Nicorette coolmint

Package leaflet: Information for the patient

Nicorette Coolmint, 2 mg, tablets for sucking
Nicorette Coolmint, 4 mg, tablets for sucking
Nicotinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.
• If after 9 months the patient still has difficulty refraining from smoking without the help of Nicorette Coolmint, he or she should consult a doctor.

Table of contents of the leaflet

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

This medicine is used to relieve withdrawal symptoms and reduce nicotine craving that occur when
attempting to stop smoking or reduce the number of cigarettes smoked, as part of a smoking cessation
program. This treatment is intended for adult smokers aged 18 years and older.
Nicorette Coolmint, 2 mg, tablets for sucking 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 those who smoke 20 or fewer cigarettes per day.
Nicorette Coolmint, 4 mg, tablets for sucking 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 those who smoke more than 20 cigarettes per day.
The medicine may help in immediately quitting smoking or in reducing the number of cigarettes smoked before ultimately stopping completely. If the patient believes they can stop smoking immediately, they should do so. However, if they feel this would be too difficult, they may wish to reduce the number of cigarettes smoked as a first step towards complete abstinence. Further details are provided in section 3, "How to use Nicorette Coolmint".
Nicorette Coolmint relieves withdrawal symptoms occurring 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, feelings of 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 severity and reduce the urge to smoke.
To increase the chances of successfully quitting smoking, it is also recommended to seek counselling 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 conditions listed below. The patient may still be able to use Nicorette Coolmint, but should first consult a doctor in case of:

• recent 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
• previous occurrence of allergic reactions, such as swelling of the lips, face and throat (angioedema) or itchy rash (urticaria). Use of NRT may sometimes provoke this type of reaction
• severe or moderately severe liver disease
• severe kidney disease
• diabetes
• overactivity of the thyroid gland (hyperthyroidism)
• adrenal gland tumour (pheochromocytoma)
• peptic ulcer disease of the stomach or duodenum
• oesophagitis
• previous episodes of epilepsy or seizures

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

Children
The adult dose may cause serious poisoning or even death in children. It is therefore essential to store Nicorette Coolmint out of sight and reach of children.

Other medicines and Nicorette Coolmint
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This is particularly important if taking medicines containing:

• theophylline for asthma
• tacrine for Alzheimer's disease
• clozapine for schizophrenia
• ropinirole for the treatment of 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. It may also lead to miscarriage or stillbirth. Ideally, a pregnant woman should stop smoking without using nicotine-containing medicines. However, if she is unable to do so, she may use Nicorette Coolmint, but only after consulting her obstetrician, 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 feed.

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 and 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 this leaflet or as directed 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
This applies to immediately stopping 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 lozen 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 used 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 urge to smoke. In such a case, a lozenge may be used again.

(b) Gradual smoking cessation
This involves gradually replacing some cigarettes with lozenges. Once this goal is achieved, the patient completely stops smoking cigarettes and continues using 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 cigarettes smoked daily after 6 weeks, they should consult an appropriate healthcare professional.
As soon as the patient feels ready, they should completely stop smoking. At this point, follow the instructions for immediate smoking cessation described above. This should be done as quickly as possible. If the attempt to completely stop smoking is unsuccessful within 6 months of starting treatment, consult an appropriate healthcare professional.
Do not exceed the recommended dose. Follow 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 be used only 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- Simultaneously pull the top part of the box firmly
Closing: Press the top part of the box down.

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 lozen in the mouth and move it from one side of the mouth to the other from time to time until it has completely dissolved. This should take less than 20 minutes. The lozenges must not be chewed or swallowed whole. Do not eat or drink while the lozen is in the mouth.

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

• is concerned about possibly starting to smoke again,
• has difficulty 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).

Accidental overdose of Nicorette Coolmint
Smoking cigarettes while using Nicorette Coolmint may lead to nicotine overdose.
If this medicine is taken by a child or if a patient uses more Nicorette Coolmint than recommended, immediately contact 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, the following symptoms may occur: low blood pressure, weak and irregular pulse, breathing difficulties, exhaustion, circulatory collapse, and generalized seizures.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may 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 dose of nicotine administered.
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,
• malaise,
• craving for a cigarette (nicotine craving),
• decreased heart rate,
• bleeding gums or oral mucosal 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 discontinue use of Nicorette Coolmint and contact a doctor immediately, as these may be signs of severe hypersensitivity (frequency is unknown: frequency cannot be estimated from available data):
• urticaria (a skin condition characterized by itchy, raised or red patches),
• swelling of the face, tongue or throat,
• difficulty breathing,
• difficulty swallowing.

Most adverse effects occur in the early phase of treatment. During the first few days of treatment, irritation of 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 occur in more than 1 in 10 patients:

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

Common: may occur in up to 1 in 10 patients:

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

Uncommon: may occur in up to 1 in 100 patients:

• nasal symptoms such as 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, malaise.

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

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

Not known: frequency cannot be estimated from available data:

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your 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, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported directly 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 this 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 to store anything else, as residue from the tablets may remain and could coat other items placed in the container.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Nicorette Coolmint contains
The active substance is nicotine. Each lozenge contains 2 mg or 4 mg of nicotine (as nicotine with cation exchange resin).
The 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), aluminium potassium 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, 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

Manufacturers
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]