Nicorette

Patient Information Leaflet

NICORETTE 2 mg medicated chewing gum, 4 mg medicated chewing gum, 2 mg medicated chewing gum, strong mint flavour, 4 mg medicated chewing gum, strong mint flavour

Nicotine
Please read this entire 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 doctor or pharmacist has instructed.

• 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 12 months of treatment.

Contents of this leaflet:

1. What NICORETTE is and what it is used for
2. What you need to know before using NICORETTE
3. How to use NICORETTE
4. Possible side effects
5. How to store NICORETTE
6. Package contents and other information

1. What NICORETTE is and what it is used for

NICORETTE is a chewing gum containing nicotine and can help you stop smoking if you have decided to quit. This type of treatment is called nicotine replacement therapy (NRT).
Consult your doctor if you do not feel better or feel worse after 12 months of treatment.

2. What you need to know before using NICORETTE

Do not use NICORETTE if:

• you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• you are not a smoker;
• you have recently had a heart attack or stroke;
• you have chest pain that occurs even at rest (unstable or worsening angina, Prinzmetal's angina);
• you have a heart disease affecting the heart rate or rhythm (severe cardiac arrhythmia);
• you are pregnant;
• you are breastfeeding;
• you are under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using NICORETTE if:

• you have high blood pressure that is not controlled by medication;
• you have severe heart diseases (e.g. peripheral occlusive arterial disease, cerebrovascular disorders, heart failure) or blood vessel disorders (vasospasms);
• you have severe kidney disease;
• you have liver disease (moderate or severe hepatic insufficiency);
• you have diabetes;
• you have an overactive thyroid (uncontrolled hyperthyroidism);
• you have a tumor of the adrenal gland (pheochromocytoma);
• you have a stomach or duodenal ulcer;
• you have inflammation of the esophagus (esophagitis).

Be careful: if you have dental prostheses, you may experience difficulty chewing NICORETTE. The gums may adhere to the prostheses and, in rare cases, damage them.
Other medicines and NICORETTE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are taking:

• theophylline or isoprenaline, medicines used in the treatment of asthma;
• tacrine, a medicine used for Alzheimer's disease;
• clozapine and olanzapine, medicines used for schizophrenia;
• imipramine, clomipramine and fluvoxamine, medicines used for depression;
• flecainide, a medicine used for heart problems;
• adenosine, a medicine used to dilate blood vessels;
• pentazocine, a medicine used for severe pain;
• paracetamol, a medicine used for fever and pain;
• oxazepam, a medicine used for anxiety;
• propranolol, a medicine used, for example, in heart conditions;
• insulin, a medicine used in diabetes;
• prazosin, a medicine used for urinary incontinence;
• labetalol, a medicine used for heart rhythm disorders;
• phenylephrine, a vasoconstrictor medicine, used to dilate pupils or as a nasal decongestant;
• phenacetin, a medicine used for fever and pain;
• preparations containing caffeine;
• ropinirole, a medicine used in Parkinson's disease;
• glutethimide, a medicine used for insomnia;
• propoxyphene, a medicine used for pain;
• medicines known as adrenergic agonists or blockers, used, for example, to treat high blood pressure, asthma or heart diseases;
• cortisone-containing medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Nicotine reaches the fetus and may cause harm. It is recommended that you stop smoking.
Consult your doctor for advice on how to proceed. Do not use NICORETTE during pregnancy unless specifically instructed by your doctor.
During breastfeeding, avoid using NICORETTE, as nicotine passes into breast milk and may cause problems for the infant. If you are breastfeeding, do not use NICORETTE unless specifically instructed by your doctor.

Driving and using machines
NICORETTE does not affect the ability to drive or operate machinery.

NICORETTE 2 mg medicated chewing gum contains 202.4 mg of sorbitol.
NICORETTE 4 mg medicated chewing gum contains 197 mg of sorbitol.
Sorbitol is a source of fructose. If your doctor has informed you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.

NICORETTE medicated chewing gum contains flavourings with cinnamal, cinnamic alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, limonene, linalool. These substances may cause allergic reactions.

NICORETTE medicated chewing gum contains flavourings that in turn contain ethanol.
This medicine contains 0.616 mg of alcohol (ethanol) per chewing gum, equivalent to less than 0.0154 ml of beer or 0.00616 ml of wine. The small amount of alcohol in this medicine will not produce any significant effects.

NICORETTE 2 mg medicated chewing gum, strong mint flavour contains 171 mg of sodium (the main component of table salt) per maximum daily dose. This corresponds to 8.55% of the maximum daily dietary intake recommended for an adult.
NICORETTE 4 mg medicated chewing gum, strong mint flavour contains 195.2 mg of sodium (the main component of table salt) per maximum daily dose. This corresponds to 9.76% of the maximum daily dietary intake recommended for an adult.

3. How to use NICORETTE

Use this medicine exactly as stated in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Chew one piece of gum whenever you feel the urge to smoke.
Normally, 10 pieces of 2 mg gum per day are sufficient.
If 15 pieces of 2 mg gum per day are not sufficient, and you are a heavy smoker (more than 20 cigarettes per
day), use 1 piece of NICORETTE 4 mg gum or 2 pieces of NICORETTE 2 mg gum simultaneously.
Do not use more than 15 pieces of NICORETTE 4 mg gum per day.
The recommended duration of treatment is 3 months. After this period, you should gradually reduce the
number of gums used daily. When you are down to using 1–2 pieces per day, you are advised to try stopping
NICORETTE completely. However, it is advisable to keep a few pieces of gum available as a reserve, in case
the urge to smoke returns suddenly.
Do not use this medicine regularly for longer than 12 months. Do not exceed the recommended doses.

Instructions for use
Chew the gum very slowly for at least 30 minutes, periodically interrupting the chewing. Chewing too quickly
may cause nicotine to be absorbed too rapidly.

Use in children and adolescents under 18 years of age
The safety and efficacy in children and adolescents under 18 years of age have not yet been established.

If you use more NICORETTE than you should
If you are an occasional smoker or smoke only a few cigarettes per day, or if you chew NICORETTE
while simultaneously using other nicotine-containing products (inhalation solution, patches), nicotine
overdose may occur. In such a case, stop treatment immediately and contact your doctor or go to the
nearest hospital. Doses of nicotine tolerated by adult smokers during treatment may cause severe
poisoning symptoms in young children, some of which may be fatal.
Symptoms of overdose include: feeling unwell (nausea), vomiting, excessive salivation, abdominal pain,
diarrhea, sweating, headache, dizziness, hearing disturbances, marked weakness, low blood pressure, weak
or irregular pulse, breathing difficulties, prostration, collapse, and seizures.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone gets them.
Inform your doctor if, during treatment with NICORETTE, you notice any of the following:

Common side effects (may affect up to 1 in 10 people)

• increased salivation, dry mouth, burning or inflamed sensation in the mouth (stomatitis), cough, hiccups, throat irritation;
• headache, altered taste (dysgeusia), disturbances in sensation (paraesthesia);
• abdominal pain, indigestion (dyspepsia), presence of intestinal gas (flatulence), nausea, vomiting, diarrhoea;
• fatigue.

Uncommon side effects (may affect up to 1 in 100 people)

• sweating, itching, skin lesions (rash, urticaria);
• difficulty breathing (bronchospasm, dyspnoea, throat tightness), voice changes (dysphonia), sensation of blocked nose (nasal congestion), sore throat, sneezing;
• awareness of heartbeat (palpitations) or rapid heartbeat (tachycardia);
• belching, inflammation of the tongue (glossitis), blisters and peeling of the mouth mucosa, disturbances in mouth sensation (paraesthesia), jaw pain;
• abnormal dreams;
• malaise, tiredness (asthenia), chest pain and discomfort;
• skin redness, increased blood pressure.

Rare side effects (may affect up to 1 in 1,000 people)

• difficulty swallowing, decreased mouth sensation (hypoesthesia), urge to vomit;

Side effects of unknown frequency (frequency cannot be estimated from the available clinical data)

• skin redness (erythema), swelling of the face, eyes, lips, or throat (angioedema) with breathing difficulty, possible signs of severe allergic reactions (anaphylactic reaction);
• mouth irritation, dry throat, sensation of thirst, stomach and intestinal disturbances, lip pain;
• blurred vision, increased tearing;
• anxiety, depression, muscle tension.

Side effects due to smoking cessation
Symptoms such as mood changes, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness or impatience, slowed heart rate (bradycardia), increased appetite or body weight, strong desire to smoke, dizziness and headache, painful oral ulcers, may be related to nicotine withdrawal.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 NICORETTE

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NICORETTE contains
The active substance is: nicotine.
NICORETTE 2 mg chewing gum medicated
One 2 mg gum contains:

• active substance: 10 mg of nicotine resin complex containing 20% nicotine, equivalent to 2 mg of nicotine;
• other components: anhydrous sodium carbonate, sodium bicarbonate, chewing gum base, sorbitol powder, 70% sorbitol solution, mint and fruit flavours (containing traces of ethanol, cinnamal, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, limonene, linalool), 85% glycerin solution.

NICORETTE 4 mg chewing gum medicated
One gum contains:

• active substance: 20 mg of nicotine resin complex containing 20% nicotine, equivalent to 4 mg of nicotine;
• other components: anhydrous sodium carbonate, chewing gum base, sorbitol powder, 70% sorbitol solution, mint and fruit flavours (containing traces of ethanol, cinnamal, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, limonene, linalool), 85% glycerin solution, quinoline yellow (E 104).

NICORETTE 2 mg chewing gum medicated, strong mint flavour
One 2 mg gum contains:

• active substance: 10 mg of nicotine resin complex containing 20% nicotine, equivalent to 2 mg of nicotine;
• other components: chewing gum base, xylitol, peppermint oil, potassium acesulfame, sodium carbonate, sodium bicarbonate, levomenthol, magnesium oxide, pregelatinized starch, titanium dioxide, carnauba wax, hypromellose, sucralose, polysorbate 80, glacial mint.

NICORETTE 4 mg chewing gum medicated, strong mint flavour
One gum contains:

• active substance: 20 mg of nicotine resin complex containing 20% nicotine, equivalent to 4 mg of nicotine;
• other components: chewing gum base, xylitol, peppermint oil, potassium acesulfame, sodium carbonate, levomenthol, magnesium oxide, pregelatinized starch, titanium dioxide, carnauba wax, quinoline yellow (E 104), hypromellose, sucralose, polysorbate 80, glacial mint.

Description of the appearance of NICORETTE and contents of the pack
NICORETTE is available in packs of 30 or 105 chewing gums.
Marketing Authorization Holder
McNeil AB - Norrbroplatsen, 2, SE-251-09, Helsingborg - Sweden
Representative in Italy: Johnson & Johnson S.p.A.
Via Ardeatina, Km 23,500 - 00071, Santa Palomba, Pomezia (Rome) - Italy
Manufacturer
McNeil AB - Norrbroplatsen, 2, SE-251-09, Helsingborg – Sweden

Patient information leaflet

NICORETTE 10 mg/16 h transdermal patches, 15 mg/16 h transparent transdermal patches

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 directed by your doctor or pharmacist.

• 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 stopped smoking after 12 weeks of treatment.

Contents of this leaflet:

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

1. What NICORETTE is and what it is used for

NICORETTE is a patch containing nicotine that can help you stop smoking if you have decided to quit. This type of treatment is known as nicotine replacement therapy (NRT).
NICORETTE relieves nicotine withdrawal symptoms, including the urge to smoke, which occur when you try to stop smoking.
When you suddenly stop smoking, your body no longer receives the nicotine previously provided by tobacco; this lack causes various unpleasant sensations, known as withdrawal symptoms.
By using NICORETTE, you can prevent or reduce these unpleasant sensations and the urge to smoke, because a small amount of nicotine is supplied to your body for a limited period of time. NICORETTE is not as harmful to health as tobacco, because it does not contain tar, carbon monoxide, or other toxic agents present in cigarette smoke.
Smokers who smoke more than 10 cigarettes per day and who have difficulty controlling the urge to smoke, or who have failed to quit smoking using only Nicorette transdermal patches, may combine these patches with Nicorette 2 mg chewing gum (all flavours) or Nicoretteicy 2 mg tablets.
To improve the chances of successfully quitting smoking, combine NICORETTE treatment with counselling and support therapy.

2. What you need to know before using NICORETTE

Do not use NICORETTE:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have recently had a heart attack or stroke;
• if you have heart disease or suffer from high blood pressure;
• if you have an abnormal heart rate or rhythm;
• if you have or have had circulatory problems;
• if you have skin disorders, for example lesions, on the skin where you intend to apply the patch;
• in children and adolescents under 18 years of age. Do not use NICORETTE if you are not a smoker or if you are an occasional smoker.

Warnings and precautions
Talk to your doctor or pharmacist before using NICORETTE if:

• you have severe kidney disease;
• you have liver disease (moderate or severe hepatic impairment);
• you have diabetes mellitus;
• you have an overactive thyroid gland;
• you have a tumour of the adrenal gland (pheochromocytoma);
• you have a stomach or duodenal ulcer;
• you have inflammation of the oesophagus (oesophagitis).

Be careful:

• if you are due to undergo a Magnetic Resonance Imaging (MRI) scan, you must remove the patch before the examination to avoid the risk of skin burns;
• DISCONTINUE TREATMENT WITH NICORETTE if skin lesions appear that are severe or persistent.

Combination therapy
For warnings and precautions for the selected oral dosage form used in combination therapy
(Nicorette 2mg tablets or Nicorette 2mg chewing gum), refer to the product information for that specific pharmaceutical form.

Children and adolescents under 18 years of age
Do not use NICORETTE in children and adolescents under 18 years of age.

Other medicines and NICORETTE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are taking:

• Theophylline or isoprenaline, medicines used in the treatment of asthma;
• Tacrine, a medicine used for Alzheimer's disease;
• Clozapine and olanzapine, medicines used for schizophrenia;
• Imipramine, clomipramine and fluvoxamine, medicines used for depression;
• Flecainide, a medicine used for heart problems;
• Adenosine, a medicine used to dilate blood vessels;
• Pentazocine, a medicine used for severe pain;
• Paracetamol, a medicine used for fever and pain;
• Oxazepam, a medicine used for anxiety;
• Insulin, a medicine used in diabetes;
• Prazosin, a medicine used for urinary incontinence;
• Labetalol, a medicine used for heart rhythm disorders;
• Phenylephrine, a vasoconstrictor medicine used to dilate pupils or as a nasal decongestant;
• Phenacetin, a medicine used for fever and pain;
• Preparations containing caffeine;
• Ropinirole, a medicine used in Parkinson's disease;
• Glutethimide, a medicine used for insomnia;
• Propoxyphene, a medicine used for pain;
• Medicines called adrenergic agonists or blockers, used for example to treat high blood pressure, asthma or heart disease;
• Medicines containing cortisone.

Pregnancy and breastfeeding
During pregnancy, it is very important to stop smoking, as smoking can harm your baby. It is best to stop smoking without using nicotine-containing medicines. If this is not possible, you may use NICORETTE, but only after consulting your doctor.

If you are breastfeeding, avoid using NICORETTE, as nicotine passes into breast milk and may cause problems for your baby. If you are unable to stop smoking without using nicotine-containing medicines, you may use NICORETTE, but only after consulting your doctor.

Consult your doctor for advice on what to do. Do not use NICORETTE during pregnancy unless specifically instructed by your doctor.

If you are breastfeeding, do not use NICORETTE unless specifically instructed by your doctor.

Driving and using machines
NICORETTE does not affect the ability to drive or operate machinery.

3. How to use NICORETTE

Use this medicine exactly as described in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
You must completely stop smoking during treatment with NICORETTE.
Use 1 patch of 15 mg per day for 8 weeks. Continue treatment with 1 patch of 10 mg per day
for another 4 weeks. After this, stop using NICORETTE.
Treatment with NICORETTE patches should not last longer than 12 weeks (3 months). In some cases,
a longer treatment period may be necessary to prevent relapse into smoking.
Do not use this medicine regularly for more than 6 months. Do not exceed the recommended doses.

Instructions for use
Apply the patch in the morning when you wake up, on clean, dry, intact, and hair-free skin,
for example on the hip, upper arm, or chest; press it firmly with the palm of your hand for 10–20 seconds. Do not touch the adhesive surface with your fingers. Remove the patch in the evening before going to bed.
Change the skin area where you apply the patch every day; avoid applying it consecutively to the same site.

Combination therapy
If you smoke more than 10 cigarettes per day and have difficulty controlling your urge to smoke, or if you have not succeeded in quitting smoking with Nicorette transdermal patches alone, combination therapy using transdermal patches together with a nicotine-containing oral formulation (Nicoretteicy 2 mg tablets or Nicorette 2 mg chewing gum) provides a better chance of quitting smoking than using patches alone.
The table below details the recommended procedure for combined use of Nicorette transdermal patches with oral formulations:

*The maximum recommended dose for oral forms is 15 pieces per day. Do not exceed the recommended maximum daily dose.
When daily use is reduced to 1-2 chewing gums/tablets, treatment should be discontinued.

Use in children and adolescents under 18 years of age
Do not use NICORETTE in children and adolescents under 18 years of age.

If you use more NICORETTE than you should
If a child uses NICORETTE, or if you use too many NICORETTE patches and/or you are an occasional smoker or smoke only a few cigarettes per day, or if you do not follow the recommended doses for combination therapy, a nicotine overdose may occur. In such a case, remove the patch and rinse the area of skin where it was applied with water; contact your doctor immediately or go to the nearest hospital. Doses of nicotine tolerated by adult smokers during treatment may cause severe poisoning symptoms in young children, some of which may be fatal.

Symptoms of overdose include: nausea, vomiting, excessive salivation, stomach and intestinal disturbances, diarrhea, sweating, headache, dizziness, hearing disturbances, marked weakness, breathing difficulties, low blood pressure, weak or irregular pulse, seizures, and cardiac collapse.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor if you notice any of the following while using NICORETTE:

Very common side effects (may affect more than 1 in 10 people)

• Itching.

Common side effects (may affect up to 1 in 10 people)

• Headache, dizziness, difficulty sleeping (insomnia);
• Nausea, vomiting;
• Skin reactions such as discolored spots or widespread skin rash (skin eruptions, urticaria).

Uncommon side effects (may affect up to 1 in 100 people)

• Increased sweating;
• Altered sensation (paresthesia);
• Difficulty breathing (dyspnea);
• Reaction at the site where the patch was applied;
• Allergic reactions (hypersensitivity);
• Abnormal dreams;
• Malaise, fatigue, tiredness (asthenia), chest pain or discomfort, muscle pain;
• Palpitations or rapid heartbeat (tachycardia);
• Flushing, increased blood pressure.

Other side effects

• Redness of the skin (erythema), swelling (angioedema) of the face, eyes, lips, or throat with breathing difficulties, possible signs of severe allergic reactions (anaphylactic reaction);
• Stomach and intestinal disturbances;
• Pain in the arms and legs.

For side effects specific to the oral form chosen for combination therapy (Nicoretteicy 2mg tablets or Nicorette 2mg chewing gum), please refer to the product information for that pharmaceutical form.

Side effects due to smoking cessation
Symptoms such as mood changes, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness or impatience, decreased heart rate (bradycardia), increased appetite or weight gain, dizziness and headache, painful mouth ulcers, may be related to nicotine withdrawal.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 NICORETTE

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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.

6. Package contents and other information

What NICORETTE contains
The active substance is: nicotine.
1 patch of NICORETTE 10 mg/16 h contains: 15.8 mg of nicotine.
1 patch of NICORETTE 15 mg/16 h contains: 23.6 mg of nicotine.
The other components are:
Nicotine matrix: medium-chain triglycerides, butyl acrylate-methacrylic acid copolymer, polyethylene terephthalate film (PET),
Acrylic matrix: acrylic adhesive solution, potassium hydroxide, sodium croscarmellose, aluminum acetylacetonate, polyethylene terephthalate film (PET).
Description of the appearance of NICORETTE and pack contents
NICORETTE 10 mg/16 h is available in packs of 7 semi-transparent transdermal patches, each with a surface area of 9 cm².
NICORETTE 15 mg/16 h is available in packs of 7 semi-transparent transdermal patches, each with a surface area of 13.5 cm².
Marketing Authorization Holder
McNeil AB - Norrbroplatsen, 2, SE-251-09, Helsingborg - Sweden
Representative in Italy: Johnson & Johnson S.p.A.
Via Ardeatina, Km 23,500 - 00071, Santa Palomba, Pomezia (Rome) - Italy
Manufacturer
LTS Lohmann Therapie-Systeme AG (LTS), D-56626 Andernach - Germany

Package leaflet: information for the patient

NICORETTE 10 mg inhalation solution, 15 mg inhalation 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 doctor or pharmacist has instructed you to do.

• 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, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 6 months of treatment.

Contents of this leaflet:

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

1. What NICORETTE is and what it is used for

NICORETTE is a nicotine replacement therapy (NRT) used to relieve nicotine withdrawal symptoms, including the urge to smoke.

2. What you need to know before using NICORETTE

Do not use NICORETTE if:

• you are allergic to the active substance, to menthol, or to any of the other ingredients of this medicine (listed in section 6);
• you have recently had a heart attack (within the last 3 months) or a stroke;
• you have chest pain occurring even at rest (unstable or worsening angina, Prinzmetal's angina);
• you have a heart disease affecting the heart rate or rhythm (severe cardiac arrhythmia);
• you are pregnant (see Pregnancy and breastfeeding);
• you are breastfeeding (see Pregnancy and breastfeeding);
• you are under 18 years of age;
• you are a non-smoker.

Warnings and precautions
Talk to your doctor or pharmacist before using NICORETTE if:

• you have uncontrolled high blood pressure;
• you have a stomach or duodenal ulcer, or inflammation of the oesophagus (oesophagitis);
• you have severe heart diseases (e.g. peripheral arterial disease, cerebrovascular disorders, heart failure) or blood vessel diseases (vasospasms);
• you have liver disease (moderate or severe hepatic insufficiency);
• you have kidney disease (severe renal insufficiency) or are on dialysis (artificial kidney treatment);
• you have long-standing throat conditions or breathing difficulties (bronchospasm);
• you have an overactive thyroid;
• you have a tumour of the adrenal gland (pheochromocytoma);
• you have diabetes; in this case, monitor your blood sugar levels more frequently.

Other medicines and NICORETTE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are taking:

• theophylline or isoprenaline, medicines used in the treatment of asthma;
• imipramine, a medicine used to treat depression;
• adenosine, a medicine used to dilate blood vessels;
• pentazocine, a medicine used for severe pain;
• paracetamol, a medicine used for fever and pain;
• oxazepam, a medicine used for anxiety;
• propranolol, a medicine used, for example, in heart conditions;
• insulin, a medicine used in diabetes;
• prazosin, a medicine used for urinary incontinence;
• labetalol, a medicine used for heart rhythm disorders;
• phenylephrine, a vasoconstrictor medicine used to dilate pupils or as a nasal decongestant;
• products containing caffeine.

If you are being treated with any of these medicines, consult your doctor, as a dose adjustment may be necessary when quitting smoking.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Nicotine reaches the fetus and may cause harm. It is recommended that you stop smoking.
Consult your doctor for advice on how to proceed. Do not use NICORETTE during pregnancy unless specifically instructed by your doctor.
During breastfeeding, avoid using NICORETTE, as nicotine passes into breast milk and may cause problems in the infant. If you are breastfeeding, do not use NICORETTE unless specifically instructed by your doctor.

Driving and using machines
NICORETTE does not impair the ability to drive or operate machinery.

3. How to use NICORETTE

Use this medicine exactly as described in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
I How to assemble the inhaler

1. Remove the mouthpiece and the sealed blister from the packaging.
2. Rotate the two sections of the mouthpiece until the marked lines align. Carefully open the inhaler mouthpiece by separating it into its two parts. Remove the aluminium foil from the blister.
3. Remove from the blister a sealed cartridge containing a nicotine filter and insert it into the lower part of the mouthpiece. Push the cartridge until the seal breaks.
4. Reconnect the two parts of the mouthpiece. Press the two parts together until the cartridge seal breaks.
5. Rotate the two parts to close the mouthpiece.

I
How to use the inhaler

1. You may use the inhaler by inhaling either deeply or shallowly. Choose the method most suitable for you. In both cases, your body will receive the amount of nicotine needed to relieve withdrawal symptoms. If relief from craving is not sufficient, increase the frequency and/or depth of inhalations. You may notice that inhalation requires more effort than when smoking a cigarette, but the amount of nicotine absorbed through the lining of the mouth is the same as that obtained from both deep and shallow inhalations of NICORETTE.
2. It is up to you to decide how many inhalations (puffs) to take, how often, and for how long. One NICORETTE 10 mg cartridge is approximately equivalent to 3–4 cigarettes, and one NICORETTE 15 mg cartridge is approximately equivalent to 7–8 cigarettes; the highest concentration of nicotine in the blood can be achieved after about 20 minutes of continuous inhalation of NICORETTE.
3. Once the cartridge is empty, it must be replaced. Most people use between 6 and 12 cartridges of NICORETTE 10 mg per day or between 3 and 6 cartridges of NICORETTE 15 mg per day.

I How to replace the cartridge

1. Open the mouthpiece as indicated in step 2 of "How to assemble the inhaler". Remove and discard the used cartridge.
2. Insert a new cartridge into the inhaler as indicated in steps 3 and 4 of "How to assemble the inhaler".

I Operating temperature
NICORETTE works well at room temperature. In cold environments, you may need to increase the number of inhalations to absorb the same amount of nicotine as when using NICORETTE at room temperature. Do not use this medicine below 15°C.
I Dosage
Below are dosage instructions for NICORETTE, indicating the number of cartridges you may use each day and for how long you may continue using the inhaler.
I Use in children and adolescents under 18 years of age
The safety and efficacy in children and adolescents under 18 years of age have not yet been established.
I Adults and elderly

Duration of Use
During treatment with NICORETTE, you must completely stop smoking. Use the inhaler to relieve
symptoms caused by nicotine withdrawal. When withdrawal symptoms have disappeared, stop using the inhaler.
The recommended duration of treatment is 3 months. After this period, gradually reduce the daily dose
over the following 6–8 weeks.
This medicine must not be used for more than 6 months.
Refer to the table below for treatment schedule details.

Preparation 12 weeks 6–8 weeks Duration of each step
Step 1 Step 2 Step 3

Step 1: Choose a quit date and stop smoking.
Step 2: Use the inhaler for 12 weeks (3 months) to relieve withdrawal symptoms.
Step 3: Begin gradually reducing the number of cartridges used. This phase lasts approximately 6–8
weeks. After 6–8 weeks, the number of cartridges used per day should be as low as possible. DO NOT USE NICORETTE FOR MORE THAN 6 MONTHS.

If you use more NICORETTE than you should
If you use excessive doses of NICORETTE and/or simultaneously take nicotine in other forms to quit smoking while undergoing NICORETTE treatment, or if you are an occasional smoker or smoke only a few cigarettes per day, nicotine overdose may occur. In such cases, immediately stop treatment and contact your doctor or go to the nearest hospital. Doses of nicotine tolerated by adult smokers during treatment may cause severe poisoning symptoms in young children, some of which may be fatal. Suspected nicotine poisoning in a child must be considered a medical emergency and treated immediately.

Symptoms of overdose include: feeling unwell (nausea), vomiting, excessive salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disturbances, marked weakness, low blood pressure, weak or irregular pulse, breathing difficulties, prostration, seizures, and cardiac collapse.

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 everybody gets them.
Inform your doctor if you experience any of the following while using NICORETTE:

Common side effects (may affect up to 1 in 10 people)

• increased salivation, dry mouth, burning or inflamed sensation in the mouth (stomatitis), painful oral ulcers, cough, hiccups, throat irritation;
• sensation of nasal congestion, inflammation of the sinuses (sinusitis);
• headache, altered taste (dysgeusia), changes in sensation (paraesthesia);
• abdominal pain, indigestion (dyspepsia), intestinal gas (flatulence), nausea, vomiting, diarrhoea;
• fatigue, allergic reactions (hypersensitivity).

Uncommon side effects (may affect up to 1 in 100 people)

• difficulty breathing (bronchospasm, dyspnoea), voice changes, throat pain and tightness, sneezing;
• awareness of heartbeat (palpitations) or rapid heartbeat (tachycardia);
• belching, inflammation of the tongue (glossitis), blisters on the oral mucosa, altered sensation in the mouth (paraesthesia);
• abnormal dreams;
• malaise, tiredness (asthenia), chest pain and discomfort;
• sweating, itching, skin lesions (skin rashes, urticaria);
• redness, increased blood pressure.

Rare side effects (may affect up to 1 in 1,000 people)

• difficulty swallowing, reduced sensation in the mouth (hypoesthesia), vomiting urges.

Side effects of unknown frequency (frequency cannot be estimated from the available clinical data)

• skin redness (erythema), swelling of the face, eyes, lips, or throat (angioedema) with breathing difficulties, possible signs of severe allergic reactions (anaphylactic reaction);
• dry throat, stomach and intestinal disturbances, lip pain;
• blurred vision, increased tear production;
• nicotine dependence.

Side effects due to smoking cessation
Some side effects that occur during treatment with NICORETTE are due to stopping smoking.
Symptoms such as mood changes, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness or impatience, slowed heart rate (bradycardia), increased appetite or weight gain, dizziness and headache, painful oral ulcers, may be related to nicotine withdrawal.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://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 NICORETTE

Keep this medicine out of the sight and reach of children.
Store NICORETTE cartridges at a temperature not exceeding 25°C. Keep the plastic mouthpiece
in the box for future use.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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.

6. Contents of the pack and other information

What NICORETTE contains
The active substance is: nicotine.
Each 10 - 15 mg container contains: 10 – 15 mg of nicotine.
The other components are: levomenthol, porous filter.

Description of the appearance of NICORETTE and contents of the pack
NICORETTE consists of a white plastic mouthpiece into which a cartridge containing 10 mg or 15 mg of nicotine is inserted. The cartridge also contains levomenthol to give the nicotine a slight mint flavour.

NICORETTE 10 mg inhalation solution is available in cartons containing:

• 6 cartridges (each containing a nicotine-impregnated filter) packed in 1 blister, and 1 mouthpiece;
• 42 cartridges (each containing a nicotine-impregnated filter) packed in 7 blisters (each containing 6 cartridges), and 1 mouthpiece.

NICORETTE 15 mg inhalation solution is available in cartons containing:

• 4 cartridges (each containing a nicotine-impregnated filter) packed in 1 blister, and 1 mouthpiece;
• 20 cartridges (each containing a nicotine-impregnated filter) packed in 5 blisters (each containing 4 cartridges), and 1 mouthpiece.

Marketing Authorization Holder
McNeil AB - Norrbroplatsen, 2, SE-251-09, Helsingborg - Sweden
Representative in Italy: Johnson & Johnson S.p.A.
Via Ardeatina, Km 23,500 - 00071, Santa Palomba, Pomezia (Rome) - Italy

Manufacturer
McNeil AB - Norrbroplatsen, 2, SE-251-09, Helsingborg - Sweden