Nicotinell Cool Mint 2 mg medicated chewing gum

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nicotinell Cool Mint 2 mg chewing gum

Nicotine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

This medicine is available without a prescription. However, to achieve the best results,
you should use Nicotinell Cool Mint 2 mg chewing gum correctly.

Always 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 further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 Cool Mint is and what it is used for
2. What you need to know before taking Nicotinell Cool Mint
3. How to take Nicotinell Cool Mint
4. Possible side 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 oral mucosa.

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

Counseling and patient support normally improve the chances of success.

2. What you need to know before starting to take 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
  medicinal product (listed in section 6).
• If you are a non-smoker.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nicotinell if you have:

• any heart problems; you should consult a healthcare professional before using any nicotine replacement product. If you experience worsening of cardiac symptoms while using a nicotine replacement therapy (NRT) product, you should reduce or stop using the product,
• recently had a heart attack or stroke, or suffer from serious heart rhythm disorders or chest pain; you should try to quit smoking without using any nicotine replacement therapy product unless your doctor specifically 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 gum. Your need for insulin or other antidiabetic 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 your symptoms,
• fructose intolerance,
• if you have ever experienced seizures.

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

People with temporomandibular joint disorders 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. 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, 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. Quitting 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 in 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 beverages (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 recommendation by a healthcare professional.

Breastfeeding

If you are breastfeeding, nicotine replacement therapy should only be used after consulting a healthcare professional, as nicotine may 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 Cool Mint contains sorbitol, butylated hydroxytoluene (BHT) 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 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 because it contains butylated hydroxytoluene (BHT).

Each Nicotinell Cool Mint 2 mg chewing gum contains 0.1 g of sorbitol, as a sweetener, which is a source of 0.02 g of fructose. The caloric value is 1.2 kcal per 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, ask 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, 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:

Start 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 whenever 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, start chewing 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 a piece of gum when you begin to feel the urge to smoke. In general, chew one piece 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 extra piece. Do not exceed 24 pieces of Nicotinell 2 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, consult your doctor or pharmacist.

Counseling 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 Cool Mint than you should

Chewing too many Nicotinell gums may cause symptoms similar to those produced by smoking a large amount of tobacco. If you use too many nicotine gums, you may begin to feel unwell, dizzy, and generally ill. 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, visual and auditory disturbances, headache, changes in heart rhythm (tachycardia), shortness of breath, confusion, prostration, circulatory problems, coma, and terminal convulsions.

With very high overdoses, 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 are dangerous and potentially fatal for children and may result in 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 any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can have 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 symptoms related to 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 100 people):

• chewing gum may cause mild pain or 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 too intensively. These problems can be avoided by chewing the gum more slowly.

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

• awareness of heartbeat (palpitations)
• skin itching or lumps (urticaria).

Rare (may affect between 1 and 10 in 10,000 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.

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 quitting 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 adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any 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 drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you 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 2 mg (corresponding to 10 mg of nicotine polacrilex).
• The other components are: sorbitol (E420), gum base (containing butylated hydroxytoluene (E321)), calcium carbonate, anhydrous sodium carbonate, sodium hydrogen carbonate, polacrilex, 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”.

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 is for Nicotinell Cool Mint 2 mg medicated chewing gum.

Nicotinell 2 mg is presented as a white, matte, rectangular medicated chewing gum.

Nicotinell 2 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 Authorization 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 Authorization Holder:

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

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

Germany: Nicotinell Kaugummi 2 mg Mint
Austria: Nicotinell MintFrisch 2 mg - Kaugummi
Belgium: Nicotinell Cool Mint, 2 mg, kauwgom
Denmark: Nicotinell Mint
Spain: Nicotinell Cool Mint 2 mg chicle medicamentoso
Estonia: Nicotinell Cool Mint
Finland: Nicotinell Mint 2 mg lääkepurukumi
France: NICOTINELL MENTHE FRAICHEUR 2 mg SANS SUCRE, gomme à mâcher médicamenteuse
Greece: Nicotinell Cool Mint 2 mg medicated chewing-gum
Hungary: Nicotinell Fresh Mint 2 mg gyógyszeres rágógumi
Ireland: Nicotinell Cool Mint 2mg Medicated Chewing Gum
Iceland: Nicotinell Mint 2 mg lyfjatyggigúmmí
Lithuania: Nicotinell Mint 2 mg medicated chewing gum
Luxembourg: Nicotinell Cool Mint 2 mg, gomme à mâcher médicamenteuse
Latvia: Nicotinell Cool Mint 2 mg medicated chewing gum
The Netherlands: Nicotinell Cool Mint 2 mg, kauwgom
Norway: Nicotinell medisinsk tyggegummi med peppermyntesmak
Portugal: Nicotinell Freshmint 2 mg
United Kingdom: Nicotinell Ice Mint 2mg Medicated Chewing Gum
Sweden: Nicotinell Mint 2 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/