Nicorette Sprai

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Nicorette Spray (Nicorette Quickspray)

1 mg/dose, oral spray, solution

Nicotine
Nicorette Spray and Nicorette Quickspray are different trade names for the same medicine.

You should carefully read the contents of the leaflet 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 directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 6 months of using Nicorette Spray you are still unable to stop smoking, you should consult your 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 pack and other information

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

Nicorette Spray is used to help you stop smoking by reducing your cravings for nicotine and managing withdrawal symptoms. It is a type of treatment called nicotine replacement therapy (NRT).
Nicorette Spray relieves the withdrawal symptoms that you experience when you stop smoking, including the craving for nicotine. When you suddenly stop smoking, you may experience various unpleasant symptoms, known as withdrawal symptoms. By using Nicorette Spray, you can prevent or reduce these symptoms and reduce your desire to smoke. This is because it continues to deliver a small amount of nicotine to your body for a short period. Nicorette Spray does not contain tar, carbon monoxide, or other toxins found in tobacco smoke.
To increase your chances of successfully stopping smoking, you should also seek advice and support from a therapist.

2. Important information before using Nicorette Spray

When not to use Nicorette Spray

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

Warnings and precautions

Before starting to use Nicorette Spray, you should discuss it with your doctor if you have any of the following conditions. You may still be able to use Nicorette Spray, but you must first consult your doctor if you have:

• recently had a heart attack or stroke (within the last 3 months),
• chest pain (unstable angina) or angina at rest,
• heart disease that affects the rhythm or rate of your heart,
• high blood pressure that is not controlled by medication,
• ever had an allergic reaction, 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,
• a history of seizures or epilepsy.

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

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those obtained without a prescription. This is especially important if you are taking medicines that contain:

• theophylline for asthma,
• tacrine for Alzheimer's disease,
• clozapine for schizophrenia,
• ropinirole for Parkinson's disease.

Nicorette Spray with food and drink

Do not eat or drink while using the oral spray.

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 stop smoking without using nicotine-containing medicines. If this is not possible, you can start using Nicorette Spray after consulting your doctor, midwife, or a specialist in smoking cessation.
You should not use Nicorette Spray while breastfeeding, as nicotine passes into breast milk and may affect your baby. If your doctor recommends using Nicorette Spray, you should use it immediately after breastfeeding and not earlier than 2 hours before the next feeding.
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 (E 1520) per dose.

Ethanol

This medicine contains approximately 7 mg of alcohol (ethanol) per 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 it is essentially sodium-free.

Butylhydroxytoluene (E 321)

Due to the presence of butylhydroxytoluene (E 321), Nicorette Spray may cause local skin reactions (such as 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 directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
People under 18 years old should not use Nicorette Spray.
If after 6 weeks of treatment you have not been able to reduce the number of doses used or the number of cigarettes smoked, or if you need to use Nicorette Spray for more than 6 months, you should consult your doctor. Nicorette Spray is usually used for 3 months, but no longer than 6 months.
The way you use Nicorette Spray depends on whether you want to stop smoking immediately or gradually by reducing the number of cigarettes smoked before quitting completely.

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 you feel the urge to smoke. First, use one dose, and if the craving does not disappear within a few minutes, use a second dose. If you need 2 doses, you can use them together the next time. For most smokers, this means 1 or 2 doses every 30 minutes to 1 hour.
For example, if you normally smoke 15 cigarettes per day, you should 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, you 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 you are using no more than 4 doses per day. When you have reduced the number of doses per day to 2-4, you can stop using Nicorette Spray.

Gradual smoking cessation

This involves gradually replacing some cigarettes with Nicorette Spray. Once you have achieved this, you will completely stop smoking cigarettes and use the spray. Finally, you will stop using the spray.
When you feel a strong urge to smoke, use 1 or 2 doses of Nicorette Spray instead of a cigarette to control your cravings. Use the spray to replace cigarettes, so do 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"). You should reduce the number of cigarettes smoked per day and replace them with the spray. If after 6 weeks of treatment you have not been able to reduce the number of cigarettes smoked per day, you should consult your doctor. You should stop smoking when you feel ready, but no later than 12 weeks after starting treatment. After completely stopping smoking, you should gradually reduce the number of doses used per day. When you have reduced the number of doses to 2-4 per day, you can 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, you may still experience the urge to smoke. Do not discard any remaining medicine, as cravings can occur suddenly. If you experience cravings, use one or two doses, depending on whether one dose provides relief within a few minutes.

Follow the instructions below, using the diagrams as a guide:

Unlocking the pump

Opening the dispenser

• 1. Using your thumb, slide the button ( a) down until you can gentlypress it in ( 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 using the oral spray for the first time, you need to prime the pump. Point the spray nozzle away from yourself, other adults, children, or pets in the vicinity. Press the top of the dispenser three times with your index finger until a fine mist appears. If you do not use the spray for 2 days, you should repeat the priming procedure.

Using 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 going down your throat, do not inhale while spraying. To get the best results, do not swallow for a few seconds after spraying.

Locking the pump

Closing the dispenser

• 5. Slide the button down ( d) until you can press it in ( 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 your eyes. If the spray gets into your eye, rinse it thoroughly with water.

Using more than the recommended dose of Nicorette Spray

If you smoke while using Nicorette Spray, you may experience nicotine overdose symptoms.
If a child uses Nicorette Spray or if you use more Nicorette Spray than recommended, you should immediatelycontact a doctor or go to the nearest hospital. Nicotine doses tolerated during treatment by adult smokers can cause severe poisoning and lead to deathin children.
Symptoms of overdose include nausea, vomiting, excessive salivation, stomach pain, diarrhea, excessive sweating, headache, dizziness, hearing disturbances, and significant weakness. In cases of large doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, breathing difficulties, exhaustion, vascular collapse, and generalized seizures.
If you have any further questions about using this medicine, you should ask your 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 of the side effects that occur when you stop 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 difficulty concentrating,
• waking up at night or sleep disturbances,
• increased appetite or weight gain,
• feeling unwell,
• craving for cigarettes ( nicotine craving),
• 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.

You should stop using Nicorette Spray and immediately consult your doctor if you experience any of the following rare and serious side effects (symptoms of angioedema):

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

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

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

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,
• feeling of indigestion,
• abdominal pain or discomfort,
• vomiting, bloating, or diarrhea,
• feeling of tiredness,
• hypersensitivity (allergy),
• tingling,
• cough.

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

• nose problems, such as congestion, sneezing,
• wheezing (bronchospasm) or feeling of increased effort when breathing (dyspnea), tightness in the throat,
• redness of the skin or increased sweating,
• reactions in the mouth, such as tingling sensation in the mouth, tongue inflammation, mouth ulcers, damage to the mucous membranes of the mouth, or change in voice, mouth pain and throat, belching, gum bleeding,
• palpitations (abnormal sensation of rapid heartbeat), rapid heartbeat, high blood pressure,
• rash and (or) itching (pruritus, urticaria) of the skin,
• unusual dreams,
• discomfort and pain in the chest,
• 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, discomfort in the stomach, lip pain,
• redness of the skin,
• allergic reactions, including swelling of the face and mouth (angioedema or anaphylaxis),
• heart rhythm disturbances,
• seizures.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nicorette Spray

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment, especially the aquatic environment.

6. Contents of the pack 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), ethanol, trometamol, poloxamer 407, glycerol (E 422), sodium bicarbonate, levomenthol, peppermint flavor (Mint Balsamic QL24245), cooling flavor (Cooler 2 SN046680), sucralose, acesulfame potassium, butylhydroxytoluene (E 321), hydrochloric acid (diluted, for pH adjustment), and purified water.

What Nicorette Spray looks like and contents of the pack

Nicorette Spray consists of a PET 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 or 2 dispensers.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Johnson & Johnson Hellas Consumer AE
Aigialeias & Epidaurou 4
15125, Marousi, Greece

Manufacturer:

McNeil AB
P.O. Box 941, Norrbroplatsen 2
SE-251 09 Helsingborg
Sweden
Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Germany
Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Greek marketing authorization number:334895/15-5-2013
112281/14/28-09-2016

Parallel import authorization number: 227/25

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

Date of leaflet approval: 01.07.2025

[Information about the trademark]