Nicotinell Mint 2 mg lozenges for sucking

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nicotinell Mint 2 mg medicated chewing tablets

nicotine

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

Follow exactly the instructions for use of the medicine contained in this leaflet or as indicated by your 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 these are effects not listed in this leaflet. See section 4.

• If symptoms worsen or persist after 6 months, you must consult your doctor.

Contents of the leaflet

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

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

Nicotinell Mint belongs to a group of medicines used as an aid to stop smoking. Nicotinell Mint tablets for sucking contain the active substance nicotinе.

When sucking the tablets, the nicotine is slowly released and absorbed through the mucous membrane of the mouth.

This medicine is used to help people stop smoking. The nicotine contained in Nicotinell Mint sucking tablets relieves nicotine withdrawal symptoms and the anxiety that occurs when quitting smoking or gradually reducing tobacco consumption, thereby facilitating the process of quitting. By relieving nicotine withdrawal symptoms and anxiety, Nicotinell Mint sucking tablets help prevent relapses in smokers who are motivated to quit.

Counselling and patient support normally improve the chances of success.

Nicotinell Mint sucking tablets are indicated for smokers aged 18 years and over.

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

Do not take Nicotinell Mint sucking tablets

• If you are allergic to nicotine or to any of the other ingredients of
  this medicine (listed in section 6).

• If you are not a smoker.

Warnings and precautions

Consult your doctor or pharmacist before taking Nicotinell Mint tablets if you have:

• Any heart problems, such as having recently suffered a heart attack, having irregular heart rhythms, heart failure, or chest pain (angina pectoris, including Prinzmetal's angina). While using this medicine, if you experience a worsening of heart problems, you should reduce or stop using this medicine.
• Stroke (cerebral apoplexy).
• High blood pressure.
• Circulatory problems.
• Diabetes. You should monitor your blood sugar levels more frequently than usual when starting to use nicotine tablets. Your insulin or medication requirements may change.
• Hyperthyroidism.
• Overactive adrenal glands (pheochromocytoma).
• Kidney or liver impairment.
• Oesophagitis, inflammation of the mouth or throat, gastritis, or peptic ulcer.
• A history of epilepsy (seizures).

Children and adolescents

Nicotinell must not be used by adolescents aged 12 to 17 without a prescription from a healthcare professional.

The correct dose for adults could severely poison or even be fatal for young children. Therefore, it is essential to keep Nicotinell Mint tablets out of the sight and reach of children at all times. Nicotinell Mint must not be used in children under 12 years of age.

Use of Nicotinell Mint with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. If you are trying to quit smoking and are taking other medications, your doctor may need to adjust your dosage.

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

Stopping smoking may alter the effect of medicines such as:

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

Use of Nicotinell Mint with food and drinks

Consumption of coffee, acidic drinks (based on lemon, orange, etc.) or soft drinks may reduce the absorption of nicotine and should therefore be avoided during the 15 minutes before taking the tablet. You should not eat or drink while a tablet is in your mouth.

Pregnancy, breastfeeding, and fertility

Pregnancy

It is very important to stop smoking during pregnancy because it can be harmful to
fetal development. It may lead to premature births or even stillbirths.
Ideally, you should stop smoking without using nicotine-containing medicines. If you are unable to quit smoking without
medication, Nicotinell should only be used after consulting a healthcare professional.

Breastfeeding

Treatment with Nicotinell Mint should be avoided during breastfeeding because nicotine passes into breast milk and may affect your baby. If a healthcare professional advises you to continue treatment
during breastfeeding, you should take the tablet immediately after breastfeeding, and
in no case when less than 2 hours remain before the next breastfeeding.

Fertility

Smoking increases the risk of infertility in both women and men. The effects of nicotine on fertility are unknown.

Driving and use of machines

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

Nicotinell Mint contains aspartame, mannitol, and sodium

This medicine contains 10 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains maltitol (E965). If your doctor has diagnosed you with intolerance to
certain sugars, consult with him before taking this medicine. It may have a mild laxative effect.

The energy value is 2.3 kcal/g of maltitol. The components of Nicotinell Mint sucking tablets are suitable for diabetics.

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

3. How to take Nicotinell Mint

Follow exactly the dosing instructions for this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Nicotinell Mint sucking tablets are available in two strengths: 1 mg and 2 mg. The appropriate dose depends on your previous smoking habits. You should take Nicotinell Mint 2 mg sucking tablets if:

• You are a smoker with high or very high nicotine dependence;
• You have previously failed to quit smoking using 1 mg sucking tablets;
• Your withdrawal symptoms are so intense that they lead to relapse and resumption of smoking.

In all other cases, you should use Nicotinell Mint 1 mg sucking tablets.

Adults over 18 years of age

Select the appropriate dose for you from the following table:

If any adverse events occur when starting treatment with a higher dosage form (2 mg sucking tablets), it should be replaced with a lower strength (1 mg sucking tablets).

Dosage for adults over 18 years of age

Take one sucking tablet when you start to feel the urge to smoke. Generally, one tablet should be taken every 1–2 hours. In most cases, 8–12 sucking tablets per day are sufficient. If you still feel the urge to smoke, you may take additional sucking tablets. Do not take more than 15 of the 2 mg sucking tablets per day (both for smoking cessation and for gradual reduction of tobacco consumption). Do not take more than one sucking tablet per hour.

The primary goal of Nicotinell sucking tablets is to stop smoking.

Smoking cessation:

To maximize your chances of success, you must not smoke at all when starting treatment with sucking tablets, nor during the entire course of treatment.

The duration of treatment is individual. Normally, treatment should continue for at least 3 months. After 3 months, the daily number of sucking tablets should be gradually reduced. Treatment should be discontinued when intake has been reduced to 1 or 2 sucking tablets per day.

It is not recommended to use Nicotinell Mint sucking tablets for longer than 6 months. However, some former smokers may require a longer treatment with sucking tablets to prevent relapse. If you are still using the sucking tablets after 6 months, you should consult your doctor or pharmacist.

Counselling and patient support generally improve the chances of success.

Gradual reduction of tobacco consumption:

You should use Nicotinell sucking tablets to extend the periods during which you do not smoke and to progressively reduce tobacco consumption as much as possible. The number of cigarettes should be gradually replaced by Nicotinell sucking tablets. If after 6 weeks you have not managed to reduce your daily cigarette consumption by at least half, you should seek professional advice. You should try to quit smoking as soon as you feel ready, but in any case within the first 4 months after starting Nicotinell sucking tablets. Then gradually reduce the number of sucking tablets, for example by eliminating one tablet every 2–5 days.

If a serious attempt to quit smoking has not been made within 6 months, you should seek professional help. Regular use of Nicotinell sucking tablets for longer than 6 months is not recommended. Some former smokers may require longer treatment to avoid relapse.

Counselling can increase your chances of successfully quitting smoking.

Instructions for use:

Sucking tablets must not be swallowed.

1. Place the tablet in your mouth and suck it slowly until the taste becomes strong.
2. Place the tablet between your cheek and gum.
3. When the taste fades, suck the tablet slowly again.
4. Repeat this process until the tablet has completely dissolved (approximately 30 minutes).

Avoid consuming coffee, acidic or carbonated drinks for 15 minutes before taking the tablet, as they may reduce nicotine absorption. Do not eat or drink while a tablet is in your mouth.

If you take more Nicotinell Mint than you should

You may experience symptoms similar to those caused by smoking a large amount of tobacco. Symptoms of nicotine overdose include: weakness, pale skin, sweating, increased salivation, throat irritation, nausea, vomiting, diarrhea, abdominal pain, disturbances in vision and hearing, headache, increased or irregular heart rate, shortness of breath, dizziness, tremor, and confusion.

In cases of severe overdose, these symptoms may be followed by exhaustion, low blood pressure, circulatory collapse, coma, breathing difficulties, and seizures.

Stop taking the tablets and contact a doctor immediately to assess the risk and receive advice if you have taken more medicine than recommended, or if a child has accidentally ingested the medicine.

If nicotine poisoning in a child is suspected, consult a doctor immediately. Even small amounts of nicotine are dangerous and potentially fatal for children and may cause severe poisoning symptoms, which can be fatal.

If you forget to take Nicotinell

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause 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. Occasionally, these may be due to insufficient nicotine administration.

Other possible withdrawal symptoms related to stopping smoking may include insomnia, cough, weakness, fatigue, malaise, and flu-like symptoms.

Stop taking Nicotinell Mint and contact a doctor immediately if you experience any of the following symptoms of a severe allergic reaction (angioedema or anaphylactic reaction):

• Swelling of the face, tongue, or throat; difficulty swallowing; hives; and breathing difficulties. These side effects are rare.

Other possible adverse effects:

Very common (may affect more than 1 in 10 people):

• Feeling sick (nausea).

Common (may affect up to 1 in 10 people):

• Inflammation of the mouth mucosa, oral discomfort.
• Sore throat.
• Vomiting.
• Stomach discomfort, stomach pain.
• Diarrhoea.
• Indigestion / heartburn. Sucking the tablet more slowly usually resolves these problems.
• Flatulence.
• Hiccups.
• Constipation.
• Headache and dizziness.
• Cough.
• Dry mouth.

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

• Palpitations.

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

• Heart rhythm disturbances and allergic reactions.
• Hypersensitivity reactions.

Frequency not known (cannot be estimated from available data):

• Urticaria.
• Ulcerative stomatitis.
• Tremor.
• Shortness of breath.
• Difficulty swallowing.
• Belching.
• Increased salivation.
• Weakness.
• Fatigue.
• Feeling unwell and flu-like symptoms.
• Fast and irregular heartbeat (Atrial fibrillation).

Mouth ulcers may occur when trying to quit smoking, but the relationship with nicotine treatment is not clear.

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 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 Mint

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

Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nicotinell Mint

• The active substance is nicotine. Each pastille contains 2 mg (equivalent to 6.144 mg of nicotine bitartrate dihydrate).
• The other components are: maltitol (E965), anhydrous sodium carbonate, sodium hydrogen carbonate, polyacrylate, xanthan gum, anhydrous colloidal silica, levomenthol, peppermint essential oil, aspartame (E951) and magnesium stearate.

Appearance of the product and contents of the pack

Nicotinell Mint pastilles are white, round, biconvex pastilles with a mint flavour.

Nicotinell Mint pastilles are available in two strengths (1 mg and 2 mg). This leaflet is for Nicotinell Mint 2 mg pastilles.

Nicotinell Mint is available in packs of 12, 36, 72, 96, 144, 192 or 204 pastilles in blister packs. Only certain pack sizes may be marketed.

Marketing Authorisation Holder

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

Manufacturer

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited
980 Great West Road, Brentford
Middlesex TW8 9GS
United Kingdom

or

Haleon Belgium NV
Da Vincilaan 5,
1930 Zaventem,
Belgium

or

Haleon Denmark ApS
Delta Park 37, 2665 Vallensbæk Strand (Denmark)

or

Haleon Germany GmbH
Barthstrasse 4 - 80339
Munich (Germany)

or

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

or

Dr. Reddy’s Denmark ApS
Delta Park 45 DK-2665
Vallensbæk Strand
Denmark

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 has been authorised in the following EEA Member States under the following names:

Germany: Nicotinell Lutschtabletten 2 mg Mint
Austria: Nicotinell Mint 2 mg Lutschtabletten
Denmark: Nicotinell Mint 2 mg Sugetablet
Spain: Nicotinell Mint 2 mg comprimidos para chupar
Finland: Nicotinell Mint 2 mg Imeskelytabletti
France: Nicotinell Menthe 2 mg, comprimé à sucer
Ireland: Nicotinell Mint 2 mg compressed Lozenge
Iceland: Nicotinell mint 2 mg Munnsogstafla
Luxembourg: Nicotinell Mint 2 mg, comprimé à sucer
The Netherlands: Nicotinell Mint 2 mg Zuigtablet
Portugal: Nicotinell Mint 2 mg Pastilhas
United Kingdom: Nicotinell Mint 2 mg Lozenge
Sweden: Nicotinell Mint 2 mg sugtablett

Date of the most recent revision of this leaflet: December 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/