Nicorette Freshfruit 2 mg medicated chewing gum

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicorette Freshfruit 2 mg chewing gum medicinal product

Nicotine

Package leaflet

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

1. What Nicorette Freshfruit 2 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 fewer than 20 cigarettes per day and who, while determined 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 successfully quit 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 Freshfruit 2 mg medicated chewing gum

It is very important that during treatment to stop smoking with Nicorette Freshfruit 2 mg medicated chewing gum you do not use any other nicotine-containing medicine.

Do not take Nicorette Freshfruit 2 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

Consult your doctor or pharmacist before starting to take Nicorette Freshfruit 2 mg medicated chewing gum.

Smokers with dentures may have difficulty chewing Nicorette Freshfruit 2 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, consult your doctor for advice on the appropriate treatment.

• If you have recently suffered (within the last 3 months) a heart attack or myocardial infarction.
• If you suffer from 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, and throat (angioedema) or skin irritation (urticaria). Nicotine replacement therapy may, in some cases, 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 tumour of the adrenal medulla (pheochromocytoma).
• If you suffer from stomach or duodenal ulcer.
• If you have oesophagitis.
• If you have a history of epilepsy or seizures.

Other medicines and Nicorette Freshfruit 2 mg medicated chewing gum

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

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 taking.

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

• Medicines containing alcohol or caffeine.

• Medicines acting on the central nervous system such as tranquilisers, antidepressants, sleeping medicines (benzodiazepines, clozapina, 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.

• Painkillers such as paracetamol or stronger ones such as morphine or its 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 anaesthetics such as lidocaine used in the mouth or throat.

Taking Nicorette Freshfruit 2 mg medicated chewing gum with food and drinks

Simultaneous consumption of Nicorette Freshfruit 2 mg medicated chewing gum and coffee, acidic drinks (based on lemon, 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 foetus, as it affects its respiratory movements and circulatory system and may even cause premature delivery or foetal death. For this reason, pregnant smokers are advised to stop smoking completely without using any medication. Nevertheless, continuing to smoke during pregnancy may pose a greater risk to the foetus than using nicotine-containing medicines within a controlled smoking cessation programme.

However, pregnant smokers should only take this medicine if recommended by their 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 both 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 if less than 2 hours remain before the next breastfeeding session.

Driving and using machines

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

Nicorette Freshfruit 2 mg contains xylitol

Nicorette Freshfruit 2 mg medicated chewing gum may produce a mild laxative effect because it contains 591.5 mg of xylitol per gum. Calorific value: 2.4 kcal/g of xylitol.

Nicorette Freshfruit 2 mg 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 Freshfruit 2 mg contains potassium

This medicine contains less than 39 mg (1 mmol) of potassium per gum and is therefore considered essentially “potassium-free”.

Nicorette Freshfruit 2 mg contains sodium

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

Nicorette Freshfruit 2 mg contains ethanol

This medicine contains 0.014 mg of alcohol (ethanol) in each gum. The amount of ethanol in each gum of this medicine is equivalent to less than 0.00035 ml of beer or 0.00014 ml of wine. The small amount of alcohol contained in this medicine will not produce any noticeable effects.

3. How to take Nicorette Freshfruit 2 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 abrupt quitting:

Use only one chewing gum at a time, and do not use another one until 1 to 2 hours have passed. Typically, 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 dependence. 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 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 gums per day.

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

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

Gradual smoking reduction:

If opting for gradual reduction of tobacco consumption, replace cigarettes with Nicorette Freshfruit as much as possible, in order to extend the periods during which no cigarettes are smoked, thereby reducing overall tobacco consumption.

The number of chewing gums per day varies and depends on each smoker'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, consult your doctor.

An attempt to permanently quit smoking should be made within 4 months; if unsuccessful, consult your doctor.

From the fourth month of treatment until the sixth month, 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 you have not been able to permanently stop treatment after 6 months, you should consult your doctor. Depending on your situation, your doctor may advise you to use the gum occasionally in case of sudden urges to smoke.

If you find that the effect of Nicorette Freshfruit 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 recommendation, as even small amounts of nicotine are dangerous for children and may cause severe symptoms of poisoning, which could be fatal (see section If you take more Nicorette Freshfruit 2 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 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 so that the nicotine can 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 slow.

Do not exceed the recommended dose.

If you take more Nicorette Freshfruit 2 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, ear disturbances, 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), indicating the name of the product and the amount used. It is recommended to bring the packaging and the patient information leaflet to the healthcare professional.

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

If you forget to take Nicorette Freshfruit 2 mg medicated chewing gum

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

If you stop treatment with Nicorette Freshfruit 2 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 Freshfruit 2 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, rarely, 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 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.
• Lassitude.
• Craving for cigarettes.
• Slowed 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 symptoms.
• 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 disturbances.
• 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

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

5. Storage of Nicorette Freshfruit 2 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly 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 medicated chewing gum

• 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 bicarbonate, anhydrous sodium carbonate, Haverstroo flavour, tobacco flavour, glycerol (E-422). Contains traces of ethanol.

Appearance of the product and contents of the pack

Beige, square-shaped medicated chewing gums, 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 revision 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/