Leaflet: information for the user

Nicotinell Mint 2 mg chewing tablets

nicotine

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

- If symptoms worsen or persist after 6 months, you must consult a doctor.

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

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

3. How to take Nicotinell Mint

4. Possible side effects

5. Storage of Nicotinell Mint

6. Contents of the pack and additional information

Nicotinell Mint belongs to a group of medications used as a help to quit smoking. Nicotinell Mint chewing tablets contain the active ingredient nicotine

.

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

This medication is used to help people quit smoking. The nicotine contained in Nicotinell Mint chewing tablets alleviates the symptoms of nicotine withdrawal and anxiety that occur when quitting smoking or progressively reducing tobacco consumption to facilitate the process of quitting smoking. By alleviating nicotine withdrawal symptoms and anxiety, Nicotinell Mint chewing tablets counteracts relapses in motivated smokers trying to quit.

Patient advice and support usually improve the chances of success.

Nicotinell Mint chewing tablets is indicated for smokers 18 years of age or older.

Do not take Nicotinell Mint chewing tablets

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

This medication (including those 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 problem, such as having recently had a heart attack, experiencing heart rhythm problems, heart failure, or chest pain (angina, including Prinzmetal's angina). While using this medication, if you experience an increase in heart problems, you should reduce or stop using this medication.
• Stroke (cerebral apoplexy).
• High blood pressure.
• Circulation problems.
• Diabetes. You should control your blood sugar levels more frequently than usual when starting to use nicotine tablets. Your insulin or medication requirements may change.
• Hypothyroidism.
• Overactive adrenal glands (pheochromocytoma).
• Renal or hepatic insufficiency.
• Esofagitis, inflammation of the mouth or throat, gastritis, or peptic ulcer.
• History of epilepsy (seizures).

Children and adolescents

Nicotinell should not be used by adolescents between 12 and 17 without a prescription from a healthcare professional.

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

Use of Nicotinell Mint with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. If you want to quit smoking and are taking other medications, your doctor may need to adjust the dose.

There is no information about interactions between Nicotinell Mint chewing tablets and other medications. However, apart from nicotine, other substances in cigarettes may affect some treatments.

Quitting smoking may modify the effect of medications 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 re-adjusted

Use of Nicotinell Mint with food and drinks

The consumption of coffee, acidic beverages (lemon, orange, etc.), or soft drinks may reduce the absorption of nicotine, so they should be avoided during the 15 minutes before taking the tablet. Do not eat or drink while having a tablet in your mouth.

Pregnancy, breastfeeding, and fertility

Pregnancy

It is very important to quit smoking during pregnancy because it can be harmful to the fetus's development. It may induce premature births and even stillbirths. It would be best to quit smoking without using medications containing nicotine. If you cannot quit smoking without medications, Nicotinell should be used only after consulting a healthcare professional.

Breastfeeding

The treatment with Nicotinell Mint should be avoided during breastfeeding because nicotine passes into breast milk and may affect your baby. If a healthcare professional recommends continuing treatment during breastfeeding, you should take the tablet immediately after feeding your baby, and in no case when there are less than 2 hours before feeding your baby again.

Fertility

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

Driving and operating machinery

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

Nicotinell Mint contains aspartame, mannitol, and sodium

This medication contains 10 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains maltitol (E965). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. You may experience a mild laxative effect.

The caloric value is 2.3 Kcal/g of maltitol. The components of Nicotinell Mint tablets are suitable for diabetics.

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

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

• You are a smoker with high or very high nicotine dependence;
• You have not been able to stop smoking previously using 1mg chewing tablets;
• Your symptoms resulting from quitting smoking are so intense that you relapse and start smoking again.

In any other case, you should use Nicotinell Mint 1mg chewing tablets.

Adults over 18 years old

Select the appropriate dose for you from the following table:

If any adverse event is observed when starting treatment with a high dosage form (2mg chewing tablets), it should be replaced by a lower dosage form (1mg chewing tablets).

Dose for adults over 18 years old

Take a chewing tablet when you start feeling the need to smoke. In general, you should take a chewing tablet every 1-2 hours. In most cases, the amount of 8-12 chewing tablets per day is sufficient. If you still feel the need to smoke, you can take additional chewing tablets. Do not take more than 15 2 mg chewing tablets per day (both for quitting smoking and for progressive reduction of tobacco consumption). Do not take more than one chewing tablet per hour.

The primary purpose of Nicotinell chewing tablets should be to quit smoking.

Drastic suppression of tobacco consumption:

To improve the possibility of success in quitting smoking, you should not smoke at all when starting the use of chewing tablets or during the complete treatment.

The duration of treatment is individual. Normally, the treatment should be followed for at least 3 months. After 3 months, the number of chewing tablets per day will be reduced gradually. The treatment should be completed when the consumption of chewing tablets has been reduced to 1 or 2 chewing tablets per day.

Do not recommend using Nicotinell Mint chewing tablets for more than 6 months. However, some ex-smokers may need a longer treatment with chewing tablets to avoid relapsing and smoking again. If you are still using chewing tablets after 6 months, you should consult your doctor or pharmacist.

Advice and support for the patient usually improve the chances of success.

Progressive reduction of tobacco consumption:

You should use Nicotinell chewing tablets to prolong the periods when you do not smoke and reduce tobacco consumption as much as possible. The number of cigarettes should be gradually replaced by Nicotinell chewing tablets. If after 6 weeks you have not been able to reduce the number of cigarettes per day by at least half, you should seek professional advice. You should try to quit smoking as soon as you feel prepared, but in any case, within the first 4 months since you started using Nicotinell chewing tablets. Then, you should gradually reduce the number of chewing tablets, for example, by removing one chewing tablet every 2-5 days.

If within 6 months there has been no serious attempt to quit smoking, you should seek professional help. Do not recommend using Nicotinell chewing tablets regularly for more than 6 months. Some ex-smokers may need a longer treatment to avoid relapsing and smoking again.

Advice can increase your chances of quitting smoking.

Usage instructions:

Chewing tablets should not be swallowed.

1.Insert the tablet into your mouth and chew it slowly until its flavor becomes intense.

2.Place the tablet between your cheek and gum.

3.As the flavor decreases, chew the tablet slowly again.

4.Repeat this process until the tablet has completely dissolved (approximately 30 minutes).

Avoid taking coffee, acidic drinks, and soda for 15 minutes before chewing the tablet, as they may reduce nicotine absorption. Do not eat or drink while you have a tablet in your mouth.

If you take more Nicotinell Mint than you should

You may experience symptoms similar to those that occur when smoking a large amount of tobacco. Symptoms of nicotine overdose include: weakness, pale skin, sweating, increased salivation, sore throat, nausea, vomiting, diarrhea, abdominal pain, visual and auditory disturbances, headache, increased or any other alteration of heart rate, shortness of breath, dizziness, tremor, and confusion.

With large overdoses, these symptoms may be followed by exhaustion, low blood pressure, circulatory collapse, coma, difficulty breathing, and convulsions.

Stop taking the tablets and contact a doctor or pharmacist immediately to evaluate the risk and receive advice if you have taken more medication than you should, or if a child has taken the medication by mistake.

If you suspect poisoning in a child, you should consult a doctor immediately. Even small amounts of nicotine are dangerous, and possibly fatal, for children and may lead to severe poisoning symptoms that can be fatal.

If you forgot to take Nicotinell

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationmay produce

side 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 can be attributed to the underlying symptoms related to quitting smoking, and in some cases, it may be due to insufficient nicotine administration.

Other possible symptoms of withdrawal related to quitting the smoking habit may be insomnia, cough, weakness, fatigue, feeling unwell, and symptoms similar to the flu.

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

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

Other possible side effects that may occur:

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

• Feeling sick (nausea).

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

• Mouth mucosa inflammation, oral discomfort.
• Throat pain.
• Vomiting.
• Stomach discomfort, stomach pain.
• Diarrhea.
• Indigestion / stomach acid. Chewing the tablet more slowly usually solves 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:

• Hives
• Ulcerative stomatitis.
• Tremor.
• Shortness of breath.
• Difficulty swallowing.
• Belching.
• Increased saliva secretion.
• Weakness.
• Fatigue.
• Feeling unwell and symptoms similar to the flu.

When trying to quit smoking, mouth ulcers may occur, but the relationship with nicotine treatment is unclear.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use. Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date indicated on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store in the original packaging.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Nicotinell Mint Composition

• The active ingredient is nicotine.Each lozenge contains 2 mg (corresponding 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 package

Nicotinell Mint lozenges are white, round, biconvex tablets with a mint flavor.

Nicotinell Mint lozenges are available in two dosages (1 and 2 mg). This leaflet corresponds to Nicotinell Mint 2 mg lozenges.

Nicotinell Mint is available in blister packs of 12, 36, 72, 96, 144, 192 or 204 lozenges. Some package sizes may not be marketed.

Marketing Authorization Holder

Haleon Spain, S.A.

Parque Tecnológico de Madrid, Calle de Severo Ochoa, 2

28760 Tres Cantos, Madrid – Spain

Responsible for manufacturing

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)

This medicinal product has been authorized in the following Member States of the EEA under the

following names:

GermanyNicotinell Lutschtabletten 2 mg Mint

AustriaNicotinell Mint 2 mg Lutschtabletten

DenmarkNicotinell Mint 2 mg Sugetablet

SpainNicotinell Mint 2 mg lozenges

FinlandNicotinell Mint 2 mg Imeskelytabletti

FranceNicotinell Menthe 2 mg, compressed tablet

IrelandNicotinell Mint 2 mg compressed Lozenge

IcelandNicotinell mint 2 mg Munnsogstafla

LuxembourgNicotinell Mint 2 mg, compressed tablet

NetherlandsNicotinell Mint 2 mg Lozenge

PortugalNicotinell Mint 2 mg Pastilhas

United KingdomNicotinell Mint 2 mg Lozenge

SwedenNicotinell Mint 2 mg sugtablett

Last reviewed date of this leaflet: March 2020

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/