NICORETTE

NICORETTE Chewing Gum 4 mg whitemint

Important notes (mandatory information)

Nicorette Gum 4 mg whitemint, medicated gum. Active ingredient: Nicotine (as nicotine polacrilin (1:4)). Areas of application: Treatment of tobacco dependence by alleviating withdrawal symptoms. Support for smoking cessation. Also for reducing cigarette consumption (smoke reduction) in order to achieve smoking cessation in this way. Warning: Contains levomenthol, peppermint oil, butylhydroxytoluene (E 321).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Nicorette Gum 4 mg whitemint, medicated gum 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 package leaflet or exactly as directed by your doctor or pharmacist.

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

What is in this package leaflet

1. WHAT IS NICORETTE GUM 4 MG WHITEMINT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING NICORETTE GUM 4 MG WHITEMINT?
3. HOW IS NICORETTE GUM 4 MG WHITEMINT USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD NICORETTE GUM 4 MG WHITEMINT BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Nicorette Gum 4 mg whitemint is a medicated gum for smoking cessation. Nicorette Gum 4 mg whitemint is used to treat tobacco dependence by alleviating withdrawal symptoms and thus supports smoking cessation. Smokers who are currently unable to quit smoking completely can also initially use Nicorette Gum 4 mg whitemint to reduce their cigarette consumption (smoke reduction) in order to achieve smoking cessation in this way. Nicorette Gum 4 mg whitemint is intended for heavily tobacco-dependent smokers who smoked more than 20 cigarettes per day before treatment. Additional counseling and support measures can increase the success rate. Nicorette Gum 4 mg whitemint is also suitable for diabetics. 1 piece of gum contains 579.5 mg of xylitol (equivalent to 1.39 kcal).

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

Nicorette Gum 4 mg whitemint must 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 per day or less.

Warnings and precautions

Please talk to your doctor beforehand if you suffer from any of the following conditions. You may still be able to use Nicorette Gum 4 mg whitemint, but you must first consult your doctor:

• if you have recently (within the last 3 months) had 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 your heart rate or heart rhythm.
• if you have high blood pressure that is not adequately controlled by medication.
• if you have severe or moderate liver disease.
• if you have severe kidney disease.
• if you have diabetes.
• if your thyroid gland 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).

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

Other notes

High blood nicotine levels with corresponding side effects can occur if you smoke soon after chewing a Nicorette Gum 4 mg whitemint. Please consider in which situations the risk of reaching for a cigarette without thinking is particularly high for you. An existing nicotine dependence caused by tobacco can also persist when using nicotine replacement products; however, the use of nicotine alone is less harmful than smoking tobacco. Denture wearers may have difficulty chewing due to the adhesiveness of Nicorette Gum 4 mg whitemint; in some cases, it is therefore not possible for them to use Nicorette Gum 4 mg whitemint. In these cases, you may be able to use other Nicorette dosage forms. Loosely fitting dental fillings or inlays may loosen further when chewing Nicorette Gum 4 mg whitemint.

Danger to children

Nicotine doses that are tolerated by adult and adolescent smokers can cause severe poisoning in children, which can be fatal. Therefore, Nicorette Gum 4 mg whitemint must be kept out of reach of children at all times (see section "If you have used more than you should").

Children and adolescents

Nicotine gum must not be used in children under 12 years of age. Use nicotine gum in adolescents (aged 12 and under 18) only on the recommendation of a doctor, as experience with the use of nicotine gum in persons under 18 years of age is limited.

Use of Nicorette Gum 4 mg whitemint with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or plan to take/use any other medicines. If you quit smoking, the body's adjustment can increase the effect of insulin. Your doctor may reduce the 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.

Use of Nicorette Gum 4 mg whitemint with food and drink

No influence of food and beverages on the effect is known.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, 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 reduced growth of your baby and also to premature birth or stillbirth. It is best if you can quit smoking during pregnancy without using nicotine-containing medicines. If you are unable to do so, you should only use Nicorette Gum 4 mg whitemint after consulting your doctor or pharmacist.

Breastfeeding

The use of Nicorette Gum 4 mg whitemint should be avoided during breastfeeding, as nicotine passes into breast milk and can affect your baby. If your doctor has recommended that you use Nicorette Gum 4 mg whitemint, you should use the gum immediately after breastfeeding and not in the last two hours before breastfeeding.

Fertility

Smoking can have adverse effects on female and male fertility. It is not known what specific role nicotine plays in these effects. However, women who wish to have children should, if possible, neither smoke nor use nicotine replacement therapy.

Driving and operating machinery

Nicorette Gum 4 mg whitemint has no or negligible influence on the ability to drive and use machines.

Nicorette Gum 4 mg whitemint contains butylhydroxytoluene (E 321)

The gum base contains butylhydroxytoluene (E 321) and may cause local irritation of the mucous membranes.

Nicorette Gum 4 mg whitemint contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per piece of gum, i.e. it is virtually "sodium-free".

3. HOW IS NICORETTE GUM 4 MG WHITEMINT USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

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

Smoking cessation with immediate cessation of smoking for adults and the elderly

1 piece of Nicorette Gum 4 mg whitemint per hour, maximum 16 pieces per day, with 8 to 12 pieces as a guideline:

• for heavily tobacco-dependent smokers (as a guideline, a smoker can be considered heavily tobacco-dependent if he or she smokes the first cigarette within 20 minutes of waking up and more than 20 cigarettes per day).
• for smokers who have not been able to quit smoking with the lower-dose Nicorette Gum 2 mg.

Nicorette Gum 4 mg whitemint should be used whenever you would normally smoke a cigarette or when cravings occur. To increase the chances of success of smoking cessation and to avoid relapse, it is important that you chew a sufficient amount of Nicorette Gum 4 mg whitemint daily. Experience has shown that smokers who want to quit smoking need a smaller number of Nicorette Gum than the number of cigarettes previously smoked per day.

Smoke reduction with subsequent cessation of smoking

Nicorette Gum 4 mg whitemint should be used between smoking cigarettes to reduce cravings and thus prolong the smoke-free period. The aim should be to reduce smoking as much as possible.

Children and adolescents
Nicotine gum must not be used in children under 12 years of age. Use nicotine gum in adolescents (aged 12 and under 18) only on the recommendation of a doctor, as experience with the use of nicotine gum in persons under 18 years of age is limited.

Method of administration

1 piece of Nicorette Gum 4 mg whitemint is chewed for about 30 minutes and with breaks to release the nicotine from the chewing gum. It is particularly important to chew Nicorette Gum 4 mg whitemint slowly. Avoid chewing the gum quickly and/or intensively so that the nicotine is not released from the chewing gum too quickly. To do this, the gum should be chewed until the taste intensifies noticeably. It is then important to move the gum into the cheek pouch until the taste subsides. Chewing can then be resumed. To increase the chances of success, it is important to avoid underdosing. Therefore, a sufficient amount of Nicorette Gum should be chewed daily.

Duration of use

Smoking cessation with immediate cessation of smoking:

• Nicorette Gum 4 mg whitemint should be used for at least 3 months in total.
• 1 piece of Nicorette Gum 4 mg whitemint per hour, maximum 16 pieces per day, with 8 to 12 pieces as a guideline.
• 4 to 6 weeks after the start of treatment, the number of pieces of gum per day should be gradually reduced by chewing Nicorette Gum 4 mg whitemint at intervals greater than 1 hour.
• The first attempt to discontinue Nicorette Gum 4 mg whitemint should be made when the average daily consumption during the last week was 1 - 2 pieces.
• However, the gum should still be kept on hand for some time after treatment has ended to counteract any renewed cravings.
• Treatment with Nicorette Gum 4 mg whitemint for more than 6 months is generally not recommended. In some former smokers, longer treatment may be necessary to prevent relapse into their smoking habits.

Smoke reduction with subsequent cessation of smoking

As soon as you feel able to do so, you should stop smoking completely, but no later than 6 months after starting to use Nicorette Gum 4 mg whitemint. However, if this is not possible within 9 months of starting to use Nicorette Gum 4 mg whitemint, a doctor should be consulted. Please follow the appropriate instructions for use for smoking cessation. For example, proceed as follows

1. Step - 0 to 6 weeks

Reduce cigarette consumption by 50%. Chew a Nicorette Gum 4 mg whitemint whenever you feel the urge to smoke. Aim to reduce your cigarette consumption by half by the end of the 6th week - or even sooner if you can.

2. Step - within 6 months

Continue to reduce your cigarette consumption until you have stopped smoking completely. Chew a Nicorette Gum 4 mg whitemint whenever you feel the urge to smoke to avoid relapse. Aim to quit smoking within 6 months - or even sooner if you can.

3. Step - within 9 months

Quit smoking!

If you have used more Nicorette Gum 4 mg whitemint than you should

Excessive use of Nicorette Gum 4 mg whitemint and/or smoking can lead to symptoms of overdose. The risk of poisoning from swallowing the gum is very low because nicotine is poorly absorbed by the body without chewing. The symptoms of an overdose of Nicorette Gum 4 mg whitemint are the same as those of acute nicotine poisoning: nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disturbances and pronounced weakness. In the event of severe overdose, these symptoms can be followed by a drop in blood pressure, weak and irregular pulse, difficulty breathing, exhaustion (prostration), circulatory collapse and generalized seizures. Dosages that are well tolerated by adult smokers during treatment can cause severe poisoning in children, which can be fatal. Suspected nicotine poisoning in a child is to be considered a medical emergency - contact your doctor immediately or go to the emergency room of the nearest hospital.

Treatment of overdose

In the event of nicotine overdose symptoms, temporarily discontinue nicotine intake. You should then reduce your nicotine intake by either reducing the frequency of use or, if necessary, using a lower strength. In the event of poisoning symptoms, nicotine intake must be stopped immediately. A doctor must be notified immediately. He or she will provide symptomatic therapy 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 Gum 4 mg whitemint

Do not take a double dose to make up for a forgotten previous dose.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Nicorette Gum 4 mg whitemint can cause the same side effects as other forms of nicotine intake. Most side effects occur at the beginning of treatment and generally depend on the dose you are using.

Effects related to smoking cessation (nicotine withdrawal)

Some of the side effects you may experience when you quit smoking may be withdrawal symptoms due to the decrease in nicotine intake. These side 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 cigarettes.
• Slow heart rate.
• Bleeding gums.
• Dizziness or lightheadedness.
• Cough, sore throat, stuffy or runny nose.

If the following serious rare side effects (signs of angioedema) occur, stop using Nicorette Gum 4 mg whitemint and seek medical attention immediately:

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

When you stop smoking, you may also experience mouth ulcers. The reason for this is not known. However, it can be assumed that the side effects are less pronounced during treatment with Nicorette Gum 4 mg whitemint due to lower peak nicotine concentrations in the blood than when smoking. In addition to the nicotine effects, smoking also poses additional risks due to the known harmful effects of cigarette smoke components such as carbon monoxide and tar. The taste of Nicorette Gum 4 mg whitemint may be perceived as unpleasant at the beginning of treatment. However, this should not deter you from continuing to take Nicorette Gum 4 mg whitemint, as almost everyone gets used to the taste after a few days. Irritation in the throat, increased salivation and occasional damage to the oral mucosa may occur. Hiccups may also occur at the beginning of treatment due to frequent swallowing of nicotine-containing saliva. If you are prone to stomach upset, Nicorette Gum 4 mg whitemint may cause mild stomach