NICORETTE ICE MINT 2 mg MEDICATED CHEWING GUMS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

NICORETTE ICE MINT 2 mg MEDICINAL CHEWING GUM

Nicotine

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 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 your condition worsens or does not improve after 6 months.

Contents of the package leaflet

1. What Nicorette Ice Mint 2 mg medicinal chewing gum is and what it is used for.
2. What you need to know before you start taking Nicorette Ice Mint 2 mg medicinal chewing gum
3. How to take Nicorette Ice Mint 2 mg medicinal chewing gum
4. Possible side effects.
5. Storage of Nicorette Ice Mint 2 mg medicinal chewing gum
6. Contents of the pack and further information

1. What Nicorette Ice Mint 2 mg medicinal chewing gum is and what it is used for

It is indicated as an aid for smokers over 18 years old who smoke less than 20 cigarettes a day and who, being determined to quit smoking, may suffer from the unpleasant effects associated with quitting this addiction: irritability, anxiety, "craving for tobacco", insomnia or constipation, mainly.

Due to its nicotine content, it reduces the unpleasant effects of abstinence that are usually felt when quitting smoking, but it 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 your condition worsens or does not improve after 6 months.

2. What you need to know before you start taking Nicorette Ice Mint 2 mg medicinal chewing gum

It is very importantthat during treatment to quit smoking with Nicorette Ice Mint 2 mg medicinal chewing gum, you do notuse any other nicotine medication

Do not take Nicorette Ice Mint 2 mg medicinal chewing gum:

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

Warnings and precautions

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

Smokers with dentures may have difficulties chewing Nicorette Ice Mint 2 mg medicinal chewing gum. The gum can stick and, in rare cases, may damage the denture.

If you have or have had any of the following diseases, you should try to quit smoking without using any medication. If you do not succeed, you should consult your doctor for advice on the treatment to follow.

• If you have recently (up to 3 months before) suffered a heart attackor stroke.
• If you suffer from chest pain(angina pectoris) or rest angina.
• If you suffer from any heart diseasethat affects the rhythm or heart rate.
• If you have high blood pressure(hypertension) that is not controlled with medication.
• If you have ever 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 medulla(pheochromocytoma).
• If you suffer from stomach or duodenal ulcers
• If you have esophagitis.
• If you have a history of epilepsy or seizures

Other medicines and Nicorette Ice Mint 2 mg medicinal chewing gum

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

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

If you are using any of the following medicines, it may be necessary to modify the dose of one of them:

• Medicines that contain alcohol or caffeine.
• Medicines that act on the central nervous system, such as tranquilizers, antidepressants, sleeping pills (benzodiazepines, clozapine, olanzapine, fluvoxamine, imipramine, clomipramine).
• Medicines for the treatment of Parkinson's disease, such as ropinirol.
• Medicines for the treatment of high blood pressure (hypertension), such as beta blockers or furosemide.
• Medicines for pain, such as paracetamol or more potent ones like morphine or derivatives (dextropropoxyphene, pentazocine).
• Oral contraceptives, such as estradiol.
• Anticoagulant medicines, such as warfarin or heparin.
• Medicines for the treatment of Alzheimer's disease, such as tacrine.
• Medicines for asthma or bronchodilators, such as theophylline.
• Medicines for heart rhythm disorders, such as mexiletine and flecainide.
• Medicines 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 medicinal chewing gum with food and drinks

The simultaneous consumption of Nicorette Ice Mint 2 mg medicinal chewing gumand coffee, acidic drinks (based on lemon, orange, etc.) or soft drinks can reduce the absorption of nicotine in the oral cavity. These drinks should be avoided during the 15 minutes prior to chewing the gum.

Pregnancy and breastfeeding

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

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Nicotine poses a risk to the fetus, as it affects their respiratory movements and circulatory system, and can even cause premature birth or fetal death. For this reason, it is recommended that pregnant smokers quit smoking completely without using any medication. However, the fact of continuing to smoke during pregnancy may pose a greater risk to the fetus than the use of nicotine medications in a controlled program to quit smoking.

However, pregnant smokers should only take this medicine if their doctor recommends it.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Nicotine passes into breast milk in amounts that can affect the baby, so breastfeeding women should avoid smoking and taking nicotine medications. In any case, during this period, women undergoing treatment with nicotine medications to quit smoking should consult their doctor about the convenience of replacing breastfeeding with artificial feeding.

If your doctor recommends continuing treatment during the breastfeeding period, you should take the gum immediately after breastfeeding, and never when there are 2 hours or less before breastfeeding the baby again.

Driving and using machines

No effects on the ability to drive or use machines have been observed, although it should be taken into account that quitting smoking produces changes in behavior.

Nicorette Ice Mint 2 mg medicinal chewing gummay produce a mild laxative effect because it contains 0.59 g of xylitol(E-967) in each medicinal chewing gum. Caloric value: 2.4 Kcal/g xylitol.

This medicine may produce local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene(E-321).

Patients with renal insufficiency or with low-potassium diets should be aware that this medicine contains 0.39 mg (0.009 mmoles) of potassiumper medicinal chewing gum.

Patients with low-sodium diets should be aware that this medicine contains 11.3 mg (0.491 mmoles) of sodiumper gum.

3. How to take Nicorette Ice Mint 2 mg medicinal chewing gum

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

People over 18 years old:

Drastic reduction in tobacco consumption.

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

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

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

If you have not definitively stopped treatment after 6 months, you should consult your doctor. The doctor may advise you, based on your situation, to use a gum occasionally in case of sudden cravings for tobacco.

Gradual reduction in tobacco consumption:

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

The number of gums per day varies and depends on the needs of each smoker. Do not exceed 24 gums per day.

At 6 weeks of treatment, the smoker should have reduced the number of cigarettes smoked by at least half; otherwise, they should consult their doctor.

An attempt to definitively quit smoking should be made in 4 months; if not successful, consult your doctor.

From the fourth month of treatment and up to the sixth month, reduce the number of gums taken gradually.

Guideline for replacing the number of daily cigarettes with gums.

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

If you have not definitively stopped treatment after 6 months, you should consult your doctor. The doctor may advise you, based on your situation, to use a gum occasionally in case of sudden cravings for tobacco.

If you think the effect of Nicorette Ice Mint is too strong or too weak, tell your doctor or pharmacist.

Use in children and adolescents

It should not be used in children under 18 years old without the recommendation of a doctor, as even small amounts of nicotine are dangerous for children and can cause serious symptoms of poisoning, which can be fatal (see section If you take more Nicorette Ice Mint 2 mg medicinal chewing gum than you should).

How to chew Nicorette Ice Mint

When you feel the urge to smoke, put a gum in your mouth and chew it slowly until you notice a strong taste. Then, place it between your cheek and gum, and when the taste decreases, chew the gum slowly again and repeat the operation for 30 minutes so that the nicotine is released gradually.

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

Do not exceed the recommended dose.

If you take more Nicorette Ice Mint than you should

Excessive use of nicotine from nicotine replacement therapy and/or smoking can cause overdose symptoms. The risk of poisoning as a result of swallowing the gum is very small, since 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 can be followed by decreased blood pressure, cardiac rhythm disturbances, weakness, irregular pulse, breathing difficulties, prostration, circulatory collapse, generalized convulsions, and coma.

If you have used too many gums, consult your doctor or pharmacist immediately, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the name and amount used. It is recommended to take the leaflet and the package of the medicine to the healthcare professional.

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

If you forget to take Nicorette Ice Mint

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Nicorette Ice Mint

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Nicorette Ice Mint 2 mg medicinal chewing gums can cause adverse effects similar to those associated with tobacco nicotine and normally depend on the amount of chewing gums used.

The chewing gums can stick and may, in rare cases, damage dentures.

Effects related to quitting smoking (nicotine abstinence)

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

These effects include:

• Irritability, aggression, impatience, or frustration.
• Feeling of anxiety, agitation, or difficulty concentrating.
• Sleep disorders.
• Increased appetite or weight gain.
• Decline.
• Craving for cigarettes.
• Decreased heart rate.
• Gingival bleeding.
• Dizziness or mild disorientation.
• Cough, sore throat, nasal congestion, or mucosity.

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

Most adverse effects occur during the first weeks of starting treatment.

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

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

Rare adverse reactions(may affect up to 1 in 1000 patients):

• Difficulty swallowing, loss of oral sensation, and gagging.

Uncommon adverse reactions(may affect up to 1 in 100 patients):

• Palpitations and tachycardia.
• Eructation, burning, and desquamation of the oral mucosa, tongue inflammation, oral paresthesia.
• Asthenia, pain, and discomfort in the chest, and feeling of discomfort.
• Jaw pain.
• Sleep disorder.
• Nasal congestion, sneezing, oropharyngeal pain, throat tightness, dysphonia, dyspnea, bronchospasm.
• Hyperhidrosis, pruritus, urticaria, rash.
• Hot flashes and hypertension.

Frequent adverse reactions(may affect up to 1 in 10 patients):

• Abdominal pain, dry mouth, diarrhea, dyspepsia, 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 Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Nicorette Ice Mint 2 mg medicinal chewing gums

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 25°C.

Do not use this medicine 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 thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Nicorette Ice Mint 2 mg medicinal chewing gums

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

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

Appearance of the product and package contents

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

Marketing authorization holder:

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid.

Spain.

Manufacturer:

McNEIL AB.

Norrboplatsen, 2.

Helsingborg (SWEDEN).

Date of the last revision of this prospectus:June 2023.

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