Nicorette coolmint

Package leaflet: Information for the user

Nicorette Coolmint, 2 mg, sucking tablets
Nicorette Coolmint, 4 mg, sucking tablets
Nicotinum
Please read this leaflet carefully before taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor or
pharmacist has advised.

• Keep this leaflet. You may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 9 months you still have difficulty refraining from smoking without the help of Nicorette Coolmint, you should consult your doctor.

Contents of the leaflet

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

1. What Nicorette Coolmint is and what it is used for

This medicine is used to relieve withdrawal symptoms and reduce nicotine craving associated with
attempts to stop smoking or reduce the number of cigarettes smoked, when trying to quit smoking.
This treatment is intended for adult smokers aged 18 years and older.
Nicorette Coolmint 2 mg sucking tablets are suitable for use in smokers with low nicotine dependence, i.e. those who smoke their first cigarette more than 30 minutes after waking up or who smoke 20 or fewer cigarettes per day.
Nicorette Coolmint 4 mg sucking tablets are suitable for use in smokers with high nicotine dependence, i.e. those who smoke their first cigarette within 30 minutes of waking up or who smoke more than 20 cigarettes per day.
This medicine may help you to stop smoking immediately or to reduce the number of cigarettes smoked before finally quitting. If you feel you can stop smoking immediately, you should do so. However, if you think this would be too difficult, you may wish to reduce the number of cigarettes smoked as a first step towards complete abstinence. Further information is provided in section 3, "How to use Nicorette Coolmint".
Nicorette Coolmint relieves withdrawal symptoms that occur after stopping smoking, including nicotine craving. When nicotine from tobacco is suddenly no longer supplied to the body, various unpleasant sensations develop, known as withdrawal symptoms, such as irritability, anger or depression, anxiety, restlessness, difficulty concentrating, increased appetite or weight gain, strong desire to smoke (craving), waking up at night or sleep disturbances. The nicotine contained in Nicorette Coolmint can help prevent these unpleasant sensations or reduce their intensity and reduce the urge to smoke.
To increase the chances of successfully quitting smoking, it is also recommended to seek advice and psychological support.

2. Information before using Nicorette Coolmint

When not to use Nicorette Coolmint:

• if the patient is allergic to nicotine or to any of the other ingredients of this medicine (listed in section 6).
• if the patient is under 12 years of age.
• if the patient has never smoked.

Warnings and precautions
Contact a doctor if the patient has any of the following conditions. The patient may still be able to use Nicorette Coolmint, but should first consult a doctor if they have:

• recent myocardial infarction (heart attack) or stroke
• chest pain (unstable angina) or symptoms of angina at rest
• heart disease affecting the speed or regularity of heartbeat (arrhythmia)
• high blood pressure not controlled by medication
• a history of allergic reactions, such as swelling of the lips, face and throat (angioedema) or itchy rash (urticaria). Nicotine replacement therapy (NRT) may sometimes provoke such reactions
• severe or moderately severe liver disease
• severe kidney disease
• diabetes
• overactive thyroid gland (hyperthyroidism)
• adrenal gland tumour (phaeochromocytoma)
• peptic ulcer disease of the stomach or duodenum
• oesophagitis (inflammation of the oesophagus)
• a history of epilepsy or seizures

This medicine should not be used by non-smokers.
Lozenges may pose a choking risk. Use with caution if the patient has difficulty swallowing solids or liquids, or frequently coughs during or after swallowing.

Children
An adult dose given to a child may cause serious poisoning and even death. It is therefore essential to store Nicorette Coolmint out of sight and out of reach of children.

Other medicines and Nicorette Coolmint
Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken. This is particularly important if using medicines containing:

• theophylline for asthma
• tacrine for Alzheimer's disease
• clozapine for schizophrenia
• ropinirole for Parkinson's disease.

Nicorette Coolmint with food and drink
Do not eat or drink while taking the lozenges.

Pregnancy, breastfeeding and fertility
It is very important to stop smoking during pregnancy, as smoking may impair fetal development and may cause miscarriage or stillbirth. Ideally, pregnant women should stop smoking without using nicotine-containing medicines. However, if this is not possible, Nicorette Coolmint may be used, but only after consultation with the doctor managing the pregnancy, a general practitioner, or a specialist centre for smoking cessation.

Nicorette Coolmint should not be used during breastfeeding, as nicotine passes into breast milk and may affect the infant. If a doctor recommends using Nicorette Coolmint, the lozenge should be taken immediately after breastfeeding and no later than 2 hours before the next feeding.

Smoking increases the risk of infertility in both women and men. The effect of nicotine on fertility is unknown.

Driving and operating machinery
No effects of the medicine on the ability to drive or operate machinery have been observed.

Nicorette Coolmint contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free". Nicorette Coolmint contains polysorbate, which may cause allergic reactions.

3. How to use Nicorette Coolmint

This medicine should always be used exactly as described in the leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. The way to use Nicorette Coolmint depends on whether the patient:
(a) is quitting smoking immediately
(b) is quitting smoking gradually

Adults (18 years and older)

(a) Immediate smoking cessation
Applies to immediate stopping of smoking and using the lozenges to reduce nicotine cravings.

• Begin treatment by using 8 to 12 lozenges per day. As soon as the urge to smoke arises, place one lozenge in the mouth and wait for it to dissolve.
• Use the lozenges in this way for up to 6 weeks, then gradually reduce the number of lozenges taken per day.
• When the patient is using only 1 or 2 lozenges per day, they should stop using them completely. After completely stopping smoking, the patient may occasionally experience a sudden strong urge to smoke. In such a case, a lozenge may be used again.

(b) Gradual smoking cessation
Applies to gradually replacing some cigarettes with lozenges. After achieving this goal, the patient completely stops smoking cigarettes and continues using the lozenges. Eventually, the use of lozenges is also discontinued.
Whenever a strong urge to smoke occurs, use a Nicorette Coolmint lozenge instead of a cigarette to control nicotine cravings. The number of cigarettes smoked per day should be reduced to the lowest possible number. If the patient is unable to reduce the number of daily cigarettes after 6 weeks, they should consult an appropriate healthcare professional.
As soon as the patient feels ready, they should completely stop smoking. At that point, follow the instructions for immediate smoking cessation described above. This should be done as quickly as possible. If the attempt to quit smoking completely fails within 6 months of starting treatment, consult an appropriate healthcare professional.
Do not exceed the recommended dose. Follow the instructions carefully and do not use more than 15 lozenges in 24 hours.
If the patient feels the need to use the medicine for longer than 9 months in total, they should consult a doctor.

Children and adolescents

Adolescents aged 12–17 years
Nicorette Coolmint should only be used on medical advice.

Children under 12 years of age
This medicine must not be given to children under 12 years of age.

Instructions for use
[Polypropylene container]

OPEN CLOSE
[Cardboard box]
Opening:

1- Gently press the tab marked "Press here"
2- At the same time, firmly pull the top part of the box
Closing: press down the top part of the box.

This medicine is intended for administration to the oral mucosa. It should be placed in the mouth and allowed to dissolve, releasing nicotine which is absorbed into the body through the lining of the mouth.
Place one lozenge in the mouth and move it from one side of the mouth to the other occasionally until it dissolves completely. This should take less than 20 minutes. Do not chew or swallow the lozenges whole. Do not eat or drink while the lozenge is in the mouth.

What to do if you are tempted to resume smoking
If the patient:

• is worried about possibly starting to smoke again,
• has difficulties completely stopping the use of lozenges,
  they should consult an appropriate healthcare professional. If the patient starts smoking again despite treatment, a healthcare professional can advise on how to achieve the best results from further courses of nicotine replacement therapy (NRT).

Taking more Nicorette Coolmint than recommended
Smoking cigarettes while using Nicorette Coolmint may lead to nicotine overdose.
If this medicine is taken by a child or if the patient takes more Nicorette Coolmint than recommended, seek immediate medical advice from a doctor or go to the nearest hospital. Doses of nicotine tolerated during treatment in adult smokers may cause severe poisoning symptoms and may be fatal in children.
Symptoms of overdose include: nausea, vomiting, increased salivation, abdominal pain, diarrhoea, excessive sweating, headache, dizziness, hearing disturbances and marked weakness. After large doses, low blood pressure, weak and irregular pulse, breathing difficulties, exhaustion, circulatory collapse and generalized seizures may occur following these symptoms.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Effects related to quitting smoking (nicotine withdrawal)
Some of the adverse effects occurring when quitting smoking may be withdrawal symptoms caused by reducing the administered dose of nicotine.
Possible effects include:

• irritability, aggression, impatience or frustration,
• feeling anxious, restlessness or difficulty concentrating,
• waking up during the night or sleep disturbances,
• increased appetite or weight gain,
• feeling unwell,
• craving for a cigarette (nicotine craving),
• decreased heart rate,
• bleeding gums or oral ulceration,
• dizziness or feeling of emptiness in the head,
• cough, sore throat, nasal congestion or runny nose,
• constipation. If the patient notices any of the following severe adverse effects, they should stop using Nicorette Coolmint and contact a doctor immediately, as these may be signs of a severe allergic reaction (frequency is unknown: frequency cannot be determined from available data):
• urticaria (skin disorder characterized by itchy, raised or red patches)
• facial, tongue or throat swelling
• breathing difficulties
• difficulty swallowing

Most adverse effects occur in the early phase of treatment. During the first few days of treatment, irritation in the mouth and throat may occur, but most patients adapt to the treatment, and this symptom subsides during continued therapy.
Other possible adverse effects:
Very common: may affect more than 1 in 10 patients:

• cough,
• headache,
• hiccups,
• nausea,
• throat, oral cavity and tongue irritation.

Common: may affect up to 1 in 10 patients:

• local reactions such as burning sensation, oral inflammation, taste disturbances,
• sensation of cold, warmth or tingling of the skin,
• dry mouth or increased salivation,
• indigestion,
• abdominal pain or discomfort,
• vomiting, flatulence or diarrhoea,
• heartburn,
• feeling of fatigue,
• hypersensitivity (allergy).

Uncommon: may affect up to 1 in 100 patients:

• nasal complaints such as nasal congestion, sneezing,
• wheezing (bronchospasm) or feeling of increased effort in breathing compared to normal (dyspnoea), throat tightness,
• skin redness or increased sweating,
• oral cavity reactions such as oral tingling, glossitis, oral ulceration, damage to the oral mucosa or voice changes, oral and throat pain, belching,
• palpitations, increased heart rate, hypertension,
• rapid and irregular heartbeat, which may be treated with appropriate therapy,
• rash and/or itching of the skin,
• unusual dreams,
• discomfort and chest pain,
• weakness, feeling unwell.

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

• difficulty swallowing, reduced sensation in the oral cavity,
• vomiting reflex.

Not known: frequency cannot be determined from available data:

• blurred vision, increased tear production,
• dry throat, stomach discomfort, lip pain,
• skin redness,
• seizures.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nicorette Coolmint

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the container and on the outer packaging. The expiry date refers to the last day of the specified month.
• Polypropylene container: Store in the original packaging to protect from moisture.
• Cardboard box: Store in the original packaging to protect from moisture. Use within 3 months after removing the protective foil.
• Do not reuse the medicine container for storing anything else, as residue from the tablets may remain and could contaminate other items placed in the container.
• Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nicorette Coolmint contains
Active substance: Nicotine. Each lozenge contains 2 mg or 4 mg of nicotine (in the form of
nicotine with cation exchange resin).
Other ingredients are: Lozenge core - mannitol (E 421), xanthan gum, Winterfresh RDE4-149
spray dried (containing gum arabic (E 414) and flavours of menthol, peppermint and eucalyptus),
anhydrous sodium carbonate (E 500)(i), sucralose (E 955), potassium acesulfame (E 950),
magnesium stearate (E 470b); coating - hypromellose (E 464), Winterfresh RDE4-149 (containing
flavours of menthol, peppermint and eucalyptus), titanium dioxide (E 171), sucralose (E 955),
Sepifilm Gloss (containing hypromellose (E 464), microcrystalline cellulose (E 460),
potassium aluminium silicate (E 555) and titanium dioxide (E 171)), potassium acesulfame (E 950),
polysorbate 80 (E 433).
Nicorette Coolmint lozenges do not contain sugar.

What Nicorette Coolmint looks like and contents of the pack
Oval lozenge, white to almost white in colour, marked with "n" on one side and "2" or "4" on the
other side, approximately 14 x 9 x 7 mm in size.
Pack sizes:
Each PP container contains 20 lozenges. Packs may contain 1 container, 4 containers or 8 containers.
Each cardboard box contains 40 lozenges. Packs may contain 1 box, 2 boxes or 4 boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
McNeil AB, 251 09 Helsingborg, Sweden
Manufacturer
McNeil AB, Norrbroplatsen 2, 251 09 Helsingborg, Sweden
Kenvue Belgium NV, Michel De Braeystraat 52, 2000 Antwerp, Belgium
Kenvue Germany GmbH, Johnson & Johnson Platz 2, 41470 Neuss, Germany

This medicinal product is authorised in the European Economic Area countries under the following names:

For more detailed information, please contact:
email: [email protected]