NICORETTE Chewing gum 4 mg freshmint, 210 pcs

Instructions for use for NICORETTE Chewing gum 4 mg freshmint, 210 pcs

Application Notes

Adult

1 Chewing gum

8-12 times a day

hourly

Application areas

Mode of action

How does the ingredient of the medicine work?

The active ingredient is used as a support for smoking cessation, especially to alleviate withdrawal symptoms. The key here is that the nicotine is not delivered in the form of a cigarette. In this way, the disadvantageous factors, such as the additional pollutants ingested and the addictive process of smoking, can be ruled out. By slowly reducing the amount of nicotine, nicotine dependence can be ended in a controlled manner.

Composition

Contraindications

What speaks against an application?

Always:
- Hypersensitivity to the ingredients
- Recent heart attack (up to 3 months)
- Prinzmetal angina (special form of angina pectoris)
- Recent stroke

Under certain circumstances - talk to your doctor or pharmacist about this:
- Ulcers in the digestive tract
- Angina pectoris
- Peripheral circulatory disorders (e.g. Arms legs)
- Circulatory disorders of the cerebral vessels
- Heart failure
- Cardiac arrhythmias
- Raynaud's syndrome
- High blood pressure
- Impaired kidney function
- Hepatic impairment
- Pheochromocytoma (adrenaline-producing tumor)
- Diabetes mellitus (sugar diabetes) that needs to be treated with insulin
- Hyperthyroidism

Non-smokers or occasional smokers should not use the medicine.

What age group do you need to consider?
- Children under 12 years of age: The medicine must not be used.
- Adolescents from 12 to 17 years: The medicine may only be used after consulting a doctor or under medical supervision.

What about pregnancy and lactation?
- Pregnancy: consult your doctor. Various considerations play a role in whether and how the drug can be used during pregnancy.
- Breast-feeding: consult your doctor or pharmacist. He will examine your particular starting position and advise you accordingly as to whether and how you can continue breastfeeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

Side effects

What adverse effects may occur?

Side effects that occur specifically when nicotine is swallowed:
- Increased salivation
- Symptoms of irritation in the mouth and throat, sometimes with inflammation of the mucous membranes in the mouth and throat
- Hiccups
- Skin redness
- Hives

Numerous side effects are reported for the drug. It should be noted:

In principle, similar side effects to smoking can occur during treatment with this medicine.

Symptoms that occur can also be caused by the withdrawal.

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Hints

What should you consider?
- The medicinal product contains a substance that can cause severe poisoning in children. Therefore, pay particular attention to keeping it safe from children, including any leftovers after use and packaging.
- Be careful if you are allergic to dyes (e.g. quinoline yellow with the E number E 104)!
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.
- Smoking should be avoided in any case, because the drug treatment is disturbed.

Detailed instructions for NICORETTE Chewing gum 4 mg freshmint, 210 pcs

Field of use

• The preparation is a chewing gum containing active ingredients for smoking cessation.
• The drug is used to treat tobacco addiction by relieving withdrawal symptoms. The preparation thus supports smoking cessation. Smokers who are currently unable to stop smoking completely can use the chewing gum to reduce their cigarette consumption (smoking reduction) in order to quit smoking in this way.
• The medicine is intended for heavily tobacco-dependent smokers who smoked more than 20 cigarettes a day before treatment.
• Additional counseling and supportive measures can increase the success rate.

Active substances / ingredients / ingredients

20 mg nicotine polacriline (1:4)
4 mg nicotine
16 mg polacriline
Acesulfame, potassium salt excipient (+)
Arabic gum excipient (+)
Carnauba wax excipient (+)
Quinoline yellow excipient (+)
Chewing gum base excipient (+)
Butylated hydroxytoluene excipient (+)
Levomenthol excipient (+)
Magnesium oxide, slightly excipient (+)
Sodium carbonate excipient (+)
Peppermint Oil Excipient (+)
Titanium dioxide excipient (+)
596 mg xylitol excipient (+)
23 mg total sodium ion excipient (+)
Total Sodium Ion Excipient (+)

Contraindications

• The drug must not be used,
  • if you are allergic to nicotine or any of the other ingredients of this medicine.
  • if you are a non-smoker
  • if you are an occasional smoker and smoke one cigarette a day or less.

dosage

• Always use this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed by the doctor, the usual dose is as follows:
  • Smoking cessation with immediate smoking cessation
    • Adults and the elderly
      • 1 Piece per hour, maximum 16 pieces per day, with 8 to 12 pieces as a guideline,
        • for heavily addicted smokers (as a guideline, a smoker is heavily addicted to tobacco if they smoke their first cigarette within 20 minutes of waking up and smoke more than 20 cigarettes per day)
        • for smokers who were unable to quit smoking with the lower dose chewing gum (2 mg).
      • The preparation should be used whenever you would normally smoke a cigarette or whenever cravings arise. In order to increase the chances of success in quitting smoking and avoiding relapses, it is important that you chew an adequate amount of gum every day.
      • Experience has shown that smokers who want to quit smoking need less chewing gum than the number of cigarettes previously smoked per day.
  • Smoking reduction followed by smoking cessation
    • The drug should be used in the period between smoking cigarettes to reduce the craving to smoke and thus prolong the smoke-free period. The goal should be to limit smoking as much as possible.
  • Children and young people
    • Nicotine gum should not be used in children under the age of 12.
    • Only use nicotine gum in adolescents (12 years and under 18 years of age) with medical advice, as experience of using nicotine gum in persons under 18 years of age is limited.

• Duration of use
  • Smoking cessation with immediate smoking cessation
    • The drug should be used for a total of at least 3 months.
    • 1 Piece per hour, maximum 16 pieces per day, with 8 to 12 pieces as a guideline.
    • 4 to 6 weeks after starting treatment, the number of chewing gums per day should be gradually reduced by chewing the medicine at intervals greater than 1 hour.
    • The first attempt to stop taking the medicine should be made when the average daily consumption over the past week has been 1-2 pieces.
    • However, the chewing gum should always be at hand for a certain time after the end of the treatment in order to counteract a renewed urge to smoke.
    • Treatment longer than 6 months is generally not recommended. For some ex-smokers, longer treatment may be necessary to prevent a return to smoking.
  • Smoking reduction followed by smoking cessation
    • Complete cessation of smoking should be attempted as soon as one feels capable, but no later than 6 months from the start of use. However, if this is not possible within 9 months of starting to use the preparation, a doctor should be consulted.
    • Please note the relevant application instructions for quitting smoking.
  • For example, do the following:
    • Step 1 - 0 to 6 weeks: Reduce cigarette consumption by 50
      • Chew a piece of gum whenever you feel the urge to smoke. Aim to cut your cigarette consumption in half by the end of the 6th week, or even sooner if you can.
    • 2Nd step - within 6 months
      • Keep reducing your cigarette consumption until you quit smoking completely. Chew a piece of gum whenever you feel the craving for cigarettes to avoid relapse. Aim to quit smoking within 6 months, or sooner if you can.
    • Step 3 - within 9 months: Quit smoking!

• If you use more than you should
  • Excessive use of the drug and/or smoking can lead to overdose symptoms.
  • 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 correspond to those of acute nicotine poisoning: nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disorders and a pronounced feeling of weakness. In severe overdose, these symptoms may be followed by a drop in blood pressure, a weak and irregular pulse, difficulty breathing, states of exhaustion (prostration), circulatory collapse and generalized seizures.
  • Doses that are well tolerated by adult smokers during treatment can cause severe intoxication in young children, which can be fatal. Suspected nicotine poisoning in a child should be considered a medical emergency - contact your doctor immediately or go to the nearest hospital casualty department.
  • Treatment of overdose: In case of nicotine overdose symptoms, temporarily stop taking nicotine. You should then reduce your nicotine intake, either by reducing the frequency of use or by using a lower strength if necessary.
  • In the event of symptoms of intoxication, the nicotine intake must be stopped immediately. A doctor must be notified immediately. If necessary, he will provide symptomatic therapy. If excessive amounts of nicotine are ingested, ingestion of activated charcoal reduces absorption of nicotine from the gastrointestinal tract.

• If you forgot the application
  • 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.

Revenue

• 1 Piece of chewing gum is chewed for about 30 minutes with breaks to release the nicotine from the chewing base. The key is to chew slowly. You should avoid chewing the gum quickly and/or intensively so that the nicotine is not released from the chewing base too quickly.
• The medicine should be used whenever you would normally smoke a cigarette or whenever cravings occur.

Patient notes

• Warnings and Precautions
  • Please talk to your doctor first if you suffer from any of the following diseases. You may be able to use this medicine, but you need to check with your doctor first,
    • 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 the speed of your heartbeat or heart rhythm.
    • if you suffer from high blood pressure that is not adequately controlled by medicines.
    • 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 (oesophagitis).
  • Your doctor will carefully weigh the risks of using nicotine replacement therapy versus continuing to smoke.
  • More information:
    • High levels of nicotine in the blood, with associated side effects, can occur if you smoke soon after chewing gum. Please consider the situations in which the risk of reaching for a cigarette thoughtlessly is particularly high.
    • Pre-existing dependence on nicotine caused by tobacco may persist with the use of nicotine replacement products; however, the use of nicotine alone is less harmful than tobacco smoking.
    • Denture wearers may have difficulty chewing because of the adhesive nature of the drug; in some cases it is therefore not possible for them to use this preparation. In these cases, you can use other dosage forms if necessary. Improperly seated dental fillings or inlays may loosen further as you chew the gum.
  • Danger in children
    • Nicotine doses that are tolerated by adult and adolescent smokers can cause severe intoxication in children, which can be fatal. Therefore, the medicinal product must be kept out of the reach of children at all times.
  • Nicotine gum should not be used in children under 12 years of age.
    • Only use nicotine gum in adolescents (12 years and under 18 years of age) on medical advice, as experience of nicotine gum use in persons under 18 years of age is limited.

• Ability to drive and use machines
  • The drug has no or negligible influence on the ability to drive and use machines.

Pregnancy

• 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 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 this, you should only use the medicine after consulting your doctor or pharmacist.
• Lactation
  • Use should be avoided while breastfeeding as nicotine passes into breast milk and may affect your child. If recommended by your doctor, you should use the gum immediately after breastfeeding and not in the two hours before breastfeeding.
• Fertility
  • Smoking can have adverse effects on female and male fertility (fertility). It is not known what specific contribution nicotine makes to these effects. If possible, women who want to have children should neither smoke nor use nicotine replacement therapy.

Hints

Manufacturer: Johnson & Johnson GmbH (OTC), Johnson & Johnson Platz 2, 41470 Neuss