Nicorette freshmint chewing gum

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging is in a foreign language!
Nicorette Freshmint Gum (Nicorette Menthe Fraiche 4 mg Sans Sucre)
4 mg, medicated chewing gum
Nicotinum
Nicorette FreshMint Gum and Nicorette Menthe Fraiche 4 mg Sans Sucre are different brand names
for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important information for you.
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 or pharmacist. See section 4.
• If after 9 months you still have difficulties refraining from smoking without the help of Nicorette Freshmint Gum, you should contact your doctor.

Contents of the leaflet:

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

1. What Nicorette Freshmint 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. These symptoms can be prevented or reduced by using Nicorette Freshmint Gum, which delivers small doses of nicotine to the body over a short period of time.
The nicotine in Nicorette Freshmint Gum is provided in pure form. Unlike cigarettes, Nicorette Freshmint Gum does not release harmful tar substances or carbon monoxide, which are produced during tobacco combustion.

Indications
Nicorette Freshmint Gum is indicated for the treatment of tobacco dependence by reducing nicotine cravings and withdrawal symptoms that occur after stopping smoking.

2. Important information before using Nicorette FreshMint Gum

When not to use Nicorette FreshMint Gum

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

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

• Recently had a stroke or heart attack,
• Chest pain or symptoms of angina,
• A heart condition affecting the heart rate or rhythm,
• Uncontrolled high blood pressure,
• A stomach or duodenal ulcer,
• Hyperthyroidism,
• Insulin-dependent diabetes (lower insulin doses may be required as a result of stopping smoking),
• A diagnosed phaeochromocytoma,
• Severe or moderate liver disease,
• Severe kidney disease,
• Oesophagitis,
• A history of epilepsy or seizures.

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

Nicorette FreshMint Gum and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines planned for use. Stopping smoking may require adjustments in dosage of certain medications.
If the patient is taking imipramine, clomipramine, fluvoxamine (medicines used to treat depression), clozapine, olanzapine (medicines used to treat schizophrenia), theophylline (used to treat bronchial asthma, chronic obstructive pulmonary disease and bronchial inflammation), 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, consult a doctor before using Nicorette FreshMint Gum chewing gum.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.
Use of Nicorette FreshMint Gum in a pregnant woman who smokes should only begin after consultation with a doctor.
If quitting smoking is not achieved, use of Nicorette FreshMint Gum by a breastfeeding woman should only begin after consultation with a doctor. To reduce infant exposure, 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 FreshMint Gum contains xylitol (E 967)
This medicine may have a laxative effect. The energy value is 2.4 kcal/g of xylitol.

Nicorette FreshMint Gum contains butylated hydroxytoluene (E 321)
This medicine may cause mucosal irritation.

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

3. How to use Nicorette Freshmint Gum

Nicorette Freshmint Gum is available in the following doses: 2 mg, 4 mg.
Children and adolescents
Nicorette Freshmint Gum should not be used in individuals under 18 years of age without medical advice. Data on treatment with Nicorette Freshmint Gum in this age group are limited.
Adults and elderly
The initial dose should be individually determined based on the degree of nicotine dependence. Typically, 8–12 pieces per day of the appropriate nicotine strength are used. Light smokers (smoking ≤ 20 cigarettes/day) should start treatment with the 2 mg dose. Heavy smokers should start treatment with the 4 mg dose. Do not use more than 15 pieces per day.
Smoking cessation
Nicorette Freshmint Gum helps individuals determined to quit smoking to stop the habit. The gum should be used for at least 3 months. After this period, gradual discontinuation should be initiated. Treatment should be completed when the dose has been reduced to 1–2 pieces per day.
Smoking reduction
Nicorette Freshmint 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 gum should be used between cigarettes, whenever the urge to smoke arises. If no reduction in daily cigarette consumption is achieved after 6 weeks, consult a doctor.
Consider attempting to quit smoking 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 doctor.
Regular use of the gum for longer than 12 months is generally not recommended. However, some former smokers may require longer treatment to prevent relapse. Unused gum should be kept available in case of sudden nicotine cravings.
Seek support from counseling or support groups, as they may improve the quitting process and help ensure successful treatment completion.
Temporary abstinence
Nicorette Freshmint 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.
How to chew Nicorette Freshmint Gum
Chew the gum whenever you feel the urge to smoke. The gum should be chewed slowly to release nicotine, then chewing should be paused to allow nicotine absorption through the oral mucosa. Nicotine swallowed with saliva has no beneficial effect and, in excess, may irritate the throat or stomach, causing symptoms such as hiccups. Nicorette Freshmint Gum should not be chewed continuously and vigorously like regular gum, as this would release nicotine too intensely. Therefore, chew Nicorette Freshmint Gum 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. Start chewing again when the taste fades.
4. Repeat this process for approximately 30 minutes—the time required for all the nicotine in the gum to be released.

Use of more than the recommended dose of Nicorette Freshmint Gum
Excessive nicotine intake, 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, profuse 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 nicotine administration immediately and seek medical help. The doctor will provide appropriate symptomatic treatment.
In cases 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 doctor immediately or go to the nearest hospital, taking the gum packaging and this leaflet with you.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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-syncopal symptoms, cough, constipation, gum bleeding, aphthous ulcers or nasopharyngitis, and nicotine craving associated with the desire to smoke.
Most of the adverse effects reported by patients occur within the first weeks of starting treatment. Irritation of the mouth and throat may occur, but most patients become accustomed to this 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 treatment with Nicorette Freshmint Gum.
Adverse effects 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 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)

Reporting adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 continuous monitoring of the benefit-risk balance of the medicinal product and helps to gather further information on the safety of the medicine.

5. How to store Nicorette Freshmint 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Package contents and other information

What Nicorette Freshmint Gum contains

• The active substance is nicotine. One chewing gum contains 4 mg of nicotine in the form of nicotine resin complex.
• The other ingredients are: core – chewing gum base, xylitol (E 967), peppermint essential oil, sodium carbonate, quinoline yellow, aluminium lake (E 104), acesulfame potassium (E 950), levo-menthol, light magnesium oxide; coating – xylitol (E 967), peppermint essential oil, arabic gum (E 414), titanium dioxide (E 171), carnauba wax, quinoline yellow, aluminium lake (E 104).

Nicorette Freshmint Gum chewing gum does not contain sugar (sucrose) or ingredients of animal origin.
What Nicorette Freshmint Gum looks like and contents of the pack
Square-shaped chewing gum measuring 15.3 x 15.3 x 6.9 mm, with a cream-coloured coating.
The pack contains 15, 30, 90, 105 or 210 chewing gums in blisters, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in France, the country of export:
Kenvue France
41 rue Camille Desmoulins
92130 Issy-les-Moulineaux
France
Manufacturer:
McNeil AB
Norrbroplatsen 2
251 09 Helsingborg
Sweden
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in France, the country of export: 365 504-9
34009 365 504 9 0
376 315-8
34009 376 315 8 7
Parallel Import Authorisation Number: 69/26