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 4 mg)
4 mg, medicated chewing gum
Nicotinum
Nicorette FreshFruit Gum and Nicorette freshfruit 4 mg are different trade names for the same
medicinal product.
Please read this 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 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, please 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.

Contents of the leaflet:

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, nicotine is no longer regularly supplied to your body, and various symptoms of nicotine withdrawal may begin to appear, such as irritability, restlessness, mood disturbances, dizziness and headaches, and sleep disturbances. Nicorette FreshFruit Gum can help prevent or reduce these symptoms by delivering small doses of nicotine to your body over a short period of time.
The nicotine contained in Nicorette FreshFruit Gum chewing gum is administered in pure form.
Unlike cigarettes, Nicorette FreshFruit Gum chewing gum does not release harmful tar substances or carbon dioxide, which are produced during tobacco combustion.
Indications
Nicorette FreshFruit Gum is indicated for the treatment of tobacco dependence by reducing nicotine craving and withdrawal symptoms occurring after stopping smoking.

2. 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).

Warnings and precautions
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Before starting to use Nicorette FreshFruit Gum, consult a doctor if the patient has:

• Recently suffered a stroke or myocardial infarction,
• Chest pain or symptoms of angina pectoris,
• Heart disease affecting heart rate or rhythm regularity,
• Uncontrolled hypertension,
• Peptic ulcer of the stomach or duodenum,
• 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,
• Esophagitis.

The chewing gum may adhere to, and in rare cases cause damage to, dental prostheses.
Some patients may continue using Nicorette FreshFruit Gum beyond the recommended treatment period; however, the potential risk of long-term use is considerably lower than the risk associated with returning to smoking.

Nicorette FreshFruit Gum and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient intends to take. Stopping smoking may require adjustment of dosages of other medications.
If the patient is taking imipramine, clomipramine, fluvoxamine (medicines used to treat depression), clozapine, olanzapine (medicines used to treat schizophrenia), theophylline (used in the treatment of bronchial asthma, chronic obstructive pulmonary disease and inflammatory airway conditions), tacrine (used in Alzheimer's disease), ropinirole (used in Parkinson's disease), flecainide (used, among others, in tachycardia, paroxysmal atrial fibrillation, cardiac arrhythmias), pentazocine (analgesic), or insulin, consult a doctor before using Nicorette FreshFruit Gum.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
To minimize exposure to the infant, the gum 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)
This medicine may cause mucosal irritation.

Nicorette FreshFruit Gum contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

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 patients in this age group with Nicorette FreshFruit Gum are limited.
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Nicorette FreshFruit Gum is available in doses: 2 mg and 4 mg.
Adults and elderly patients
The initial dose should be individually determined based on the patient's degree of nicotine dependence. Typically, 8–12 chewing gums per day containing the appropriate amount of nicotine are used.
Smokers with low nicotine dependence (smoking ≤ 20 cigarettes/day) should begin treatment with the 2 mg dose. Smokers with high nicotine dependence should begin 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. Then, gradual discontinuation of the gum should be initiated. Treatment should be completed when the dose has been reduced to 1–2 chewing gums per day.
Smoking reduction
Nicorette FreshFruit Gum helps reduce smoking in individuals who are unwilling or unable to quit completely. To extend the intervals between cigarettes and maximally reduce the number of cigarettes smoked, the chewing gum should be used during periods between smoking, when the urge to smoke arises. If no reduction in daily cigarette consumption is achieved within 6 weeks, consult a physician.
Consider making a serious attempt to quit smoking as soon as possible, but no later than 6 months after starting treatment. If a serious attempt to quit smoking has not been possible within 9 months of starting treatment, consult a physician.
Regular use of chewing gum for longer than 12 months is generally not recommended. Some former smokers may require longer treatment to prevent relapse to smoking. Unused gums should be kept in case of sudden nicotine cravings.
Seek advice from support groups, as they may enhance the smoking cessation 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.
How to chew Nicorette FreshFruit Gum
Chew the gum whenever you feel the urge to smoke a cigarette. Chew the gum slowly to release nicotine, then stop chewing and place the gum between your cheek and gum to allow nicotine absorption through the oral mucosa. Nicotine swallowed with saliva has no beneficial effect and may irritate the throat or stomach, potentially causing hiccups. Nicorette FreshFruit Gum should not be chewed continuously and vigorously like ordinary chewing gum, as this causes too rapid release of nicotine. Therefore, Nicorette FreshFruit Gum should be chewed slowly, with regular pauses.
Chewing technique

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

Use of a higher than recommended dose of Nicorette FreshFruit Gum
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Abuse of nicotine, either from nicotine replacement products and/or continued smoking, may lead to symptoms of overdose. The risk of poisoning following swallowing of the chewing gum is very low, as absorption of nicotine 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.
Doses of nicotine tolerated by adults during treatment may cause severe poisoning in young children and may 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 physician will initiate appropriate symptomatic treatment.
In cases of excessive nicotine ingestion, activated charcoal reduces gastrointestinal absorption of nicotine.
If too many gums have been used, or if a child has chewed or swallowed the gum, contact a physician immediately or go to the nearest hospital, bringing the gum packaging and this leaflet with you.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
Some symptoms may occur as a result of stopping smoking. These include: depressed 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, gum bleeding, aphthous ulcers or inflammation of the nasopharynx, and nicotine craving associated with the urge to smoke.
Most of the reported adverse reactions occur during the first weeks of treatment. Irritation of the mouth and throat may occur, but most patients become accustomed to it during treatment.
The chewing gum may stick to, and in rare cases cause damage to, dental prostheses.
Allergic reactions (including severe allergic reactions) may rarely occur during the use of Nicorette FreshFruit Gum.
Adverse reactions reported in at least 1% of patients treated with nicotine in clinical trials and post-marketing are listed in the table below.
The frequency of occurrence is defined according to the following classification:
Very common (may occur in 1 to 10 out of 10 people)
Common (may occur in 1 to 10 out of 100 people)
Uncommon (may occur in 1 to 10 out of 1,000 people)
Rare (may occur in 1 to 10 out of 10,000 people)
Not known (frequency cannot be estimated from the 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 a 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 medicine can be collected.

5. How to store Nicorette FreshFruit Gum

Keep this medicine out of sight and reach of children.
Store below 25°C.
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. Such measures 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 4 mg of nicotine in the form of nicotine cation-exchange resin.
• The other ingredients are: core – chewing gum base, xylitol, peppermint essential oil, anhydrous sodium carbonate, potassium acesulfame, levomenthol, light magnesium oxide, quinoline yellow, aluminium lake; coating – tuttifrutti QL 84441, hypromellose, sucralose, polysorbate 80, xylitol, gum arabic, titanium dioxide (E 171), carnauba wax, quinoline yellow, aluminium lake.

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 placed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
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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, SE-251 09 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 Numbers in Greece, country of export: 71280/12-11-2008
26051/28-04-2010
51965/19-07-2011
24980/21-3-2016
Parallel Import Licence Number: 862/12
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