PROSPECTO: INFORMATION FOR THE USER

Nicorette Freshfruit 2 mg Medicinal Chewing Gum

Nicotine

It is indicated as an aid for smokers 18 years of age or older who smoke fewer than 20 cigarettes per day and who, being determined to quit smoking, may experience the unpleasant effects associated with the abandonment of this addiction: irritability, anxiety, "nicotine hunger", insomnia, or constipation, mainly.

Due to its nicotine content, it reduces the unpleasant effects of withdrawal that are usually felt when quitting smoking but 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 you worsen or do not improve after 6 months.

It is veryimportantthat during the treatment to stop smoking with Nicorette Freshfruit 2 mg medicated chewing gumdo notuse any other medication with nicotine.

Do not take Nicorette Freshfruit 2 mg medicated 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 joint problems in the jaw.

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 diseases, try to stop smoking without using any medication. If you cannot, consult your doctor for further guidance.

• If you have recently (within 3 months) had aheart attackorheart attack.
• If you suffer fromchest pain(angina pectoris) or resting angina.
• If you have anyheart diseasethat affects heart rhythm or frequency.
• If you havehigh blood pressurethat is not controlled with medication.
• If you have ever had anyallergic reactionwith inflammation of the lips, face, and throat (angioedema) or skin irritation (urticaria). The use of nicotine replacement therapy may, in some cases, produce this type of reaction.
• If you have severe or moderateliver disease.
• If you have severekidney disease.
• If you havediabetes.
• If you havehyperthyroidism.
• If you have a tumor in theadrenal medulla(pheochromocytoma).
• If you suffer fromstomach or duodenal ulcers.
• If you haveesophagitis.
• If you have a history of epilepsy or seizures

Other medications and Nicorette Freshfruit 2 mg medicated chewing gum

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

Smoking may 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 taking.

If you are taking any of the following medications, you may need 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, sleep medications (benzodiazepines, clozapine, olanzapine, fluvoxamine, imipramine, clomipramine).
• Medications for the treatment of Parkinson's disease, such as ropinirol.
• Medications for the treatment of high blood pressure (hypertension) such as beta-blockers or furosemide.
• Medications for pain such as paracetamol or stronger ones like morphine or derivatives (dextropropoxifeno, pentazocina).
• Oral contraceptives such as estradiol.
• Anticoagulants 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 Freshfruit 2 mg medicated chewing gum with food and drinks

The simultaneous consumption ofNicorette Freshfruit 2 mg medicated chewing gumand coffee, acidic beverages (lemon, orange, etc) or soft drinks may reduce the absorption of nicotine in the oral cavity. These beverages should be avoided during the 15 minutes before chewing the gum.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 its respiratory movements and circulatory system, and may even cause premature birth or fetal death. Therefore, it is recommended that pregnant smokers quit smoking completely, without using any medication. However, the fact that smoking during pregnancy may pose a greater risk to the fetus than the use of nicotine-containing medications in a controlled program to quit smoking.

However, a pregnant smoker should only take this medication if recommended by her doctor.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Nicotine passes into breast milk in amounts that may affect the baby, so women who are breastfeeding should avoid smoking and taking nicotine-containing medications. In any case, during this period, women who are undergoing treatment with nicotine-containing medications to quit smoking should consult their doctor about the possibility of substituting breast milk with artificial milk.

If your doctor recommends continuing treatment during breastfeeding, you should take the gum immediately after feeding and not within 2 hours of the next feeding.

Driving and operating machinery

No effects have been observed on the ability to drive or operate machinery, although it should be noted that quitting smoking produces changes in behavior.

Nicorette Freshfruit 2 mg contains xylitol

Nicorette Freshfruit 2 mg medicated chewing gum may cause a mild laxative effect due to the presence of 591.5 mg of xylitol per gum.

Nicorette Freshfruit 2 mg contains butylhydroxytoluene (E-321)

This medication may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes due to the presence ofbutilhidroxitolueno (E-321).

Nicorette Freshfruit 2 mg contains potassium

This medication contains less than 39 mg (1 mmol) of potassium per gum, making it essentially "potassium-free".

Nicorette Freshfruit 2 mg contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per gum, making it essentially "sodium-free".

Nicorette Freshfruit 2 mg contains ethanol

This medication contains 0.014 mg of alcohol (ethanol) per gum. The amount of ethanol in each gum of this medication is equivalent to less than0.00035ml of beer or0.00014ml of wine. The small amount of alcohol in this medication will not produce perceptible effects.

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Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults 18 years and older

Drastic suppression of tobacco consumption:

Only one piece of gum should be used at a time and not another one should be used until 1 or 2 hours have passed. Generally, 8 to 12 pieces are used per day. No more than 24 pieces should be used per day.

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

It is not recommended to use the gum regularly for more than 6 months.

If you have not managed to quit definitively after 6 months, you should consult your doctor. The doctor may advise you, depending on your situation, the use of gum on an occasional basis in case of sudden urges to smoke.

Gradual suppression of tobacco consumption:

In the case of opting for a gradual reduction in tobacco consumption, you will replace, as far as possible, cigarettes with Nicorette Freshfruit, with the aim of prolonging the periods in which no cigarettes are smoked, thus reducing tobacco consumption.

The number of pieces of gum per day varies and depends on the needs of each smoker. No more than 24 pieces should be used per day.

At 6 weeks of treatment, the smoker should have reduced their cigarette consumption by at least half; if not, they should consult their doctor.

Attempt to quit smoking definitively in 4 months; if not, consult your doctor.

From the fourth month of treatment and until the sixth month, reduce the number of pieces of gum taken gradually.

Guideline for substitution of daily cigarette number by gum pieces.

It is not recommended to use the gum regularly for more than 6 months.

If you have not managed to quit definitively after 6 months, you should consult your doctor. The doctor may advise you, depending on your situation, the use of gum on an occasional basis in case of sudden urges to smoke.

If you think the action of Nicorette Freshfruit 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 without the recommendation of a doctor, as even small amounts of nicotine are hazardous to children and can cause severe symptoms of poisoning, which can be fatal (see sectionif you take more Nicorette Freshfruit 2 mg medicated gum than you should).

How to chew Nicorette gum

When you feel the urge to smoke, insert a piece of gum into your mouth and chew it slowly until you notice a strong flavor. Then, place it between your cheek and gum and, when the flavor decreases, chew the gum slowly again and repeat the operation for 30 minutes to allow the nicotine to be released gradually.

The gum should be chewed in the indicated way to release the nicotine and left to rest so that the nicotine can be absorbed in the mouth. Nicotine swallowed with saliva is not beneficial and in excess can 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 gum than you should

Excessive use of nicotine from nicotine replacement therapy and/or smoking can cause symptoms of overdose. 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 may be followed by decreased blood pressure, cardiac arrhythmias, weakness, shortness of breath, prostration, circulatory collapse, convulsions, and coma.

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

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

if you forget to take Nicorette Freshfruit 2mg medicated gum

Do not take a double dose to compensate for the missed doses.

if you interrupt the treatment with Nicorette Freshfruit 2mg medicated gum

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

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

Nicorette Freshfruit 2 mg chewing gum may cause side effects similar to those associated with tobacco nicotine and usually depend on the amount of gum used.

The gum may become stuck and may, in rare cases, damage the teeth.

Effects related to quitting smoking (nicotine withdrawal)

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

These effects include:

• Irritability, aggression, impatience, or frustration.
• Sensation of anxiety, agitation, or difficulty concentrating.
• Sleep disturbances.
• Increased appetite or weight gain.
• Depression.
• Cravings to smoke.
• Decreased heart rate.
• Gingival bleeding.
• Dizziness or mild disorientation.
• Cough, sore throat, nasal congestion, or mucous.

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 side effects occur during the first weeks of treatment initiation.

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 anaphylaxis symptoms).
• Muscle stiffness.
• Angioedema and erythema.
• Seizures

Adverse reactions rare(may affect up to 1 in 1000 patients):

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

Adverse reactions infrequent(may affect up to 1 in 100 patients):

• Palpitations and tachycardia.
• Eructation, burning, and oral mucosa desquamation, inflammation of the tongue, oral paresthesia.
• Weakness, chest pain, and discomfort, and feeling unwell.
• Mandibular pain.
• Sleep disturbances.
• Nasal congestion, sneezing, oropharyngeal pain, throat constriction, dysphonia, dyspnea, bronchospasm.
• Hyperhidrosis, pruritus, urticaria, rash.
• Hot flashes and hypertension

Adverse reactions frequent(may affect up to 1 in 10 patients):

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

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

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Nicorette 2 mg chewing gum

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

• The other components are: gum base (containing butylhydroxytoluene (E-321), an antioxidant), sorbitol (E-420), sodium hydrogen carbonate, anhydrous sodium carbonate, Haverstroo aroma, tobacco aroma, glycerol (E-422). It contains traces of ethanol.

Appearance of the product and contents of the packaging

They are beige, square-shaped medicinal chewing gums that are presented in boxes containing 30, 105, and 210 chewing gums.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Responsible for manufacturing

McNEIL AB

Norrboplatsen, 2

Helsingborg (SWEDEN)

Last review date of this leaflet: June 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/