Product Information for the Patient

Nicorette BucoMist 1 mg/pulse Oral Solution, Fruit Mint Flavor

Nicotine

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this product information or those indicated by your doctor or pharmacist.

• Keep this product information, as you may need to refer to 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 they are not listed in this product information. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 6 months of treatment with Nicorette BucoMist.

1. What is Nicorette BucoMist and how is it used

2. What you need to know before starting to use Nicorette BucoMist

3. How to use Nicorette BucoMist

4. Possible adverse effects

5. Storage of Nicorette BucoMist

6. Contents of the package and additional information

Nicorette BucoMist belongs to a group of medicines used as a help to quit smoking when there is the intention to quit or reduce tobacco consumption before quitting definitively. This type of treatment is called Nicotine Replacement Therapy (NRT).

Nicorette BucoMist relieves the symptoms of withdrawal that appear when quitting smoking, including cravings to smoke. When nicotine from tobacco is suddenly stopped from the body, different unpleasant sensations may appear, which is collectively known as nicotine withdrawal syndrome. The use of Nicorette BucoMist can prevent or reduce nicotine withdrawal syndrome, including cravings to smoke. Its action is due to the fact that Nicorette BucoMist continues to administer a small amount of nicotine to the body for a short period of time. Nicorette BucoMist does not contain tar, carbon monoxide, or other toxins present in tobacco.

To increase the chances of quitting smoking, it is essential to have advice and support.

You should consult a doctor if you get worse or do not improve after 6 months of treatment.

Do not use Nicorette BucoMist

• If you are allergic to nicotine or any of the other components of this medication (listed in section 6).
• If you are under 18 years old.
• If you have never smoked.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Nicorette BucoMist.

Consult your doctor before starting to use this medication if you suffer from any of the following conditions. You may be able to use Nicorette BucoMist, but you will need to consult your doctor first:

• You have recently (within 3 months) had a heart attack or heart attack.
• You suffer from chest pain (angina) or resting angina.
• You suffer from any heart condition that affects heart rhythm or frequency.
• You have uncontrolled high blood pressure (hypertension).
• You have had any allergic reaction with inflammation of the lips, face, and throat (angioedema) or skin irritation (urticaria). Nicotine replacement therapy can sometimes cause this type of reaction.
• You suffer from severe or moderate liver disease.
• You suffer from severe kidney disease.
• You suffer from diabetes.
• You have hyperactivity of the thyroid gland.
• You have a tumor in the adrenal gland (pheochromocytoma).
• You suffer from stomach or duodenal ulcers.
• You have esophagitis.
• You have a history of epilepsy or seizures.

Non-smokers should not use Nicorette BucoMist.

Children and adolescents

Do not administer this medication to children and adolescents.

Using Nicorette BucoMist with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication. This is especially important if you take medications that contain:

theophyllinefor asthma treatment

tacrinefor Alzheimer's disease

clozapinefor schizophrenia

ropinirolefor Parkinson's disease treatment.

Using Nicorette BucoMist with food and drinks

Do not eat or drink while applying a spray.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

It is very important to stop smoking during pregnancy because it may cause intrauterine growth retardation, premature birth, or stillbirth. Ideally, you should try to stop smoking without using any nicotine-containing medication. If you cannot, you should only use Nicorette BucoMist if your general practitioner, the doctor controlling your pregnancy, or a specialist in smoking cessation recommends it.

Breastfeeding

You should avoid using Nicorette BucoMist during breastfeeding, as nicotine passes into breast milk in amounts that may affect the baby. If your doctor has recommended using Nicorette BucoMist during breastfeeding, the spray or sprays should be applied immediately after feeding and never during the two hours before feeding.

Fertility

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

Driving and operating machinery

No effects have been observed on the ability to drive or operate machinery.

Nicorette BucoMistcontains12 mg of propylene glycol per spray. This medication contains approximately 7 mg of alcohol (ethanol) in each spray, equivalent to 97 mg/ml. The amount of alcohol contained in each spray of this medication is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medication will have no perceptible effect. This medicinal product also contains less than 1 mmol of sodium (23 mg) per spray, i.e., it is practically sodium-free. Due to the presence of butyl hydroxytoluene, Nicorette BucoMist may cause skin reactions (e.g., contact dermatitis) or irritation in the eyes or mucous membranes

.

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

Nicorette BucoMist should not be used in individuals under18 years.

Consult your doctor if you have not achieved a reduction in the number of sprays or in the number of cigarettes smoked after 6 weeks of treatment or if you need to use Nicorette BucoMist for more than 6 months. Normally, you should use Nicorette BucoMist for 3 months. Nicorette BucoMist should not be taken for more than 6 months.

The use of Nicorette BucoMist will depend on whether you stop smoking immediately or if you are gradually reducing the number of cigarettes before quitting completely.

Stopping smoking immediately

The goal is to stop smoking immediately and use the spray to alleviate nicotine cravings.

Do not use more than 2 sprays at a time or 4 sprays per hour for 16 hours. The maximum dose is 64 sprays over 16 hours in any 24-hour period.

Gradually stopping smoking

The goal is to start replacing some cigarettes with Nicorette BucoMist gradually. Once this goal is achieved, stop smoking completely and switch to using only the spray.

When you feel a strong urge to smoke, apply 1-2 sprays from the spray instead of a cigarette to help you control your cravings. The spray is to replace a cigarette, do not smoke shortly after using it. Using the spray without reducing the number of cigarettes you smoke will make you feel sick (see the section “If you use more Nicorette BucoMist than you should”). Reduce the number of cigarettes you smoke per day as much as possible and replace them with a spray. As soon as you feel ready, you should stop smoking completely, in any case no later than 12 weeks after starting treatment. After stopping smoking, gradually reduce the number of sprays per day. When you have reduced the sprays to 2-4 per day, stop using Nicorette BucoMist.

Do not use more than 2 sprays at a time or 4 sprays per hour for 16 hours. The maximum dose is 64 sprays over 16 hours in any 24-hour period.

Atthe end of treatment, you may again feel the urge to smoke. Keep the packaging with the unused doses of the medication for those situations where you suddenly feel a very strong urge to smoke. You can apply a spray, or two sprays if the first spray does not help within a few minutes.

Follow these instructions carefully and use the diagrams as a guide

Open the nozzle

How to open the dispenser

1. Use your thumb to slide the button (a) down until it can be pressed lightly inward (b). Do not press too hard.
2. While pressing the button, slide (c) up to open the top of the dispenser.

How to load the dispenser

When using Nicorette BucoMist for the first time, you must load the spray pump. Point the nozzle at a safe place for you where there are no other adults, children, or pets. Press the top of the dispenser with your index finger three times until a fine spray appears. If you do not use Nicorette BucoMist for two days, the loading procedure must be repeated.

How to use the dispenser

1. Point the nozzle at the open mouth as close as possible.
2. Press the top of the dispenser firmly to release a spray into the mouth, avoiding the lips. Do not inhale while applying to avoid the spray entering the throat. For better results, do not swallow in the seconds following the spray.

To remove the nozzle

How to close the dispenser

1. Slide the button (d) down until it can be pressed inward.
2. While pressing, slide the top of the dispenser down (f).Release the button. The dispenser will now be closed.

To use another dose, repeat the steps mentioned above.

Close the dispenser after each use to prevent Nicorette BucoMist from being used by children or accidental sprays. Be careful not to spray your eyes during the administration of Nicorette BucoMist. If the spray comes into contact with your eyes, they should be flushed abundantly with water.

If you use more Nicorette BucoMist than you should

If you smoke at the same time as using Nicorette BucoMist, you may experience symptoms of nicotine overdose.

If a child uses Nicorette BucoMist or if you use too many sprays, consultimmediatelyyour doctor, go to the nearest hospital, or call the Toxicology Information Service (phone91 562 04 20), indicating the name and amount used. The tolerated doses by adults during treatment can cause severe poisoning inchildrenand even cause theirdeath.

The symptoms of overdose are nausea, vomiting, excessive salivation, stomach pain, diarrhea, sweating, headache, and dizziness, auditory disturbances, and a feeling of weakness. At high doses, these symptoms may be followed by a drop in blood pressure, weak and irregular pulse, difficulty breathing, extreme fatigue, circulatory collapse, and generalized convulsions.

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

Like all medicines, Nicorette BucoMist can cause side effects, although not everyone will experience them.

Nicorette BucoMist can cause the same side effects as other forms of nicotine. These effects depend, generally, on the dose taken.

Effects related to quitting smoking (nicotine withdrawal)

Some of the unwanted effects that occur when quitting smoking may be nicotine withdrawal syndromes due to the decrease in nicotine consumption.

These effects include:

• Irritability, aggression, impatience, or frustration.
• Sensation of anxiety, agitation, or difficulty concentrating.
• Sleep disturbances.
• Increased appetite or weight gain.
• Depression.
• Urges to smoke (anxiety).
• Decreased heart rate.
• Bleeding gums or mouth ulcers.
• Dizziness or mild disorientation.
• Cough, sore throat, nasal congestion, or nasal discharge.
• Constipation.

If you notice any of the following rare side effects, stop using Nicorette BucoMist and consult your doctor immediately (signs of angioedema):

• Swelling of the face, tongue, or throat.
• Difficulty swallowing.
• Hives or difficulty breathing.

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

• Hiccup (particularly common).
• Headache, nausea (sensation of illness).
• Irritation of the throat.

Common: may affect up to 1 in 10 people:

• Effects at the administration site such as a burning sensation, inflammation of the mouth, or changes in the perception of flavors.
• Dry mouth or increased saliva production.
• Sensation of indigestion.
• Pain or discomfort in the abdomen.
• Vomiting, flatulence, or diarrhea.
• Sensation of fatigue (fatigue).
• Hypersensitivity (allergy)
• Tickling.

Rare: may affect up to 1 in 100 people:

• Effects in the nose such as nasal congestion or sneezing.
• Nasal discharge
• Snoring (bronchospasm), or sensation of needing to breathe more deeply than normal (dyspnea), throat constriction.
• Redness of the skin (flushing) or increased sweating.
• Effects in the mouth such as tingling, inflammation of the tongue, mouth ulcers, damage to the mucous membrane of the mouth, or changes in the sound of the voice, pain in the mouth and throat, belching, bleeding gums.
• Palpitations (unusual sensation of heart beating), increased heart rate, hypertension.
• Hives and/or itching (pruritus, urticaria) of the skin.
• Abnormal dreams.
• Discomfort in the chest and pain.
• Sensation of weakness, sensation of discomfort.

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

• Difficulty swallowing, sensation of numbness in the mouth.
• Yawning.

Frequency not known: frequency that cannot be estimated with the available data

• Blurred vision, increased tear production (lacrimation).
• Dry throat, stomach discomfort, lip pain.
• Abnormal heart rhythm.
• Redness of the skin.
• Allergic reactions including swelling of the face and mouth (angioedema or anaphylaxis).
• Seizures

Reporting of side effects

Ifyou experience side effects, consult your doctor or pharmacist,even if it is for side effects that do not appear in this leaflet.

You can also report them directly throughthe Spanish System for the Pharmacovigilance of Medicines for Human Use. Website:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment, especially the aquatic environment in the case of nicotine.

Nicorette BucoMist Composition

• The active ingredient is nicotine. A spray releases 1 mg of nicotine.
• The other components (excipients) are propylene glycol (E1520), anhydrous ethanol, trometamol, poloxamer 407, glycerol (E422), sodium hydrogen carbonate, levomenthol, red fruit flavoring, refreshing aroma, sucralose, potassium acesulfame, butyl hydroxytoluene (E321), hydrochloric acid, and purified water.

Product Appearance and Packaging Contents

Nicorette BucoMist consists of a plastic bottle located in a dispenser with a mechanical spray pump.The dispenser has a child safety system.

Each bottle contains 13.2 ml of solution equivalent to 150 sprays.

Nicorette BucoMist is supplied in packs of 1.2 or 3 dispensers.

Nicorette BucoMist is also available in packs of 1.2 or 3 dispensers that include, under the rear label, a near-field communication (NFC) field communication chip that allows connectivity with the mobile application. Those dispensers carry this icon

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Marketing Authorization Holder:

JNTL Consumer Health (Spain), S.L.

Paseo de las Doce Estrellas 5-7

28042 Madrid- Spain

Manufacturer Responsible:

McNeil AB,

P.O. Box 941, Norrbroplatsen 2, SE-251 09 Helsingborg, Sweden

or

Johnson & Johnson Consumer NV/SA,

Michel De Braeystraat 52, 2000 Antwerp

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: June 2023

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es