Nicorette Ice Mint 4 mg medicated chewing gum

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

NICORETTE ICE MINT 4 mg MEDICATED GUM

Nicotine

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

Follow exactly the instructions for taking this medicine as described in this leaflet or as advised 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 6 months.

Leaflet contents:

1. What Nicorette Ice Mint 4 mg medicated chewing gum is and what it is used for
2. What you need to know before taking Nicorette Ice Mint 4 mg medicated chewing gum
3. How to take Nicorette Ice Mint 4 mg medicated chewing gum
4. Possible adverse effects
5. Storage of Nicorette Ice Mint 4 mg medicated chewing gum
6. Package contents and additional information

1. What Nicorette Ice Mint 4 mg chewing gum is and what it is used for

It is indicated as an aid for smokers over 18 years of age who smoke more than 20 cigarettes per day and who, having decided to quit smoking, may experience the unpleasant effects associated with giving up this addiction: irritability, anxiety, tobacco craving, insomnia, or constipation, primarily.

Due to its nicotine content, it reduces the unpleasant withdrawal symptoms commonly experienced when quitting smoking, but it does not provide the same satisfaction as a cigarette. Therefore, to stop smoking, you must rely on your own conviction, determination, and willpower.

Consult a doctor if your condition worsens or does not improve after 6 months.

2. What you need to know before starting to take Nicorette Ice Mint 4 mg medicated chewing gum

It is very important that during treatment with Nicorette Ice Mint 4 mg medicated chewing gum to stop smoking, you do not use any other nicotine-containing medicine.

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

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

Warnings and precautions

Talk to 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 conditions, you should try to stop smoking without using any medication. If you are unable to do so, you should consult your doctor to determine the appropriate treatment.

• If you have recently suffered (within the last 3 months) a heart attack or myocardial infarction.
• If you have chest pain (angina pectoris) or rest angina.
• If you have a heart condition affecting heart rhythm or rate.
• If you have uncontrolled high blood pressure (hypertension) despite medication.
• If you have ever had an allergic reaction with swelling of the lips, face, or throat (angioedema), or skin irritation (urticaria). Nicotine replacement therapy may sometimes cause such reactions.
• If you have severe or moderate liver disease.
• If you have severe kidney disease.
• If you have diabetes.
• If you have overactivity of the thyroid gland.
• If you have a tumor of the adrenal medulla (pheochromocytoma).
• If you have stomach or duodenal ulcer.
• If you have oesophagitis.
• If you have a history of epilepsy or seizures.

Other medicines and Nicorette Ice Mint 4 mg medicated chewing gum

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

Smoking can affect how your body responds to certain medicines. Therefore, when you stop smoking (with or without nicotine replacement therapy), you may need adjustments in the doses of medicines you are taking.

If you are taking any of the following medicines, it may be necessary to adjust their doses:

• Medicines containing alcohol or caffeine
• Medicines acting on the central nervous system such as tranquilizers, antidepressants, sleeping medicines (benzodiazepines, clozapine, olanzapine, fluvoxamine, imipramine, clomipramine)
• Medicines for Parkinson’s disease, such as ropinirole
• Medicines for high blood pressure (hypertension), such as beta-blockers or furosemide
• Pain medicines such as paracetamol or stronger ones such as morphine or derivatives (dextropropoxyphene, pentazocine)
• Oral contraceptives such as estradiol
• Anticoagulant medicines such as warfarin or heparin
• Medicines for 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 anaesthetics such as lidocaine used in the mouth or throat

Taking Nicorette Ice Mint 4 mg medicated chewing gum with food and drinks

Simultaneous consumption of Nicorette Ice Mint 4 mg medicated chewing gum and coffee, acidic drinks (lemon, orange-based, etc.) or soft drinks may reduce the absorption of nicotine in the oral cavity. These drinks should be avoided during the 15 minutes before chewing the gum.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 because it affects its respiratory movements and circulatory system, and may even cause premature delivery or fetal death. For this reason, pregnant smokers are advised to stop smoking completely without using any medication. However, continuing to smoke during pregnancy may pose a greater risk to the fetus than using nicotine-containing medicines within a controlled smoking cessation program.

Nevertheless, a pregnant smoker should only take this medicine if recommended by her doctor.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Nicotine passes into breast milk in amounts that may affect the baby. Therefore, women who are breastfeeding should avoid smoking and taking nicotine-containing medicines. In any case, women undergoing treatment with nicotine-containing medicines to stop smoking should consult their doctor about the advisability of switching from breastfeeding to artificial feeding.

If your doctor recommends continuing treatment during breastfeeding, you should chew the gum immediately after breastfeeding and in no case when less than 2 hours remain before the next breastfeeding.

Driving and using machines

No effects on the ability to drive or use machines have been observed. However, it should be noted that quitting smoking may cause changes in behavior.

Nicorette Ice Mint 4 mg medicated chewing gum may produce a mild laxative effect because it contains 0.57 g of xylitol (E-967) in each medicated chewing gum. Energy value: 2.4 kcal/g xylitol.

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

Patients with renal impairment or on potassium-restricted diets should be aware that this medicine contains 0.39 mg (0.009 mmol) of potassium per medicated chewing gum.

Patients on sodium-restricted diets should be aware that this medicine contains 13.03 mg (0.566 mmol) of sodium per medicated chewing gum.

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

Follow exactly the dosage instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults over 18 years of age

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

The duration of treatment depends on each smoker's individual needs, and abruptly stopping treatment is not advisable, as this could increase the risk of returning to tobacco addiction. It is preferable to gradually reduce the dose. For example: every 4 or 5 days, reduce daily consumption by one or two chewing gums, until you reach a daily intake of only 1 or 2 chewing gums. This may be achieved within 2 or 3 months. Do not discontinue treatment completely until your daily dose has stabilized at 1 or 2 chewing gums per day.

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

If you have not been able to stop treatment completely after 6 months, you should consult your doctor. Your doctor may advise you, based on your individual situation, to use the chewing gum occasionally in case of sudden urges to smoke.

If you feel that the effect of Nicorette 4 mg is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

This product must not be used in individuals under 18 years of age without medical advice, as even small amounts of nicotine are dangerous for children and may cause severe symptoms of poisoning, which can be fatal (see section If you take more Nicorette Ice Mint 4 mg medicated chewing gum than you should).

How to chew Nicorette chewing gum

When you feel a craving to smoke, place a piece of gum in your mouth and chew it slowly until you notice a strong taste. Then place it between your cheek and gum (gingiva). When the taste fades, chew the gum slowly again and repeat this process for 30 minutes to allow the nicotine to be gradually released.

The gum must be chewed as indicated to release the nicotine, and then held in place to allow the nicotine to be absorbed through the lining of the mouth. Swallowed nicotine is not beneficial and, in excess, may irritate the throat or cause stomach discomfort, such as hiccups. To avoid this, chewing should be done slowly.

Do not exceed the recommended dose.

If you take more Nicorette Ice Mint 4 mg medicated chewing gum than you should:

Excessive use of nicotine from nicotine replacement therapy and/or continued smoking may cause symptoms of overdose. The risk of poisoning due to swallowing the gum is very low, as absorption without chewing is slow and incomplete.

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

If you have used too many chewing gums, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (telephone 91 562 04 20), stating the name of the product and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Even small amounts of nicotine are dangerous for children and may cause severe symptoms of poisoning, which can be fatal. If nicotine poisoning in a child is suspected, seek immediate medical attention.

If you forget to take Nicorette Ice Mint 4 mg medicated chewing gum

Do not take a double dose to make up for a missed dose.

If you stop using Nicorette Ice Mint 4 mg medicated chewing gum

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

4. Possible adverse effects

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

Nicorette Ice Mint 4 mg medicated chewing gum may cause adverse effects similar to those associated with tobacco nicotine and are usually dependent on the number of chewing gums used.

The chewing gums may stick and, in rare cases, may damage dental work.

Effects related to quitting smoking (nicotine withdrawal)

Some of the unwanted effects experienced when quitting smoking may be withdrawal symptoms due to reduced nicotine intake. Mouth ulcers may develop when quitting smoking. The reason for this is unknown.

These effects include:

• Irritability, aggression, impatience, or frustration.
• Feelings of anxiety, restlessness, or difficulty concentrating.
• Sleep disturbances.
• Increased appetite or weight gain.
• Lethargy.
• Craving for cigarettes.
• Slowing of heart rate.
• Bleeding gums.
• Dizziness or mild disorientation.
• Cough, sore throat, nasal congestion, or mucus production.

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 adverse 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, lip discomfort, and gastrointestinal discomfort.
• Allergic reactions (including symptoms of anaphylaxis).
• Muscle stiffness.
• Angioedema and erythema.
• Seizures.
• Rapid and irregular heartbeat (atrial fibrillation).

Rare adverse reactions (may affect up to 1 in 1,000 patients):

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

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

• Palpitations and tachycardia.
• Belching, oral mucosal burning and peeling, tongue inflammation, oral tingling.
• Asthenia, chest pain and discomfort, and malaise.
• Jaw pain.
• Sleep disorders.
• Nasal congestion, sneezing, oropharyngeal pain, throat tightness, dysphonia, dyspnea, bronchospasm.
• Hyperhidrosis, pruritus, urticaria, rash.
• Hot flushes 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.
• Taste disturbance, paresthesia.

Very frequent adverse reactions:

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

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

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nicorette Ice Mint 4 mg medicated chewing gum

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

The other components are: chewing gum base (containing butylated hydroxytoluene E-321), xylitol (E-967), peppermint oil, anhydrous sodium carbonate, potassium acesulfame (E-950), levomenthol, light magnesium oxide, mint flavouring, hypromellose, sucralose, polysorbate 80, pregelatinized corn starch, titanium dioxide (E-171), carnauba wax (E-903), quinoline yellow (E-104) and talc.

Appearance of the product and contents of the pack

Medicated chewing gum, white in colour and rectangular in shape, available in boxes containing 30, 105 and 210 chewing gums.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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 most recent review of this leaflet: September 2025

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