Nicorette Sprai

Leaflet attached to the packaging: patient information

Nicorette Spray, 1 mg/dose, oral spray, solution

Nicotine

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 6 months of using Nicorette Spray, the patient is still unable to stop smoking, they should consult a doctor.

Table of contents of the leaflet:

• 1. What is Nicorette Spray and what is it used for
• 2. Important information before using Nicorette Spray
• 3. How to use Nicorette Spray
• 4. Possible side effects
• 5. How to store Nicorette Spray
• 6. Contents of the packaging and other information

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

Nicorette Spray is used to help people quit smoking, either by stopping immediately or by reducing smoking before quitting altogether. It is a type of treatment called nicotine replacement therapy (NRT).
Nicorette Spray relieves withdrawal symptoms that occur when smoking is stopped, including nicotine cravings. When nicotine from tobacco is suddenly stopped, various unpleasant feelings called withdrawal symptoms develop. By using Nicorette Spray, these unpleasant feelings can be prevented or their intensity reduced, and the desire to smoke can be decreased. This is because a small amount of nicotine is still delivered to the body for a short time. Nicorette Spray does not contain tar, carbon monoxide, and other toxins found in tobacco smoke.
To increase the chances of a successful quit attempt, it is also recommended to use counseling and behavioral support.

2. Important information before using Nicorette Spray

When not to use Nicorette Spray

• If the patient is allergicto nicotine or any of the other ingredients of this medicine (listed in section 6).
• If the patient is under 18 years old.
• If the patient has never smoked.

Warnings and precautions

Before starting to use Nicorette Spray, the patient should discuss it with their doctor if they have any of the following conditions. It may be possible for the patient to use Nicorette Spray, but they must first consult their doctor if they have:

• recently had (within the last 3 months) a heart attackor stroke,
• chest pain(unstable angina) or angina at rest,
• heart diseasethat affects the heart rate or rhythm,
• high blood pressurethat is not controlled by medication,
• ever had allergic reactions, such as swelling of the lips, face, and throat (angioedema) or itchy rash (urticaria); using NRT may occasionally provoke this type of reaction,
• severe or moderate liver disease,
• severe kidney disease,
• diabetes,
• overactive thyroid gland,
• adrenal gland tumor(pheochromocytoma),
• stomach or duodenal ulcer disease,
• esophagitis,
• ever had epilepsyor seizures.

Nicorette Spray should not be used by non-smokers.

Children and adolescents

This medicine should not be used in children and adolescents.

Nicorette Spray and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, and about any medicines they plan to take, including those obtained without a prescription. This is especially important if they are taking medicines that contain:

• theophyllinefor asthma,
• tacrinefor Alzheimer's disease,
• clozapinefor schizophrenia,
• ropinirolefor Parkinson's disease.

Nicorette Spray with food and drink

While using the oral spray, the patient should not eat or drink.

Pregnancy, breastfeeding, and fertility

It is very important to stop smoking during pregnancy, as it can cause fetal growth restriction and may lead to miscarriage or stillbirth. It is best to try to quit smoking without using nicotine-containing medicines. If this is not possible, Nicorette Spray can be started after consulting the doctor responsible for the pregnancy, the primary care physician, or a doctor specializing in smoking cessation.
Nicorette Spray should not be taken while breastfeeding, as nicotine passes into breast milk and may affect the baby. If the doctor recommends using Nicorette Spray, the spray should be used immediately after breastfeeding and not earlier than 2 hours before the next breastfeeding. Smoking increases the risk of infertility in both men and women. The effect of nicotine on fertility is unknown.

Driving and using machines

No effects on the ability to drive or use machines have been observed.

Nicorette Spray contains propylene glycol (E 1520), ethanol, sodium, and butylhydroxytoluene (E 321)

Propylene glycol (E 1520)

The medicine contains 11 mg of propylene glycol in each dose.

Ethanol

This medicine contains approximately 7 mg of alcohol (ethanol) in each dose, which is equivalent to 97 mg/ml. The amount of alcohol in one dose 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 noticeable effects.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

Butylhydroxytoluene (E 321)

Due to the presence of butylhydroxytoluene, Nicorette Spray may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use Nicorette Spray

This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Persons under 18 years old should not use Nicorette Spray.
If after 6 weeks of treatment, the patient is unable to reduce the number of doses used or the number of cigarettes smoked, or if they need to use Nicorette Spray for more than 6 months, they should consult a doctor. Nicorette Spray is usually used for 3 months, but not longer than 6 months.
The way to use Nicorette Spray depends on whether the patient wants to stop smoking immediately or gradually by reducing the number of cigarettes smoked before quitting altogether.

Immediate smoking cessation

The goal is to stop smoking immediately and use the spray to reduce nicotine cravings.
Do not use more than 2 doses at a time or 4 doses per hour for 16 hours. The maximum dose is 64 doses (applications) per 16 hours per day.
Stage 1:weeks 1-6
Use 1 or 2 doses instead of reaching for a cigarette or when experiencing nicotine cravings. First, use one dose, and if the craving does not disappear within a few minutes, use a second dose. If two doses are needed, they can be used at the same time next time. For most smokers, this means 1 or 2 doses every 30 minutes to 1 hour.
For example, if the average number of cigarettes smoked per day is 15, use 1-2 doses at least 15 times a day.
Stage 2:weeks 7-9
Start reducing the number of doses per day.
By the end of week 9, the patient should be using HALF the average number of doses used in stage 1.
Stage 3:weeks 10-12
Continue to reduce the number of doses used per day, so that by week 12, no more than 4 doses are used per day. When the number of doses per day is reduced to 2-4, the patient should stop using Nicorette Spray.

Gradual smoking cessation

This involves starting to replace some cigarettes with Nicorette Spray. Once this goal is achieved, the patient will completely stop smoking cigarettes and then stop using the spray.
When experiencing a strong desire to smoke, use 1 or 2 doses of Nicorette Spray instead of a cigarette to control nicotine cravings. The spray is used to replace cigarettes, so the patient should not smoke after using the spray. Using the spray without reducing the number of cigarettes smoked may lead to nicotine overdose symptoms (see "Using more than the recommended dose of Nicorette Spray"). The patient should reduce the number of cigarettes smoked per day to as few as possible and replace them with the spray. If after 6 weeks of treatment, the patient is unable to reduce the number of cigarettes smoked per day, they should consult a doctor. The patient should quit smoking as soon as they feel ready, but no later than 12 weeks after starting treatment. After completely stopping smoking, the patient should gradually reduce the number of doses used per day. When the number of doses is reduced to 2-4 per day, the patient should stop using Nicorette Spray.
Do not use more than 2 doses at a time or 4 doses per hour for 16 hours. The maximum dose is 64 doses (applications) per 16 hours per day.
After completing treatment, the desire to smoke may still occur. Do not discard any remaining medicine, as nicotine cravings may occur suddenly. If cravings occur, use one or two doses, depending on whether one dose provides relief within a few minutes.

Follow the instructions below, guided by the diagrams:

Unlocking the pump

Opening the dispenser

• 1. Using the thumb, slide the button ( a) down until it can be gentlypressed inward ( b). Do not press too hard.
• 2. Holding the button, slide it up ( c) to extend the pump. Then release the button.

Priming the dispenser

Before first using the oral spray, the patient must prime the pump in the dispenser. Point the spray nozzle away from themselves and others, children, or pets nearby. Press the top of the dispenser three times with the index finger until a fine mist appears. If the spray is not used for 2 days, the patient should repeat the priming procedure.

How to use the dispenser

• 3. Point the spray nozzle towards the open mouth, holding it as close to the mouth as possible.
• 4. Press the top of the dispenser firmly and spray one dose into the mouth, trying to avoid the lips. To avoid the spray getting into the throat, the patient should not inhale while spraying. For optimal treatment results, the patient should not swallow for a few seconds after spraying.

Locking the pump

Closing the dispenser

• 5. Slide the button down ( d) until it can be pressed inward ( e).
• 6. While pressing the button, slide the pump down ( f). Release the button. The dispenser is now closed. To use another dose, repeat the above steps.

Close the dispenser after each use to prevent children from using the spray or accidental release of the medicine.
Be careful not to direct the oral spray towards the eyes. If the spray gets into an eye, it should be rinsed thoroughly with water.

Using more than the recommended dose of Nicorette Spray

If the patient smokes while using Nicorette Spray, nicotine overdose may occur.
If a child uses Nicorette Spray or if the patient uses more Nicorette Spray than recommended, they should immediatelyconsult a doctor or go to the nearest hospital. Nicotine doses tolerated during treatment by adult smokers may cause severe poisoning and lead to deathin children.
Symptoms of overdose are nausea, vomiting, excessive salivation, abdominal pain, diarrhea, excessive sweating, headache, dizziness, hearing disturbances, and significant weakness.
After these symptoms, large doses may cause low blood pressure, weak and irregular pulse, breathing difficulties, exhaustion, circulatory collapse, and generalized seizures.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Nicorette Spray can cause side effects, although not everybody gets them. Nicorette Spray may cause the same side effects as other nicotine products. These effects are generally dose-dependent.

Withdrawal symptoms (nicotine withdrawal)

Some side effects that occur when quitting smoking may be withdrawal symptoms caused by reducing the nicotine dose.

Possible side effects include:

• irritability, aggression, frustration, or impatience,
• feeling anxious, restless, or having trouble concentrating,
• waking up at night or sleep disturbances,
• increased appetite or weight gain,
• feeling unwell,
• craving for cigarettes ( nicotine cravings),
• decreased heart rate,
• gum bleeding or mouth ulcers,
• dizziness or feeling of emptiness in the head,
• cough, sore throat, stuffy nose, or runny nose,
• constipation.

The patient should stop using Nicorette Spray and immediately consult their doctor if they experience any of the following rare and serious side effects (symptoms of angioedema):

• swollen face, tongue, or throat,
• difficulty swallowing,
• hives and breathing difficulties.

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

• hiccups (especially common),
• headache, nausea (nausea),
• throat irritation.

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

• local reactions, such as burning sensation, mouth irritation, changes in taste,
• dry mouth or increased salivation,
• nausea,
• abdominal pain or discomfort,
• vomiting, bloating, or diarrhea,
• feeling tired,
• hypersensitivity (allergy),
• tingling,
• cough.

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

• nose problems, such as congestion, sneezing,
• wheezing (bronchospasm) or feeling more breathless than usual (dyspnea), tightness in the throat,
• redness of the skin or increased sweating,
• mouth reactions, such as tingling in the mouth, tongue inflammation, mouth ulcers, damage to the mouth mucosa, or change in voice, mouth and throat pain, belching, gum bleeding,
• palpitations (abnormal sensation of rapid or forceful heartbeat), rapid heartbeat, high blood pressure,
• skin rash and (or) itching (pruritus, urticaria),
• unusual dreams,
• discomfort and chest pain,
• weakness, feeling unwell,
• runny nose.

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

• difficulty swallowing, reduced sensation in the mouth,
• gagging reflex.

Unknown (frequency cannot be estimated from the available data):

• blurred vision, increased tear production (lacrimation),
• dry throat, stomach discomfort, lip pain,
• redness of the skin,
• allergic reactions, including face and mouth swelling (angioedema or anaphylaxis),
• heart rhythm disturbances,
• seizures.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. HOW TO STORE NICORETTE SPRAY

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the dispenser and outer packaging. The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment, especially the aquatic environment, in the case of nicotine.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Nicorette Spray contains

• The active substance is nicotine. One dose delivers 1 mg of nicotine.
• The other ingredients are: propylene glycol (E 1520), anhydrous ethanol, trometamol, poloxamer 407, glycerol (E 422), sodium bicarbonate, levomenthol, peppermint flavor, cooling flavor, sucralose, acesulfame potassium, butylhydroxytoluene (E 321), hydrochloric acid (10%) (to adjust pH 9), and purified water.

What Nicorette Spray looks like and what the pack contains

Nicorette Spray consists of a plastic bottle containing the solution, in a dispenser with a mechanical pump. The dispenser is equipped with a child-resistant lock. Each bottle contains 13.2 ml of solution, equivalent to 150 doses.
Nicorette Spray is available in packs containing 1, 2, or 3 dispensers.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
McNeil AB, SE-251 09 Helsingborg, Sweden
Manufacturer:
McNeil AB, Norrbroplatsen 2, Box 941, SE-251 09 Helsingborg, Sweden
Johnson & Johnson Consumer NV/SA, Michel De Braeystraat 52, 2000 Antwerp, Belgium
Johnson & Johnson GmbH, Johnson & Johnson Platz 2, Nordrhein-Westfalen, 41470 Neuss, Germany
To obtain more detailed information, the patient should contact:
email: [email protected]

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Date of last revision of the leaflet: April 2025