NICORETTE SUPERMINT 4 mg LOZENGES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicorette Supermint 4 mg lozenges

Nicotine

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if after 6 months of treatment you still have difficulty abstaining from smoking without the help of Nicorette Supermint.

Contents of the package leaflet:

1. What is Nicorette Supermint and what is it used for
2. What you need to know before taking Nicorette Supermint
3. How to take Nicorette Supermint
4. Possible side effects
5. Storage of Nicorette Supermint

Contents of the pack and additional information

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

Nicorette Supermint is used to relieve withdrawal symptoms and reduce nicotine cravings that occur when trying to quit smoking. This treatment is indicated for adult smokers over 18 years old who smoke more than 20 cigarettes a day or have a high dependence on nicotine.

Nicorette Supermint 4 mg lozenges are suitable for those smokers who have a high dependence on nicotine, for example, those who smoke their first cigarette of the day within the first 30 minutes of waking up or those who smoke more than 20 cigarettes a day.

Nicorette Supermint relieves nicotine withdrawal symptoms, including anxiety, associated with tobacco cessation. When you suddenly stop providing nicotine from tobacco to your body, you are affected by different types of unpleasant sensations, known as withdrawal symptoms, such as irritability or aggression, depression, anxiety, restlessness, concentration problems, increased appetite or weight gain, craving for cigarettes (anxiety), nocturnal awakenings or sleep disorders. The nicotine in Nicorette Supermint can help prevent or reduce these unpleasant symptoms, as well as your craving for cigarettes.

To improve the chances of quitting smoking, it is recommended to seek medical advice and support.

2. What you need to know before taking Nicorette Supermint

Do not take Nicorette Supermint

• If you are allergicto nicotine or any of the other components of this medication (listed in section 6).
• If you are under 18 years old.
• If you are a non-smoker.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Nicorette Supermint.

Tell your doctor before taking this medication if you suffer from any of the following diseases, as although you may be able to use Nicorette Supermint, you will first need to consult your doctor:

• If you have recently suffered a heart attackor stroke.
• If you suffer from chest pain(unstable angina) or rest angina.
• If you suffer from any heart diseasethat affects heart rate or frequency (arrhythmia).
• If you have high blood pressurethat is not being controlled with medication.
• If you have heart failureor circulation problems.
• If you have had an allergic reactionwith inflammation of the lips, face, and throat (angioedema) or skin irritation (urticaria). The use of nicotine replacement therapy may sometimes cause this type of reaction.
• If you suffer from severe or moderate liver disease.
• If you suffer from severe kidney disease.
• If you suffer from diabetes.
• If you have hyperthyroidism.
• If you have a tumor in the adrenal gland(pheochromocytoma).
• If you suffer from duodenal or stomach ulcers.
• If you have esophagitis.
• If you have a history of epilepsy or seizures

The lozenges may pose a choking hazard. Use with caution if you have problems swallowing solids or liquids or if you cough frequently during or after swallowing.

Children and adolescents

Do not administer this medication to children and adolescents.

Using Nicorette Supermint with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This is especially important if you are taking medications that contain:

Theophylline for asthma

Tacrine for Alzheimer's disease

Clozapine for schizophrenia

Ropinirol for Parkinson's disease

Using Nicorette Supermint with food and drinks

Do not eat or drink when using the lozenges. Acidic drinks, such as coffee, juice, or soft drinks, can reduce nicotine absorption. To achieve maximum nicotine absorption, avoid taking these drinks until 15 minutes before using the lozenge.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

It is very important to quit smoking during pregnancy because it could produce intrauterine growth retardation, premature birth, or stillbirth. It is advisable to quit smoking without the use of nicotine-containing medications. If you do not succeed, you may use Nicorette Supermint only after consulting your doctor.

Since nicotine passes into breast milk and can affect the baby, it should only be used during breastfeeding after consulting your doctor. If your doctor has recommended using Nicorette Supermint, the lozenges should be used immediately after breastfeeding the baby and never during the 2 hours prior.

Driving and using machines

Using this medication does not affect the ability to drive or use machines.

Nicorette Supermint contains less than 23 mg of sodium (1 mmol) per lozenge, which is essentially "sodium-free".

Nicorette Supermint contains polysorbate, which can cause allergic reactions.

3. How to take Nicorette Supermint

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Minors under 18 years old should not use this medication.

This medication is for oral use. Place the lozenge in your mouth and let it dissolve, releasing the nicotine for absorption through the oral mucosa into the rest of the body.

In all cases, place a lozenge in your mouth and periodically move the lozenge from one side of your mouth to the other until it is completely dissolved. This usually takes less than 20 minutes. Do not chew the lozenge or swallow it whole. Do not use more than 15 lozenges per day. If you feel the need to continue taking Nicorette Supermint after 6 months of treatment, you should consult your doctor.

The goal is to completely quit smoking immediately, using Nicorette Supermint lozenges to alleviate the desire to smoke.

Adults over 18 years old

• Start using 8 to 12 lozenges per day. Each time you feel the urge to smoke, use a lozenge, placing it in your mouth and letting it dissolve completely.
• Follow this schedule for up to 6 weeks, then gradually reduce the number of lozenges used each day.
• Once you have reached 1 or 2 lozenges per day, stop using Nicorette Supermint. Once you have stopped, you may feel sudden cravings for cigarettes. In these cases, you can use a lozenge.

Do not exceed the established dose. Follow the instructions for use carefully and do not use more than 15 lozenges per day (24 hours).

Do not eat or drink while the lozenge is in your mouth (see section Nicorette Supermint with food and drinks)

In the case of a plastic container:

In the case of a cardboard box:

TO OPEN:

1. Gently press the tab where it says "press here"

2. At the same time, pull the top part of the box upwards with force

TO CLOSE: Press on the top of the box

Consult your doctor if you feel the need to smoke again:

• If you are concerned that you may start smoking again.
• If you have difficulty stopping the lozenges.

If you start smoking again, your doctor may advise you on how to get the best results in future treatments with nicotine replacement therapy (NRT).

If you use more Nicorette Supermint than you should

Nicotine overdose can occur if you smoke at the same time as using Nicorette Supermint.

If a child takes Nicorette Supermint, contact your doctor immediatelyor go to the nearest hospital. The nicotine doses tolerated by adult smokers during treatment can cause poisoning symptoms in childrenand even death.

The symptoms of overdose are a feeling of discomfort (nausea), vomiting, excessive salivation, stomach pain, diarrhea, sweating, headache, and dizziness, hearing disturbances, and a feeling of weakness. At high doses, these symptoms can be followed by a drop in blood pressure, weak and irregular pulse, difficulty breathing, extreme fatigue, circulatory collapse, and generalized convulsions.

If you have any other questions about the use of this medication, consult your doctor or pharmacist.

In case of overdose or accidental poisoning, go immediately to a medical center or call the Toxicological Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Effects related to quitting smoking (nicotine withdrawal)

Some of the unwanted effects experienced when quitting smoking may be withdrawal symptoms due to the decrease in nicotine consumption.

These effects include:

• Irritability, aggression, impatience, or frustration.
• Feeling of anxiety, agitation, or difficulty concentrating.
• Nocturnal awakenings or sleep disorders.
• Increased appetite or weight gain.
• Depression.
• Craving for cigarettes.
• Decrease in heart rate.
• Gum bleeding or mouth ulcers.
• Dizziness or mild disorientation.
• Cough, sore throat, nasal congestion, or mucus.
• Constipation.

If you notice any of the following serious side effects, stop using Nicorette Supermint and contact your doctor immediately, as they may be symptoms of a severe allergy:

• Hives (a skin condition characterized by itching and red spots).
• Swollen face, tongue, or throat.
• Difficulty breathing.
• Difficulty swallowing.

Most of these side effects occur during the initial phases of treatment. During the first few days of this treatment, irritation in the mouth and throat may occur; however, in most cases, the patient adapts with continued use.

Other side effects that may occur

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

• Cough
• Headache
• Hiccups
• Nausea (feeling of discomfort)
• Irritation of the throat, mouth, and tongue

Common: may affect up to 1 in 10 people:

• Effects at the administration site, such as a burning sensation, inflammation of the mouth, or changes in taste perception
• Dry mouth or increased saliva production
• Feeling of indigestion
• Abdominal pain or discomfort
• Vomiting, flatulence, or diarrhea
• Acidity
• Feeling of fatigue
• Feeling of dizziness
• Hypersensitivity (allergy)
• Irritability and feeling of anxiety

Uncommon: may affect up to 1 in 100 people:

• Nasal effects, such as nasal congestion, sneezing
• Wheezing (bronchospasm), or feeling the need to breathe more forcefully than normal (dyspnea), throat tightness
• Redness of the skin (flushing), tingling, or increased sweating
• Mouth effects, such as tingling, inflammation of the tongue, mouth ulcers, damage to the mouth mucosa, or changes in voice, mouth and throat pain, belching
• Palpitations (unusual sensation of heartbeat), increased heart rate, hypertension
• Rashes and/or itching (pruritus, urticaria) or redness of the skin
• Depression, feeling of nervousness, abnormal dreams
• Chest discomfort or pain
• Feeling of weakness, feeling of discomfort

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

• Difficulty swallowing, feeling of numbness in the mouth.
• Rapid and erratic heartbeat, which can be treated with appropriate medication
• Hiccups

Frequency not known: the frequency cannot be estimated from the available data:

• Blurred vision, increased tear production (lacrimation)
• Dry throat, stomach discomfort, lip pain
• Redness of the skin.
• Seizures

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

You can also report them directly through the Spanish Medicines Monitoring System. Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Nicorette Supermint

Keep this medication out of the sight and reach of children.

Do not use Nicorette Supermint after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

For the polypropylene container: Store in the original container to protect from moisture.

In a cardboard box: Store in the original container to protect it from moisture. Use within 3 months of opening the packaging.

Do not reuse the container to store anything else, as the powder from the lozenges may remain in the container and deposit onto the items stored in it.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Nicorette Supermint

• The active ingredient is Nicotine (in the form of nicotine resin). Each lozenge contains 4 mg of nicotine.
• The other ingredients are: Lozenge core: mannitol (E421), xanthan gum, winterfresh RDE4-149 spray-dried flavor (gum arabic (E414), peppermint, menthol, and eucalyptus flavors), anhydrous sodium carbonate (E500)(i), sucralose (E955), acesulfame potassium (E950), magnesium stearate (E470b), Coating: hypromellose (E464), winterfresh RDE4-149 flavor (peppermint, menthol, and eucalyptus flavors), titanium dioxide (E171), sucralose (E955), sepifilm gloss (hypromellose (E464), microcrystalline cellulose (E460), aluminum potassium silicate (E555), titanium dioxide (E171)), acesulfame potassium (E950), polysorbate 80 (E433).

Appearance of the product and contents of the pack

Nicorette Supermint are oval, white or almost white lozenges, printed with an "n" on one side and a "4" on the other side. The size of a lozenge is approximately 14 x 9 x 7 mm.

Pack sizes:

Plastic container containing 20 lozenges. Packaged with 1 or 4 containers.

Cardboard box containing 40 lozenges. Packaged with 1 or 2 boxes.

Not all pack sizes may be marketed

Marketing authorization holder and manufacturer:

Marketing authorization holder

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-MADRID

Manufacturer

McNeil AB

Norrbroplatsen 2, SE-251 09

Sweden

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-MADRID

This medication is authorized in other member states under the following names:

Italy: Nicoretteicy

Spain: Nicorette Supermint

Date of the last revision of the package leaflet: January 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.