Nicorette cool berry

Patient Information Leaflet

Nicorette Cool Berry, 1 mg/dose, oral spray, solution
Nicotinum
Please read the entire leaflet carefully before using this 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
a physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If after 6 months of using Nicorette Cool Berry you are still unable to refrain from smoking, consult your doctor.

Table of contents:

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

1. What Nicorette Cool Berry is and what it is used for

Nicorette Cool Berry is used to help people who want to stop smoking immediately or to reduce smoking before quitting completely. This is a type of treatment known as nicotine replacement therapy (NRT).
Nicorette Cool Berry helps relieve withdrawal symptoms that occur after stopping smoking, including nicotine cravings. When nicotine from tobacco is suddenly withdrawn, various unpleasant sensations develop, known as withdrawal symptoms. Using Nicorette Cool Berry can prevent these unpleasant sensations or reduce their severity, and can also reduce the urge to smoke a cigarette. This is because a small amount of nicotine continues to be supplied to the body for a short period. Nicorette Cool Berry does not contain tar, carbon monoxide, or other toxins found in tobacco smoke.
To increase the chances of successfully quitting smoking, it is also recommended to seek counseling and psychological support.

2. Important information before using Nicorette Cool Berry

When not to use Nicorette Cool Berry

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

Warnings and precautions
Before starting to use this medicine, consult a doctor if the patient has any of the following conditions. The patient may still be able to use Nicorette Cool Berry, but should first seek medical advice in case of:

• recent (within the last 3 months) myocardial infarction or stroke,
• chest pain (unstable angina) or symptoms of angina at rest,
• heart disease affecting the heart rate or rhythm,
• high blood pressure not controlled by medication,
• history of allergic reactions, such as swelling of the lips, face, and throat (angioedema) or itchy rash (urticaria); nicotine replacement therapy (NRT) may sometimes trigger such reactions,
• severe or moderately severe liver disease,
• severe kidney disease,
• diabetes,
• overactivity of the thyroid gland (hyperthyroidism),
• adrenal gland tumour (pheochromocytoma),
• peptic ulcer disease of the stomach or duodenum,
• oesophagitis,
• history of epilepsy or seizures.

Nicorette Cool Berry should not be used by non-smokers.
Children and adolescents
This medicine should not be used in children and adolescents.
Nicorette Cool Berry and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including those available without a prescription. This is particularly important if the patient is taking medicines containing:

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

Nicorette Cool Berry with food and drink
Do not eat or drink while administering the oral cavity spray.
Pregnancy, breastfeeding and fertility
It is very important to stop smoking during pregnancy, as smoking leads to impaired fetal development. It may also cause miscarriage or stillbirth. It is best to try to quit smoking without using nicotine-containing medicines. If this is not successful, use of Nicorette Cool Berry may be considered only after consultation with the doctor managing the pregnancy, a general practitioner, or a specialist in tobacco addiction treatment.
Nicorette Cool Berry should not be used during breastfeeding, as nicotine passes into breast milk and may affect the infant. If a doctor recommends using Nicorette Cool Berry, the spray should be used immediately after breastfeeding and no later than 2 hours before the next feeding.
Smoking increases the risk of infertility in both women and men. The effect of nicotine on fertility is unknown.
Driving and operating machinery
No effects of the medicine on the ability to drive or operate machinery have been observed.
Nicorette Cool Berry contains propylene glycol (E 1520), ethanol, sodium and butylated hydroxytoluene (E 321)
Propylene glycol (E 1520)
The medicine contains 12 mg of propylene glycol per dose.
Ethanol
This medicine contains approximately 7 mg of alcohol (ethanol) per dose, 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 cause noticeable effects.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".
Butylated hydroxytoluene (E 321)
Due to the presence of butylated hydroxytoluene, Nicorette Cool Berry may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Nicorette Cool Berry

This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
People under 18 years of age should not use Nicorette Cool Berry.
If after 6 weeks of treatment you have not managed to reduce the number of doses used or the number
of cigarettes smoked, or if you need to use Nicorette Cool Berry for longer than 6 months, consult your
doctor. Treatment with Nicorette Cool Berry usually lasts 3 months, but should not exceed 6 months.
The way to use Nicorette Cool Berry depends on whether you intend to stop smoking
immediately or gradually by progressively reducing the number of cigarettes smoked before
completely quitting.

Immediate smoking cessation
The goal is to stop smoking immediately and to use the aerosol to reduce nicotine cravings.
Do not use more than 2 doses at the same time or more than 4 doses per hour for 16 hours. The
maximum dose is 64 doses (applications) over 16 hours in any 24-hour period.

Stage 1: weeks 1–6
Instead of reaching for a cigarette or when a nicotine craving occurs, use 1 or 2 doses. First, use one
dose; if the craving does not subside within a few minutes, use a second dose. If two doses are
needed, the next time you may use both doses immediately. For most smokers, this means using 1 or
2 doses every 30 minutes to 1 hour.
For example, if the average number of cigarettes smoked per day is 15, you should use 1–2 doses at
least 15 times per day.

Stage 2: weeks 7–9
Begin reducing the number of daily doses.
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 reducing the number of daily doses so that by week 12 you use no more than 4 doses per day.
When the number of daily doses has been reduced to 2–4, stop using Nicorette Cool Berry.
Do not use more than 2 doses at the same time or more than 4 doses per hour for 16 hours. The
maximum dose is 64 doses (applications) over 16 hours in any 24-hour period.

Gradual smoking cessation
This approach involves gradually replacing some cigarettes with Nicorette Cool Berry.
Once this goal is achieved, completely stop smoking cigarettes and continue using the aerosol.
Eventually, stop using the aerosol as well.
When you feel a strong urge to smoke, use 1 or 2 doses of the medicine instead of a cigarette to
control nicotine cravings. The aerosol is used to replace cigarettes, so do not smoke after using the
medicine. Using the aerosol without simultaneously reducing the number of cigarettes smoked may
lead to symptoms of overdose (see section “Use of more than the recommended dose of Nicorette
Cool Berry”). You should reduce the number of cigarettes smoked per day to the lowest possible and
replace them with the aerosol. If after 6 weeks of treatment you have not managed to reduce the
number of cigarettes smoked per day, consult your doctor. You should quit smoking as soon as you
feel ready, but no later than 12 weeks after starting treatment. After completely stopping smoking,
gradually reduce the number of daily doses of the medicine. When the number of daily doses has
been reduced to 2–4, stop using Nicorette Cool Berry.

After treatment ends, you may still experience an urge to smoke. Do not discard any remaining
medicine, as nicotine cravings may occur suddenly. If a craving occurs, use one dose or two doses if
one does not relieve the craving within a few minutes.

Follow the instructions below, referring to the illustrations:

Unlocking the pump

Opening the dispenser

1. Using your thumb, slide the button ( a ) downward until it can be gently pressed inward ( b ). Do not press too hard.
2. While holding the button, slide it upward ( c ) to extend the pump. Then release the button.

Filling the dispenser
Before first use of the oral aerosol, the dispenser pump must be primed. Point the nozzle away from
yourself, other adults, children, or nearby animals. Press the top of the dispenser three times with
your index finger until a fine mist appears. If the aerosol has not been used for 2 days, repeat the
priming procedure.

How to use the dispenser

3. Point the pump nozzle toward your open mouth, holding it as close to your mouth as possible.

4. Firmly press the top of the dispenser and spray one dose into your mouth, trying to avoid your lips. Do not inhale while spraying, to prevent the aerosol from entering your throat. For optimal treatment results, do not swallow for several seconds after spraying.

Locking the pump

Closing the dispenser

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

Always close the dispenser after each use to prevent accidental use by children or unintended
release of the medicine.
Be cautious and avoid directing the oral aerosol toward the eyes. If the aerosol gets into the eye, rinse
it thoroughly with water.

Use of more than the recommended dose of Nicorette Cool Berry
If you smoke tobacco while using Nicorette Cool Berry, nicotine overdose may occur.
If a child takes Nicorette Cool Berry or if you use more than the recommended dose, seek medical
advice immediately by contacting your doctor or going to the nearest hospital. Doses of nicotine
tolerated during treatment in adult smokers may cause severe poisoning and lead to death in
children.

Symptoms of overdose include nausea, vomiting, excessive salivation, abdominal pain, diarrhoea,
excessive sweating, headache, dizziness, hearing disturbances, and marked weakness.
With larger doses, these symptoms may be followed by low blood pressure, weak and irregular pulse,
breathing difficulties, exhaustion, circulatory collapse, and generalized seizures.

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

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
Nicorette Cool Berry may cause the same adverse reactions as other forms of nicotine.
Generally, these reactions depend on the dose used.
Reactions related to quitting smoking (nicotine withdrawal)
Some of the adverse reactions occurring when quitting smoking may be withdrawal symptoms
caused by reducing the administered dose of nicotine.
Possible reactions include:

• irritability, aggression, impatience or frustration,
• feeling anxious, restlessness or difficulty concentrating,
• waking up during the night or sleep disturbances,
• increased appetite or weight gain,
• malaise,
• craving for a cigarette (nicotine craving),
• decreased heart rate,
• gum bleeding or oral ulceration,
• dizziness or feeling lightheaded,
• cough, sore throat, nasal congestion or runny nose,
• constipation.

You should stop using Nicorette Cool Berry and immediately consult a doctor
if any of the following rare and serious adverse reactions (symptoms of angioedema) occur:

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

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

• hiccups (particularly frequent),
• headache, nausea,
• throat irritation.

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

• local reactions such as burning sensation, oral inflammation, changes in taste perception,
• dry mouth or increased salivation,
• indigestion,
• abdominal pain or discomfort,
• vomiting, bloating or diarrhoea,
• feeling tired,
• hypersensitivity (allergy),
• tingling,
• cough.

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

• nasal symptoms such as congestion, sneezing,
• runny nose,
• wheezing (bronchospasm) or feeling greater effort than normal when breathing (dyspnea), throat tightness,
• skin redness or increased sweating,
• oral reactions such as oral tingling, glossitis, oral ulceration, oral mucosal damage or voice changes, mouth and throat pain, belching, gum bleeding,
• palpitations (unusual sensation of strong heartbeat), increased heart rate, hypertension,
• skin rash and/or itching (pruritus, urticaria),
• unusual dreams,
• chest discomfort and pain,
• weakness, malaise.

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

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

Not known (frequency cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Nicorette Cool Berry

Keep this medicine 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 specified 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 in use. This will help protect the environment, particularly aquatic ecosystems in the case of nicotine.

6. Contents of the pack and other information

What Nicorette Cool Berry contains

• The active substance is nicotine. One dose delivers 1 mg of nicotine.
• The other ingredients are: propylene glycol (E 1520), anhydrous ethanol, tromethamine, poloxamer 407, glycerol (E 422), sodium hydrogen carbonate, levomenthol, red fruit flavour, cooling flavour, sucralose, acesulfame potassium, butylhydroxytoluene (E 321), hydrochloric acid (for pH adjustment) and purified water.

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
McNeil AB, Box 941, SE-251 09 Helsingborg, Sweden
Manufacturers:
McNeil AB, Norrbroplatsen 2, SE-251 09 Helsingborg, Sweden
Kenvue Belgium NV, Michel De Braeystraat 52, 2000 Antwerp, Belgium
Kenvue Germany GmbH, Johnson & Johnson Platz 2, Nordrhein-Westfalen, 41470 Neuss, Germany
For further information, please contact:
email: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names: