NICORETTE FRESHFRUIT GUM

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Nicorette FreshFruit Gum (Nicorette freshfruit 2 mg)
2 mg, chewing gum, medicinal
Nicotinum
Nicorette FreshFruit Gum and Nicorette freshfruit 2 mg are different brand names of the same
medicinal product.
Please read this leaflet carefully before taking this medicine because it contains important
information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• 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, pharmacist, or nurse. See section 4.
• If after 9 months you still have difficulty refraining from smoking without the help of Nicorette FreshFruit Gum, you should contact your doctor.

Leaflet contents:

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

1. What Nicorette FreshFruit Gum is and what it is used for

Mechanism of action
When you stop smoking, and nicotine is no longer regularly supplied to the body, various withdrawal symptoms begin to appear, including irritability, restlessness, mood disturbances, dizziness and headaches, and sleep disturbances. Nicorette FreshFruit Gum can help prevent or reduce these symptoms by delivering small amounts of nicotine to the body over a short period of time.
The nicotine in Nicorette FreshFruit Gum is delivered in pure form.
Unlike cigarettes, Nicorette FreshFruit Gum does not release harmful tar substances or carbon dioxide, which result from the burning of tobacco.
Indications
Nicorette FreshFruit Gum is indicated for the treatment of tobacco dependence by reducing nicotine craving and withdrawal symptoms that occur after stopping smoking.

2. Important information before using Nicorette FreshFruit Gum

When not to use Nicorette FreshFruit Gum

• If the patient is allergic to nicotine or to any of the other ingredients of this medicine (listed in section 6).

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Warnings and precautions
Before starting to use Nicorette FreshFruit Gum, consult your doctor if you have:

• recently suffered a stroke or heart attack,
• chest pain or symptoms of angina pectoris,
• heart disease affecting the speed or regularity of heart rhythm,
• uncontrolled high blood pressure,
• gastric or duodenal ulcer,
• hyperthyroidism,
• insulin-dependent diabetes (lower insulin doses may be required as a result of stopping smoking),
• diagnosed pheochromocytoma,
• severe or moderate liver disease,
• severe kidney disease,
• oesophagitis.

The chewing gum may adhere to, and in rare cases cause damage to, dental prostheses.
Some patients may continue to use Nicorette FreshFruit Gum for longer than the recommended treatment period; however, the potential risk of long-term use is considerably lower than the risk associated with returning to smoking tobacco.
Nicorette FreshFruit Gum and other medicines
Tell your doctor about all medicines currently taken or taken recently, as well as any medicines you plan to take. Stopping smoking may require adjustment of their dosage.
If you are taking imipramine, clomipramine, fluvoxamine (medicines used to treat depression), clozapine, olanzapine (medicines used to treat schizophrenia), theophylline (a medicine used to treat bronchial asthma, chronic obstructive pulmonary disease and bronchial inflammation), tacrine (a medicine used in Alzheimer's disease), ropinirole (a medicine used in Parkinson's disease), flecainide (a medicine used, among others, in tachycardia, paroxysmal atrial fibrillation, cardiac arrhythmias), pentazocine (a painkiller), or insulin, consult your doctor before using Nicorette FreshFruit Gum.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, you should consult your doctor before using this medicine.
To reduce exposure to the infant, the medicine should be used immediately after breastfeeding.
Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery.
Nicorette FreshFruit Gum contains butylated hydroxytoluene (E 321) and sodium
The medicine may cause irritation of mucous membranes.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".
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3. How to use Nicorette FreshFruit Gum

Children and adolescents
Nicorette FreshFruit Gum should not be used in individuals under 18 years of age without medical advice. Data on the treatment of this age group with Nicorette FreshFruit Gum are limited.
Nicorette FreshFruit Gum is available in two strengths: 2 mg and 4 mg.
Adults and elderly
The initial dose should be individually determined based on the degree of nicotine dependence. Typically, 8–12 chewing gums per day containing the appropriate amount of nicotine are used.
Smokers with low dependence (smoking ≤ 20 cigarettes/day) should start treatment with the 2 mg dose. Smokers with high dependence should start treatment with the 4 mg dose. Do not use more than 15 chewing gums per day.
Smoking cessation
Nicorette FreshFruit Gum helps individuals determined to quit smoking overcome their addiction. The gum should be used for at least 3 months. After this period, gradual discontinuation should be initiated. Treatment should be concluded when the dose has been reduced to 1–2 chewing gums per day.
Smoking reduction
Nicorette FreshFruit Gum helps reduce smoking in individuals who do not wish or are unable to quit completely. To extend the intervals between cigarettes and maximally reduce the number of cigarettes smoked, the chewing gum should be used between cigarettes when the urge to smoke arises. If after 6 weeks there is no reduction in the number of cigarettes smoked per day, consult a doctor.
Consider attempting to quit smoking as soon as possible, but no later than 6 months after starting treatment. If a serious quit attempt cannot be made within 9 months of starting treatment, consult a doctor.
Regular use of chewing gums for longer than 12 months is generally not recommended. However, some former smokers may require longer treatment to prevent relapse.
Unused gums should be kept available in case of sudden nicotine cravings.
Seek support from support groups, as they may enhance the quitting process and help ensure successful completion of therapy.
Temporary abstinence
Nicorette FreshFruit Gum helps smokers temporarily refrain from smoking. The chewing gum should be used during breaks between cigarettes when the urge to smoke arises, for example, in places where smoking is prohibited or in other situations where one wishes to avoid smoking.
Use of gum in combination with patches
The chewing gum can be used alone or in combination with nicotine-containing patches. Using more than one form of nicotine replacement therapy (NRT) may be beneficial for smokers who have relapsed despite previous monotherapy with NRT, or who experience difficulties controlling cigarette cravings during monotherapy. Therefore, if necessary, Nicorette Invisipatch 15 mg/16 h patch and Nicorette FreshFruit Gum 2 mg can be used together.
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The Nicorette Invisipatch 15 mg/16 h patch should be applied in the morning upon waking and removed after 16 hours, before going to sleep. It should be used according to the dosing regimen approved for monotherapy. The Nicorette FreshFruit Gum 2 mg should be chewed whenever a strong urge to smoke occurs, without exceeding the maximum daily dose of 15 gums. This combined approach may be used for up to 12 weeks; thereafter, chewing gum use should be gradually reduced. The maximum duration of chewing gum use is 12 months.
How to chew Nicorette FreshFruit Gum
Chew the gum when you feel the need to smoke. Chew the gum slowly to release nicotine, then stop chewing and place the gum between your cheek and gum to allow nicotine to be absorbed through the oral mucosa. Nicotine swallowed with saliva has no beneficial effect and may irritate the throat or stomach, potentially causing hiccups. Do not chew Nicorette FreshFruit Gum continuously and vigorously like regular chewing gum, as this causes too rapid release of nicotine. Therefore, chew Nicorette FreshFruit Gum slowly, taking regular breaks.
Chewing technique

1. Chew the gum slowly until you notice the taste.
2. Then stop chewing and place the gum between your cheek and gum.
3. Start chewing again when the taste fades.
4. Repeat this process for approximately 30 minutes.

Use of more than the recommended dose of Nicorette FreshFruit Gum
Abuse of nicotine, either from nicotine replacement products and/or continued smoking, may lead to symptoms of overdose. The risk of poisoning following accidental swallowing of the chewing gum is very low, as nicotine absorption without chewing is slow and incomplete.
Symptoms of nicotine overdose include: nausea, vomiting, excessive salivation, abdominal pain, diarrhea, excessive sweating, headache, dizziness, hearing disturbances, and marked weakness. After large doses, these symptoms may be accompanied by hypotension, weak and irregular pulse, breathing difficulties, exhaustion, circulatory collapse, and generalized seizures.
Nicotine doses tolerated by adults during treatment may cause severe poisoning in young children and can be fatal.
Keep the medicine out of sight and reach of children. In case of overdose, stop administering nicotine immediately and seek medical help. The doctor will provide appropriate symptomatic treatment.
In cases of ingestion of excessive amounts of nicotine, activated charcoal reduces gastrointestinal absorption of nicotine.
If too many gums have been used, or if a child has chewed or swallowed a gum, contact a doctor immediately or go to the nearest hospital, taking the gum packaging and this leaflet with you.

4. Possible adverse reactions

Like all medicines, this product can cause adverse reactions, although not everyone experiences them.
Some symptoms may occur as a result of stopping smoking. These include: low mood, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness or impatience. Physical symptoms may also occur, such as decreased heart rate, increased appetite or weight gain, dizziness or pre-syncope symptoms, cough, constipation, gum bleeding, aphthous ulcers or inflammation of the nasopharynx, and nicotine craving associated with the urge to smoke.
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Most reported adverse reactions occur during the first weeks of treatment. Irritation of the mouth and throat may occur, but most patients become accustomed to this during continued use of the medicine.
The chewing gum may stick to, and in rare cases cause damage to, dental prostheses.
Allergic reactions (including severe allergic reactions) have been reported rarely during use of Nicorette FreshFruit Gum.
Adverse reactions reported in at least 1% of patients treated with nicotine in clinical trials and post-marketing experience are listed in the table below.
The frequency of occurrence is defined according to the following classification:
Very common (may affect 1 to 10 out of 10 people)
Common (may affect 1 to 10 out of 100 people)
Uncommon (may affect 1 to 10 out of 1,000 people)
Rare (may affect 1 to 10 out of 10,000 people)
Not known (frequency cannot be estimated from available data)

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Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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 adverse reactions, additional information on the safety of the medicinal product can be collected.

5. How to store Nicorette FreshFruit Gum

Keep the medicine out of the sight and reach of children.
Store below 25°C.
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Do not use Nicorette FreshFruit Gum after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nicorette FreshFruit Gum contains

• The active substance is nicotine. Each chewing gum contains 2 mg of nicotine in the form of nicotine resin complex.
• The other ingredients are: core – chewing gum base, xylitol, peppermint oil, anhydrous sodium carbonate, sodium hydrogen carbonate, potassium acesulfame, levomenthol, light magnesium oxide; coating – tutti frutti flavour QL 84441, hypromellose, sucralose, polysorbate 80, xylitol, gum arabic, titanium dioxide (E 171), carnauba wax.

Nicorette FreshFruit Gum chewing gum does not contain sugar (sucrose) or ingredients of animal origin.
What Nicorette FreshFruit Gum looks like and contents of the pack
The pack contains 15, 30, 90, 105 or 210 chewing gums in blisters packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Greece, country of export:
Johnson & Johnson Hellas Consumer AE, Aigialeias & Epidavrou 4, 15125 Marousi, Athens, Greece
Manufacturer:
McNeil AB, Norrbroplatsen 2, Helsingborg, Sweden
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Greece, country of export: 21651/13/23-04-2014
Parallel import authorisation number: 304/22
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