Nicotinell Fruit 4 mg medicated chewing gum

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nicotinell Fruit 4 mg medicated chewing gum

Nicotine

Read all of this leaflet carefully before starting to take this medicine, because it contains important information for you.

This medicine is available without a prescription. However, to achieve the best results,
you must use Nicotinell Fruit 4 mg medicated chewing gum correctly.

Follow exactly the instructions for use provided in this leaflet or those given 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 you still need to use Nicotinell after 6 months.

Contents of the leaflet:

1. What Nicotinell Fruit is and what it is used for
2. What you need to know before taking Nicotinell Fruit
3. How to take Nicotinell Fruit
4. Possible adverse effects
5. How to store Nicotinell Fruit
6. Contents of the pack and other information

1. What Nicotinell Fruit is and what it is used for

Nicotinell belongs to a group of medicines used as an aid to stop smoking.

Nicotinell contains the active substance nicotine.

When chewing the gum, nicotine is slowly released and absorbed through the mucous membrane of the mouth.

It is indicated to relieve symptoms of nicotine withdrawal in nicotine dependence, as an aid to stop smoking.

Counselling and patient support normally improve the chances of success.

2. What you need to know before starting to take Nicotinell Fruit

Do not take Nicotinell Fruit

• 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.

Warnings and precautions

Consult your doctor or pharmacist before using Nicotinell if you have:

• any heart problems – you should consult a healthcare professional before using any nicotine replacement product. If you experience an increase in heart-related symptoms while using a nicotine replacement therapy product, you should reduce or stop using the product,
• recently had a heart attack or stroke, or suffer from serious heart rhythm problems or chest pain (angina) – you should try to quit smoking without using any nicotine replacement therapy product, unless your doctor advises you to use it,
• heart failure, angina, Prinzmetal's angina, or high blood pressure (uncontrolled hypertension),
• circulation problems,
• diabetes – you should monitor your blood sugar levels more frequently when starting to use nicotine chewing gum. Your need for insulin or medication may change,
• overactive thyroid gland (hyperthyroidism),
• overactive adrenal glands (pheochromocytoma),
• kidney or liver impairment,
• stomach or duodenal ulcers or inflammation of the oesophagus or throat (the tube between the mouth and stomach), as nicotine replacement therapy may worsen these symptoms,
• fructose intolerance,
• if you have ever experienced seizures.

Keep all medicines out of the sight and reach of children.

People with jaw joint problems or some individuals with dentures may have difficulty chewing the gum. If this applies to you, it is recommended to use a different pharmaceutical form of nicotine replacement therapy. Please consult your doctor or pharmacist.

Children and adolescents

Even small amounts of nicotine can be dangerous for children and may cause severe symptoms or death. If nicotine poisoning in a child is suspected, seek immediate medical advice. For this reason, it is essential to keep Nicotinell out of the sight and reach of children at all times.

Taking Nicotinell Fruit with other medicines

Inform your doctor or pharmacist if you are currently taking or have recently taken any other medicines. Stopping smoking may alter the effects of other medicines you are taking. If you have any questions or concerns about this, consult a healthcare professional.

There is no information available regarding interactions between Nicotinell and other medicines. However, apart from nicotine, other substances in cigarettes may affect certain treatments.

Stopping smoking may alter the effects of medicines such as:

• Theophylline (used in the treatment of bronchial asthma).
• Tacrine (used in the treatment of Alzheimer's disease).
• Olanzapine and Clozapine (used for the treatment of schizophrenia).
• Insulin (used in the treatment of diabetes), whose dose may need to be adjusted.

Taking Nicotinell Fruit with food and drinks

Consumption of coffee, acidic drinks (e.g. fruit juices) or soft drinks may reduce the absorption of nicotine and should therefore be avoided during the 15 minutes before chewing Nicotinell, as they may affect nicotine absorption.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you should stop smoking without using nicotine replacement therapy. However, if you have tried and failed, nicotine replacement therapy should only be used to help you quit smoking upon the recommendation of a healthcare professional.

Breastfeeding

If you are breastfeeding, nicotine replacement therapy should only be used after consulting a healthcare professional, as nicotine can pass into breast milk.

Fertility

Smoking increases the risk of infertility in both women and men.

Driving and using machines

Although no effects on the ability to drive or operate machinery are known at the recommended doses, it should be noted that quitting smoking may cause changes in behaviour.

Nicotinell Fruit contains sorbitol, butylhydroxytoluene and sodium

This medicine contains sorbitol, which is a source of fructose. If your doctor has informed you of an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which fructose cannot be broken down, consult your doctor before taking this medicine. Do not use this product if you are intolerant to sorbitol.

This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes, as it contains butylhydroxytoluene.

Each Nicotinell Fruit 4 mg chewing gum contains 0.2 g of sorbitol as a sweetener, which corresponds to 0.04 g of fructose. The energy value is 0.9 kcal per gum.

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

3. How to take Nicotinell Fruit

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

To maximize the chances of successfully quitting smoking, you must not smoke at all when starting Nicotinell or during the entire course of treatment.

Nicotinell is available in two strengths: 2 mg and 4 mg. The appropriate dose depends on your previous smoking habits. You should use Nicotinell 4 mg if:

• You are a smoker with high or very high nicotine dependence.
• You have previously failed to quit smoking using Nicotinell 2 mg.
• Your withdrawal symptoms are so intense that they lead to relapse and resumption of smoking.

In all other cases, you should use Nicotinell 2 mg.

Select the appropriate dosage for you from the following table:

If any adverse events occur when starting treatment with a higher dosage form (Nicotinell 4 mg), it should be replaced with a lower dosage form (Nicotinell 2 mg).

Instructions for use:

Begin using this product on the day you stop smoking. To successfully quit smoking with this treatment, you must stop smoking completely.

Chew one piece of gum when you feel the urge to smoke. Do not use more than one piece of gum at a time. Do not use more than one piece of gum per hour.

1. Chew the gum slowly until the taste becomes strong. Do not eat or drink while the gum is in your mouth.
2. Place the gum between your cheek and gum.
3. When the taste fades, start chewing again.
4. Repeat this process for approximately 30 minutes to allow the nicotine to be released gradually.

Medicated chewing gums must not be swallowed.

Recommended dose for adults over 18 years of age and elderly people:

Chew one piece of gum when you start feeling the urge to smoke. Generally, one piece should be chewed every 1–2 hours. In most cases, 8–12 pieces of gum per day are sufficient. If you still feel the urge to smoke, you may chew an additional piece. Do not exceed 15 pieces of Nicotinell 4 mg gum per day.

The duration of treatment is individual. Normally, treatment should continue for 3 months. After 3 months, gradually reduce the number of daily gum pieces. Treatment should end when gum consumption has decreased to 1 or 2 pieces per day.

It is not recommended to use Nicotinell for longer than 6 months. However, some former smokers may require a longer treatment with medicated gum to prevent relapse.

If you are still using Nicotinell after 6 months, you should consult your doctor or pharmacist.

Counselling and patient support generally improve the chances of success.

Use in children and adolescents

Nicotinell must not be used by individuals under 18 years of age without medical advice.

If you take more Nicotinell Fruit than you should

Chewing too many Nicotinell gums may cause symptoms similar to those experienced when smoking large amounts of tobacco. If you use too many nicotine gums, you may begin to feel unwell, dizzy, or nauseous. Stop using the gum and consult a healthcare professional immediately. General symptoms of nicotine overdose include: weakness, pale skin, increased sweating, involuntary muscle contractions, increased salivation, dizziness, throat irritation, nausea, vomiting, diarrhea, abdominal pain, disturbances in vision and hearing, headache, changes in heart rhythm (tachycardia), shortness of breath, confusion, prostration, circulatory problems, coma, and terminal convulsions.

In cases of very high overdose, exhaustion, convulsions, low blood pressure leading to circulatory collapse, or respiratory failure may occur.

Consult your doctor or pharmacist if you experience any problems.

If nicotine poisoning is suspected in a child, seek medical advice immediately. Even small amounts of nicotine can be dangerous and potentially fatal for children and may lead to severe symptoms or death.

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

If you forget to use Nicotinell

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

If you stop using Nicotinell

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

4. Possible adverse effects

Like all medicines, Nicotinell can have adverse effects, although not everyone will experience them.

Some of the effects you may notice during the first few days are dizziness, headache, and sleep disturbances, which may be attributed to the symptoms associated with quitting smoking itself, and occasionally may be due to insufficient nicotine administration.

They are grouped according to how likely they are to occur:

Very common (may affect up to 1 in 10 people):

• feeling unwell (nausea).

Common (may affect between 1 and 10 in every 100 people):

• chewing gum may cause pain or mild irritation in the mouth or tongue

• sore throat or inflammation

• feeling sick

• stomach discomfort

• diarrhoea

• indigestion/heartburn

• flatulence

• hiccups

• excessive salivation

• constipation

• difficulty swallowing

• dizziness and headache

• vomiting

• insomnia

• cough

• dry mouth

• jaw muscle pain, especially as a result of chewing the gum intensely. These problems can be avoided by chewing the gum more slowly.

Uncommon (may affect up to 1 in 100 people):

• awareness of heartbeat (palpitations)
• itching or raised rash on the skin (urticaria).

Rare (may affect up to 1 in 1,000 people):

• rapid and irregular heartbeats (atrial fibrillation)

• difficulty breathing

• symptoms of severe allergic reaction including sudden wheezing or chest tightness, skin rash, and feeling faint

• disturbances in heart rhythm (faster heartbeat) and allergic reactions. Allergic reactions may very rarely be severe and include the following symptoms:

• skin swelling

• swelling of the face and mouth

• dizziness, dizziness and fainting (symptoms of low blood pressure)

• difficulty breathing.

Mouth ulcers may occur, which may be related to stopping smoking, not to the treatment.

On rare occasions, Nicotinell may adhere to and damage dentures or other dental prostheses.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nicotinell Fruit

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

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

Do not store above 25°C.

Do not dispose of medicines via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nicotinell Fruit

• The active substance is nicotine. Each medicated chewing gum contains 4 mg (corresponding to 20 mg of nicotine polacrilex).
• The other components are: gum base (containing butylated hydroxytoluene (E321)), calcium carbonate, sorbitol (E420), anhydrous sodium carbonate, sodium bicarbonate, polacrilex, glycerol (E422), purified water, levomenthol, tutti frutti flavouring, saccharin, sodium saccharin, acesulfame potassium, xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax and talc. See section 2 “Nicotinell Fruit contains sorbitol, butylated hydroxytoluene and sodium”.

Presentation of the product and contents of the pack

Nicotinell medicated chewing gum is available in two strengths (2 and 4 mg) and three flavours (Nicotine, Fruit and Cool Mint). This leaflet refers to Nicotinell Fruit 4 mg medicated chewing gum.

Nicotinell 4 mg is presented as a white, matte, rectangular medicated chewing gum.

Nicotinell 4 mg is available in packs of 2, 12, 24, 36, 48, 60, 72, 96, 120 or 204 medicated chewing gums in blister packs. Only certain pack sizes may be marketed.

Marketing Authorization Holder

Haleon Spain, S.A.
Parque Tecnológico de Madrid, Calle de Severo Ochoa, 2
28760 Tres Cantos, Madrid - Spain

Manufacturer

FAMAR S.A.
48th km National Road Athens-Lamia,
19011, Avlonas, Attiki – Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria Nicotinell Fruit 4 mg - wirkstoffhaltige Kaugummis zur Raucherentwöhnung
Belgium Nicotinell Fruit, 4 mg, kauwgom
Denmark Nicotinell Fruit, medicinsk tyggegummi
Spain Nicotinell Fruit 4 mg medicated chewing gum
Estonia Nicotinell Fruit
Finland Nicotinell Fruit 4 mg lääkepurukumi
France NICOTINELL FRUIT 4 mg SANS SUCRE, gomme à mâcher médicamenteuse
Greece Nicotinell Fruit
Ireland Nicotinell Fruit 4mg Medicated Chewing Gum
Latvia Nicotinell Fruit 4 mg arstnieciska košlajama gumija
Lithuania Nicotinell Fruit 4 mg vaistine kramtomoji guma
Luxembourg Nicotinell Fruit, 4 mg, gomme à mâcher médicamenteuse
Norway Nicotinell medisinsk tyggegummi med fruktsmak
Netherlands Nicotinell Fruit, 4 mg, kauwgom
Portugal Nicotinell Fruit 4 mg
United Kingdom Nicotinell Fruit 4mg Medicated Chewing Gum
Sweden Nicotinell Fruit 4 mg medicinskt tuggummi.

This leaflet has been reviewed in November 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/