Nicorette freshfruit gum

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Nicorette FreshFruit Gum (Nicorette Fruits 4 mg Sugar-Free)
4 mg, chewing gum, medicinal
Nicotinum
Nicorette FreshFruit Gum and Nicorette Fruits 4 mg Sans Sucre are different trade names for the
same medicine.
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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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.

Table of 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, as well as sleep disturbances. Nicorette FreshFruit Gum can help prevent or reduce these symptoms by delivering small doses of nicotine to the body over a short period of time.
The nicotine in Nicorette FreshFruit Gum is administered in pure form.
Unlike cigarettes, Nicorette FreshFruit 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 smoking cessation.

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).

Warnings and precautions
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,
• A heart condition affecting heart rate or rhythm,
• Uncontrolled hypertension,
• Peptic ulcer of the stomach or duodenum,
• Hyperthyroidism,
• Insulin-dependent diabetes (cessation of smoking may require lower insulin doses),
• Confirmed pheochromocytoma,
• Severe or moderate liver disease,
• Severe kidney disease,
• Oesophagitis,
• A history of epilepsy or seizures.

The chewing gum may adhere to, and in rare cases damage, 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 tobacco smoking.

Nicorette FreshFruit Gum and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines planned for future use. Stopping smoking may necessitate adjustments in dosage of other medicines.
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 (a painkiller), or insulin, medical advice should be sought before using Nicorette FreshFruit Gum.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a 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). 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".

3. How to use Nicorette FreshFruit Gum

Children and adolescents
Nicorette FreshFruit Gum chewing gum should not be used in individuals under 18 years of age without medical advice. Data on treatment with Nicorette FreshFruit Gum in this age group are limited.

Adults and elderly
The initial dose should be individually determined based on the patient's degree of nicotine dependence. Typically, 8–12 pieces of gum per day containing the appropriate amount of nicotine are used. Individuals with low nicotine dependence (smoking ≤ 20 cigarettes/day) should start treatment with the 2 mg dose. Individuals with high nicotine dependence should start treatment with the 4 mg dose. Do not use more than 15 pieces of gum per day.

Smoking cessation
Nicorette FreshFruit Gum helps individuals committed to quitting smoking. The gum should be used for at least 3 months. After this period, gradual discontinuation of the gum should be initiated. Treatment should be completed when the dose has been reduced to 1–2 pieces per day.

Smoking reduction
Nicorette FreshFruit Gum helps reduce smoking in individuals unwilling or unable to quit smoking completely. To extend the intervals between cigarettes and maximize reduction in cigarette consumption, the gum should be used during periods between cigarettes when the urge to smoke arises. If no reduction in daily cigarette consumption is achieved after 6 weeks, consult a physician.

Consider attempting complete smoking cessation as soon as possible, but no later than 6 months after starting treatment. If a serious attempt to quit smoking is not possible within 9 months of starting treatment, consult a physician. Regular use of the gum for longer than 12 months is generally not recommended. However, some former smokers may require prolonged treatment to prevent relapse. Unused gum should be kept available in case of sudden nicotine cravings.

Seek advice from support groups, as they may improve the smoking cessation process and help ensure successful completion of therapy.

Temporary abstinence
Nicorette FreshFruit Gum helps smokers temporarily refrain from smoking. The 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 gum may be used alone or in combination with nicotine-containing patches. Using more than one form of nicotine replacement therapy (NRT) is beneficial for smokers who have relapsed despite previous monotherapy with NRT, or who have difficulty controlling cigarette cravings during monotherapy. Therefore, if necessary, Nicorette Invisipatch 15 mg/16 h and Nicorette FreshFruit Gum 2 mg may be used together.

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. Nicorette FreshFruit Gum 2 mg should be chewed whenever there is a strong urge to smoke, without exceeding the maximum daily dose of 15 pieces. The gum may be used in this way for up to 12 weeks, after which gum use should be gradually reduced. The maximum duration of gum use is 12 months.

How to chew Nicorette FreshFruit Gum
Chew the gum when you feel the need to smoke. Chew the gum to release nicotine, then stop chewing and place it between your gum and cheek 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 regular 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 gum and cheek.
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

Abuse of nicotine, either from nicotine replacement products and/or continued smoking, may lead to symptoms of overdose. The risk of poisoning following ingestion 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 may be fatal.

Keep the medicine out of reach of children. In case of overdose, stop administering nicotine immediately and seek medical help. The physician will provide appropriate symptomatic treatment.

In case of excessive nicotine ingestion, activated charcoal reduces gastrointestinal absorption of nicotine.

If too many pieces of gum have been used, or if a child has chewed or swallowed the gum, contact a physician 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 may cause adverse reactions, although not everybody experiences them.
Some symptoms may occur as a result of stopping smoking. These include mood disturbances, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, nervousness, or impatience. Physical symptoms may also occur, such as decreased heart rate, increased appetite or weight gain, dizziness or pre-syncopal symptoms, cough, constipation, 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. Oral and throat irritation may occur, but most patients become accustomed to this during continued use of the medicine.
The chewing gum may adhere to, and in rare cases cause damage to, dental prostheses.
Allergic reactions (including severe allergic reactions) have rarely been reported 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 the available data)

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables better assessment of the safety of the medicinal product.

5. How to store Nicorette FreshFruit Gum

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Nicorette FreshFruit Gum contains

• The active substance is nicotine. One chewing gum contains 4 mg of nicotine in the form of nicotine with cationite.
• Other ingredients are: core – chewing gum base, xylitol, peppermint essential oil, sodium carbonate, potassium acesulfame, levomenthol, light magnesium oxide, quinoline yellow, lac (E 104);

coating – Tuttifrutti flavour, hypromellose, sucralose, polysorbate 80, xylitol, gum arabic, titanium dioxide (E 171), carnauba wax, quinoline yellow, lac (E 104).
Nicorette FreshFruit 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 medicinal chewing gums in blisters placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in France, country of export:
Johnson & Johnson Santé Beauté France
43, rue Camille Desmoulins
92130 Issy-les-Moulineaux
France
Manufacturer:
McNeil AB
Norrbroplatsen 2
SE-25109 Helsingborg
Sweden
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in France, country of export: 3400937100731
Parallel import authorisation number: 76/25