PROSPECTO: INFORMATION FOR THE USER

Nicorette 4 mg Medicinal Chewing Gum

Nicotine

It is indicated as a help for smokers 18 years of age or older who smoke more than 20 cigarettes a day and who, being determined to quit tobacco, may suffer from 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 tobacco, you will need to rely on your conviction, decision, and willpower.

You should consult a doctor if it worsens or does not improve after 6 months.

It is veryimportantthat during treatment to stop smoking with Nicorette 4 mg medicated chewing gumdo notuse any other medication with nicotine.

Do not take Nicorette 4 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 4 mg medicated chewing gum.

Smokers with dentures may have difficulty chewing Nicorette 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 diseases, try to quit smoking without using any medication. If you cannot, consult your doctor to determine the treatment to follow.

• If you have recently (within 3 months) had aheart attackorheart attack.
• If you havechest pain(angina pectoris) or angina at rest.
• 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). Nicotine replacement therapy may, in some cases, cause 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 apheochromocytoma(tumor in the adrenal gland).
• If you havepeptic ulcer or duodenal ulcer.
• If you haveesophagitis.
• If you have a history ofepilepsy or seizures.

Other medications and Nicorette 4 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 containing 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 Parkinson's disease, such as ropinirol.
• Medications for high blood pressure (hypertension) such as beta-blockers or furosemide.
• Pain medications 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 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 4 mg medicated chewing gum with food and drinks

The simultaneous consumption ofNicorette 4 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 lactation

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 a pregnant woman continues to smoke 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 woman should only take this medication if her doctor recommends it.

Lactation

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 advisability of substituting breast milk with artificial milk.

If your doctor recommends continuing treatment during lactation, 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 4mg medicated chewing gum contains sorbitol (E-420)

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

Nicorette 4mg medicated chewing gum contains sodium

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

Nicorette 4mg medicated chewing gum contains butylhydroxytoluene (E-321)

This medication may cause local reactions on the skin (such as contact dermatitis) or irritation of the eyes and mucous membranes because it containsbutilhidroxitolueno (E-321).

Nicorette 4mg medicated chewing gum contains ethanol

This medication contains 0.616 mg of alcohol (ethanol) per gum. The amount of ethanol in each gum of this medication is equivalent to less than0.0154ml of beer or0.00616ml of wine. The small amount of alcohol contained in this medication will not have perceptible effects.

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 aged 18 years and over

Drastic suppression of tobacco consumption:

Only one piece of gum should be used at a time and not another one 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 will be able to advise you based on your situation, the use of gum on an as-needed basis in case of sudden urges to smoke.

If you estimate that the action of Nicorette is too strong or too weak, inform your doctor or pharmacist.

Gradual suppression of tobacco consumption:

In the case of opting for gradual reduction, the patient will replace, as far as possible, cigarettes with Nicorette 4 mg medicated gum, with the aim of prolonging the periods in which no cigarettes are smoked, thus reducing tobacco consumption.

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

At 6 weeks of treatment, the smoker should have reduced at least half the number of cigarettes smoked; otherwise, the patient should consult their doctor.

Attempt to quit smoking definitively in 4 months; if not, the patient should consult their doctor.

From the fourth month of treatment to the sixth month, the patient will gradually reduce the number of gum pieces taken.

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 the smoker has not managed to quit definitively after 6 months, they should consult their doctor. The doctor will be able to advise based on the patient's situation, the use of gum on an as-needed basis in case of sudden urges to smoke.

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

Use in children and adolescents

It should not be used in children under 18 years without a doctor's recommendation, 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 4 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 process for 30 minutes to allow the nicotine to be released gradually.

The gum should be chewed as indicated to release the nicotine, and it should be left to rest so that the nicotine can be absorbed in the mouth. Nicotine that is 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 4 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 Toxicology Information Service (phone 91 562 04 20), indicating the name and amount used. It is recommended to bring the packaging and the leaflet 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 4 mg medicated gum

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

If you interrupt treatment with Nicorette 4 mg 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 4 mg medicated chewing gum can cause side effects similar to those associated with tobacco nicotine and usually depend on the amount of gum used.

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

Effects related to quitting smoking (nicotine withdrawal)

Some of the unwanted effects experienced 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.
• Jaw 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 for 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 medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Nicorette 2 mg medicated 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). Tobacco aroma (contains traces of ethanol, cinamal, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, limonene, linalol).

Appearance of the product and contents of the packaging

They are beige medicated chewing gum in square shape presented in boxes with 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)

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Last review date of this leaflet: June 2023

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