spray
Poland
Slovak Republic
Bulgaria	Nicorette Freshmint
Finland
Romania
Cyprus	Nicorette Quickspray
Greece
Hungary
Estonia	Nicorette Coolmint
Latvia
Lithuania
Norway	Nicorette
Slovenia
Croatia
France	Nicorettespray

Page 9 of 18

Italy	Nicorettequick
Spain	Nicorette Bucomist
Portugal

Page 10 of 18

Package leaflet: information for the user

Nicorettequick 1 mg/dose, buccal spray, solution, red fruit flavour

Nicotine
Please read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your pharmacist or doctor has told you to.

• Keep this leaflet, you may need to read it again.
• If you would like more information or advice, please consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you have not succeeded in quitting smoking after 6 months of treatment with Nicorettequick.

Contents of this leaflet

7. What Nicorettequick is and what it is used for
8. What you need to know before using Nicorettequick
9. How to use Nicorettequick
10. Possible side effects
11. How to store Nicorettequick
12. Contents of the pack and other information

4. What Nicorettequick is and what it is used for

Nicorettequick is used as an aid when you want to stop smoking or reduce the number of cigarettes smoked before quitting completely. This treatment is known as nicotine replacement therapy (NRT).
Nicorettequick relieves nicotine withdrawal symptoms, including the urge to smoke and other symptoms experienced when quitting smoking. When you suddenly stop supplying nicotine from tobacco to your body, you experience various unpleasant sensations known as withdrawal symptoms.
Nicorettequick helps prevent or reduce these unpleasant sensations and the urge to smoke by continuing to provide a small amount of nicotine to your body for a limited period of time. Nicorettequick does not contain tar, carbon monoxide, or other toxins present in cigarette smoke.
To increase your chances of successfully quitting smoking, you should also seek support and advice from trained professionals, if possible.

5. What you should know before using NicoretteQuick

Do not use NicoretteQuick

• If you are allergic to nicotine or to any of the other ingredients of this medicine (listed in section 6).
• If you are under 18 years of age.
• If you have never smoked.

Warnings and precautions
Consult your doctor before using this medicine if you have any of the following conditions.
You may still be able to use NicoretteQuick, but you should consult your doctor first if:

• You have recently (within the past 3 months) had a heart attack or stroke;
• You have experienced chest pain (unstable angina) or angina at rest;
• You suffer from a heart condition affecting heart rate or rhythm;
• You have uncontrolled high blood pressure;
• You have experienced allergic reactions including swelling of the lips, face and throat (angioedema) or itchy skin rash (urticaria). In some cases, nicotine replacement therapy may trigger such reactions.
• Moderate or severe liver disease
• Severe kidney disease
• Diabetes
• Hyperthyroidism
• Tumour of the adrenal glands (pheochromocytoma)
• Gastric or duodenal ulcer
• Oesophagitis

NicoretteQuick must not be used by non-smokers.
Children and adolescents
Do not administer this medicine to children or adolescents.
Other medicines and NicoretteQuick
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. This is particularly important if you are taking medicines containing:
theophylline for the treatment of asthma;
tacrine for Alzheimer's disease;
clozapine for schizophrenia;
ropinirole for the treatment of Parkinson's disease.
NicoretteQuick with food and drinks
Do not eat or drink while administering the oromucosal spray.
Pregnancy, breastfeeding and fertility
It is very important to stop smoking during pregnancy, as smoking can lead to reduced fetal growth, premature birth or stillbirth. It is preferable to stop smoking without using nicotine-containing medications. If you are unable to manage this, NicoretteQuick should only be used after consulting the healthcare professional managing your pregnancy, your general practitioner, or a doctor at a specialist smoking cessation centre.
NicoretteQuick should not be taken during breastfeeding, as nicotine in breast milk may have harmful effects on the infant. If your doctor has advised you to use NicoretteQuick, the spray should be taken immediately after breastfeeding and not within the 2 hours preceding it.
Smoking increases the risk of infertility in both women and men. The effects of nicotine on fertility are unknown.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
NicoretteQuick contains 12 mg of propylene glycol per dose. This medicine contains approximately 7 mg of alcohol (ethanol) per dose, equivalent to 97 mg/mL. The amount per dose of this medicine is equivalent to less than 2 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine will not produce significant effects. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially 'sodium-free'. Due to the presence of butylated hydroxytoluene, NicoretteQuick may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

6. How to use Nicorettequick

Page 12 of 18
Use this medicine exactly as described in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Individuals under the age of 18 years must not use Nicorettequick.
Consult your doctor if you have not reduced the number of sprays or cigarettes after 6
weeks of treatment, or if you require treatment with Nicorettequick for longer than 6 months.
Nicorettequick is usually taken for a period of 3 months. Nicorettequick must not be used for
longer than 6 months.
Instructions for using Nicorettequick depend on whether you intend to stop smoking immediately or wish to gradually reduce the number of cigarettes smoked before quitting completely.

Stopping smoking immediately
The aim is to stop smoking immediately and use the spray to relieve the urge to smoke.
Do not use more than 2 sprays at a time or 4 sprays per hour for 16 hours. The maximum dose is 64
sprays within 16 hours in a 24-hour period.
The table below details the recommended procedure for using Nicorettequick:

Phase 1: weeks 1 to 6
Use 1 or 2 sprays instead of the cigarette you would normally smoke, or when you feel the urge to smoke. First administer only one spray; if the urge does not disappear after a few minutes, administer the second spray. If two sprays are needed, in the future you may administer two consecutive sprays. For most smokers, this means 1 or 2 sprays every 30 minutes or 1 hour.
For example, if you smoke an average of 15 cigarettes per day, you should administer 1 or 2 sprays at least 15 times during the day.

Phase 2: weeks 7 to 9
Begin reducing the number of daily sprays.
By the end of week 9, you must have HALVED the average number of daily sprays used during phase 1.

Phase 3: weeks 10 to 12
Continue reducing the number of daily sprays so that by week 12 you use no more than 4 sprays per day. When the number of sprays has been reduced to 2–4 per day, you must stop using Nicorettequick.

Gradual smoking cessation
The aim is to start treatment by replacing some cigarettes with Nicorettequick. Once this goal is achieved, you must stop smoking cigarettes completely while continuing to use the spray. Finally, discontinue use of the spray.
When you feel a strong urge to smoke, use 1–2 sprays instead of a cigarette to help manage the craving. The spray is intended to replace a cigarette; do not smoke shortly after using the spray. Using the spray without reducing the number of cigarettes smoked may make you feel unwell (see section "If you use more Nicorettequick than you should"). Reduce the number of cigarettes you smoke each day as much as possible and replace them with the spray. If after 6 weeks of treatment no reduction in cigarette consumption has been achieved, consult a doctor. As soon as you feel ready, you must stop smoking completely, but no later than 12 weeks after starting treatment. After quitting smoking, gradually reduce the number of sprays per day. When you have reduced to 2–4 sprays per day, stop using Nicorettequick.

Page 13 of 18
Do not use more than 2 sprays at a time or 4 sprays per hour for 16 hours. The maximum dose is 64 sprays within 16 hours in a 24-hour period. After stopping treatment, you may still feel tempted to start smoking again. Keep the remaining spray, as sudden cravings may occur.
If you feel the urge to smoke, use one or two sprays, using the second if the first has no effect within a few minutes.

Follow the instructions carefully and use the images as a guide
Unblocking the nozzle

How to open the dispenser

1. Slide the button downwards with your thumb ( a ) until it can be gently pushed inwards ( b ). Do not apply excessive pressure.
2. While pushing inwards, slide the top part of the dispenser upwards ( c ) to unlock the upper section. Then release the button.

How to prime the dispenser
When using the oromucosal spray for the first time, you must first prime the spray pump. Point the spray nozzle away from yourself and from any other person, child, or pet nearby. Press the top of the dispenser with your index finger 3 times until a fine spray is observed. If the spray has not been used for 2 days, repeat the priming procedure.

How to use the dispenser

3. Point the spray nozzle towards your open mouth and hold it as close to your mouth as possible.
4. Press the top of the dispenser firmly to release one spray into your mouth, avoiding the lips. To avoid spraying into the throat, do not inhale during administration. For optimal results, do not swallow for several seconds after spraying.

To retract the nozzle
Page 14 of 18

How to close the dispenser

5. Slide the button downwards (d) until it can be pushed inwards (e).
6. While pushing inwards, slide the top part of the dispenser downwards (f). Release the button. The dispenser is now closed. To take another dose, repeat the above procedure.

Close the dispenser after each use to prevent accidental spraying and use by children.
Be careful to avoid contact of the oromucosal spray with the eyes during administration.
If the spray comes into contact with the eyes, rinse thoroughly with water.

If you use more Nicorettequick than you should
If you smoke a cigarette while using Nicorettequick, an overdose of nicotine may occur.
If a child ingests Nicorettequick or if you have used more Nicorettequick than recommended, seek medical advice immediately or go to the nearest hospital. Doses of nicotine tolerated by adult smokers during treatment may cause severe symptoms of poisoning, potentially fatal, in children.
Symptoms of overdose include nausea, vomiting, excessive salivation, stomach pain, diarrhoea, sweating, headache, dizziness, hearing disturbances, and extreme weakness. At higher doses, the symptoms listed above may progress to low blood pressure, weak and irregular pulse, breathing difficulties, excessive fatigue, circulatory collapse, and generalized seizures.

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

7. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nicorettequick may cause the same side effects as other forms of nicotine. Generally, side effects depend on the dose taken.

Effects related to smoking cessation (nicotine withdrawal)
Some of the side effects experienced when quitting smoking may be withdrawal symptoms due to reduced nicotine intake.
These effects include:

• irritability, aggression, impatience, or frustration;
• anxiety, restlessness, or difficulty concentrating;
• night awakenings or sleep disturbances;
• increased appetite or weight gain;
• feeling depressed;
• urge to smoke (craving for tobacco);
• reduced heart rate;
• bleeding gums or mouth ulcers;
• dizziness or lightheadedness;
• cough, sore throat, nasal congestion, or runny nose;
• constipation.

If you notice any of the following rare but serious side effects, stop taking Nicorettequick and contact a doctor immediately (signs of angioedema):

• swelling of the face, tongue, or pharynx;
• difficulty swallowing;
• hives and breathing difficulties.

Very common: may affect more than 1 in 10 people

• hiccups (particularly common);
• headache, nausea (feeling unwell);
• throat irritation.

Common: may affect up to 1 in 10 people

• local effects such as burning sensation, mouth inflammation, altered taste perception;
• dry mouth or increased salivation;
• dyspepsia;
• abdominal pain or discomfort;
• vomiting, flatulence, or diarrhoea;
• feeling of fatigue (tiredness);
• hypersensitivity (allergy);
• tingling;
• cough.

Uncommon: may affect up to 1 in 100 people

• effects on the nose such as nasal congestion or sneezing;
• wheezing (bronchospasm) or sensation of breathing difficulty (dyspnoea), feeling of throat tightness;
• skin redness (flushing) or increased sweating;
• oral effects such as mouth tingling, tongue inflammation, mouth ulcers, damage to oral mucosa or voice changes, mouth and throat pain, belching, gum bleeding;
• palpitations (unusual awareness of heartbeat), increased heart rate, hypertension;
• skin rashes and/or itching (urticaria);
• disturbed sleep;
• chest discomfort and pain;
• weakness, feeling unwell;
• runny nose.

Rare: may affect up to 1 in 1,000 people

• difficulty swallowing, reduced sensitivity in the mouth;
• nausea, vomiting.

Not known (frequency cannot be estimated from the available data):

• blurred vision, increased lacrimation;
• dry throat, gastrointestinal disturbances, lip pain;
• skin redness;
• allergic reactions, including swelling of the face and mouth (angioedema or anaphylaxis);
• irregular heartbeat.

If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
Page 16 of 18
Reporting of suspected adverse reactions
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

8. How to store Nicorette Quick

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the dispenser and blister pack. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

9. Package contents and other information

What Nicorette Quick contains

• The active substance is nicotine. One spray delivers 1 mg of nicotine.
• The excipients are: propylene glycol (E1520), anhydrous ethanol, tromethamine, poloxamer 407, glycerol (E422), sodium hydrogen carbonate, levomenthol, red fruit flavour, refreshing flavour, sucralose, acesulfame potassium, butylated hydroxytoluene (BHT, E321), hydrochloric acid (for pH adjustment) and purified water.

Description of the appearance of Nicorette Quick and contents of the pack
Nicorette Quick is a solution contained in a plastic bottle housed in a spray pump dispenser.
The dispenser has a child-resistant mechanism.
Each bottle contains 13.2 ml of solution, equivalent to 150 sprays.
Nicorette Quick is supplied in packs containing either 1 or 2 dispensers.
Nicorette Quick is also available in packs of 1 or 2 dispensers which include, under the rear label,
a Near Field Communication (NFC) chip to enable connection to a smartphone app. The dispensers display the following symbol:

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
McNeil AB
Norrbroplatsen 2
SE-251 09 Helsingborg
Sweden
Local representative in Italy:
Johnson & Johnson S.p.A.,
Via Ardeatina km 23.500
00071 Santa Palomba
Pomezia (RM)
Manufacturer:
McNeil AB,
Norrbroplatsen 2,
Page 17 of 18
SE-251 09 Helsingborg,
Sweden

This medicinal product is authorised in the EEA Member States under the following names:

Sweden	Nicorette Fruitmint
Austria	Nicorette Fruit & Mint Spray
Belgium / Netherlands	Nicorette Fruit & Mint Mouth Spray
Bulgaria	Nicorette Berrymint
Croatia	Nicorette with forest fruit flavour
Cyprus	Nicorette Quickspray Berry
Czech Republic	Nicorette Spray with forest fruit flavour
Denmark	Nicorette QuickMist Cool Berry
Estonia	Nicorette Coolberry
Finland	Nicorette Berrymint
France	NICORETTESPRAY® RED FRUITS
Germany	Nicorette Fruit & Mint Spray
Greece	Nicorette Quickspray Berry
Hungary	Nicorette Berrymint
Iceland	Nicorette Quickmist Cool Berry
Ireland	Nicorette QuickMist Cool Berry
Italy	Nicorettequick
Latvia	Nicorette Coolberry
Luxembourg	Nicorette Fruit & Mint Buccal Spray
Norway	Nicorette
Poland	Nicorette Cool Berry
Portugal	Nicorette Bucomist mint fruit flavour
Romania	Nicorette Berrymint
Slovakia	Nicorette Spray with forest fruit flavour
Slovenia	Nicorette with forest fruit flavour
Spain	Nicorette Bucomist mint fruit flavour

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