Nicorette Coolmint

Package Leaflet: Information for the Patient

Nicorette Coolmint, 2 mg, Lozenges

Nicorette Coolmint, 4 mg, Lozenges

Nicotine

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

Always take this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including those not listed in the package leaflet, tell your doctor or pharmacist. See section 4.
• If after 9 months you are still having trouble not smoking without the help of Nicorette Coolmint, you should talk to your doctor.

Table of Contents of the Package 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

Nicorette Coolmint is used to help you stop smoking or reduce the number of cigarettes you smoke by relieving the symptoms of nicotine withdrawal, including the desire to smoke. This medicine is for use in adults over 18 years of age.

Nicorette Coolmint, 2 mg, lozenges are suitable for smokers with a low level of 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, lozenges are suitable for smokers with a high level of 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 can help you stop smoking immediately or reduce the number of cigarettes you smoke before stopping completely. If you think you can stop smoking immediately, you should try to do so. However, if you find it too difficult, you may want to reduce the number of cigarettes you smoke as a first step towards quitting completely. More detailed instructions are provided in section 3, "How to use Nicorette Coolmint".

Nicorette Coolmint relieves the withdrawal symptoms that occur when you stop smoking, including the desire to smoke. When you suddenly stop smoking, you may experience various unpleasant symptoms, known as withdrawal symptoms, such as irritability, anger, or depression, anxiety, restlessness, difficulty concentrating, increased appetite or weight gain, or a strong desire to smoke.

To increase your chances of successfully quitting smoking, you should also use counseling and behavioral support.

2. Important information before using Nicorette Coolmint

When not to use Nicorette Coolmint:

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

Warnings and precautions

Tell your doctor if you have any of the following conditions. You may still be able to use Nicorette Coolmint, but you must first consult your doctor:

• if you have recently had a heart attack or stroke
• if you have chest pain (unstable angina) or angina at rest
• if you have heart disease that affects your heart rate or rhythm (arrhythmias)
• if you have high blood pressure that is not controlled by medication
• if you have ever had an allergic reaction, such as swelling of the lips, face, and throat (angioedema) or itchy rash (hives)
• if you have severe liver disease
• if you have severe kidney disease
• if you have diabetes
• if you have an overactive thyroid gland
• if you have a tumor of the adrenal gland (pheochromocytoma)
• if you have stomach or duodenal ulcers
• if you have inflammation of the esophagus
• if you have a history of seizures or epilepsy

This medicine should not be used by non-smokers.

Lozenges can pose a choking hazard. Use with caution if you have problems swallowing solids or liquids, or if you frequently cough while swallowing or after swallowing.

Children

An adult dose given to children can cause serious poisoning and even death. It is essential to keep Nicorette Coolmint out of the reach and sight of children.

Other medicines and Nicorette Coolmint

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take. This is especially important if you are taking medicines that contain:

• 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 using the lozenges.

Pregnancy, breastfeeding, and fertility

It is very important to stop smoking during pregnancy, as it can cause harm to the unborn baby. Nicorette Coolmint should only be used during pregnancy if your doctor recommends it.

Nicorette Coolmint should not be used during breastfeeding, as nicotine passes into breast milk and may affect the baby. If your doctor recommends using Nicorette Coolmint, use the lozenge immediately after breastfeeding and not 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 Coolmint contains less than 1 mmol of sodium (23 mg) per lozenge, which is essentially sodium-free. Nicorette Coolmint contains polysorbate, which may cause allergic reactions.

3. How to use Nicorette Coolmint

Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. The way to use Nicorette Coolmint depends on whether you:

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

Adults (18 years and over)

• (a) Immediate quittingThis involves stopping smoking immediately and using lozenges to reduce the desire to smoke.
• Start with 8-12 lozenges per day. When you feel the urge to smoke, place one lozenge in your mouth and let it dissolve.
• Use the lozenges for up to 6 weeks, then gradually reduce the number of lozenges used per day.
• When you are down to 1 or 2 lozenges per day, you can stop using them altogether. After quitting smoking, you may still feel the urge to smoke from time to time. In this case, you can use a lozenge again.
• (b) Gradual quittingThis involves gradually replacing some cigarettes with a lozenge, then quitting smoking completely while using lozenges, and finally stopping the use of lozenges.

If you feel a strong urge to smoke, use a Nicorette Coolmint lozenge instead of a cigarette to control your nicotine cravings. Reduce the number of cigarettes you smoke per day to as few as possible. If you are unable to reduce the number of cigarettes you smoke per day after 6 weeks, consult a doctor or pharmacist.

When you feel ready, quit smoking completely. Then follow the instructions for immediate quitting above. You should do this as soon as possible. If you are unable to quit smoking completely within 6 months of starting treatment, consult a doctor or pharmacist.

Do not exceed the recommended dose. Follow the instructions carefully and do not use more than 15 lozengesin 24 hours. If you need to use the medicine for longer than 9 months in total, consult a doctor.

Children and adolescents

Adolescents 12-17 years

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

Children under 12 years

Nicorette Coolmint should not be given to children under 12 years of age.

Instructions for use

[Polypropylene container]

OPENING
CLOSING
[Carton box]
Opening:

• 1- Press the tab marked "Press here"
• 2- At the same time, pull the top part of the carton strongly

Closing: push the top part of the carton.

The medicine is intended for administration to the oral mucosa. Place one lozenge in your mouth and let it dissolve, releasing the nicotine to be absorbed through the lining of your mouth.

Place one lozenge in your mouth and move it from time to time from one side of your mouth to the other until it is completely dissolved. This should take less than 20 minutes. Do not chew or swallow the lozenge whole. Do not eat or drink while the lozenge is in your mouth.

What to do if you feel like smoking again

If you:

• worry that you might start smoking again,
• have trouble quitting the lozenges, you should talk to a doctor or pharmacist. If you do start smoking again, a doctor or pharmacist can advise you on how to get the best results from further courses of nicotine replacement therapy (NRT).

What to do if you take more Nicorette Coolmint than you should

If you smoke while using Nicorette Coolmint, you may experience nicotine overdose.

If a child accidentally ingests Nicorette Coolmint or if you use more Nicorette Coolmint than recommended, contact a doctor or pharmacist immediately. Doses of nicotine tolerated during treatment by adult smokers can cause serious poisoning and even death in children.

Symptoms of overdose include nausea, vomiting, increased salivation, stomach pain, diarrhea, excessive sweating, headache, dizziness, and severe weakness. In severe cases, these symptoms may be followed by low blood pressure, weak and irregular pulse, difficulty breathing, exhaustion, and collapse.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nicorette Coolmint 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 amount of nicotine you are taking.

These side effects may include:

• irritability, aggression, frustration, or anxiety,
• feeling anxious, restless, or having trouble concentrating,
• waking up at night or having trouble sleeping,
• increased appetite or weight gain,
• feeling unwell,
• desire to smoke (nicotine craving),
• decreased heart rate,
• gum bleeding or mouth ulcers,
• dizziness or feeling lightheaded,
• coughing, sore throat, stuffy nose, or runny nose,
• constipation.

If you notice any of the following serious side effects, stop using Nicorette Coolmint and contact a doctor immediately, as they may be signs of a severe allergic reaction(frequency not known: cannot be estimated from the available data):

• hives (a skin disorder characterized by itchy, raised, or red patches)
• swelling of the face, tongue, or throat
• difficulty breathing
• difficulty swallowing

Most side effects occur in the early stages of treatment and may disappear as you continue to use the medicine.

Other possible side effects:

Very common: may affect more than 1 in 10 people:

• coughing,
• headache,
• hiccups,
• nausea (feeling sick),
• irritation of the throat, mouth, and tongue.

Common: may affect up to 1 in 10 people:

• local reactions, such as a burning sensation, mouth ulcers, changes in taste,
• feeling cold, hot, or tingling on the skin,
• dry mouth or increased salivation,
• indigestion,
• abdominal pain or discomfort,
• vomiting, bloating, or diarrhea,
• heartburn,
• feeling tired,
• allergic reactions (hypersensitivity)

Uncommon: may affect up to 1 in 100 people:

• nose problems, such as stuffiness, sneezing,
• wheezing (bronchospasm) or feeling more breathless than usual (dyspnea), tightness in the throat,
• redness of the skin or increased sweating,
• mouth problems, such as tingling, mouth ulcers, gum bleeding, or changes in voice,
• rapid or irregular heartbeat (palpitations), increased heart rate, high blood pressure,
• fast or irregular heartbeat, which may require treatment,
• skin rash and/or itching,
• unusual dreams,
• discomfort and pain in the chest,
• weakness, feeling unwell.

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

• difficulty swallowing, reduced sensation in the mouth,
• retching.

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 you experience any side effects, including those not listed in the package leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this 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 outer packaging. The expiry date refers to the last day of that 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.
• Do not use the container 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. 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

The active substance is nicotine.One lozenge contains 2 mg or 4 mg of nicotine (as nicotine bitartrate dihydrate).

The other ingredients are: lozenge core - mannitol (E 421), xanthan gum, Winterfresh RDE4-149 spray-dried (contains gum arabic (E 414) and flavors of menthol, peppermint, and eucalyptus), 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 flavors of menthol, peppermint, and eucalyptus), 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 pack

Oval lozenge, white to off-white, marked with "n" on one side and "2" or "4" on the other, approximately 14 x 9 x 7 mm in size.

Pack sizes:

Each polypropylene container contains 20 lozenges. Packs may contain 1, 4, or 8 containers.

Each carton box contains 40 lozenges. Packs may contain 1, 2, 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:

For further information, please contact:

email: [email protected]

Date of last revision of the package leaflet:January 2025