NICORETTE ICE MINT 4 mg MEDICATED CHEWING GUMS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

NICORETTE ICE MINT 4 mg MEDICINAL CHEWING GUM

Nicotine

Read the entire package leaflet carefully before starting to take this medication, as 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 not listed in this package 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 4 mg medicinal chewing gum is and what it is used for.
2. What you need to know before taking Nicorette Ice Mint 4 mg medicinal chewing gum
3. How to take Nicorette Ice Mint 4 mg medicinal chewing gum
4. Possible side effects
5. Storage of Nicorette Ice Mint 4 mg medicinal chewing gum
6. Package contents and additional information

1. What Nicorette Ice Mint 4 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 more 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 withdrawal 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 taking Nicorette Ice Mint 4 mg medicinal chewing gum

It is very importantthat during treatment to quit smoking with Nicorette Ice Mint 4 mg medicinal chewing gum, you do notuse any other nicotine medication.

Do not take Nicorette Ice Mint 4 mg medicinal 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 jaw joint disorders

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nicorette Ice Mint 4 mg medicinal chewing gum.

Smokers with dentures may have difficulty chewing Nicorette Ice Mint 4 mg medicinal chewing gum. The gum can stick and, in rare cases, 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 guidance on the treatment to follow.

• If you have recently (up to 3 months prior) suffered a heart attackor heart stroke.
• If you suffer from chest pain(angina pectoris) or rest angina. If you suffer from any heart diseasethat affects heart rate or frequency.
• 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 produce 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 medications and Nicorette Ice Mint 4 mg medicinal chewing gum

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

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

If you are using any of the following medications, it may be necessary 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, sleeping pills (benzodiazepines, clozapine, olanzapine, fluvoxamine, imipramine, clomipramine)
• Medications for the treatment of Parkinson's disease, such as ropinirole
• Medications for the treatment of high blood pressure (hypertension), such as beta blockers or furosemide
• Pain medications, such as paracetamol or more potent ones like morphine or derivatives (dextropropoxyphene, pentazocine)
• Oral contraceptives, such as estradiol
• Anticoagulant medications, 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 medicinal chewing gum with food and drinks

The simultaneous consumption of Nicorette Ice Mint 4 mg medicinal chewing gumand coffee, acidic beverages (based on lemon, orange, etc.) or soft drinks can decrease the absorption of nicotine in the oral cavity. These beverages 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 medication.

Pregnancy

Consult your doctor or pharmacist before using any medication.

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, the 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 can affect the baby. Therefore, breastfeeding women should avoid smoking and taking nicotine medications. In any case, during this period, women who are being treated 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 4 mg medicinal chewing gummay produce a mild laxative effect because it contains 0.57 g of xylitol(E-967) in each medicinal chewing gum. Caloric value: 2.4 Kcal/g xylitol.

This medication may produce local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene(E-321).

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

Patients with low-sodium diets should be aware that this medication contains 13.03 mg (0.566 mmoles) of sodiumper gum.

3. How to take Nicorette Ice Mint 4 mg medicinal chewing gum

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.

People over 18 years old

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 convenient 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 only 1 or 2 gums are consumed 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 can advise you based on your situation, the use of a gum on an occasional basis in case of sudden cravings for tobacco.

If you think 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 minors under 18 years old without the recommendation of a doctor, as even small amounts of nicotine are dangerous for children and can produce severe symptoms of poisoning, which can be fatal (see section If you take more Nicorette Ice Mint 4 mg medicinal chewing gum than you should).

How to chew Nicorette gum

When you feel the urge to smoke, introduce a gum into 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 that is swallowed with saliva is not beneficial and can irritate the throat or cause stomach upset, producing, for example, hiccups. To avoid this, chewing should be slow.

Do not exceed the recommended dose.

If you take more Nicorette Ice Mint 4 mg medicinal chewing gum 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, 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 can be followed by decreased blood pressure, heart rhythm disturbances, weakness, irregular pulse, difficulty breathing, prostration, circulatory collapse, generalized convulsions, and coma.

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

Even small amounts of nicotine are dangerous for children and can produce severe 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 4 mg medicinal chewing gum

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

If you interrupt treatment with Nicorette Ice Mint 4 mg medicinal chewing gum

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

4. Possible side effects

Like all medications, this medication can produce side effects, although not all people experience them.

Nicorette Ice Mint 4 mg medicinal chewing gum can cause side effects similar to those associated with nicotine from tobacco and usually depend on the number of gums used.

The gums can stick and, in rare cases, damage the denture.

Effects related to quitting smoking (nicotine withdrawal)

Some of the unwanted effects experienced when quitting smoking may be withdrawal syndromes due to decreased nicotine consumption. When quitting smoking, oral ulcers can develop. The reason they 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.
• Depression.
• Cravings for tobacco.
• 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 medication, do not smoke, and consult your doctor as soon as possible.

Most side effects occur during the first few weeks of starting treatment.

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

• Blurred vision and increased lacrimation.
• Dry throat, discomfort in the lips, and gastrointestinal disorders.
• 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, inflammation of the tongue, oral paresthesia.
• Asthenia, pain, and discomfort in the chest, and feeling of malaise.
• Jaw pain.
• Sleep disorders.
• 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.
• Altered taste, paresthesia

Very frequent adverse reactions:

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

Reporting side effects

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

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

5. Storage of Nicorette Ice Mint 4 mg medicinal chewing gum

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 package after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Packaging Contents and Additional Information

Nicorette Ice Mint 4 mg Medicinal Chewing Gum Composition

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

The other components are: chewing gum base (containing butylhydroxytoluene E-321), xylitol (E-967), peppermint oil, anhydrous sodium 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), quinoline yellow (E-104), and talc.

Product Appearance and Packaging Contents

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

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

Spain

Manufacturer:

McNEIL AB

Norrboplatsen, 2

Helsingborg (SWEDEN)

Date of the Last Revision of this Leaflet: June 2023

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