Nicorette Cool Berry Oral Aerosol 13.2 ml

Read the leaflet before using the drug.

The maximum amount is 2 doses at a time or 4 doses per hour.
The maximum daily dose is 64 doses in 16 hours.

Press firmly on the top of the dispenser to spray one dose into the mouth. To prevent the aerosol from entering the throat, do not inhale air while spraying. For optimal treatment results, do not swallow for a few seconds after spraying.

One dose delivers 1 mg of nicotine.

Administration to the oral mucosa.
Storage: Store at ambient temperature
Packaging: blister pack

Contains ethanol and propylene glycol (see package insert for additional information), propylene glycol, ethanol anhydrous, tromethanol, poloxamer 407, glycerol, sodium bicarbonate, levomenthol, red fruit flavor, cooling flavor, sucralose, acesulfame potassium, hydrochloric acid (to determine pH), purified water

McNeil AB

Responsible party
McNeil AB,
Box 941,
SE-251 09 Helsingborg,
Sweden

Manufacturer
McNeil AB,
Norrbroplatsen 2,
SE-251 09 Helsingborg,
Sweden

Persons under 18 years of age should not use Nicorette Cool Berry.

Keep the drug out of sight and reach of children.

Recommended: 18 years/years/years

Read the leaflet carefully before using the drug, as it contains important information for the patient.
Always take this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- Ask your pharmacist if you need advice or additional information.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If you still cannot stop smoking after 6 months of using Nicorette Cool Berry, tell your doctor.

Table of contents of the leaflet:
1. what is Nicorette Cool Berry and what is it used for?
2. important information before using Nicorette Cool Berry
3. how to use the drug Nicorette Cool Berry
4 Possible side effects
5. how to store the drug Nicorette Cool Berry
6. package contents and other information

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

The drug Nicorette Cool Berry is used to help stop smoking for people who want to quit immediately or reduce smoking before stopping completely. This is a type of treatment called nicotine replacement therapy (NTZ).

Nicorette Cool Berry relieves withdrawal symptoms that occur after smoking cessation, including nicotine craving. When the body's supply of nicotine from tobacco is abruptly stopped, different types of unpleasant sensations called withdrawal symptoms develop. With the use of Nicorette Cool Berry, these unpleasant sensations can be prevented or lessened and the desire to smoke a cigarette can be reduced. This is because it continues to deliver a small amount of nicotine to the body for a short period of time. Nicorette Cool Berry drug does not contain tar, carbon monoxide and other toxins found in tobacco smoke.

To increase the chances of a successful outcome of a smoking cessation attempt, it is also important to take advantage of psychotherapeutic counseling and support.

3 How to use the drug Nicorette Cool Berry

Always use this medication as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

People under the age of 18 should not use Nicorette Cool Berry.

If, after 6 weeks of treatment, you do not manage to reduce the number of doses of the drug or the number of cigarettes you smoke, or if you need to use Nicorette Cool Berry for more than 6 months, consult your doctor. Usually, you should use the drug Nicorette Cool Berry for 3 months, but no longer than 6 months.

The way you use Nicorette Cool Berry depends on whether you want to stop smoking immediately or gradually by gradually reducing the number of cigarettes you smoke before stopping completely.

Immediate smoking cessation
The goal is to stop smoking immediately and use the spray to reduce nicotine craving.

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) for 16 hours each day.

Stage 1: weeks 1-6
Use 1 or 2 doses instead of reaching for a cigarette or if nicotine craving develops. Use one dose first, and then, if nicotine craving does not subside within a few minutes, a second dose. If two doses are needed, the next time, 2 more doses can be used right away. 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 per day.

Stage 2: weeks 7-9
Start reducing the number of doses per day.
Before the end of week 9, the patient should use HALF of 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 per day are used. When the number of doses per day is reduced to 2-4, Nicorette Cool Berry should be discontinued.

Gradual smoking cessation
Refers to the start of gradual replacement of some cigarettes with the drug Nicorette Cool Berry. Once this is achieved, smoking cigarettes are completely stopped with the aerosol. Finally, the use of the aerosol is also discontinued.

If you feel a strong desire to smoke a cigarette, use 1 or 2 doses of the drug instead of a cigarette to control nicotine craving. Aerosol is used to replace a cigarette, so do not smoke after using the drug . Using the aerosol without reducing the number of cigarettes smoked at the same time can lead to symptoms of overdose (see subsection "Use of a higher than recommended dose of Nicorette Cool Berry"). The number of cigarettes smoked per day should be reduced to as low as possible and replaced with an aerosol. If a reduction in the number of cigarettes smoked per day is not achieved after 6 weeks of treatment, consult a doctor. Patients should quit smoking as soon as they feel ready to do so, but no later than 12 weeks after starting treatment. After smoking is completely stopped, the number of daily doses of the drug should be gradually reduced. When the number of doses used is reduced to 2-4 per day, Nicorette Cool Berry should be discontinued. 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) for 16 hours each day.

The urge to smoke a cigarette may still be present after the end of treatment. Do not throw away the remaining medicine, as nicotine craving may appear suddenly. If nicotine craving occurs, take one dose, or two if one does not result in improvement within a few minutes.

Unlocking the pump

Opening the dispenser
1 Use your thumb to push the button (a) down until it can be gently pushed inward (b). Do not push too hard.
2. While holding the button, move it up (c) to eject the pump. Then release the button.

Filling the dispenser
Before using the oral spray for the first time, fill the dispenser pump. Point the pump outlet 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 aerosol for 2 days, repeat the filling procedure.

How to use the dispenser
3 Point the outlet of the pump toward the open mouth, keeping 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 prevent the aerosol from entering the throat, do not inhale air while spraying. For optimal treatment results, do not swallow for a few seconds after spraying.

Locking the pump

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

Close the dispenser after each application to prevent children from using the aerosol or accidentally releasing the drug.
Use caution and do not direct the oral spray toward the eyes. If the aerosol gets into the eye, rinse it thoroughly with water.

Use of a larger dose of Nicorette Cool Berry than recommended.
If tobacco is smoked while taking Nicorette Cool Berry, an overdose of nicotine may occur.
If your child takes Nicorette Cool Berry or if you take a higher dose of Nicorette Cool Berry than recommended, contact your doctor immediately or go to the nearest hospital. The doses of nicotine tolerated during treatment by adult smokers can cause symptoms of severe poisoning in children and can lead to death.

Symptoms of overdose include nausea, vomiting, excessive saliva production, abdominal pain, diarrhea, excessive sweating, headache, dizziness, hearing impairment and significant weakness. In high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, difficulty breathing, exhaustion, vascular collapse and generalized convulsions.

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

5 How to store the drug Nicorette Cool Berry

Store the drug out of sight and reach of children.

Do not use this medication after the expiration date on the dispenser and outer packaging. The expiration date means the last day of the month stated.

Do not store at temperatures above 30°C.

Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Such treatment will help protect the environment, in the case of nicotine especially the water environment.

4 Possible side effects

Like any drug, this medication may cause side effects, although they will not occur in everyone.

Nicorette Cool Berry may cause the same side effects as other forms of nicotine. Generally, these effects depend on the dose taken.

Actions associated with smoking cessation (nicotine withdrawal).
Some of the side effects that occur when quitting smoking may be withdrawal symptoms caused by a reduction in the nicotine dose administered.

Possible actions include:
- irritability, aggression, impatience or frustration,
- feelings of restlessness, motor restlessness or difficulty concentrating,
- waking up during the night or sleep disturbances,
- increased appetite or weight gain,
- malaise,
- desire to smoke a cigarette (nicotine craving),
- decreased heart rate,
- bleeding gums or ulceration of the mouth,
- dizziness or a feeling of emptiness in the head,
- cough, sore throat, blocked nose or nasal leakage,
- constipation.

Stop using Nicorette Cool Berry and seek immediate medical attention if any of the following rare and serious side effects (symptoms of angioedema) occur:
- swollen face, tongue or throat,
- difficulty swallowing,
- urticaria and difficulty breathing.

Very common (may occur in more than 1 in 10 patients):
- hiccups (occurs especially often),
- headache, nausea (nausea),
- irritation of the throat.

Frequent (may occur in no more than 1 in 10 patients):
- local reactions such as burning sensation, stomatitis, changes in taste sensation,
- dry mouth or increased saliva production,
- indigestion sensation,
- pain or discomfort in the abdominal cavity,
- vomiting, bloating or diarrhea,
- feeling of fatigue,
- hypersensitivity (allergy),
- tingling,
- cough.

Uncommon (may occur in no more than 1 in 100 patients):
- nasal complaints such as obstruction, sneezing,
- nasal leakage,
- wheezing (bronchospasm) or feeling more labored breathing than normal (shortness of breath), tightness in the throat,
- redness of the skin or increased sweating,
- oral reactions such as a tingling sensation in the mouth, inflammation of the tongue, ulceration of the mouth, damage to the oral mucosa or a change in the sound of the voice, pain in the mouth and throat, belching, bleeding gums,
- palpitations (unusual feeling of increased heartbeat), accelerated heart rate, hypertension,
- rash and/or itching (pruritus, hives) of the skin,
- unusual dreams,
- discomfort and pain in the chest,
- weakness, malaise.

Rare (may occur in no more than 1 in 1,000 patients):
- difficulty swallowing, decreased sensation in the mouth,
- vomiting reflex.

Unknown (frequency cannot be determined from available data):
- blurred vision, increased tear production (tearing),
- Dryness in the throat, discomfort in the stomach, pain in the lips,
- heart rhythm disturbances,
- redness of the skin,
- allergic reactions, including swelling of the face and mouth (angioedema or anaphylaxis).

Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of 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 responsible party. By reporting side effects, more information on the safety of the drug can be gathered.

6 Package contents and other information

What the drug Nicorette Cool Berry contains
- The active substance is nicotine. One dose provides 1 mg of nicotine.
- The other ingredients are: propylene glycol (E1520), anhydrous ethanol, tromethamol, poloxamer 407, glycerol (E422), sodium bicarbonate, levomenthol, red fruit flavor, cooling flavor, sucralose, acesulfame potassium, butylhydroxytoluene (E321), hydrochloric acid (to determine pH) and purified water.

What the drug Nicorette Cool Berry looks like and what it contains in the package.

Nicorette Cool Berry consists of a plastic bottle containing the solution in a dispenser with a mechanical dosing pump. The dispenser is equipped with child protection. Each bottle contains 13.2 ml of solution equivalent to 150 doses. Nicorette Cool Berry is available in packages containing 1 or 2 dispensers. Not all package sizes are necessarily on the market.

2.Information important before using Nicorette Cool Berry.

When not to use the drug Nicorette Cool Berry
- If the patient is allergic to nicotine or any of the other ingredients of this drug(listed in section 6).
- If the patient is less than 18 years old.
- If the patient has never smoked.

Warnings and precautions
Before taking this drug, discuss it with your doctor if you have any of the following conditions. It is possible that you may be able to use Nicorette Cool Berry, but you must first consult your doctor if you have:
- a recent (within the last 3 months) heart attack or stroke,
- chest pain (unstable angina) or symptoms of angina at rest,
- heart disease that affects the speed or regularity of the heart rhythm,
- high blood pressure that is not balanced by medication,
- the ever occurrence of allergic reactions such as swelling of the lips, face and throat (angioedema) or an itchy rash (urticaria); the use of NTZs can sometimes provoke this type of reaction,
- severe or moderately severe liver disease,
- severe kidney disease,
- diabetes,
- hyperthyroidism,
- adrenal tumor (pheochromocytoma of the adrenal glands),
- gastric or duodenal ulcer disease,
- esophagitis.

Nicorette Cool Berry drug should not be used by non-smokers.

Children and adolescents
This drug should not be used in children and adolescents.

Nicorette Cool Berry drug and other drugs
Tell your doctor or pharmacist about all medicines you are currently or recently taking, as well as medicines you plan to take, including medicines that are dispensed without a prescription. This is especially important if you are using medications containing:
- theophylline in the treatment of asthma,
- tacrine in Alzheimer's disease,
- clozapine in schizophrenia,
- ropinirole in the treatment of Parkinson's disease.

Nicorette Cool Berry with food and drink
Do not eat or drink during administration of the oral spray.

Pregnancy, breastfeeding and effects on fertility
It is very important to stop smoking during pregnancy, as it leads to fetal stunting. It can also cause miscarriage or stillbirth. It is best to try to quit smoking without using nicotine-containing drugs. If this is unsuccessful, use of Nicorette Cool Berry can only be started after consultation with a pregnancy doctor, general practitioner or a doctor from a center specializing in treating tobacco addiction.

Nicorette Cool Berry should not be taken while breastfeeding because nicotine enters breast milk and may affect the baby. If your doctor prescribes the use of Nicorette Cool Berry, the spray should be used immediately after breastfeeding and no later than 2 hours before you start nursing.

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

Driving and operating machinery
The effects of the drug on the ability to drive and operate machinery have not been observed.

Nicorette Cool Berry contains 12 mg of propylene glycol per dose. The drug contains about 7 mg of alcohol (ethanol) per dose, which is equivalent to 97 mg/mL. The amount of alcohol in one dose of this drug is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this drug will not cause noticeable effects. The drug also contains less than 1 mmol (23 mg) of sodium per dose, that is, the drug is considered "sodium free." Due to its butylhydroxytoluene content, Nicorette Cool Berry may cause a local skin reaction (such as contact dermatitis) or irritation of the eyes and mucous membranes.

Nicorette Cool Berry, 13.6 mg/ml, oral spray, solution

Nicotinum