Nicorette Freshfruit Gum

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Nicorette FreshFruit Gum (Nicorette freshfruit 2 mg)

2 mg, chewing gum, medicinal

Nicotine
Nicorette FreshFruit Gum and Nicorette freshfruit 2 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet 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 a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If after 9 months the patient still has difficulty quitting smoking without the help of Nicorette FreshFruit Gum, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Nicorette FreshFruit Gum and what is it 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 packaging and other information

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

Description of action

When a patient stops smoking cigarettes and nicotine is no longer regularly delivered to the body, various symptoms resulting from nicotine withdrawal begin to appear, including irritability, anxiety, mood disturbances, dizziness, and headaches, as well as sleep disturbances. With the help of Nicorette FreshFruit Gum, these can be prevented or alleviated by delivering small doses of nicotine to the body in a short period.
Nicotine in Nicorette FreshFruit Gum is administered in its pure form.
Unlike cigarettes, Nicorette FreshFruit Gum does not release harmful tar substances or carbon dioxide, which appear during tobacco combustion.

Indications for use

Nicorette FreshFruit Gum is indicated for the treatment of tobacco dependence by reducing nicotine craving and withdrawal symptoms that occur after quitting smoking.

2. Important information before using Nicorette FreshFruit Gum

When not to use Nicorette FreshFruit Gum

• If the patient is allergic to nicotine or 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, the patient should discuss it with their doctor in the following cases:

• if they have recently had a stroke or heart attack,
• if they have chest pain or symptoms of angina pectoris,
• if they have heart disease that affects the speed or regularity of the heart rhythm,
• if they have uncontrolled high blood pressure,
• if they have stomach or duodenal ulcers,
• if they have hyperthyroidism,
• if they have insulin-dependent diabetes (they may need smaller doses of insulin as a result of quitting smoking),
• if they have a diagnosed pheochromocytoma,
• if they have severe or moderate liver disease,
• if they have severe kidney disease,
• if they have esophagitis.

Chewing gum may stick to dental work, 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, but the potential risk of long-term use is much lower than the risk of nicotine dependence associated with returning to smoking tobacco.

Nicorette FreshFruit Gum and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Quitting smoking may require modification of their dosing.
If the patient is taking imipramine, clomipramine, fluvoxamine (medicines used to treat depression), clozapine, olanzapine (medicines used to treat schizophrenia), theophylline (a medicine used to treat asthma, chronic obstructive pulmonary disease, and bronchitis), tacrine (a medicine used to treat Alzheimer's disease), ropinirole (a medicine used to treat Parkinson's disease), flecainide (a medicine used to treat arrhythmias), pentazocine (a pain reliever), or insulin, they should consult their doctor before using Nicorette FreshFruit Gum.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
To minimize exposure to the baby, the medicine should be used immediately after breastfeeding.

Driving and using machines

The medicine does not affect or has a negligible effect on the ability to drive and use machines.

Nicorette FreshFruit Gum contains butylhydroxytoluene (E 321) and sodium

The medicine may cause irritation of the mucous membranes.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it 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 people under 18 years of age without a doctor's recommendation. Data on the treatment of people in this age group with Nicorette FreshFruit Gum are limited.
Nicorette FreshFruit Gum is available in doses of 2 mg and 4 mg.
Adults and the elderly
The initial dose should be determined individually based on the patient's degree of nicotine dependence. Usually, 8-12 pieces of gum are used per day with the appropriate nicotine content.
People who smoke with a low degree of dependence (smoking ≤ 20 cigarettes/day) should start treatment with a 2 mg dose. People who smoke with a high degree of dependence should start treatment with a 4 mg dose. No more than 15 pieces of gum should be used per day.
Quitting smoking
Nicorette FreshFruit Gum helps people who are determined to quit smoking.
The gum should be used for at least 3 months. Then, the gum should be gradually reduced. Treatment should be completed when the dose is reduced to 1-2 pieces of gum per day.
Reducing smoking
Nicorette FreshFruit Gum helps people who do not want to or cannot quit smoking to reduce their smoking.
To prolong the intervals between smoking and to maximize the reduction in the number of cigarettes smoked, the gum should be used during the periods between smoked cigarettes when the urge to smoke appears. If after 6 weeks, there is no reduction in the number of cigarettes smoked per day, the patient should consult their doctor.
It is recommended to consider trying to quit smoking as soon as possible, but no later than 6 months after starting treatment. If after 9 months of treatment, it is not possible to make a serious attempt to quit smoking, the patient should consult their doctor.
Regular use of gum for a period longer than 12 months is not usually recommended.
Some former smokers may require longer treatment to avoid returning to smoking.
Unused gum should be kept in case of sudden nicotine craving.
The patient should take advantage of support groups, as they can improve the smoking cessation process and help complete the therapy successfully.
Temporary abstinence
Nicorette FreshFruit Gum helps smokers to temporarily abstain from smoking.
The gum should be used during breaks between smoked cigarettes when the urge to smoke appears, for example, in places where smoking is prohibited or in other situations where the patient wants to avoid smoking.
Using gum in combination with patches
Gum can be used alone or in combination with nicotine patches. Using more than one form of nicotine replacement therapy is beneficial for smokers who have returned to smoking despite previously using monotherapy or who have difficulty controlling the urge to smoke during monotherapy. Therefore, if necessary, Nicorette Invisipatch 15 mg/16 h and Nicorette FreshFruit Gum 2 mg can be used together.
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Nicorette Invisipatch 15 mg/16 h should be applied in the morning, after waking up, and removed after 16 hours, before going to bed. It should be used according to the approved dosing for monotherapy. Nicorette FreshFruit Gum 2 mg should be chewed when a strong urge to smoke appears, not exceeding the maximum daily dose of 15 gum. The gum can be used in this way for a period of 12 weeks, after which the use of gum should be gradually reduced. The maximum duration of gum use is 12 months.
How to chew Nicorette FreshFruit Gum
The gum should be chewed when the patient feels the need to smoke. The gum is chewed to release nicotine, and then the chewing is stopped to allow the nicotine to be absorbed through the mucous membrane of the mouth. Nicotine swallowed with saliva has no beneficial effect and in excess can irritate the throat or stomach, causing hiccups, for example. Nicorette FreshFruit Gum should not be chewed like regular chewing gum in a continuous and energetic manner, as nicotine is released too intensely. Therefore, Nicorette FreshFruit Gum should be chewed slowly, with regular breaks.

• 1. The gum should be chewed slowly until the taste is felt.
• 2. Then, the chewing should be stopped, and the gum should be placed between the gum and the cheek.
• 3. Chewing should be started again when the taste disappears.
• 4. This process should be repeated for 30 minutes.

Using more than the recommended dose of Nicorette FreshFruit Gum

Nicotine overdose, both from nicotine replacement products and (or) due to smoking cigarettes, can cause symptoms of overdose. The risk of poisoning due to swallowing gum is very low, as the 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, and hearing disturbances, as well as significant weakness. After large doses, these symptoms may be accompanied by hypotension, weak and irregular pulse, breathing difficulties, exhaustion, circulatory collapse, and generalized convulsions.
Doses of nicotine tolerated by adults during treatment can cause severe poisoning in small children and can be fatal.
The medicine should be stored in a place that is invisible and inaccessible to children. In case of overdose, nicotine administration should be stopped immediately, and medical help should be sought. The doctor will provide appropriate symptomatic treatment.
In case of swallowing an excessive amount of nicotine, activated charcoal reduces gastrointestinal absorption of nicotine.
If too many gum are used or if a child chews or swallows gum, medical help should be sought immediately, taking the packaging and this leaflet to the hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms may occur in connection with quitting smoking. These include: worsening mood, insomnia, irritability, frustration, anger, anxiety, concentration problems, nervousness, or impatience. Physical symptoms may also occur, such as decreased heart rate, increased appetite or weight gain, dizziness or hyperventilation symptoms, cough, constipation, gum bleeding, aphthous ulcers, or pharyngitis, as well as nicotine craving associated with the desire to smoke.
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Most reported side effects occur within the first few weeks of starting treatment. Mouth and throat irritation may occur, but most patients get used to it during treatment.
Chewing gum may stick to dental work, and in rare cases, cause damage to dental prostheses.
Rarely, allergic reactions (including severe allergic reactions) may occur during treatment with Nicorette FreshFruit Gum.
Side effects reported in at least 1% of patients treated with nicotine in clinical trials and after marketing are presented in the table below.
The frequency of occurrence is defined according to the following scheme:
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)
Unknown (frequency cannot be estimated from available data)

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Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Nicorette FreshFruit Gum

The medicine should be stored in a place that is invisible and inaccessible to children.
Store in a temperature below 25°C.
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Nicorette FreshFruit Gum should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nicorette FreshFruit Gum contains

• The active substance of the medicine is nicotine. One piece of gum contains 2 mg of nicotine, in the form of nicotine with a cationic exchange resin.
• Other ingredients are: core - chewing gum base, xylitol, peppermint essential oil, sodium carbonate anhydrous, sodium bicarbonate, acesulfame potassium, levomenthol, light magnesium oxide; coating - tutti frutti QL 84441 flavor, hypromellose, sucralose, polysorbate 80, xylitol, gum arabic, titanium dioxide (E 171), carnauba wax.

Nicorette FreshFruit Gum does not contain sugar (sucrose) or ingredients of animal origin.

What Nicorette FreshFruit Gum looks like and what the packaging contains

The packaging contains 15, 30, 90, 105, or 210 pieces of gum in blisters placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Greece, the country of export: 21651/13/23-04-2014

Parallel import authorization number: 304/22 Date of leaflet approval: 17.08.2022

[Information about the trademark]
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