NICOTINELL FRUIT 4 mg MEDICINAL CHEWING GUM

Introduction

Package Leaflet: Information for the User

Nicotinell Fruit 4 mg Medicinal Chewing Gum

Nicotine

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

This medication can be obtained without a prescription. Nevertheless, to achieve the best results,

you should use Nicotinell Fruit 4 mg medicinal chewing gum correctly.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

You should consult a doctor if you still need to use Nicotinell after 6 months.

Contents of the Package Leaflet:

1. What is Nicotinell Fruit and what is it used for
2. What you need to know before taking Nicotinell Fruit
3. How to take Nicotinell Fruit
4. Possible side effects
5. Storage of Nicotinell Fruit
6. Package Contents and Additional Information

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

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

Nicotinell contains the active ingredient nicotine.

When you chew the gum, the nicotine is released slowly and absorbed through the mouth mucosa.

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

Counseling and patient support usually improve the chances of success.

2. What you need to know before taking Nicotinell Fruit

Do not take Nicotinell Fruit

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

• If you are a non-smoker.

Warnings and Precautions

Consult your doctor or pharmacist before taking 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 problems 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, you should try to stop smoking without using any nicotine replacement therapy product, unless your doctor tells 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 often when you start using nicotine gum. Your need for insulin or medication may change,
• overactive thyroid gland (hyperthyroidism),
• overactive adrenal glands (pheochromocytoma),
• you suffer from kidney or liver failure,
• stomach or duodenal ulcers or inflammation of the esophagus or throat (the passage between the mouth and stomach), as nicotine replacement therapy may worsen your symptoms,
• fructose intolerance,
• if you have ever experienced seizures.

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

People with jaw joint problems and some people with dentures may have difficulty chewing the gum. If this is your case, 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 are dangerous and can cause serious symptoms or death in children. If poisoning is suspected in a child, consult a healthcare professional immediately. 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 medications

Tell your doctor or pharmacist if you are using or have recently used any other medication. Quitting smoking may alter the effect of other medications you may be taking. If you have any questions or concerns about this, consult a healthcare professional.

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

Quitting smoking may change 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 adjusted.

Taking Nicotinell Fruit with food and drinks

Consuming coffee, acidic beverages (e.g., fruit juices), or soft drinks can decrease the absorption of nicotine, so they should be avoided during the 15 minutes prior to chewing Nicotinell because they can 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 stop smoking after the recommendation of a healthcare professional.

Breastfeeding

If you are breastfeeding, nicotine replacement therapy should only be used after the advice of a healthcare professional because nicotine can pass into breast milk.

Fertility

Smoking increases the risk of infertility in women and men.

Driving and Using Machines

Although there are no known effects on the ability to drive or use machines at the recommended doses, it should be taken into account that quitting smoking causes changes in behavior.

Nicotinell Fruit contains sorbitol, butylhydroxytoluene, and sodium

This medication contains sorbitol, which is a source of fructose. If your doctor has told 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 person cannot break down fructose, consult with them before taking this medication. If you do not tolerate sorbitol, do not use this product.

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

Each Nicotinell Fruit 4 mg gum contains 0.2 g of sorbitol, as a sweetener, which is a source of 0.04 g of fructose. The caloric value is 0.9 kcal/gum.

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

3. How to take Nicotinell Fruit

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

To improve the chances of success in quitting smoking, you should not smoke at all when starting to use Nicotinell and during the entire treatment.

Nicotinell is available in two dosages: 2 and 4 mg. The appropriate dose depends on your previous habits as a smoker. You should take Nicotinell 4 mg if:

• You are a smoker with high or very high nicotine dependence.
• You have not managed to quit smoking previously using Nicotinell 2 mg.
• Your symptoms from quitting smoking are so intense that you relapse and start smoking again.

In any other case, you should use Nicotinell 2 mg.

Select the appropriate dosage for you based on the following table:

If you experience any adverse event when starting treatment with a high-dose form (Nicotinell 4 mg), it should be replaced with a lower-dose form (Nicotinell 2 mg).

Method of Administration:

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

Chew 1 gum when you feel the urge to smoke. Do not use more than 1 gum at a time. Do not use more than 1 gum per hour.

1. Chew the gum slowly until the flavor becomes intense. Do not eat or drink while you have a gum in your mouth.
2. Place the gum between your cheek and gum.
3. When the flavor decreases, chew the gum again.
4. Repeat this process for 30 minutes to release the nicotine gradually.

Medicinal gums should not be swallowed.

Recommended dose for adults over 18 years and elderly:

Chew a gum when you start to feel the need to smoke. In general, you should chew a gum every 1-2 hours. In most cases, 8-12 gums per day are sufficient. If you still feel the need to smoke, you can chew an extra gum. Do not take more than 15 Nicotinell 4 mg gums per day.

The duration of treatment is individual. Normally, treatment should be followed for 3 months. After 3 months, the number of gums per day will be gradually reduced. The treatment should end when gum consumption has been reduced to 1 or 2 gums per day.

It is not recommended to use Nicotinell for more than 6 months. However, some ex-smokers may need longer treatment with medicinal gums to avoid relapse.

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

Counseling and patient support usually improve the chances of success.

Use in Children and Adolescents

Nicotinell should notbe used by minors under 18 years without the recommendation of a doctor.

If you take more Nicotinell Fruit than you should

Chewing too many Nicotinell gums can cause symptoms similar to those that occur when smoking a large amount of tobacco. If you use too many nicotine gums, you may start to feel sick, dizzy, and unwell. Stop using the gums 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, changes in vision and hearing, headache, alteration of heart rhythm (tachycardia), shortness of breath, confusion, prostration, circulation 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 poisoning is suspected in a child, you should consult a doctor immediately. Even small amounts of nicotine are dangerous and potentially fatal for children and can cause serious symptoms or death.

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

If you forget to use Nicotinell

Do not take a double dose to make up for the forgotten dose.

If you stop using Nicotinell

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

4. Possible Side Effects

Like all medications, Nicotinell can have 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 symptoms related to quitting smoking, and sometimes may be due to insufficient nicotine administration.

They are grouped according to the likelihood with which they may occur:

Very Common(may affect 1 in 10 people)

• feeling unwell (nausea).

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

• the gums can cause mild pain or irritation in the mouth or tongue
• sore throat or inflammation
• feeling sick
• stomach upset
• diarrhea
• indigestion/stomach acid
• flatulence
• hiccups
• excessive salivation
• constipation
• difficulty swallowing

• dizziness and headache
• vomiting
• insomnia
• cough
• dry mouth
• and jaw muscle pain, especially as a result of intense gum chewing. Chewing the gum more slowly can solve these problems.

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

• feeling heartbeats (palpitations)
• skin itching with hives (urticaria).

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

• rapid or irregular heartbeats
• difficulty breathing
• symptoms of severe allergic reaction including sudden wheezing or tightness of the chest, rash, and feeling of fainting

• heart rhythm disturbances (faster heartbeat) and allergic reactions. Allergic reactions can, in very rare cases, be severe and have the following symptoms:
• skin swelling;
• facial and mouth inflammation;
• fainting, dizziness, and fainting (symptoms of low blood pressure);
• difficulty breathing.

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

In rare cases, Nicotinell can stick to and damage dentures or other dental prosthetics.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Nicotinell Fruit

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

Do not use Nicotinell after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Do not dispose of medications through wastewater or household waste. Deposit the packaging and unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Nicotinell Fruit Composition

• The active ingredient is nicotine. Each medicinal gum contains 4 mg (corresponding to 20 mg of nicotine-polacrilin).
• The other components are: gum base (contains butylhydroxytoluene (E321)), calcium carbonate, sorbitol (E420), sodium carbonate anhydrous, sodium hydrogen carbonate, polacrilin, glycerol (E422), purified water, levomenthol, tutti-frutti flavoring, saccharin, saccharin sodium acesulfame potassium, xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax, and talc. See section 2 "Nicotinell Fruit contains sorbitol, butylhydroxytoluene, and sodium".

Product Appearance and Package Contents

Nicotinell medicinal gum is available in two dosages (2 and 4 mg) and three flavors (Nicotine, Fruit, and Cool Mint). This package leaflet corresponds to Nicotinell Fruit 4 mg medicinal gum.

Nicotinell 4 mg is presented in the form of a white, matte, rectangular medicinal gum.

Nicotinell 4 mg is presented in packages of 2, 12, 24, 36, 48, 60, 72, 96, 120, or 204 medicinal gums in blisters. Not all package 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 medication 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 medicinal 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 package leaflet was revised in November 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/