NicoretteIcy

Patient Information Leaflet

Nicoretteicy 2 mg, tablets

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

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Consult your doctor if after 6 months you still have difficulty quitting smoking without the help of Nicoretteicy.

Contents of this leaflet:

1. What Nicoretteicy tablets are and what they are used for
2. What you need to know before taking Nicoretteicy tablets
3. How to use Nicoretteicy tablets
4. Possible side effects
5. How to store Nicoretteicy tablets
6. Contents of the pack and other information

1. What Nicoretteicy tablets are and what they are used for

This medicinal product is used to relieve withdrawal symptoms and reduce nicotine cravings when trying to stop smoking. The treatment is intended for adult smokers aged 18 years and over.
Nicoretteicy 2 mg tablets are suitable for smokers with low nicotine dependence, for example those who smoke their first cigarette of the day more than 30 minutes after waking up, or who smoke 20 cigarettes or fewer per day.
This medicine helps relieve nicotine withdrawal symptoms, including cravings, when quitting smoking. When the body suddenly stops receiving nicotine from tobacco, a series of unpleasant sensations may occur, known as withdrawal symptoms, such as irritability, anger or depression, anxiety, restlessness, poor concentration, increased appetite or weight gain, urge to smoke ( craving ), nighttime awakenings or sleep disturbances. The nicotine contained in Nicoretteicy helps prevent or reduce these unpleasant sensations and control the urge to smoke.
To improve the chances of successfully quitting smoking, it is advisable to seek advice and support from qualified professionals.

2. What you need to know before taking Nicoretteicy tablets

Do not use Nicoretteicy tablets:

• 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 are not a smoker.

Warnings and precautions
Talk to your doctor before taking this medicine if you have any of the conditions listed below. It may still be possible to use Nicoretteicy tablets, but you should consult your doctor first if you have:

• recently had a heart attack or stroke
• chest pain (unstable angina) or angina at rest
• a heart condition affecting heart rate or rhythm (arrhythmia)
• high blood pressure not controlled by medication
• impaired heart function or circulation problems
• previously 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 to severe liver impairment
• severe kidney disease
• diabetes
• an overactive thyroid gland
• adrenal gland tumour (pheochromocytoma)
• gastric or duodenal ulcer
• oesophagitis
• history of epilepsy or seizures

The tablets may pose a choking risk. Use with caution if you have difficulty swallowing solids or liquids, or if you frequently cough during or after swallowing.
Children and adolescents
Do not give this medicine to children or adolescents.
Other medicines and Nicoretteicy tablets
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 medicines containing:

• theophylline, used to treat asthma;
• tacrine, for Alzheimer's disease;
• clozapine, for schizophrenia;
• ropinirole, used to treat Parkinson's disease.

Nicoretteicy tablets with food and drinks
Do not eat or drink while taking the tablets. Drinks that create an acidic environment in the mouth, such as coffee, fruit juices, and soft drinks, may reduce the absorption of nicotine. To achieve optimal nicotine absorption, such drinks should be avoided for 15 minutes before taking a tablet.
Pregnancy and breastfeeding
It is very important to stop smoking during pregnancy, as smoking can lead to poor fetal growth. It may also result in premature birth or stillbirth. It is best if you can stop smoking without using nicotine-containing medicines. If you are unable to do so, Nicoretteicy tablets should only be used on medical advice.
Since nicotine passes into breast milk and may affect the baby, this medicine should only be used during breastfeeding on medical advice. If your doctor advises you to take Nicoretteicy, the tablet should be taken immediately after breastfeeding and not within the two hours preceding breastfeeding.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Nicoretteicy contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to use Nicoretteicy tablets

How to use the container
[Plastic bottle]

[Paperboard container]

To open:
1- Gently press the tab marked "press here"
2- At the same time, firmly lift the top part of the box
To close: press down on the top of the box.

How to use the medicine
This medicine must not be used by individuals under 18 years of age.
Always 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.
This medicine is intended for oromucosal use. The tablet should be placed in the mouth to allow it to dissolve and release nicotine, which is then absorbed through the oral mucosa into the body.
Always take the medicine by placing only one tablet in the mouth and moving it occasionally from one side of the mouth to the other until it has completely dissolved. This usually takes less than 20 minutes. Do not chew or swallow the tablet whole. Do not take more than 15 tablets per day. If you feel the need to use this medicine for more than 6 months in total, consult your doctor for advice.
The goal is to stop smoking immediately and to use the tablets to relieve the urge to smoke.

Adults aged 18 years and over

• Start by taking 8 to 12 tablets per day. When you feel the urge to smoke, place a tablet in your mouth and let it dissolve.
• Use the tablets in this way for up to 6 weeks, then gradually reduce the number of tablets taken per day.
• When you reach the point of taking only 1 or 2 tablets per day, stop taking them. After stopping, you may occasionally still feel the urge to smoke. In such cases, you may take one tablet.

Do not exceed the recommended dose. Follow the instructions carefully and do not use more than 15 tablets in one day (24 hours).
Do not eat or drink while using the tablet (see Nicoretteicy tablets with food and drinks).

Craving to start smoking again
If:

• you are afraid of starting to smoke again, or
• you have difficulty completely stopping the use of the tablets, consult a healthcare professional. If you start smoking again, you may be advised on how to achieve optimal results with further nicotine replacement therapies (NRT).

If you take more Nicoretteicy tablets than you should
If you smoke while taking this medicine, an overdose of nicotine may occur.
If a child takes Nicoretteicy, or if you have taken more Nicoretteicy than recommended, contact your doctor or go immediately to the nearest hospital. Doses of nicotine that are tolerated by adult smokers during treatment may cause severe poisoning symptoms in children, which may even be fatal.
Symptoms of overdose include: feeling unwell (nausea), vomiting, excessive salivation, stomach pain, diarrhoea, sweating, headache, dizziness, hearing disturbances, and marked weakness. At high doses, these symptoms may progress to low blood pressure, weak or irregular pulse, breathing difficulties, prostration, circulatory collapse, and convulsions.
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 can cause side effects, although not everyone experiences them.

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

• irritability, aggression, impatience, or frustration
• feeling anxious, restless, or difficulty concentrating
• waking during the night or sleep disturbances
• increased appetite or body weight gain
• feeling depressed
• urge to smoke (craving)
• slowing of heart rate
• bleeding gums or mouth ulcers
• dizziness or lightheadedness
• cough, sore throat, stuffy or runny nose
• constipation

If you experience any severe side effects, stop taking Nicorette icy pastilles and seek immediate medical advice, as this may be a sign of a severe allergic reaction (frequency is very rare: may affect up to 1 in 10,000 people):

• urticaria (a skin condition characterized by itching or red patches)
• swelling of the face, tongue, or throat
• difficulty breathing
• difficulty swallowing

Most side effects occur during the initial phase of treatment. Irritation of the mouth and throat may occur during the first days of treatment, but most people adapt to these effects with continued use.

Other possible side effects:

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

• cough
• headache
• hiccups
• nausea (feeling unwell)
• irritation of the throat, mouth, or tongue

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

• local effects such as burning sensation, inflammation of the mouth, altered taste
• dry mouth or increased salivation
• feeling of indigestion
• pain or discomfort in the abdomen
• vomiting, flatulence, diarrhea
• heartburn
• fatigue
• dizziness
• hypersensitivity (allergy)
• irritability and feeling anxious

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

• sensation of stuffy nose (nasal congestion), sneezing
• wheezing (bronchospasm) or sensation that breathing is more difficult than usual (dyspnea), throat tightness
• skin redness (flushing), itching, increased sweating
• oral effects such as mouth itching, inflammation of the tongue, mouth ulcers, shedding of the oral mucosa, voice changes, mouth and throat pain, belching
• palpitations (unusual awareness of heartbeat) or fast heartbeat, hypertension
• rash and/or itching (pruritus, urticaria) or skin redness
• depression, feeling nervous, abnormal dreams
• chest pain and discomfort
• weakness, feeling unwell

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

• difficulty swallowing, decreased mouth sensitivity
• fast and irregular heartbeat, which may require treatment with specific medicines
• retching

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

• blurred vision, increased tear production (lacrimation)
• dry throat, stomach disturbances, lip pain
• skin redness
• seizures

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also 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 Nicorette lozenges

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the container and on the outer packaging after {EXP}. The expiry date refers to the last day of the month.
• For the polypropylene container: store in the original container, protected from moisture.
• For the paper container: Store the lozenges in the original container, protected from moisture. Use within 3 months after removing the wrapper.
• Do not reuse the container for any reason, as there may be residual lozenge powder which can deposit and form a thin film on objects placed inside.
• Dispose of the container responsibly. 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 Nicoretteicy tablets contain
The active substance is nicotine (in the form of nicotine resinate). Each tablet contains 2 mg of nicotine.
The other components are:
Tablet core: mannitol (E421), xanthan gum, Winterfresh RDE4-149 Spray Dried (gum arabic (E414), peppermint flavour, menthol and eucalyptol), anhydrous sodium carbonate (E500)(i), sucralose (E955), potassium acesulfame (E950), magnesium stearate (E470b)
Coating: hypromellose (E464), Winterfresh RDE4-149 (peppermint flavour, menthol and eucalyptol), titanium dioxide (E171), sucralose (E955), Sepifilm Gloss (hypromellose (E464), microcrystalline cellulose (E460), potassium aluminium silicate (E555), titanium dioxide (E171)), potassium acesulfame (E950), polysorbate 80 (E433).
Description of the appearance of Nicoretteicy tablets and pack contents
Oval tablet, white to off-white, marked with a "n" on one side and "2" on the other.
The size of a tablet is approximately 14 x 9 x 7 mm.
Pack sizes:
Each plastic bottle contains 20 tablets. Packs may contain one or four bottles.
Each cardboard box contains 40 tablets. Packs may contain one or two boxes.
Not all pack sizes are available on the market.
Marketing Authorisation Holder and Manufacturer
McNeil AB Norrbroplatsen 2, SE 251 – 09 Helsingborg SWEDEN
Representative in Italy: Johnson & Johnson S.p.A.
This medicinal product is authorised in the EEA Member States under the following names:
Italy Nicoretteicy
Spain Nicorette Supermint

Patient Information Leaflet: Information for the user

Nicoretteicy 4 mg, tablets

Nicotine
Please read this entire leaflet carefully before using this medicine because it contains
important information for you.
Always take 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if, after 6 months, you still have difficulty quitting smoking without the help of Nicoretteicy.

Contents of this leaflet:

1. What Nicoretteicy tablets are and what they are used for
2. What you need to know before taking Nicoretteicy tablets
3. How to use Nicoretteicy tablets
4. Possible side effects
5. How to store Nicoretteicy tablets
6. Package contents and other information

1. What Nicoretteicy tablets are and what they are used for

This medicinal product is used to relieve withdrawal symptoms and reduce the craving for nicotine that occurs when trying to stop smoking. The treatment is intended for adult smokers aged 18 years and over.
Nicoretteicy 4 mg tablets are suitable for smokers who have a high dependence on nicotine, for example those who smoke their first cigarette of the day within 30 minutes of waking up or who smoke more than 20 cigarettes per day.
This medicine helps relieve nicotine withdrawal symptoms, including craving, when quitting smoking. When the body suddenly stops receiving nicotine from tobacco, a series of unpleasant sensations known as withdrawal symptoms may begin, such as irritability, anger or depression, anxiety, restlessness, poor concentration, increased appetite or weight gain, urge to smoke (craving), nighttime awakenings or sleep disturbances. The nicotine contained in Nicoretteicy helps prevent or reduce these unpleasant sensations and control the urge to smoke.
To improve the chances of successfully quitting smoking, it is advisable to seek advice and support from qualified professionals.

2. What you need to know before taking Nicoretteicy tablets

Do not use Nicoretteicy tablets:

• 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 are not a smoker.

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

• recently had a heart attack or stroke
• chest pain (unstable angina) or angina at rest
• a heart disease affecting your heart rate or rhythm (arrhythmia)
• uncontrolled high blood pressure
• impaired heart function or circulation problems
• previously had allergic reactions including swelling of the lips, face and throat (angioedema) or itchy skin rash (urticaria). Nicotine replacement therapy may in some cases trigger such reactions
• moderate to severe liver impairment
• severe kidney disease
• diabetes
• an overactive thyroid gland
• a tumour of the adrenal glands (pheochromocytoma)
• gastric or duodenal ulcer
• oesophagitis
• history of epilepsy or seizures

The tablets may pose a choking risk. Use with caution if you have difficulty swallowing solids or liquids or if you frequently cough during or after swallowing.
Children and adolescents
Do not give this medicine to children or adolescents.
Other medicines and Nicoretteicy tablets
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 medicines containing:

• theophylline, used to treat asthma;
• tacrine, for Alzheimer's disease;
• clozapine, for schizophrenia;
• ropinirole, used to treat Parkinson's disease.

Nicoretteicy tablets with food and drinks
Do not eat or drink while taking the tablets. Drinks that create an acidic environment in the mouth, such as coffee, fruit juices and soft drinks, may reduce nicotine absorption.
To achieve optimal nicotine absorption, such drinks should be avoided for 15 minutes before taking the tablet.
Pregnancy and breastfeeding
It is very important to stop smoking during pregnancy, as smoking may result in poor growth of your baby. It may also lead to premature birth or stillbirth. It is best if you can stop smoking without using nicotine-containing medicines. If you are unable to do so, Nicoretteicy tablets should only be used on medical advice.
Since nicotine passes into breast milk and may affect the baby, this medicine should only be used during breastfeeding on medical advice. If your doctor advises you to take Nicoretteicy, the tablet should be taken immediately after breastfeeding and not within the two hours preceding breastfeeding.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Nicoretteicy contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to use Nicoretteicy tablets

Container instructions
[Plastic bottle]

[Carton box]

To open:
1- Gently press the tab marked "press here"
2- At the same time, firmly lift the top part of the box
To close: press down on the top of the box.

Medicinal product instructions
This medicine must not be used by individuals under 18 years of age.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended for oromucosal use. The medicine must be placed in the mouth so that it dissolves and releases nicotine, which is absorbed through the oral mucosa into the body.
In any case, place only one tablet in the mouth at a time and move it occasionally from one side of the mouth to the other until it has completely dissolved. This usually takes less than 20 minutes. Do not chew or swallow the tablet whole. Do not take more than 15 tablets per day. If you feel the need to use this medicine for more than 6 months in total, consult your doctor for advice.
The goal is to stop smoking immediately and to take the tablets to relieve the urge to smoke.

Adults aged 18 years and over

• Start by taking 8 to 12 tablets per day. When you feel the urge to smoke, place a tablet in your mouth and let it dissolve.
• Use the tablets in this way for up to 6 weeks, then gradually reduce the number of tablets taken per day.
• When you reach the point of taking only 1 or 2 tablets per day, stop taking them. After stopping, you may occasionally feel the urge to smoke. In such cases, you may take one tablet.

Do not exceed the recommended dose. Follow the instructions carefully and do not use more than 15 tablets in one day (24 hours).
Do not eat or drink while using the tablet (see Nicoretteicy tablets with food and drinks).

Craving to smoke again
If:

• you are afraid of starting to smoke again, or
• you have difficulty stopping the tablets completely, consult a healthcare professional.
  If you start smoking again, you may be advised on how to achieve optimal results from further nicotine replacement therapies (NRT).

If you use more Nicoretteicy tablets than you should
If you smoke while taking this medicine, nicotine overdose may occur.
If a child takes Nicoretteicy, or if you have taken more Nicoretteicy than you should, contact your doctor or go immediately to the nearest hospital. Doses of nicotine that are tolerated by adult smokers during treatment may cause severe poisoning symptoms in children, even resulting in fatal outcomes.
Symptoms of overdose include: feeling unwell (nausea), vomiting, excessive salivation, stomach pain, diarrhoea, sweating, headache, dizziness, hearing disturbances, and marked weakness. At high doses, these symptoms may progress to low blood pressure, weak or irregular pulse, breathing difficulties, prostration, circulatory collapse, and 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 gets them.

Effects related to stopping smoking (nicotine withdrawal)
Some of the side effects you may experience when you stop smoking may be withdrawal symptoms due to reduced nicotine intake.

These effects include:

• irritability, aggression, impatience or frustration
• feeling anxious, restless or difficulty concentrating
• night awakenings or sleep disturbances
• increased appetite or body weight gain
• feeling depressed
• urge to smoke (craving)
• slowing of heart rate
• bleeding gums or mouth ulcers
• dizziness or lightheadedness
• cough, sore throat, blocked or runny nose
• constipation

If you experience any severe side effect, stop taking Nicoretteicy tablets and consult a doctor immediately,
as this may be a severe allergic reaction (frequency is very rare: may affect up to 1 in 10,000 people):

• urticaria (a skin condition characterized by itching or red patches)
• swelling of the face, tongue or throat
• difficulty breathing
• difficulty swallowing

Most side effects occur during the initial phase of treatment. During the first days of treatment, irritation of the mouth and throat may occur; however, most people adapt to these effects with continued use.

Other possible side effects:

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

• cough
• headache
• hiccups
• nausea (feeling unwell)
• irritation of throat, mouth and tongue

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

• local effects such as burning sensation, inflammation of the mouth, altered taste
• dry mouth or increased salivation
• feeling of indigestion
• pain or discomfort in the abdomen
• vomiting, flatulence, diarrhoea
• heartburn
• fatigue
• dizziness
• hypersensitivity (allergy)
• irritability and feeling anxious

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

• sensation of blocked nose (nasal congestion), sneezing
• wheezing (bronchospasm) or sensation of more difficult breathing than usual (dyspnoea), throat tightness
• skin redness (flushing), itching, increased sweating
• oral effects such as mouth itching, inflammation of the tongue, mouth ulcers, peeling of the oral mucosa, voice changes, mouth and throat pain, burping
• palpitations (unusual awareness of heartbeat) or fast heartbeat, hypertension
• rash and/or itching (pruritus, urticaria) or skin redness
• depression, feeling nervous, abnormal dreams
• chest pain and discomfort
• weakness, feeling unwell

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

• difficulty swallowing, decreased mouth sensitivity
• fast and irregular heartbeat, which may be treated with appropriate medicines
• retching
• seizures

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

• blurred vision, increased tear production (lacrimation)
• dry throat, stomach disturbances, lip pain

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 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 lozenges

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the container and outer packaging after {EXP}. The expiry date refers to the last day of the month.
• For the polypropylene container: keep in the original container, protected from moisture.
• For the paper container: store the lozenges in the original container, protected from moisture. Use within 3 months after removal of the wrapper.
• Do not reuse the container for any reason, as residue from the lozenge may be present, which can deposit and form a thin coating on objects placed inside.
• Dispose of the container responsibly. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Nicoretteicy tablets contain
The active substance is nicotine (in the form of nicotine resinate). Each tablet contains 4 mg of nicotine.
The other components are:
Tablet core: mannitol (E421), xanthan gum, Winterfresh RDE4-149 Spray Dried (acacia gum (E414), peppermint, menthol and eucalyptol flavours), anhydrous sodium carbonate (E500)(i), sucralose (E955), acesulfame potassium (E950), magnesium stearate (E470b)
Coating: hypromellose (E464), Winterfresh RDE4-149 (peppermint, menthol and eucalyptol flavours), titanium dioxide (E171), sucralose (E955), Sepifilm Gloss (hypromellose (E464), microcrystalline cellulose (E460), potassium aluminium silicate (E555), titanium dioxide (E171)), acesulfame potassium (E950) and polysorbate 80 (E433).
Description of the appearance of Nicoretteicy tablets and package contents
Oval tablet, white to off-white in colour, with a "n" imprinted on one side and "4" on the other.
The size of a tablet is approximately 14 x 9 x 7 mm.
Pack sizes:
Each plastic bottle contains 20 tablets. Packs may contain one or four bottles.
Each cardboard box contains 40 tablets. Packs may contain one or two boxes.
Not all pack sizes are commercially available.
Marketing Authorisation Holder and Manufacturer
McNeil AB Norrbroplatsen 2, SE 251 – 09 Helsingborg, SWEDEN
Representative in Italy: Johnson & Johnson S.p.A.
This medicinal product is authorised in EEA Member States under the following names:
Italy Nicoretteicy
Spain Nicorette Supermint