NICOTINELL FRUIT 2 mg MEDICINAL CHEWING GUM

Introduction

Package Leaflet: Information for the User

Nicotinell Fruit 2 mg Medicinal Chewing Gum

Nicotine

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

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

you should use Nicotinell Fruit 2 mg medicinal chewing gum correctly.

Follow the administration instructions of the medicine 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 side effects 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. Contents of the pack and further information

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

Nicotinell belongs to a group of medicines 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 medicine

(including those 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 be altered,
• 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,

Keep all medicines 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 medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicine. Stopping smoking may alter the effect of other medicines 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 medicines. However, apart from nicotine, other substances in cigarettes may affect some treatments.

Stopping smoking may change 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 adjusted.

Taking Nicotinell Fruit with food and drinks

Consuming coffee, acidic beverages (e.g., fruit juices), or soft drinks may decrease the absorption of nicotine, so they should be avoided during the 15 minutes prior to chewing Nicotinell because 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 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 stopping smoking causes changes in behavior.

Nicotinell Fruit contains sorbitol, butylhydroxytoluene, and sodium

This medicine 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 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 because it contains butylhydroxytoluene.

Each Nicotinell Fruit 2 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 1.0 kcal/gum.

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

3. How to take Nicotinell Fruit

Follow the administration instructions of the medicine 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 stopping smoking, you should not smoke at all when starting to use Nicotinell or 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 stop smoking previously using Nicotinell 2 mg.
• Your symptoms derived from stopping 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 from 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 stop smoking successfully 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 a 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 operation 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 24 Nicotinell 2 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 use 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 produced by 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 medicine, 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 medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 smoking cessation syndrome itself, 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 sick (nausea).

Common(may affect 1 to 10 in 100 people):

• The gums may cause pain or mild irritation in the mouth or tongue
• sore throat or inflammation
• feeling sick
• stomach upset
• diarrhea
• indigestion/heartburn
• 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)
• itching of skin bumps (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 chest tightness, skin 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;
• inflammation of the face and mouth;
• fainting, dizziness, and fainting (symptoms of low blood pressure);
• difficulty breathing.

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

In rare cases, Nicotinell may adhere to and damage dentures or other dental prostheses.

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect 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 medicine.

5. Storage of Nicotinell Fruit

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

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

Do not store above 25°C.

Do not throw away medicines via wastewater or household waste. Dispose of the packaging and medicines you no longer need in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer use. This way, you will help protect the environment.

6. Contents of the pack and further information

Composition of Nicotinell Fruit

• The active ingredient is nicotine. Each medicinal gum contains 2 mg (corresponding to 10 mg of nicotine-polacrylate).
• The other ingredients are: gum base (contains butylhydroxytoluene (E321)), calcium carbonate, sorbitol (E420), sodium carbonate anhydrous, sodium hydrogen carbonate, polacrylate, glycerol (E422), purified water, levomenthol, tutti-frutti flavoring, saccharin, sodium saccharin, acesulfame potassium, xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax, and talc. See section 2 "Nicotinell Fruit contains sorbitol, butylhydroxytoluene, and sodium".

Appearance of the product and pack contents

Nicotinell medicinal chewing 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 2 mg medicinal chewing gum.

Nicotinell 2 mg is presented in the form of a white, matte, rectangular medicinal gum.

Nicotinell 2 mg is available in packs of 2, 12, 24, 36, 48, 60, 72, 96, 120, or 204 medicinal gums in blisters. Not all pack 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium Nicotinell Fruit, 2 mg, kauwgom

Denmark Nicotinell Fruit, medicinsk tyggegummi

Spain Nicotinell Fruit 2 mg medicinal chewing gum

Estonia Nicotinell Fruit

Finland Nicotinell Fruit 2 mg lääkepurukumi

France NICOTINELL FRUIT 2 mg SANS SUCRE, gomme à mâcher médicamenteuse

Greece Nicotinell Fruit

Hungary Nicotinell Fruit 2 mg gyógyszeres rágógumi

Ireland Nicotinell Fruit 2mg Medicated Chewing Gum

Latvia Nicotinell Fruit 2 mg arstnieciska košlajama gumija

Lithuania Nicotinell Fruit 2 mg vaistine kramtomoji guma

Luxembourg Nicotinell Fruit, 2 mg, gomme à mâcher médicamenteuse

Netherlands Nicotinell Fruit, 2 mg, kauwgom

Norway Nicotinell medisinsk tyggegummi med fruktsmak

Portugal Nicotinell Fruit 2 mg

United Kingdom Nicotinell Fruit 2mg Medicated Chewing Gum

Sweden Nicotinell Fruit 2 mg medicinskt tuggummi

This package leaflet was last revised in November 2021

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