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 4 mg)

4 mg, chewing gum, medicinal

Nicotine
Nicorette FreshFruit Gum and Nicorette freshfruit 4 mg are different trade names for the same medicine.

It is necessary to 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 weakened by delivering small doses of nicotine to the body in a short time.
Nicotine contained in Nicorette FreshFruit Gum is administered in its pure form.
Unlike cigarettes, Nicorette FreshFruit Gum does not release harmful tar substances or carbon dioxide that 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).

Warnings and precautions

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Before starting to use Nicorette FreshFruit Gum, the patient should discuss it with their doctor in the following cases:

• recent stroke or heart attack,
• chest pain or symptoms of angina pectoris,
• heart disease affecting the speed or regularity of the heart rhythm,
• uncontrolled hypertension,
• peptic ulcer disease of the stomach or duodenum,
• hyperthyroidism,
• insulin-dependent diabetes (smaller doses of insulin may be required as a result of quitting smoking),
• proven pheochromocytoma of the adrenal gland,
• severe or moderate liver disease,
• severe kidney disease,
• esophagitis.

Chewing gum may stick, 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 smaller 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 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 for arrhythmia, paroxysmal atrial fibrillation, heart rhythm disorders), pentazocine (a pain reliever), insulin, the patient 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 child, 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)

The medicine may cause irritation of the mucous membranes.

Nicorette FreshFruit Gum contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Nicorette FreshFruit Gum

Children and adolescents
Without a doctor's recommendation, Nicorette FreshFruit Gum should not be used in people under 18 years of age. Data on the treatment of people in this age group with Nicorette FreshFruit Gum are limited.
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Nicorette FreshFruit Gum is available in doses of 2 mg and 4 mg.
Adults and the elderly
The initial dose should be determined individually depending on the 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 dose of 2 mg. People who smoke with a high degree of dependence should start treatment with a dose of 4 mg. No more than 15 pieces of gum should be used per day.
Quitting smoking
Nicorette FreshFruit Gum helps people quit smoking who are determined to quit the habit.
The gum should be used for at least 3 months. Then, gradual withdrawal of the gum should be started. Treatment should be completed when the dose is reduced to 1-2 pieces of gum per day.
Reducing smoking
Nicorette FreshFruit Gum helps reduce smoking in people who do not want to or cannot quit the habit.
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.
The patient should 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 tobacco.
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 therapy successfully.
Temporary abstinence
Nicorette FreshFruit Gum helps smokers 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.
How to chew Nicorette FreshFruit Gum
The gum should be chewed when the patient feels the need to smoke a cigarette.
The gum is chewed to release nicotine, and then chewing is stopped to allow nicotine to be absorbed through the oral mucosa.
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, making regular breaks.

• 1. The gum should be chewed slowly until the taste is felt.
• 2. Then, 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 action should be repeated for 30 minutes.

Using a higher dose of Nicorette FreshFruit Gum than recommended

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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 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 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 symptoms of 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.
In case of using too many gums or chewing or swallowing gum by a child, the patient should immediately contact their doctor or go to the nearest hospital, taking the packaging of the gum and this leaflet with them.

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 accompanied by the desire to smoke.
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, 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 collected 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.
Do not use Nicorette FreshFruit Gum after the expiry date stated on the packaging.
The expiry 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 4 mg of nicotine, in the form of nicotine with cationite.
• Other ingredients are: core - chewing gum base, xylitol, peppermint essential oil, anhydrous sodium carbonate, acesulfame potassium, levomenthol, light magnesium oxide, quinoline yellow, aluminum lake; coating - tuttifrutti QL 84441, hypromellose, sucralose, polysorbate 80, xylitol, gum arabic, titanium dioxide (E 171), carnauba wax, quinoline yellow, aluminum lake.

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 parallel importer.
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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, SE-251 09 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
License number in Greece, the country of export: 71280/12-11-2008
26051/28-04-2010
51965/19-07-2011
24980/21-3-2016

Parallel import license number: 862/12 Date of leaflet approval: 29.11.2022

[Information about the trademark]
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