PATIENT INFORMATION LEAFLET

Nicorette Supermint 4 mg Lozenges

Nicotine

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this 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 pack and additional information

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

Nicorette Supermint 4 mg chewing tablets is suitable for smokers with high nicotine dependence, for example, those who smoke their first cigarette of the day within the first 30 minutes after waking or those who smoke more than 20 cigarettes per day.

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

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

Do not take Nicorette Supermint

• If you areallergicto nicotine or any of the other components of this medication(listed in section 6).
• If you areunder 18 years old.
• If you are anon-smoker.

Warnings and precautions

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

Inform your doctor before taking this medication if you suffer from any of the following conditions, as you may need to consult your doctor first:

• If you have recently had aheart attackorheart attack.
• If you suffer fromchest pain(unstable angina) or resting angina.
• If you suffer from anyheart diseasethat affects heart rhythm or frequency (arrhythmia).
• If you havehigh blood pressurethat is not being controlled with medication.
• If you haveheart failureor circulation problems.
• If you have had anyallergic reactionswith inflammation of the lips, face, and throat (angioedema) or skin irritation (urticaria). Nicotine replacement therapy can sometimes cause this type of reaction.
• If you suffer fromsevere or moderate liver disease.
• If you suffer fromsevere kidney disease.
• If you suffer fromDiabetes.
• If you havehyperactivity of the thyroid gland.
• If you have aadrenal gland tumor(pheochromocytoma).
• If you suffer fromduodenal or stomach ulcers.
• If you haveesophagitis.
• If you have a history ofepilepsyorseizures.

The lozenges may pose a choking hazard. Use with caution if you have trouble 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.

Use of Nicorette Supermint with other medications

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

Theophylline for asthma

Tacrine for Alzheimer's disease

Clozapine for schizophrenia

Ropinirole for Parkinson's disease.

Use of Nicorette Supermint with food and drinks

Do not eat or drink while using the lozenges. Acidic beverages, such as coffee, juice, or soda, may reduce nicotine absorption. To achieve maximum nicotine absorption, avoid these beverages for 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 may cause intrauterine growth retardation, premature birth, or stillbirth. It is recommended to quit smoking without using medications that contain nicotine. If you cannot, you may use Nicorette Supermint only after consulting your doctor.

Since nicotine passes through breast milk and may affect the baby, it should only be used during breastfeeding after consulting with your doctor. If your doctor recommends using Nicorette Supermint, the lozenges should be used immediately after feeding the baby and never within 2 hours beforehand.

Driving and operating machinery

The use of this medication does not affect your ability to drive or operate machinery.

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

Nicorette Supermint contains polysorbate, which may cause allergic reactions.

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

Individuals under 18 years old should not use this medication.

This medication is for oral use. Place the tablet in the mouth, and let it dissolve and release nicotine by absorption through the buccal mucosa to the rest of the body.

In all cases, place a lozenge in the mouth and periodically, move the lozenge from one side to the other of the mouth until its complete dissolution. This usually requires 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 continuetaking Nicorette Supermint after 6 months of treatment, you must ask your doctor for advice.

It is about quitting smoking completely immediately, using the Nicorette Supermint lozenges to alleviate the desire to smoke.

Adults over 18 years old

• Start using between 8 and 12 lozenges per day. Each time you feel the desire to smoke, use a lozenge, place it in the mouth, and let it dissolve completely.
• Follow this pattern until 6 weeks, then gradually reduce the number oflozenges used each day.
• Once you have reached the number of 1 or 2 lozenges per day, stop consuming Nicorette Supermint. Once you have stopped, you may feel sudden desires to smoke. In these cases, you can use a lozenge.

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

You should not eat or drink while having the lozenge in the mouth (see sectionNicorette 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 upwards on the top of the box 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 because you think you may start smoking again.
• If you have difficulties in stopping taking the Nicorette Supermint lozenges.

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

If you use more Nicorette Supermint than you should

You may experience nicotine overdose if you smoke at the same time as using Nicorette Supermint.

. If a child takes Nicorette Supermint, contactimmediatelywith your doctor or go to the nearest hospital. The nicotine doses tolerated by adult smokers during treatment, may cause small children to experience symptoms of poisoning and evendeath.

The symptoms of overdose are a feeling of discomfort (nausea), vomiting, excessive salivation, stomach pain, diarrhea, sweating, headache, and dizziness, auditory disturbances, and a feeling of weakness. At high doses, these symptoms may 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 doubts 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 Toxicology Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Effects related to quitting smoking (nicotine withdrawal)

Some of the unwanted effects that occur when quitting smoking may be nicotine withdrawal syndromes due to a decrease in nicotine consumption.

These effects include:

• Irritability, aggression, impatience, or frustration.
• Sensation of anxiety, agitation, or difficulty concentrating.
• Waking up at night or sleep disturbances.
• Increased appetite or weight gain.
• Depression.
• Cravings to smoke.
• Decreased heart rate.
• Blistering of the gums or mouth ulcers.
• Dizziness or mild disorientation.
• Cough, sore throat, nasal congestion, or mucous.
• Constipation.

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

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

Most of these side effects appear during the initial stages of treatment. During the first days of this treatment, you may experience irritation in the mouth and throat, 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
• Hiccup
• Nausea (feeling of discomfort)
• Irritation of the throat, mouth, and tongue

Common: may affect up to 1 in 10 people:

• Effects at the site of administration such as a burning sensation, inflammation of the mouth, or changes in the perception of flavors
• Dry mouth or increased saliva production
• Sensation of indigestion
• Pain or discomfort in the abdomen
• Vomiting, flatulence, or diarrhea
• Acid reflux
• Sensation of fatigue (fatigue)
• Sensation of dizziness
• Hypersensitivity (allergy)
• Irritability and sensation of anxiety

Rare: may affect up to 1 in 100 people:

• Effects in the nose such as nasal congestion, sneezing
• Snoring (bronchospasm), or sensation of needing to breathe more heavily than normal (dyspnea), throat constriction
• Redness of the skin (flushing), tingling, or increased sweating
• Effects in the mouth such as tingling, inflammation of the tongue, mouth ulcers, damage to the mucous membrane of the mouth, or changes in the sound of the voice, pain in the mouth and throat, eruptions
• Palpitations (unusual sensation of the heartbeat), increased heart rate, hypertension
• Itching and/or redness (pruritus, urticaria) or redness of the skin
• Depression, sensation of nervousness, abnormal dreams
• Discomfort and pain in the chest
• Sensation of weakness, sensation of discomfort

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

• Difficulty swallowing, sensation of numbness in the mouth.
• Fast and irregular heart rate, which can be treated with appropriate medication
• Convulsions

Unknown frequency: the frequency cannot be estimated from the available data:

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

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist,even if it is about side effects that do not appear in this prospectus.

You can also report them directly throughthe Spanish System for the Pharmacovigilance of Medicines for Human Use. Website:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Nicorette Supermint after the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

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

Incarton packaging: Store in the original container to protect it from moisture. Use within 3 months after removing the packaging.

Do not reuse the container to store any other item, as it may contain powder from the tablets, which could be deposited on items stored in this container.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Nicorette Supermint

- The active ingredient is Nicotine (in the form of nicotine resinate). Each lozenge contains 4 mg of nicotine.

- The other components are: Lozenge core: mannitol (E421), xanthan gum, winterfresh RDE4-149 dry spray flavoring (arabic gum (E414), peppermint, menthol, and eucalyptus aromas), sodium carbonate anhydrous (E500)(i), sucralose (E955), acesulfame potassium (E950), magnesium stearate (E470b), Coating: hypromellose (E464),winterfresh RDE4-149 flavoring (peppermint, menthol, and eucalyptus aromas),titania dioxide (E171), sucralose (E955), sepifilm gloss (hypromellose (E464), microcrystalline cellulose (E460), aluminium potassium silicate (E555), titania dioxide (E171)), acesulfame potassium (E950) polisorbate 80 (E433).

Appearance of the product and contents of the package

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

Package sizes:

Plastic package containing 20 lozenges. Packaged with 1 or 4 packages.

Carton package containing 40 lozenges. Packaged with 1 or 2 packages.

You may not find all package sizes commercially available

Holder of the marketing authorization and responsible for manufacturing:

Holder

JNTL Consumer Health (Spain), S.L.

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

28033-MADRID

Responsible for manufacturing

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 with the following names:

Italy: Nicoretteicy

Spain: Nicorette Supermint

Last prospectus review date: January 2025

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