NICORETTE Chewing Gum 4 mg freshmint

Pack size:

105 pieces

Dosage form:

chewing gum

Nicorette Chewing Gum 4 mg freshmint, medicated chewing gum. Active ingredient: Nicotine (as nicotine polacrilin (1:4)). Indications: Treatment of tobacco dependence by relieving withdrawal symptoms. Support for smoking cessation. Also for reducing cigarette consumption (smoking reduction) to help quit smoking. Warning: Contains levomenthol, peppermint oil, butylhydroxytoluene (E 321).

For risks and side effects, read the package insert and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicorette Chewing Gum 4 mg freshmint, medicated chewing gum, for the treatment of tobacco dependence by relieving withdrawal symptoms, supporting smoking cessation and reducing cigarette consumption (smoking reduction), in order to achieve smoking cessation, for use in adults
Active ingredient: nicotine (as nicotine polacrilin (1:4))

Read the entire package leaflet carefully before you start using this medicine because it contains important information. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may want to read it again later.
• Ask your pharmacist if you need further information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. WHAT IS NICORETTE CHEWING GUM 4 MG FRESHMINT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING NICORETTE CHEWING GUM 4 MG FRESHMINT?
3. HOW TO USE NICORETTE CHEWING GUM 4 MG FRESHMINT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD I STORE NICORETTE CHEWING GUM 4 MG FRESHMINT?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS NICORETTE CHEWING GUM 4 MG FRESHMINT AND WHAT IS IT USED FOR?

Nicorette Chewing Gum 4 mg Freshmint is a medicated chewing gum for smoking cessation.

Nicorette Chewing Gum 4 mg Freshmint is used to treat tobacco dependence by relieving withdrawal symptoms, thus supporting smoking cessation. Even smokers who are currently unable to quit smoking completely immediately can initially use Nicorette Chewing Gum 4 mg Freshmint to reduce their cigarette consumption (smoking reduction) and thus achieve smoking cessation.

Nicorette Chewing Gum 4 mg Freshmint is intended for smokers who are heavily dependent on tobacco and who smoked more than 20 cigarettes a day before treatment.

The success rate can be increased with additional counseling and supportive measures.

Nicorette Chewing Gum 4 mg Freshmint is also suitable for diabetics. One chewing gum contains 596 mg xylitol (equivalent to 1.43 kcal).

2. WHAT SHOULD YOU CONSIDER BEFORE USING NICORETTE CHEWING GUM 4 MG FRESHMINT?

Nicorette Chewing Gum 4 mg Freshmint should not be used:

• if you are allergic to nicotine, levomenthol, peppermint oil, butylhydroxytoluene (E 321) or any of the other ingredients of this medicine listed in section 6.
• if you are a non-smoker.
• if you are an occasional smoker and smoke one cigarette a day or less.

Warnings and Precautions:
Please consult your doctor beforehand if you suffer from any of the following conditions. You may be able to use Nicorette Chewing Gum 4 mg Freshmint, but you must consult your doctor first:

• if you have recently (within the last 3 months) suffered a heart attack or stroke.
• if you have chest pain (unstable angina pectoris) or angina pectoris at rest.
• if you have a heart condition that affects the speed or rhythm of your heartbeat.
• if you suffer from high blood pressure that is not adequately controlled by medication.
• if you have severe or moderate liver disease.
• if you suffer from severe kidney disease.
• if you have diabetes.
• if your thyroid is overactive.
• if you have a tumor of the adrenal glands (pheochromocytoma).
• if you have a stomach or duodenal ulcer.
• if you suffer from inflammation of the esophagus (esophagitis).
• if you have a history of epilepsy or seizures.

Your doctor will carefully weigh the risks of nicotine replacement therapy against those of continued smoking.

Further information:
High nicotine concentrations in the blood with corresponding side effects can occur if you smoke soon after chewing Nicorette Chewing Gum 4 mg Freshmint. Please consider in which situations you are most at risk of mindlessly reaching for a cigarette.

An existing tobacco-induced dependence on nicotine can persist even when using nicotine replacement products; however, the use of nicotine alone is less harmful than smoking tobacco.

People with dentures may have difficulty chewing due to the adhesive nature of Nicorette Chewing Gum 4 mg Freshmint; in some cases, this may not be possible for them. In these cases, you may be able to use other Nicorette dosage forms. Dental fillings or inlays that are not firmly attached may become further loosened when chewing Nicorette Chewing Gum 4 mg Freshmint.

Danger for children:
Nicotine doses tolerated by adult and adolescent smokers can cause severe, potentially fatal, poisoning in children. Therefore, Nicorette Chewing Gum 4 mg freshmint must be kept out of the reach of children at all times (see section ###If you use more... than you should###).

Children and adolescents:
Nicotine chewing gum must not be used on children under 12 years of age.

Nicotine chewing gum should only be used on adolescents (12 years and older and under 18 years of age) on medical advice, as experience with the use of nicotine chewing gum in people under 18 years of age is limited.

Use of Nicorette Chewing Gum 4 mg freshmint with other medicines:
Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or intend to take/use any other medicines.

When you stop smoking, the effect of insulin may be increased as your body adjusts. Your doctor may reduce your insulin dose if necessary. The effectiveness of the following drugs may also be increased:

• Theophylline for the treatment of asthma
• Tacrine for the treatment of Alzheimer's disease
• Clozapine for the treatment of schizophrenia
• Ropinirole for the treatment of Parkinson's disease.

Taking Nicorette Chewing Gum 4 mg Freshmint with food and drink:
There is no known effect from food or drink.

Pregnancy, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy:
It is very important to stop smoking during pregnancy, as smoking can lead to stunted growth in your baby and also to premature birth or stillbirth. It is best if you can stop smoking during pregnancy without using nicotine-containing products. If you are unable to do so, you should only use Nicorette Chewing Gum 4 mg Freshmint after consulting your doctor or pharmacist.

Breast-feeding:
The use of Nicorette Chewing Gum 4 mg Freshmint should be avoided during breastfeeding, as nicotine passes into breast milk and may affect your child. If your doctor has recommended that you use Nicorette Chewing Gum 4 mg freshmint, you should use the chewing gum immediately after breastfeeding and not within two hours before breastfeeding.

Fertility:
Smoking can have adverse effects on female and male fertility. It is not known what specific contribution nicotine makes to these effects. However, women who are trying to conceive should, if possible, neither smoke nor use nicotine replacement therapy.

Driving and using machines:
Nicorette Chewing Gum 4 mg freshmint has no or negligible influence on the ability to drive and use machines.

Nicorette Chewing Gum 4 mg freshmint contains butylhydroxytoluene (E 321):
The chewing gum base contains butylhydroxytoluene (E 321) and may cause local irritation of the mucous membranes.

Nicorette Chewing Gum 4 mg Freshmint contains sodium:
This medicine contains less than 1 mmol (23 mg) sodium per chewing gum, which means it is essentially sodium-free.

3. HOW TO USE NICORETTE CHEWING GUM 4 MG FRESHMINT

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Unless otherwise prescribed by your doctor, the usual dose is as follows:

Adults and the elderly:

To stop smoking immediately:
1 piece of Nicorette chewing gum 4 mg freshmint per hour, maximum 16 pieces per day, with 8 to 12 pieces being considered a guideline,

• for smokers who are heavily dependent on tobacco (as a guideline, a smoker is considered to be heavily dependent on tobacco if he or she smokes the first cigarette within 20 minutes of getting up and more than 20 cigarettes per day).
• for smokers who were unable to quit smoking with the lower dose Nicorette 2 mg chewing gum.

Nicorette Chewing Gum 4 mg Freshmint should be used whenever you would normally smoke a cigarette or whenever you feel the urge to smoke. To increase your chances of quitting smoking successfully and avoid relapse, it is important that you chew a sufficient amount of Nicorette Chewing Gum 4 mg Freshmint every day.

Experience has shown that smokers who want to quit smoking need fewer Nicorette Chewing Gums than the number of cigarettes they previously smoked per day.

Smoking reduction followed by quitting:
Nicorette Chewing Gum 4 mg Freshmint should be used in the phase between smoking cigarettes to reduce the urge to smoke and thus prolong the smoke-free phase. The goal should be to limit smoking as much as possible.

Children and adolescents:
Nicotine gum must not be used on children under 12 years of age.

Nicotine chewing gum should only be used by young people (aged 12 and over and under 18) on medical advice, as experience with the use of nicotine chewing gum in people under 18 is limited.

Method of use:
Chew 1 piece of Nicorette 4 mg freshmint chewing gum for approximately 30 minutes, with breaks in between, to release the nicotine from the gum. It is particularly important to chew Nicorette 4 mg freshmint chewing gum slowly. Avoid chewing the gum quickly and/or vigorously to prevent the nicotine from being released too quickly from the gum.

To do this, chew the gum until the taste noticeably intensifies. Then it is important to push the gum into your cheek until the taste subsides.

You can then start chewing again. To increase the chances of success, it is important to avoid underdosing. A sufficient amount of Nicorette chewing gum should therefore be chewed daily.

Duration of use:

Smoking cessation with immediate smoking cessation:

• Nicorette chewing gum 4 mg freshmint should be used for at least 3 months in total.
• 1 piece of Nicorette chewing gum 4 mg freshmint per hour, maximum 16 pieces per day, with 8 to 12 pieces being a guideline.
• 4 to 6 weeks after starting treatment, the number of chewing gums per day should be gradually reduced by chewing Nicorette Chewing Gum 4 mg freshmint at intervals longer than 1 hour.
• The first attempt to stop using Nicorette chewing gum 4 mg freshmint should be made if the average daily consumption during the last week was 1 - 2 pieces.

However, the chewing gum should always be kept to hand for some time after treatment has ended to prevent any recurring cravings.

Treatment with Nicorette Chewing Gum 4 mg freshmint for longer than 6 months is generally not recommended. For some former smokers, longer treatment may be necessary to prevent a relapse.

Smoking reduction followed by quitting:
As soon as you feel able, you should quit smoking completely, but no later than 6 months after starting to use Nicorette Chewing Gum 4 mg freshmint. However, if you are unable to do so within 9 months of starting to use Nicorette Chewing Gum 4 mg freshmint, you should consult a doctor.

Please follow the relevant instructions for quitting smoking.

For example, proceed as follows:

Step 1 - 0 to 6 weeks: Reduce cigarette consumption by 50%:
Chew one Nicorette Chewing Gum 4 mg freshmint whenever you feel the urge to smoke. Make a commitment to halve your cigarette consumption by the end of week 6 – or even sooner if you can.

Step 2 – within 6 months:
Continue to reduce your cigarette consumption until you have quit smoking completely. Chew a Nicorette 4 mg freshmint chewing gum whenever you feel the urge to smoke to avoid relapse. Make a commitment to quit smoking within 6 months – or even sooner if you can.

Step 3 – within 9 months:
Quit smoking!

If you use more Nicorette 4 mg freshmint chewing gum than you should:
Excessive use of Nicorette 4 mg freshmint chewing gum and/or smoking can lead to symptoms of an overdose.

The risk of poisoning from swallowing the chewing gum is very low because the nicotine is poorly absorbed by the body without chewing.

The symptoms of an overdose of Nicorette Chewing Gum 4 mg Freshmint are similar to those of acute nicotine poisoning: nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing impairment, and severe weakness. In severe overdoses, these symptoms may be followed by a drop in blood pressure, a weak and irregular pulse, difficulty breathing, exhaustion (prostration), circulatory collapse, and generalized seizures.

Doses that are well tolerated by adult smokers during treatment can cause severe, potentially fatal, symptoms of poisoning in children. Suspected nicotine poisoning in a child is a medical emergency; contact your doctor immediately or go to the emergency department of the nearest hospital.

Treatment of overdose: If symptoms of nicotine overdose occur, temporarily stop taking nicotine. Afterwards, you should reduce your nicotine intake by either reducing the frequency of use or, if necessary, using a lower strength.

If symptoms of poisoning occur, nicotine intake must be stopped immediately. A doctor must be contacted promptly. They will treat the symptoms if necessary. If excessive amounts of nicotine are swallowed, taking activated charcoal reduces the absorption of nicotine from the gastrointestinal tract.

If you forget to use Nicorette Chewing Gum 4 mg Freshmint:
Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Nicorette Chewing Gum 4 mg Freshmint can cause the same side effects as other forms of nicotine delivery. Most side effects occur at the beginning of treatment and are generally related to the dose you are using.

Effects related to quitting smoking (nicotine withdrawal)
Some of the unwanted effects you may experience when you stop smoking may be withdrawal symptoms due to the reduction in nicotine supply.

These unwanted effects include:

• Irritability, frustration, impatience or anger
• Anxiety, restlessness or difficulty concentrating
• Nighttime awakenings or sleep disturbances
• Increased appetite or weight gain, constipation
• Depressed mood
• Strong cravings for smoking
• Slow heartbeat
• Bleeding gums
• Dizziness or lightheadedness
• Cough, sore throat, blocked or runny nose

If the following serious rare side effects (signs of angioedema) occur, stop using Nicorette Chewing Gum 4 mg freshmint and seek immediate medical advice:

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Hives along with breathing difficulties

If you quit smoking, you may also develop mouth ulcers. The reason for this is unknown.

However, it can be assumed that the side effects of Nicorette Chewing Gum 4 mg Freshmint are less severe than with smoking due to lower peak nicotine concentrations in the blood. When smoking, in addition to the effects of nicotine, there are additional risks from the known harmful effects of components in cigarette smoke, such as carbon monoxide and tar.

The taste of Nicorette Chewing Gum 4 mg Freshmint may be unpleasant at the beginning of treatment. However, this should not deter you from continuing to take Nicorette Chewing Gum 4 mg Freshmint, as you almost always get used to the taste after a few days.

Irritation of the throat, increased salivation, and occasional damage to the oral mucosa may occur. Likewise, hiccups may occur at the beginning of treatment due to frequently swallowing saliva containing nicotine.

If you are prone to stomach intolerances, Nicorette Chewing Gum 4 mg Fresh Mint may cause mild stomach upset or heartburn. Chewing slowly with longer breaks in between chewing helps overcome this side effect.

In sensitive patients, levomenthol and peppermint oil may trigger hypersensitivity reactions (including shortness of breath).

Possible side effects:

Side effects with oral nicotine dosage forms from clinical trials and since launch:

Very common (may affect more than 1 in 10 people):
Headache, cough, hiccups, nausea, mouth or throat irritation.

Common (may affect up to 1 in 10 people):
Hypersensitivity, dizziness, taste disturbances, abnormal sensations, diarrhea, indigestion, dry mouth, increased salivation, mouth inflammation, vomiting, flatulence, abdominal pain, burning sensation, fatigue.

Uncommon (may affect up to 1 in 100 people):
Abnormal dreams, palpitations, rapid heartbeat, hot flushes, high blood pressure, muscle spasms of the airways, voice disturbance, shortness of breath, blocked nose, pain in the mouth and throat, sneezing, tightness in the throat, belching, inflammation of the tongue, blisters and peeling of the lining of the mouth, numbness in the mouth, weakness, chest discomfort and pain, feeling unwell, excessive sweating, itching, rash, hives, pain in the muscles of mastication.

Rare (may affect up to 1 in 1,000 people):
Difficulty swallowing, reduced sensitivity in the mouth, gagging.

Not known (frequency cannot be estimated from the available data):
Hypersensitivity reactions (anaphylaxis), blurred vision, increased tear secretion, dry throat, gastrointestinal discomfort, sore lips, swelling of the face, tongue, or throat (angioedema), skin reddening, muscle hardening, seizures.

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD NICORETTE CHEWING GUM 4 MG FRESHMINT BE STORE?

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ###Use by### or ###Use by### or ###EXP###. The expiry date refers to the last day of that month.

Do not store Nicorette Chewing Gum 4 mg freshmint above 25°C. Store in the original packaging to protect from light.

Medicines should be disposed of in accordance with local requirements. Never dispose of medicines via wastewater (e.g. down the toilet or sink). Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment. Further information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Nicorette Chewing Gum 4 mg freshmint contains:

The active ingredient is:
nicotine. Each medicated chewing gum contains 4 mg nicotine (as 20 mg nicotine polacrilin (1:4)).

The other ingredients are:
chewing gum base (contains butylhydroxytoluene (E 321)), acesulfame potassium, gum arabic, carnauba wax, quinoline yellow (E 104), levomenthol, light magnesium oxide, sodium carbonate, peppermint oil, titanium dioxide, xylitol.

What Nicorette Chewing Gum 4 mg freshmint looks like and contents of the pack:
Nicorette Chewing Gum 4 mg freshmint is a coated, square, medicated chewing gum. It is available in packs of 30, 105, and 210 medicated chewing gums.

Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer:
Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss


Manufacturer:
McNeil AB,
Norrbroplatsen 2,
S-25109 Helsingborg, Sweden.

This package leaflet was last revised in June 2025.

Source: Information from the package leaflet,
as of April 2025.

Active ingredient: Nicotine (as nicotine polacrilin (1:4)). Indications: Treatment of tobacco dependence by relieving withdrawal symptoms. Support for smoking cessation. Also for reducing cigarette consumption (smoking reduction) to help quit smoking. Warning: Contains levomenthol, peppermint oil, butylhydroxytoluene (E 321).