Nicorette 4 mg medicated chewing gum

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicorette 4 mg medicated chewing gum

Nicotine

Package leaflet:

1. What Nicorette 4 mg medicated chewing gum is and what it is used for
2. What you need to know before starting to take Nicorette 4 mg medicated chewing gum
3. How to take Nicorette 4 mg medicated chewing gum
4. Possible side effects
5. Storage of Nicorette 4 mg medicated chewing gum
6. Contents of the pack and other information

1. What Nicorette 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, despite being determined to quit smoking, may experience the unpleasant effects associated with withdrawal from 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 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 4 mg medicinal chewing gum

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

Do not take Nicorette 4 mg medicinal chewing gum

• if you are allergic to nicotine or to any of the other ingredients 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 4 mg medicinal chewing gum.

Smokers with dentures may have difficulty chewing Nicorette 4 mg medicinal chewing gum. The gum may stick, and in rare cases may damage 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, consult your doctor to determine the appropriate treatment.

• If you have recently (within the last 3 months) suffered a heart attack or heart attack.
• If you suffer chest pain (angina pectoris) or rest angina.
• If you have a heart disease affecting heart rhythm or rate.
• If you have high blood pressure (hypertension) not controlled by medication.
• If you have ever had an allergic reaction with swelling of the lips, face, and throat (angioedema) or skin irritation (urticaria). Nicotine replacement therapy may occasionally cause such reactions.
• If you have severe or moderate liver disease.
• If you have severe kidney disease.
• If you have diabetes.
• If you have hyperactivity of the thyroid gland.
• If you have a tumor of the adrenal medulla (pheochromocytoma).
• If you have stomach or duodenal ulcer.
• If you have esophagitis.
• If you have a history of epilepsy or seizures.

Other medicines and Nicorette 4 mg medicinal chewing gum

Tell 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 to adjust the doses of medicines you are using.

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

• Medicines containing alcohol or caffeine.
• Medicines acting 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 ropinirole.
• Medicines for the treatment of 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 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 4 mg medicinal chewing gum with food and drink

Concurrent consumption of Nicorette 4 mg medicinal chewing gum and coffee, acidic drinks (lemon-based, orange, 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, during this period, women undergoing treatment with nicotine-containing medicines to stop smoking should consult their doctor about the advisability of replacing breastfeeding with artificial feeding.

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

Driving and using machines

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

Nicorette 4 mg medicinal chewing gum contains sorbitol (E-420)

This medicine contains 190.4 mg of sorbitol per gum. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child's doctor) before taking this medicine.

Nicorette 4 mg medicinal chewing gum contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per gum; this is essentially "sodium-free."

Nicorette 4 mg medicinal chewing gum contains butylated hydroxytoluene (E-321)

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).

Nicorette 4 mg medicinal chewing gum contains ethanol

This medicine contains 0.616 mg of alcohol (ethanol) in each gum. The amount of ethanol in each gum of this medicine is equivalent to less than 0.0154 ml of beer or 0.00616 ml of wine. The small amount of alcohol contained in this medicine will not have perceptible effects.

3. How to take Nicorette 4 mg medicated chewing gum

Follow exactly the dosing 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

Smoking cessation with immediate reduction:

Use only one chewing gum at a time, and do not use another 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 the individual needs of each smoker, and abrupt discontinuation is not recommended, 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 reaching only 1 or 2 chewing gums per day. This may be achieved within 2 or 3 months. Do not discontinue treatment completely until the dose has stabilized at 1 or 2 chewing gums daily.

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 is too strong or too weak, inform your doctor or pharmacist.

Gradual smoking reduction:

If opting for gradual reduction, the patient should, as much as possible, replace cigarettes with Nicorette 4 mg medicated chewing gum, with the aim of extending the periods during which no cigarettes are smoked, thereby reducing tobacco consumption.

The number of chewing gums per day varies and depends on the patient's individual needs. Do not exceed 24 chewing gums per day.

By 6 weeks of treatment, the smoker should have reduced cigarette consumption by at least half; otherwise, the patient should consult their doctor.

A definite attempt to quit smoking completely should be made within 4 months; if unsuccessful, the patient should consult their doctor.

From the fourth month of treatment until the sixth month, the patient should gradually reduce the number of chewing gums used.

Guideline for substituting daily cigarettes with chewing gums:

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

If the smoker has not succeeded in permanently stopping treatment after 6 months, they should consult their doctor. Depending on the patient's situation, the doctor may advise using the gum on an occasional basis if sudden urges to smoke arise.

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

Use in children and adolescents

This medicine 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 4 mg medicated chewing gum than you should).

How to chew Nicorette chewing gum

When you feel the urge 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. When the taste fades, chew the gum slowly again and repeat this process for about 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. Nicotine swallowed with saliva 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 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 from swallowing the gum is very low, since absorption without chewing is slow and incomplete.

Symptoms of overdose are those of acute nicotine poisoning and include nausea, vomiting, increased salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, increased blood pressure, disturbances in hearing, and marked weakness. These symptoms may be followed by decreased blood pressure, irregular heartbeat, 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 package and the leaflet to the healthcare professional.

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

If you forget to take Nicorette 4 mg medicated chewing gum

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

If you stop treatment with Nicorette 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 can cause adverse effects, although not everyone will experience them.

Nicorette 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. Oral ulcers may develop when quitting smoking. The reason for their occurrence 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 disturbances.
• 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 general 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 disturbances, 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 4 mg medicated chewing gum

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

Do not store above 25ºC.

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

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nicorette 2 mg chewing gum medicinal

• The active substance is nicotine (2 mg, equivalent to 10 mg of 20% resin complex).

• The other components are: chewing gum base (containing butylated hydroxytoluene (E-321), an antioxidant), sorbitol (E-420), sodium hydrogen carbonate, anhydrous sodium carbonate, Haverstroo flavour, tobacco flavour, glycerol (E-422). Tobacco flavour (contains traces of ethanol, cinnamal, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, limonene, linalool).

Appearance of the product and contents of the pack

Beige, square-shaped medicinal chewing gums, available in cartons 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)

Further information about this medicinal product can be requested from the local representative of the Marketing Authorization Holder:

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Date of the most recent review of this leaflet: September 2025

Detailed and up-to-date 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/