PRODUCT INFORMATION FOR THE USER

NICORETTE ICE MINT 4 mg MEDICATED LOZENGES

Nicotine

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 6 months.

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

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 it worsens or does not improve after 6 months.

It is veryimportantthat during treatment to stop smoking with Nicorette Ice Mint 4 mg medicated chewing gumdo notuse any other medication with nicotine.

Do not take Nicorette Ice Mint 4 mg medicated chewing gum:

• if you are allergic to nicotine or any of the other components of this medication (listed in section 6).
• if you 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 4 mg medicated chewing gum.

Smokers with dentures may have difficulty chewing Nicorette Ice Mint 4 mg medicated 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 angina at rest. 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). The use of nicotine replacement therapy may, in some cases, produce this type of reaction
• if you havesevere or moderate liver disease
• if you havesevere kidney disease
• if you havediabetes.
• if you havehyperactivity of the thyroid gland.
• if you have amedulla adrenal tumor(pheochromocytoma).
• if you havestomach or duodenal ulcer.
• if you haveesophagitis.
• if you have a history of epilepsy or seizures

Other medications and Nicorette Ice Mint 4 mg medicated 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 the treatment of Parkinson's disease, such as ropinirol
• Medications for the treatment of high blood pressure (hypertension) such as beta blockers or furosemide
• Medications for pain 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 the treatment of 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 4 mg medicated chewing gum with food and drinks

The simultaneous consumption ofNicorette Ice Mint 4 mg medicated 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. For this reason, it is recommended that pregnant smokers stop smoking completely, without using any type of medication. However, the fact that a pregnant woman continues to smoke 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 in no case when there are less than 2 hours before feeding the baby again.

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 4 mg medicated chewing gummay cause a mild laxative effect because it contains 0.57 g ofxylitol(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 13.03 mg (0.566 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 aged 18 years and over

Only one piece of gum should be used at a time and not another one should be used until 1 or 2 hours have passed. Generally, 8 to 12 pieces are used per day. The daily dose should not exceed 24 pieces.

The duration of treatment depends on the needs of each smoker, and it is not advisable to abruptly stop treatment, as this could lead to a 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. Treatment should not be definitively abandoned until the dose has stabilized at 1 or 2 pieces per day.

Regular use of the gum for more than 6 months is not recommended.

If you have not been able to quit treatment 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 estimate that the action of Nicorette 4 mg 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 a doctor's recommendation, as even small amounts of nicotine are hazardous to children and can cause severe symptoms of poisoning, which can be fatal (see sectionif you take more Nicorette Ice Mint 4 mg medicated gum than you should).

How to chew Nicorette gum

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 operation for 30 minutes to allow the nicotine to be released 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.

if you take more Nicorette Ice Mint 4 mg medicated gum 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, cardiac arrhythmias, 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 Toxicological Information Service (phone 91 562 04 20), indicating the name and amount used. It is recommended to bring the packaging and the leaflet 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.

if you forget to take Nicorette Ice Mint 4 mg medicated gum

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

if you interrupt treatment with Nicorette Ice Mint 4 mg medicated gum

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 4 mg medicated chewing gum may cause side effects similar to those associated with nicotine from tobacco and usually depend on the amount of gum used.

The gum may stick to your teeth and, in rare cases, may damage your 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 they 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.
• Nicotine cravings.
• 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.
• Mandibular 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 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 above 25°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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Nicorette Ice Mint 4 mg chewing gum

The active ingredient is nicotine (4 mg, equivalent to 20 mg of resinous complex at 20%).

The other components are: gum base (containing butylhydroxytoluene E-321), xylitol (E-967), peppermint oil, anhydrous sodium carbonate, potassium acesulfame (E-950), levomenthol, magnesium oxide, spearmint flavoring, hypromellose, sucralose, polysorbate 80, pregelatinized cornstarch, titanium dioxide (E-171), carnauba wax (E-903), quinoline yellow (E-104), and talc.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing:

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)

Last review date of this leaflet: June 2023

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