Nicotinell Cool Mint 4 mg medicated chewing gum

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nicotinell Cool Mint 4 mg medicated chewing gum

Nicotine

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

This medicine can be obtained without a prescription. However, to achieve the best results,
you must use Nicotinell Cool Mint 4 mg medicated chewing gum correctly.

Follow exactly the dosing instructions provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further 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.

Leaflet contents:

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

1. What Nicotinell Cool Mint 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 quitting smoking.

Counselling and patient support normally improve the chances of success.

2. What you need to know before using Nicotinell Cool Mint

Do not take Nicotinell Cool Mint

• If you are allergic (hypersensitive) 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 therapy. 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 stop smoking without using any nicotine replacement therapy, 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 other diabetes 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 and may cause severe symptoms or death in children. If nicotine poisoning is suspected in a child, consult a healthcare professional immediately. For this reason, it is essential to keep Nicotinell out of sight and reach of children at all times.

Taking Nicotinell Cool Mint with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 on 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 Cool Mint with food and drinks

Consumption of coffee, acidic drinks (e.g. fruit juices) or soft drinks may reduce the absorption of nicotine. Therefore, these should 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 use machines are known at the recommended doses, it should be noted that quitting smoking may cause changes in behaviour.

Nicotinell Cool Mint contains sorbitol, butylhydroxytoluene and sodium

This medicine contains sorbitol, which is a source of fructose. If your doctor has informed you 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 body cannot break down fructose, consult your doctor before taking this medicine. If you do not tolerate sorbitol, do not use this product.

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 Cool Mint 4 mg chewing gum contains 0.1 g of sorbitol, as a sweetener, which is a source of 0.02 g of fructose. The energy value is 1.2 kcal per chewing gum.

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

3. How to take Nicotinell Cool Mint

Follow exactly the administration instructions for Nicotinell contained in this leaflet or as directed 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 dosage 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).

Method of administration:

Begin using this product on the day you quit 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 chewing the gum.
2. Place the gum between your cheek and gum.
3. When the taste fades, chew the gum again.
4. Repeat this process for about 30 minutes to allow the nicotine to be released gradually.

Medicated chewing gums must not be swallowed.

Adults over 18 years of age:

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 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. Typically, 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.

Use of Nicotinell for longer than 6 months is not recommended. 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 likelihood 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 Cool Mint 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, and generally sick. 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 burning, nausea, vomiting, diarrhea, abdominal pain, visual and auditory disturbances, headache, changes in heart rhythm (tachycardia), shortness of breath, confusion, prostration, circulatory problems, coma, and terminal seizures.

With very high overdoses, exhaustion, seizures, 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 in a child is suspected, seek immediate medical attention. Even small amounts of nicotine can be dangerous and potentially fatal for children, possibly causing severe symptoms or death.

If you have any further questions about the use of this product, 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, this medicine may cause adverse effects, although not everyone experiences 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 sometimes may be due to insufficient nicotine administration.

The adverse effects are grouped according to how likely they are to occur:

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

• feeling unwell (nausea).

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

• the gum may cause pain or mild irritation in the mouth or tongue
• sore throat or inflammation
• feeling sick
• stomach discomfort
• diarrhoea
• indigestion/acid reflux
• 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 too intensively. These problems can be avoided by chewing the gum more slowly.

Uncommon (may affect between 1 and 10 in 1,000 patients):

• awareness of heartbeats (palpitations)
• itching or skin swellings (urticaria).

Rare (may affect between 1 and 10 in 10,000 patients):

• rapid and irregular heartbeats (atrial fibrillation)

• difficulty breathing

• symptoms of a severe allergic reaction including sudden wheezing or tightness in the chest, 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, lightheadedness, and fainting (symptoms of low blood pressure);

• difficulty breathing.

If you experience any of these symptoms, STOP taking Nicotinell medicated chewing gum and seek immediate medical help.

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.

If you consider any of the adverse effects you experience to be severe, or if you notice any other adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nicotinell Cool Mint

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

Do not use Nicotinell after the expiry date stated on the packaging after 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nicotinell Cool Mint

• The active substance is nicotine. Each medicated chewing gum contains 4 mg (corresponding to 20 mg of nicotine-polacriline).
• The other components are: sorbitol (E420), gum base (contains butylated hydroxytoluene (E321)), calcium carbonate, anhydrous sodium carbonate, sodium hydrogen carbonate, polacriline, glycerol (E422), purified water, levomenthol, natural mint flavour, mint millicaps, sucralose, acesulfame potassium, xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax and talc. See section 2 “Nicotinell Cool Mint contains sorbitol, butylated hydroxytoluene and sodium”.

Appearance 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 is for Nicotinell Cool Mint 4 mg medicated chewing gum.

Nicotinell 4 mg is presented as a matte white, rectangular-shaped 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. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dr. Reddy’s Netherlands B.V.
Claude Debussylaan 10
1082 MD Amsterdam
The Netherlands

Manufacturer

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Vemedia Pharma Hispania, S.A.
C/ Aragón, 182, 5th floor
08011 - Barcelona (Spain)

This medicinal product is authorised in the European Economic Area countries under the following names:

Germany Nicotinell Kaugummi 4 mg Cool Mint
Austria Nicotinell MintFrisch 4 mg - Kaugummi
Belgium Nicotinell Cool Mint, 4 mg, kauwgom
Denmark Nicotinell Mint
Spain Nicotinell Cool Mint 4 mg medicated chewing gum
Estonia Nicotinell Cool Mint
Greece Nicotinell Cool Mint 4 mg medicated chewing-gum
Finland Nicotinell Mint 4 mg lääkepurukumi
France NICOTINELL MENTHE FRAICHEUR 4 mg SANS SUCRE, gomme à mâcher médicamenteuse
Ireland Nicotinell Cool Mint 4mg Medicated Chewing Gum
Iceland Nicotinell Mint 4 mg lyfjatyggigúmmí
Lithuania Nicotinell Mint 4 mg medicated chewing-gum
Luxembourg Nicotinell Cool Mint, 4 mg, gomme à mâcher médicamenteuse
Latvia Nicotinell Cool Mint 4 mg medicated chewing gum
Norway Nicotinell medisinsk tyggegummi med peppermyntesmak
The Netherlands Nicotinell Cool Mint, 4 mg, kauwgom
Portugal Nicotinell Freshmint 4 mg
United Kingdom Nicotinell Ice Mint 4mg Medicated Chewing Gum
Sweden Nicotinell Mint 4 mg

This leaflet was last revised in November 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/