Nicorette 1 mg/puff solution for oral spray

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Nicorette BucoMist 1 mg/spray oral spray solution

Nicotine

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or 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 they are effects not listed in this leaflet. See section 4.

• You should consult a doctor if your condition worsens or if you do not improve after 6 months of treatment with Nicorette BucoMist.

Contents of the leaflet

1. What Nicorette BucoMist is and what it is used for
2. What you need to know before using Nicorette BucoMist
3. How to use Nicorette BucoMist
4. Possible adverse effects
5. How to store Nicorette BucoMist
6. Contents of the pack and other information

1. What Nicorette BucoMist is and what it is used for

Nicorette BucoMist belongs to a group of medicines used to help people stop smoking when there is an intention to quit or reduce tobacco consumption before stopping completely. This type of treatment is known as Nicotine Replacement Therapy (NRT).

Nicorette BucoMist relieves the withdrawal symptoms that occur when quitting smoking, including cigarette cravings. When nicotine from tobacco is suddenly withdrawn from the body, various unpleasant sensations may arise, collectively known as withdrawal syndrome. Using Nicorette BucoMist can prevent or reduce withdrawal symptoms, including the urge to smoke. Its action is based on the fact that Nicorette BucoMist continues to deliver 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 successfully quitting smoking, it is important to receive advice and support.

2. What you need to know before using Nicorette BucoMist

Do not use Nicorette BucoMist

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

Warnings and precautions

Consult your doctor before starting to use this medicine if you have any of the following conditions. You may still be able to use Nicorette BucoMist, but you should discuss it with your doctor first:

• If you have recently had a heart attack or stroke (within the last 3 months).
• If you suffer from chest pain (angina pectoris) or rest angina.
• If you have a heart disease affecting your heart rhythm or heart rate.
• If you have uncontrolled high blood pressure (hypertension) not managed with medication.
• If you have ever had an allergic reaction with swelling of the lips, face, and throat (angioedema) or skin irritation (urticaria). Nicotine replacement therapy may sometimes cause such reactions.
• If you have severe or moderate liver disease.
• If you have severe kidney disease.
• If you have diabetes.
• If you have overactivity of the thyroid gland (hyperthyroidism).
• If you have a tumor of the adrenal medulla (pheochromocytoma).
• If you have a stomach or duodenal ulcer.
• If you have esophagitis.
• If you have a history of epilepsy or seizures.

Non-smokers must not use Nicorette BucoMist.

Children and adolescents

Do not give this medicine to children or adolescents.

Use of Nicorette BucoMist with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is especially important if you are taking medicines containing:

• Theophylline for asthma
• Tacrine for Alzheimer's disease
• Clozapine for schizophrenia
• Ropinirole for the treatment of Parkinson's disease.

Use of Nicorette BucoMist with food and drink

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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

It is very important to stop smoking during pregnancy, as smoking may cause intrauterine growth retardation, premature birth, or stillbirth. Ideally, you should try to stop smoking without using any nicotine-containing medication. If you are unable to do so, you should only use Nicorette BucoMist if your general practitioner, obstetrician, or smoking cessation specialist advises you to.

Breastfeeding

The use of Nicorette BucoMist should be avoided during breastfeeding, as nicotine passes into breast milk in amounts that may affect the baby. If your doctor recommends using Nicorette BucoMist while breastfeeding, the spray(s) should be applied immediately after breastfeeding and never within the two hours preceding breastfeeding.

Fertility

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

Driving and using machines

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

Nicorette BucoMist contains 11 mg of propylene glycol per spray. This medicine contains approximately 7 mg of alcohol (ethanol) in each spray, equivalent to 97 mg/ml. The amount of alcohol in each spray of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effect. This medicinal product also contains less than 1 mmol of sodium (23 mg) per spray, meaning it is practically sodium-free. Due to the presence of butylated hydroxytoluene, Nicorette BucoMist may cause skin reactions (e.g., contact dermatitis) or irritation in the eyes or mucous membranes.

3. How to use Nicorette BucoMist

Follow exactly the instructions for administering this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Nicorette BucoMist must not be used in individuals under 18 years of age.

Consult your doctor if you have not managed to reduce the number of sprays or the number of cigarettes smoked after 6 weeks of treatment, or if you need to use Nicorette BucoMist for longer than 6 months. Nicorette BucoMist is usually intended to be used for 3 months, but not for more than 6 months.

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

Quitting smoking immediately

The goal is to stop smoking immediately and use the sprays from the device to relieve tobacco cravings.

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

Quitting smoking gradually

The goal is to start by gradually replacing some cigarettes with Nicorette BucoMist. Once this goal is achieved, stop smoking cigarettes completely and switch to using only the spray device. Finally, discontinue the use of the medicine completely.

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When you feel a strong urge to smoke, apply 1–2 sprays instead of a cigarette to help control your cravings. The sprays are intended to replace a cigarette; do not smoke shortly after using the spray. Using the spray without reducing the number of cigarettes smoked will make you feel unwell (see section “If you use more Nicorette BucoMist than you should”). Reduce the number of cigarettes you smoke each day as much as possible, replacing them with a spray. As soon as you feel ready, you should stop smoking completely, no later than 12 weeks after starting treatment. After quitting smoking, gradually reduce the number of daily sprays. When you have reduced your use to 2–4 sprays per day, stop using Nicorette BucoMist.

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

At the end of treatment, you may again feel tempted to smoke. Keep the unused portion of the medicine available for situations when a sudden, strong urge to smoke arises. You may apply one spray, or two if the first spray does not help within a few minutes.

Follow these instructions carefully and use the illustrations as a guide

Open the mouthpiece

How to open the dispenser

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

How to prime the dispenser

When using Nicorette BucoMist for the first time, you must prime the spray pump. Point the nozzle in a safe direction, away from yourself and from other adults, children, or pets. Press the top of the dispenser firmly with your index finger 3 times until a fine spray appears. If you do not use Nicorette BucoMist for two days, the priming procedure must be repeated.

How to use the dispenser

1. Point the nozzle toward your open mouth, as close as possible.
2. Press firmly on the top of the dispenser to release one spray into your mouth, avoiding the lips. Do not inhale while administering to prevent the spray from entering your throat. For best results, avoid swallowing for several seconds after spraying.

To remove the mouthpiece

How to close the dispenser

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

To use another dose, repeat the steps described above.

Always close the dispenser after each use to prevent accidental use by children or unintended sprays. Be careful not to spray into your eyes during administration of Nicorette BucoMist. If the spray comes into contact with your eyes, rinse them thoroughly with water.

If you use more Nicorette BucoMist than you should

If you smoke while using Nicorette BucoMist, symptoms of nicotine overdose may occur.

If a child uses Nicorette BucoMist or if you use too many sprays, consult a doctor immediately, go to the nearest hospital, or call the Toxicology Information Service (telephone 91 562 04 20), stating the name of the product and the amount used. Doses tolerated by adults during treatment may cause severe poisoning symptoms in children and may even result in death.

Symptoms of overdose include nausea, vomiting, excessive salivation, stomach pain, diarrhea, sweating, headache, dizziness, hearing disturbances, and a feeling of weakness. At high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, difficulty breathing, extreme fatigue, circulatory collapse, and generalized seizures.

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

4. Possible adverse effects

Like all medicines, Nicorette BucoMist can cause adverse effects, although not everyone experiences them.

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

Effects related to quitting smoking (nicotine withdrawal)

Some of the unwanted effects experienced when quitting smoking may be withdrawal symptoms due to reduced nicotine intake.

These effects include:

• Irritability, aggression, impatience, or frustration.
• Feelings of anxiety, restlessness, or difficulty concentrating.
• Sleep disturbances.
• Increased appetite or weight gain.
• Lethargy.
• Craving to smoke (urges).
• Slowed heart rate.
• Bleeding gums or mouth ulcers.
• Dizziness or mild disorientation.
• Cough, sore throat, nasal congestion, or runny nose.
• Constipation.

If you experience any of the following rare adverse 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:

• Hiccups (particularly common).
• Headache, nausea (feeling unwell).
• Throat irritation.

Common: may affect up to 1 in 10 people:

• Effects at the site of administration such as burning sensation, mouth inflammation, or changes in taste perception.
• Dry mouth or increased salivation.
• Indigestion-like sensation.
• Pain or discomfort in the stomach (abdomen).
• Vomiting, flatulence, or diarrhea.
• Feeling of tiredness (fatigue).
• Hypersensitivity (allergy).
• Tingling.
• Cough.

Uncommon: may affect up to 1 in 100 people:

• Nasal effects such as nasal congestion or sneezing.
• Wheezing (bronchospasm), or feeling of needing to breathe harder than normal (dyspnea), throat tightness.
• Skin redness (flushing) or increased sweating.
• Mouth-related effects such as tingling, tongue swelling, mouth ulcers, damage to the oral mucosa, changes in voice, mouth and throat pain, burping, bleeding gums.
• Palpitations (unusual awareness of heartbeat), increased heart rate, hypertension.
• Skin rashes and/or itching (pruritus, urticaria).
• Abnormal dreams.
• Chest discomfort and pain.
• Feeling of weakness, feeling of malaise.
• Runny nose.

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

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

Frequency not known: frequency cannot be estimated from the available data:

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

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

You may 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 Nicorette BucoMist

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

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

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment, particularly the aquatic environment, in the case of nicotine.

6. Contents of the pack and other information

Composition of Nicorette BucoMist

• The active substance is nicotine. One spray releases 1 mg of nicotine.
• The other components (excipients) are propylene glycol (E1520), anhydrous ethanol, tromethamine, poloxamer 407, glycerol (E422), sodium bicarbonate, levomenthol, peppermint flavor, refreshing aroma, sucralose, acesulfame potassium, butylated hydroxytoluene (E 321), hydrochloric acid and purified water.

Appearance of the product and contents of the pack

Nicorette BucoMist consists of a plastic bottle placed in a dispenser with a mechanical spray pump. The dispenser has a child-resistant 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 which include, under the back label, a near field communication (NFC) chip enabling connectivity with the mobile application. These dispensers carry this icon>

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

JNTL CONSUMER HEALTH (SPAIN), S.L.

Paseo de las Doce Estrellas 5-7

28042 Madrid

Spain

Manufacturer:

McNeil AB, P.O.

Box 941, Norrbroplatsen 2, SE-251 09 Helsingborg, Sweden

or

Kenvue Belgium NV,

Michel De Braeystraat 52, 2000 Antwerpen

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es