PRODUCT INFORMATION FOR THE USER

NICORETTE ICE MINT 2 mg MEDICATED LOZENGES

Nicotina

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given 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 you get worse or do not improve after 6 months.

It is indicated as an aid for smokers 18 years of age or older who smoke fewer than 20 cigarettes per day and who, being determined to quit smoking, may experience unpleasant effects associated with the abandonment of this addiction: irritability, anxiety, "nicotine hunger", insomnia, or constipation, primarily.

Due to its nicotine content, it reduces the unpleasant effects of withdrawal that are usually felt when quitting smoking but does not provide the same satisfaction as a cigarette. Therefore, to quit smoking, you will need to rely on your conviction, decision, and willpower.

You should consult a doctor if you worsen or do not improve after 6 months.

It is veryimportantthat during treatment to stop smoking with Nicorette Ice Mint 2 mg chewing gumdo notuse any other medication with nicotine

Do not take Nicorette Ice Mint 2 mg chewing gum:

• If you are allergic to nicotine or any of the other components of this medication (listed in section 6).
• Ifyou are not a smoker
• If you have joint problems in the jaw

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nicorette Ice Mint 2 mg chewing gum.

Smokers with dentures may have difficulty chewing Nicorette Ice Mint 2 mg chewing gum. The gum may stick and in rare cases may damage the dentures.

If you have or have had any of the following diseases, try to stop smoking without using any medication. If you cannot, consult your doctor to determine the treatment to follow.

• If you have recently (within 3 months) had aheart attackorheart attack
• If you havechest pain(angina pectoris) or resting angina.
• If you have anyheart diseasethat affects heart rhythm or frequency.
• If you havehigh blood pressure(hypertension) that is not controlled with medication.
• If you have ever had anyallergic reactionwith inflammation of the lips, face, and throat (angioedema) or skin irritation (urticaria). Nicotine replacement therapy may, in some cases, cause this type of reaction.
• If you havesevere or moderate liver disease
• If you havesevere kidney disease
• If you havediabetes
• If you havehyperthyroidism
• If you have apheochromocytoma(adrenal gland tumor).
• If you havestomach or duodenal ulcers
• If you haveesophagitis
• If you have a history of epilepsy or seizures

Other medications and Nicorette Ice Mint 2 mg chewing gum

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Smoking may affect how the body responds to some medications. Therefore, when you stop smoking (with or without nicotine replacement therapy) you may need to adjust the doses of the medications you are taking.

If you are taking any of the following medications, you may need to modify the dose of one of them:

• Medications that contain alcohol or caffeine.
• Medications that act on the central nervous system such as tranquilizers, antidepressants, sleep medications (benzodiazepines, clozapine, olanzapine, fluvoxamine, imipramine, clomipramine).
• Medications for Parkinson's disease, such as ropinirol.
• Medications for high blood pressure (hypertension) such as beta blockers or furosemide.
• Pain medications such as paracetamol or stronger ones like morphine or derivatives (dextropropoxifeno, pentazocina).
• Oral contraceptives such as estradiol.
• Anticoagulants such as warfarin or heparin.
• Medications for Alzheimer's disease such as tacrine.
• Medications for asthma or bronchodilators such as theophylline.
• Medications for heart rhythm disorders such as mexiletine and flecainide.
• Medications for diabetes such as insulin.
• Vitamin B12 (cyanocobalamin).
• Local anesthetics such as lidocaine used in the mouth or throat.

Taking Nicorette Ice Mint 2 mg chewing gum with food and drinks

The simultaneous consumption ofNicorette Ice Mint 2 mg chewing gumand coffee, acidic beverages (lemon, orange, etc) or soft drinks may reduce the absorption of nicotine in the oral cavity. These beverages should be avoided during the 15 minutes before chewing the gum.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

Consult your doctor or pharmacist before using any medication.

Nicotine poses a risk to the fetus, as it affects its respiratory movements and circulatory system, and may even cause premature birth or fetal death. Therefore, it is recommended that pregnant smokers stop smoking completely, without using any medication. However, the fact that smoking during pregnancy may pose a greater risk to the fetus than the use of nicotine-containing medications in a controlled program to stop smoking.

However, a pregnant smoker should only take this medication if the doctor recommends it.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Nicotine passes into breast milk in amounts that may affect the baby, so women who are breastfeeding should avoid smoking and taking nicotine-containing medications. In any case, during this period, women who are undergoing treatment with nicotine-containing medications to stop smoking should consult their doctor about the possibility of substituting breast milk with artificial milk.

If your doctor recommends continuing treatment during breastfeeding, you should take the gum immediately after feeding and never within 2 hours of the next feeding.

Driving and operating machinery

No effects have been observed on the ability to drive or operate machinery, although it should be noted that stopping smoking produces changes in behavior.

Nicorette Ice Mint 2 mg chewing gummay cause a mild laxative effect because it contains0.59 gofxylitol(E-967) in each medicated gum. Caloric value: 2.4 Kcal/g xylitol.

This medication may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it containsbutilhydroxytoluene(E-321).

Patients with renal insufficiency or low-potassium diets should note that this medication contains 0.39 mg (0.009 mmoles) ofpotassiumper medicated gum.

Patients with low-sodium diets should note that this medication contains 11.3 mg (0.491 mmoles) ofsodiumper gum.

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

Adults (18 years and older):

Drastic suppression of tobacco consumption.

Only one piece of gum should be used at a time and not another one until 1 or 2 hours have passed. Generally, 8 to 12 pieces are used per day. No more than 24 pieces should be used per day.

The duration of treatment depends on the needs of each smoker, and it is not advisable to abruptly stop, as this could favor the return to tobacco addiction. It is preferable to gradually reduce the dose. For example: every 4 or 5 days, reduce the daily consumption by one or two pieces, until only 1 or 2 pieces are consumed per day. This can be achieved in 2 or 3 months. Do not abandon the treatment definitively until the dose has stabilized at 1 or 2 pieces per day.

It is not recommended to use the gum regularly for more than 6 months.

If you have not been able to quit definitively after 6 months, you should consult your doctor. The doctor may advise you, based on your situation, the use of gum on an as-needed basis in case of sudden urges to smoke.

Gradual suppression of tobacco consumption:

In the case of opting for a gradual reduction in tobacco consumption, you will replace, as much as possible, cigarettes with Nicorette Ice Mint, with the aim of prolonging the periods in which no cigarettes are smoked, thus reducing tobacco consumption.

The number of pieces used per day varies and depends on the needs of each smoker. No more than 24 pieces should be used per day.

At 6 weeks of treatment, the smoker should have reduced their cigarette consumption by at least half; if not, they should consult their doctor.

Make an attempt to quit smoking definitively in 4 months, if not, consult your doctor.

From the fourth month of treatment and until the sixth month, reduce the number of pieces taken gradually.

Guideline for substituting the number of cigarettes per day with gum pieces.

It is not recommended to use the gum regularly for more than 6 months.

If you have not been able to quit definitively after 6 months, you should consult your doctor. The doctor may advise you, based on your situation, the use of gum on an as-needed basis in case of sudden urges to smoke.

If you think that the action of Nicorette Ice Mint is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

It should not be used in children under 18 years without the recommendation of a doctor, as even small amounts of nicotine are hazardous to children and can cause severe symptoms of poisoning, which can be fatal (see sectionWhat to do if you take more Nicorette Ice Mint 2 mg medicated gum than you should).

How to chew Nicorette Ice Mint

When you feel the urge to smoke, insert a piece of gum into your mouth and chew it slowly until you notice a strong flavor. Then, place it between your cheek and gum and, when the flavor decreases, chew the gum slowly again and repeat the process for 30 minutes to release the nicotine gradually.

The gum should be chewed in the indicated way to release the nicotine and left to rest so that the nicotine can be absorbed in the mouth. Nicotine swallowed with saliva is not beneficial and in excess can irritate the throat or cause stomach discomfort, such as hiccups, to avoid this, chewing should be slow.

Do not exceed the recommended dose.

What to do if you take more Nicorette Ice Mint than you should

Excessive use of nicotine from nicotine replacement therapy and/or smoking can cause symptoms of overdose. The risk of poisoning as a result of swallowing the gum is very small, as absorption in the absence of chewing is slow and incomplete.

The symptoms of overdose are those of acute nicotine poisoning and include nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, increased blood pressure, ear disturbances, and marked weakness. These symptoms may be followed by decreased blood pressure, heart rhythm disturbances, weakness, irregular pulse, difficulty breathing, prostration, circulatory collapse, convulsions, and coma.

If you have used too many pieces, consult your doctor or pharmacist immediately, or call the Toxicology Information Service (phone 91 562 04 20), indicating the name and amount used. It is recommended to bring the leaflet and the packaging of the medication to the healthcare professional.

Even small amounts of nicotine are hazardous to children and can cause severe symptoms of poisoning, which can be fatal. If poisoning is suspected in a child, you should go to a medical center immediately.

What to do if you forget to take Nicorette Ice Mint

Do not take a double dose to compensate for the missed doses.

What to do if you interrupt treatment with Nicorette Ice Mint

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

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

Nicorette Ice Mint 2 mg chewing gum may cause side effects similar to those associated with tobacco nicotine and usually depend on the amount of gum used.

The gum may stick together and may, on rare occasions, damage the teeth.

Effects related to quitting smoking (nicotine withdrawal)

Some of the unwanted effects that occur when quitting smoking may be nicotine withdrawal syndromes due to the decrease in nicotine consumption. When quitting smoking, mouth ulcers may develop. The reason why they may appear is unknown.

These effects include:

• Irritability, aggression, impatience, or frustration.
• Sensation of anxiety, agitation, or difficulty concentrating.
• Sleep disturbances.
• Increased appetite or weight gain.
• Depression.
• Cravings to smoke.
• Decreased heart rate.
• Gingival bleeding.
• Dizziness or mild disorientation.
• Cough, sore throat, nasal congestion, or mucous.

If you experience palpitations, chest pain, leg pain, or indigestion, stop taking the medicine, do not smoke, and consult your doctor as soon as possible.

Most side effects occur during the first weeks of treatment initiation.

Adverse reactions of unknown frequency(cannot be estimated from available data):

• Blurred vision and increased lacrimation.
• Dry throat, lip discomfort, and gastrointestinal discomfort.
• Allergic reactions (including anaphylaxis symptoms).
• Muscle stiffness.
• Angioedema and erythema.
• Seizures

Adverse reactions rare(may affect up to 1 in 1000 patients):

• Difficulty swallowing, loss of oral sensitivity, and hiccups.

Adverse reactions infrequent(may affect up to 1 in 100 patients):

• Palpitations and tachycardia.
• Eructation, burning, and oral mucosa desquamation, inflammation of the tongue, oral paresthesia.
• Weakness, chest pain, and discomfort, and feeling unwell.
• Temporomandibular joint pain.
• Sleep disturbances.
• Nasal congestion, sneezing, oropharyngeal pain, throat constriction, dysphonia, dyspnea, bronchospasm.
• Hyperhidrosis, pruritus, urticaria, rash.
• Hot flashes and hypertension

Adverse reactions frequent(may affect up to 1 in 10 patients):

• Abdominal pain, dry mouth, diarrhea, indigestion, flatulence, hypersalivation, stomatitis, vomiting. Burning sensation, fatigue.
• Hypersensitivity.
• Alteration of taste, paresthesia

Very frequent adverse reactions:

• Nausea.
• Headache.
• Cough, hiccups, and throat irritation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting adverse 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 store at a temperature above25°C

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Nicorette Ice Mint 2 mg chewing gum

The active ingredient is nicotine (2 mg, equivalent to 10 mg of resinous complex at 20%).

The other components are: gum base (containing butylhydroxytoluene E-321), xylitol (E-967), peppermint oil, anhydrous sodium carbonate, sodium hydrogen carbonate, potassium acesulfame (E-950), levomenthol, magnesium oxide, peppermint flavoring, xanthan gum, sucralose, polysorbate 80, pregelatinized cornstarch, titanium dioxide (E-171), carnauba wax (E-903), and talc.

Appearance of the product and contents of the packaging

They are white, rectangular-shaped medicinal chewing gums presented in boxes containing 30, 105, and 210 chewing gums.

Holder of the marketing authorization:

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Responsible for manufacturing:

McNEIL AB

Norrboplatsen, 2

Helsingborg (SWEDEN)

Date of the last review of this leaflet:June 2023

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