Nicorette Coolmint

Leaflet accompanying the packaging: patient information

Nicorette Coolmint, 2 mg, lozenges

Nicorette Coolmint, 4 mg, lozenges

Nicotine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 9 months the patient still has trouble quitting smoking without the help of Nicorette Coolmint, they 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 packaging and other information

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

The medicine is used to alleviate withdrawal symptoms and reduce nicotine cravings that occur when trying to quit smoking or reduce the number of cigarettes smoked, when trying to quit smoking. This treatment is intended for adult smokers aged 18 and over.
Nicorette Coolmint, 2 mg, lozenges are suitable for use in smokers with a low degree of nicotine dependence, i.e. those who smoke their first cigarette of the day more than 30 minutes after waking up or who smoke 20 or fewer cigarettes per day.
Nicorette Coolmint, 4 mg, lozenges are suitable for use in smokers with a high degree of nicotine dependence, i.e. those who smoke their first cigarette of the day within 30 minutes of waking up or who smoke more than 20 cigarettes per day.
The medicine can help quit smoking immediately or reduce the number of cigarettes smoked before finally quitting smoking. If the patient thinks they can quit smoking immediately, they should do so. However, if they think it will be too difficult, they may want to reduce the number of cigarettes smoked as a first step before achieving complete abstinence. More detailed information is provided in section 3 "How to use Nicorette Coolmint".
Nicorette Coolmint alleviates withdrawal symptoms that occur after quitting smoking, including nicotine cravings. When nicotine from tobacco is suddenly stopped, various unpleasant feelings, called withdrawal symptoms, develop, such as irritability, feelings of anger or depression, anxiety, restlessness, decreased concentration, increased appetite or weight gain, strong desire to smoke (cravings), insomnia or sleep disturbances. The nicotine in Nicorette Coolmint can prevent these unpleasant feelings or reduce their severity and reduce the desire to smoke.
To increase the chances of a successful quit attempt, it is also recommended to use counseling and behavioral support.

2. Important information before using Nicorette Coolmint

When not to use Nicorette Coolmint:

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

Warnings and precautions

The patient should consult a doctor if they have any of the following conditions. It may be possible for the patient to use Nicorette Coolmint, but they must first consult a doctor in the case of:

• recently having had a heart attackor stroke
• chest pain(unstable angina) or symptoms of angina at rest
• heart diseaseaffecting the heart rate or rhythm (arrhythmias)
• high blood pressurethat is not controlled by medication
• having ever had allergic reactions, such as swelling of the lips, face, and throat (angioedema) or itchy rash (hives). Using NRT can sometimes trigger this type of reaction
• severe or moderate liver disease
• severe kidney disease
• diabetes
• hyperthyroidism
• pheochromocytoma(a tumor of the adrenal gland)
• stomach or duodenal ulcers
• esophagitis
• having ever had epilepsyor seizures

The medicine should not be used by non-smokers.
Lozenges can pose a choking hazard. The medicine should be used with caution in patients with problems swallowing solids or liquids, or who frequently cough when swallowing or after swallowing.

Children

An appropriate dose for adults, given to children, can cause serious poisoning and even be fatal. It is essential to keep Nicorette Coolmint out of sight and out of reach of children.

Other medicines and Nicorette Coolmint

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is especially important if they are taking medicines containing:

• theophyllinefor asthma
• tacrinefor Alzheimer's disease
• clozapinefor schizophrenia
• ropinirolefor Parkinson's disease.

Nicorette Coolmint with food and drink

The patient should not eat or drink while taking the lozenges.

Pregnancy, breastfeeding, and fertility

It is very important to quit smoking during pregnancy, as it can lead to fetal growth restriction. It can also cause miscarriage or stillbirth. The best option is for pregnant women to quit smoking without using nicotine-containing medications. However, if they are unable to do so, they may use Nicorette Coolmint, but only after consulting their doctor, obstetrician, or a doctor specializing in smoking cessation treatment.
Nicorette Coolmint should not be taken during breastfeeding, as nicotine passes into breast milk and may affect the baby. If the doctor recommends using Nicorette Coolmint, the lozenge should be taken immediately after breastfeeding and no sooner than 2 hours before the next breastfeeding.
Smoking increases the risk of infertility in both men and women. The effect of nicotine on fertility is unknown.

Driving and using machines

No effects on the ability to drive or use machines have been observed.
Nicorette Coolmintcontains less than 1 mmol of sodium (23 mg) per lozenge, which means the medicine is essentially "sodium-free". Nicorette Coolmint contains polysorbate, which may cause allergic reactions.

3. How to use Nicorette Coolmint

This medicine should always be taken exactly as described in the leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist. The way to use Nicorette Coolmint depends on whether the patient:

• (a) quits smoking immediately
• (b) quits smoking gradually

Adults (18 years and over)

• (a) Immediate quittingThis involves quitting smoking immediately and using lozenges to reduce cigarette cravings.
• Treatment should start with 8-12 lozenges per day. Whenever the urge to smoke occurs, one lozenge should be placed in the mouth and allowed to dissolve.
• Lozenges should be used in this way for up to 6 weeks, then the number of lozenges used per day should be gradually reduced.
• When the patient is using only 1 or 2 lozenges per day, they should stop using them altogether. After quitting smoking, the patient may sometimes experience a strong desire to smoke. In such cases, a lozenge can be used again.
• (b) Gradual quittingThis involves gradually replacing some cigarettes with a lozenge. Once this goal is achieved, the patient should quit smoking cigarettes altogether, using lozenges. Finally, the patient should also stop using lozenges.

In case of a strong desire to smoke, the patient should use a Nicorette Coolmint lozenge instead of a cigarette to control nicotine cravings. The number of cigarettes smoked per day should be reduced to as few as possible. If the patient is unable to reduce the number of cigarettes smoked per day after 6 weeks, they should consult a healthcare professional.
As soon as the patient feels they can do so, they should quit smoking cigarettes altogether. They should then follow the instructions for immediate quitting, described above. The patient should do this as soon as possible. If the attempt to quit smoking altogether is not successful within 6 months of starting treatment, the patient should consult a healthcare professional.
The patient should not exceed the recommended dose. They should follow the instructions carefully and not use more than 15 lozengesin 24 hours.
If the patient needs to use the medicine for more than 9 months in total, they should consult a doctor.

Children and adolescents

Adolescents aged 12-17

Nicorette Coolmint should only be used on the advice of a doctor.

Children under 12

The medicine should not be given to children under 12.

Instructions for use

[Polypropylene container]

OPENING
CLOSING
[Carton box]
Opening:

• 1- Gently press the latch with the words "Press here"
• 2- At the same time, firmly pull the top part of the box

Closing: press the top part of the box.
The medicine is intended for administration to the oral mucosa. It should be placed in the mouth and allowed to dissolve, releasing nicotine to be absorbed into the body through the mucous membrane lining the mouth.
The patient should place one lozenge in the mouth and move it from time to time from one side of the mouth to the other, until it is completely dissolved. This should take less than 20 minutes. The lozenges should not be chewed or swallowed whole. The patient should not eat or drink while a lozenge is in the mouth.

What to do if there is a desire to start smoking again

If the patient:

• is worried that they may start smoking again,
• is having trouble quitting lozenges, they should consult a healthcare professional. If the patient starts smoking again despite this, the healthcare professional may advise them on how to get the best results from further nicotine replacement therapy (NRT) courses.

Taking more than the recommended dose of Nicorette Coolmint

If the patient smokes while taking Nicorette Coolmint, nicotine overdose may occur.
If the medicine is taken by a child or if the patient uses more Nicorette Coolmint than recommended, they should immediatelyconsult a doctor or go to the nearest hospital. Nicotine doses tolerated during treatment by adult smokers can cause serious poisoning and may be fatal to children.
Symptoms of overdose are: nausea (vomiting), vomiting, increased salivation, abdominal pain, diarrhea, excessive sweating, headache, dizziness, hearing disturbances, and significant weakness. In the case of large doses, after these symptoms, low blood pressure, weak and irregular pulse, breathing difficulties, exhaustion, vascular collapse, and generalized seizures may occur.
In case of any further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects related to quitting smoking (nicotine withdrawal)

Some of the side effects that occur when quitting smoking may be withdrawal symptoms caused by reducing the nicotine dose.
Possible side effects include:

• irritability, aggression, impatience, or frustration,
• feeling anxious, restless, or having trouble concentrating,
• waking up at night or sleep disturbances,
• increased appetite or weight gain,
• feeling unwell,
• desire to smoke (nicotine cravings),
• decreased heart rate,
• gum bleeding or mouth ulcers,
• dizziness or feeling empty-headed,
• cough, sore throat, stuffy nose, or runny nose,
• constipation.
• If the patient notices any of the following serious side effects, they should stop using Nicorette Coolmint and consult a doctor immediately, as they may be a sign of a severe allergic reaction(frequency not known: frequency cannot be estimated from the available data):
• hives (a skin disorder characterized by the presence of itchy, raised, or reddened patches)
• swelling of the face, tongue, or throat
• difficulty breathing
• difficulty swallowing

Most side effects occur in the early stages of treatment. During the first few days of treatment, mouth and throat irritation may occur, but most patients adapt to the treatment with the disappearance of this symptom during continued therapy.

Other possible side effects:

Very common: may occur more often than in 1 in 10 patients:

• cough,
• headache,
• hiccups,
• nausea (vomiting),
• irritation of the throat, mouth, and tongue.

Common: may occur less often than in 1 in 10 patients:

• local reactions, such as burning sensation, mouth inflammation, changes in taste,
• feeling cold, heat, and tingling on the skin,
• dry mouth or increased salivation,
• feeling sick,
• abdominal pain or discomfort,
• vomiting, bloating, or diarrhea,
• heartburn,
• feeling tired,
• hypersensitivity (allergy)

Uncommon: may occur less often than in 1 in 100 patients:

• nasal complaints, such as congestion, sneezing,
• wheezing (bronchospasm) or feeling more breathless than normal (dyspnea), tightness in the throat,
• redness of the skin or increased sweating,
• mouth reactions, such as tingling sensation in the mouth, tongue inflammation, mouth ulcers, damage to the mucous membrane of the mouth, or change in voice, mouth and throat pain, belching,
• palpitations, rapid heart rate, high blood pressure,
• fast and irregular heartbeat, which may require treatment,
• skin rash and (or) itching,
• unusual dreams,
• discomfort and pain in the chest,
• weakness, feeling unwell.

Rare: may occur less often than in 1 in 1,000 patients:

• difficulty swallowing, decreased sensation in the mouth,
• gagging reflex.

Unknown: frequency cannot be estimated from the available data:

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

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Nicorette Coolmint

• The medicine should be kept out of sight and out of reach of children.
• The medicine should not be used after the expiry date stated on the container and outer packaging. The expiry date refers to the last day of the month.
• Polypropylene container: store in the original packaging to protect from moisture.
• Carton box: store in the original packaging to protect from moisture. Use within 3 months of opening the protective foil.
• The container should not be used to store anything else, as it may contain powder from the lozenges, which can coat other objects placed in the container.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Nicorette Coolmint contains

The active substanceis nicotine. One lozenge contains 2 mg or 4 mg of nicotine (as nicotine bitartrate).
The other ingredients are: lozenge core - mannitol (E 421), xanthan gum, Winterfresh RDE4-149 spray-dried (contains gum arabic (E 414) and menthol, peppermint, and eucalyptus flavors), sodium carbonate anhydrous (E 500)(i), sucralose (E 955), acesulfame potassium (E 950), magnesium stearate (E 470b); coating - hypromellose (E 464), Winterfresh RDE4-149 (contains menthol, peppermint, and eucalyptus flavors), titanium dioxide (E 171), sucralose (E 955), Sepifilm Gloss (contains hypromellose (E 464), microcrystalline cellulose (E 460), potassium aluminum silicate (E 555), and titanium dioxide (E 171)), acesulfame potassium (E 950), polysorbate 80 (E 433).
Nicorette Coolmint lozenges do not contain sugar.

What Nicorette Coolmint looks like and contents of the packaging

Oval lozenge, white to almost white in color, 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 polypropylene container contains 20 lozenges. Packs may contain 1 container, 4 containers, or 8 containers.
Each carton box contains 40 lozenges. Packs may contain 1 carton, 2 cartons, or 4 cartons.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

McNeil AB, 251 09 Helsingborg, Sweden

Manufacturer

McNeil AB, Norrbroplatsen 2, 251 09 Helsingborg, Sweden
Johnson & Johnson Consumer NV/SA, Michel De Braeystraat 52, 2000 Antwerp, Belgium
Johnson & Johnson GmbH, Johnson & Johnson Platz 2, 41470 Neuss, Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

To obtain more detailed information, the patient should contact:
email: [email protected]
Date of last revision of the leaflet:January 2025