Nicorette Fresh Fruit Chewing Gum, 4 mg 30pcs

Pharmacodynamics:

After abrupt smoking cessation in patients who have used tobacco-containing products daily for a long time, withdrawal syndrome may develop, which includes: dysphoria, insomnia, increased irritability, anxiety, impaired concentration, reduced heart rate, increased appetite or weight gain. An important symptom of withdrawal syndrome is also a desire to smoke.

In the treatment of tobacco addiction nicotine replacement therapy reduces the number of cigarettes smoked, reduces the severity of withdrawal symptoms arising from complete cessation of smoking in those who decided to quit smoking; facilitates temporary abstinence from smoking and also helps to reduce the number of cigarettes smoked by those who can not or do not want to give up smoking completely.

Pharmacokinetics:

Nicotine from chewing gum is quickly absorbed through the mucous membrane of the cheek and detected in the blood in 5-7 minutes. The maximum concentration of nicotine is reached after 30 minutes after the beginning of chewing.

The distribution volume of nicotine during intravenous administration is about 2-3 liters/kg, and the half-life is about 2 hours. Nicotine is mainly excreted by the liver, its average plasma clearance is about 70 l/h. Nicotine is also metabolized in the kidneys and lungs. More than 20 nicotine metabolites have been identified that are inferior to it in activity.

The binding of nicotine to plasma proteins is less than 5%.
Primary metabolite of nicotine in plasma – cotinine – has a half-life of 15-20 hours, and its concentration is 10 times higher than that of nicotine.

Urinary excretion is primarily cotinine (15% of the dose) and trans-3-hydroxy-cotinine (45% of the dose). Between 10% and 30% of the dose of nicotine is excreted unchanged in the urine.

Progressive deterioration of renal function is accompanied by a decrease in total clearance of nicotine. Its pharmacokinetics does not change in cirrhotic patients with mild impairment of liver function (Child-Pugh index 5) and decreases in cirrhotic patients with moderate impairment of liver function (Child-Pugh index 7). Smokers treated with hemodialysis have increased plasma nicotine concentrations.

Elderly patients have a slight decrease in total nicotine clearance, which does not require dose adjustment.

Indications

Treatment of tobacco addiction by reducing the need for nicotine in the following cases:

– reduction of withdrawal symptoms that occur when patients choose to quit smoking completely;

– in temporary smoking cessation;

– reduction of the number of cigarettes smoked in those who are unable or unwilling to give up smoking completely.

Active ingredient

Nicotine

Composition

1 chewing drug gum contains:

The active ingredient:

nicotine-polymer complex – 22 mg (the indicated amount is equivalent to 4.4 mg of nicotine, including 10% excess).

Excipients:

Chewing gum medicinal core: chewing gum (base)* – 560 mg, xylitol – 302 mg, peppermint oil – 30 mg, sodium carbonate – 30 mg, acesulfame potassium – 2 mg, levomenthol – 2 mg, magnesium oxide – 1 mg, quinoline yellow E104 – 1 mg;

Chewing gum shell:
xylitol – 294 mg, peppermint oil – 9 mg, Arabian gum – 9 mg, titanium dioxide – 7 mg, carnauba wax – 1 mg, quinoline yellow E104 – 0.06 mg.

* The base of chewing gum is a mixture of different types of wax, resin and other hydrocarbons (about 60%) and calcium carbonate (up to 40%).

How to take, the dosage

Adults and adolescents over 18 years

The dosage is selected individually depending on the intensity of smoking.

Generally:

– nicorette® chewing gum 2 mg (moderate nicotine content) should be used if you smoke less than 20 cigarettes a day,

– Nicorette® 4 mg chewing gum (increased nicotine content) should be used if you smoke more than 20 cigarettes a day or if you have failed to quit smoking with a 2 mg dose of chewing gum.

How to use “Nicorette®”

“Nicorette®” chewing gum should be used in all cases when you have an irresistible desire to smoke according to the following scheme:

1. The chewing gum should be chewed for about 30 minutes at intervals. Slowly chew the chewing gum until a distinct taste appears.
2. Stop chewing and leave the gum between the inside of your cheek and your gum.
3. When the taste disappears, start chewing the gum again.

If you have symptoms of overdose (see section “Overdose”) you should immediately stop using the drug.

Complete cessation of smoking

Only one pad should be chewed at a time, stopping smoking.

In case of full smoking cessation the dose of chewing gum per day is determined by the degree of nicotine addiction, but usually it is 8-12 pieces per day and should not exceed 15 pieces per day. Chewing gum at this dose should be used for up to 3 months, after which the daily number of gums should be gradually reduced until the complete abolition. Chewing gum is discontinued when the daily dose is 1-2 pieces per day.

Regular use of chewing gum for more than 12 months is usually not recommended, but some people need a longer therapy to avoid relapse to smoking.

Reducing the number of cigarettes smoked

Chewing gum should be used as needed between smoking episodes in order to increase the intervals between smoking and to reduce smoking as much as possible. If a reduction in daily cigarette consumption is not achieved within 6 weeks, you should seek professional help.

You should attempt to quit smoking as soon as you feel ready to do so, but no later than 6 months after starting therapy. If you have not been able to make a serious attempt to stop smoking within 9 months of starting therapy, you should see a specialist.
After smoking cessation, you should follow the recommendations of therapy, gradual dose reduction and cessation of the drug as outlined above for complete smoking cessation.

Regular use of chewing gum for more than 12 months is generally not recommended. However, some former smokers may need longer treatment with chewing gum to prevent a return to smoking or previous levels of tobacco use.

The simultaneous provision of medical counseling and psychological support usually increases the effectiveness of therapy.

Temporary smoking cessation

Chewing gum can be used at times when you need to abstain from smoking, such as when you are in non-smoking areas or in other situations where you need to abstain from smoking.

In combination with the transdermal patch

The Nicorette® chewing gum Fresh fruit in 2 mg dosage can also be used in combination with the patch in situations when against the background of the patch application the person continues to experience periodic irresistible urges to smoke, or if smoking cessation using chewing gums or the patch only failed. In combination with the patch, Nicorette® Fresh Fruit 2 mg chewing gum can quickly relieve the strong urges to smoke when needed. Patients must completely stop smoking during therapy.

Initial therapy:

Treatment should begin with a 25 mg/16 hour patch (Stage 1) in combination with 2 mg chewing gum. A minimum of 4 2 mg chewing gum per day is used; usually 5-6 chewing gums are sufficient. The number of chewing gums should not exceed 15 per day. The total course of treatment usually lasts for 8 weeks. After that the nicotine dose should be reduced gradually.

The patch is applied immediately after waking up in the morning and removed before going to bed. The patch should be applied to dry, clean, undamaged skin that does not contain hair, such as the thighs, upper extremities or chest. It is necessary to change the place of application every day: you should not use the same area for the next two days.

After applying the patch, wash your hands thoroughly to avoid eye irritation from possible nicotine ingestion.

Cancellation of Combination Therapy:

Cancellation of Combination Therapy can be done in two ways.

Method 1: For the next 2 weeks, switch from a 25 mg/16 hour patch (Stage 1) to a 15 mg/16 hour patch (Stage 2), and then for the next 2 weeks to a 10 mg/16 hour patch (Stage 3), while maintaining the amount of Nicorette® Fresh Fruit chewing gum with a 2 mg dosage, as with Initial Therapy. Then gradually reduce the amount of chewing gum until complete abolition within the time that the person needs depending on his/her needs, but no later than 12 months after the beginning of combined therapy.

Method 2: consists in complete abolition of the patch immediately after the end of the Initial Therapy stage. Then gradually reduce the amount of Nicorette® Fresh Fruit gum with a dosage of 2 mg until complete withdrawal within the time that the person needs, depending on his/her needs, but no later than 12 months after the beginning of combined therapy.

Special Instructions

Diabetic patients may need lower doses of insulin after stopping smoking.

Doses of nicotine that are easily tolerated by adult smokers and teenage smokers can cause severe intoxication in children, which can lead to death. It is important not to leave nicotine-containing medications unattended, as this may involve misuse and ingestion by children.

Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolized by the CYP1A2 isoenzyme (and possibly CYP1A1). Smoking cessation may cause slower metabolism and, consequently, increased blood concentrations of these drugs. This has potential clinical implications for drugs with a narrow therapeutic index, such as theophylline, tacrine, clozapine, and ropinirole.

Persons with impaired masticatory function are advised to use other dosage forms. Individuals with dentures may have difficulty chewing Nicorette® chewing gum. The chewing gum can stick to dentures and in rare cases lead to their damage.

If the medicine is out of date or expired – do not throw it in the sewage or on the street! Place the medication in a bag and put it in a trash container. These measures will help protect the environment!

Synopsis

Nicorette® is a wide range of nicotine replacement therapy for smoking cravings. Nicorette® helps to reduce smoking cravings and relieves various manifestations of withdrawal syndrome: cravings, irritability, bad mood, anxiety, poor concentration and increased appetite.

Safety and effectiveness of nicotine replacement therapy as an approach to treating tobacco addiction has been studied in 150 clinical studies 1 and recommended by the World Health Organization 2.

MAIN BENEFITS

Keep the habit under control – Clinically proven to help combat smoking cravings 3 including physical and psychological addiction to nicotine.

Flexible quitting scheme – Nicorette® chewing gum helps to fight the craving for smoking both with full quitting and reducing the number of cigarettes smoked.

Calm and self-control – The chewing format helps control anxiety and irritability .

Fighting cravings on the go – Nicorette® chewing gum helps fight cravings and take your mind off smoking in any convenient place 7.

It helps to decrease craving for smoking and relieve various manifestations of withdrawal syndrome 4 – craving, irritability, bad mood, anxiety, poor concentration and increased appetite

It helps control weight gain5 – Nicorette® chewing gum helps keep appetite under control when quitting smoking. In addition, all Nicorette® chewing gum contains no sugar.

A fresh way to quit smoking – Nicorette® chewing gum to combat smoking cravings has a pleasant taste of fresh mint

How does Nicorette® work?

Nicorette® chewing gum is specially designed to allow your body to gradually adjust to quitting nicotine. This anti-smoking drug contains medical nicotine which is released when you chew it6. At the same time, the nicotine level in chewing gum is much lower than that of cigarettes. Gradually reducing the dosage of nicotine helps the body develop the habit of living without it, helping to treat tobacco addiction.7

How to choose Nicorette ® chewing gum?

– You smoke less than 20 cigarettes a day? Try Nicorette® 2mg chewing gum (moderate nicotine content)

– Do you smoke more than 20 cigarettes a day or were you unable to quit smoking with the 2mg dose of chewing gum? Try chewing gum 4 mg.

– Nicorette® chewing gum can also be used in combination with the patch in those situations when a person continuously experiences irresistible urges to smoke occasionally during the patch application or when smoking cessation with chewing gums or the patch only failed. When combined with the patch, Nicorette® chewing gum can relieve the strong urge to smoke when needed. Patients must stop smoking completely during therapy. Combination therapy increases your chances of quitting smoking by 2.5 times.8

How to use Nicorette® Chewing Gum?

Step 1- Slowly chew Nicorette® Chewing Gum until you can taste the nicotine and feel a tingling sensation in your mouth7. It usually takes one or two bites.

Step 2- Stop chewing and leave the Nicorette® chewing gum between your cheek and gums.

Step 3- After about a minute, when the tingling is almost gone, start chewing again. Repeat this process until the tingling is gone.

Step 4- Repeat this pattern for about 30 minutes.

Important:

Use Nicorette® gum every time you feel the urge to smoke, up to 15 pieces per day maximum.

Gradually reduce the number of uses until you quit

How to use Nicorette® when choosing combination therapy?

Stage 1: Use the 25 mg patch along with the 2 mg chewing gum or spray. Use this dosage for 8 weeks

Stage 2: You can choose one of two ways to complete therapy. 1 way: Use 15 mg patch for the first 2 weeks and 10 mg patch for the next 2 weeks. Continue to use the same amount of gum or spray as you did at the beginning of therapy. Method 2: Stop using the patch completely immediately after completing the first stage, and reduce the amount of gum or spray gradually. End therapy no later than 12 weeks.

Choose your way to quit smoking:

The Nicorette® range includes a spray, chewing gum and patch.

Nicorette® Spray helps reduce cravings for smoking. Activation of the spray occurs in 60 seconds9. Combats smoking cravings in cases when you decide to give up cigarettes both immediately and gradually.

Nicorette® chewing gum combats smoking cravings and helps to distract. To fight smoking cravings when you decide to give up cigarettes both immediately and gradually.

Translucent Nicorette® patch does not require replacement for 16 hours10. A format designed for those who have decided to give up cigarettes from the first application.

REFERENCES

1 – Staad LF, Perera R, Ballen S, Mant D, Hartmann-Boyce J, Cahill K, Lancaster T. Nicotine replacement therapy in smoking cessation. Cochrane Library. Systematic review 2012, Edition 11.

2 – Policy recommendation for smoking cessation and treatment of tobacco dependence. WHO 2003; WHO Model List of Essential Medicines 18th Edition (April 2013).

3 – Cochrane Review (Hartmann-Boyce, 2019) https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009670.pub4/references

4- Comparing Willpower. Stead et al. 2012. Nicotine replacement therapy for smoking cessation (Review). Cochrane Bibliotheca.

5 – Doherty K, et al. Nicotine gum dosing and weight gain after smoking cessation. Journal of Counseling and Clinical Psychology, 1996; 64: 799-807

6 – Instructions for Use

7- See instructions for full descriptions of uses and doses

8 – Compared with willpower. Cahill K, Stephen S, Perera R, Lancaster T, Pharmacological effects in smoking cessation: a review and network meta-analysis. Cochrane Database of Systematic Reviews 2013, edition 5.

9 – When using 2 doses of 1 mg according to instructions for use.

10 – Formulation 10 mg/16h, 15 mg/16h, 25mg/16h.

Contraindications

Hypersensitivity to nicotine or other components of chewing gum.

Side effects

Some symptoms may be due to nicotine withdrawal due to smoking cessation.

These include: dysphoria or depressed mood, insomnia, irritability, frustration or anger, anxiety, difficulty concentrating, restlessness or impatience.

Other effects associated with smoking cessation may also occur: decreased heart rate, increased appetite or weight gain, dizziness or presyncopal conditions, cough, constipation, bleeding gums or aphthous ulcers, nasopharyngitis.

Nicotine cravings, considered a clinically significant symptom, are an important manifestation of nicotine withdrawal after smoking cessation.

Most adverse reactions have been noted in the early phase of treatment and are predominantly dose-dependent.

In the first few days of treatment, irritation of the oral and pharyngeal mucosa may be observed. Continued treatment leads to adaptation.
Allergic reactions (including symptoms of anaphylaxis) rarely develop during the use of chewing gum Fresh Mint.

Overdose

Excessive nicotine intake during substitution therapy and/or smoking may cause symptoms of overdose.

Symptoms of overdose are similar to those of acute nicotine poisoning and include nausea, salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing loss and marked weakness. High doses of nicotine may cause arterial hypotension, weak and irregular pulse, difficulty breathing, circulatory collapse, and generalized seizures.

Nicotine in doses tolerated by adult smokers can cause marked symptoms of intoxication in young children, including fatal.

Treatment of overdose: you should immediately stop using nicotine and prescribe symptomatic treatment. Activated charcoal reduces absorption of nicotine in the gastrointestinal tract. If necessary, administer artificial respiration and oxygen.

Pregnancy use

Smoking during pregnancy is associated with risks such as delayed intrauterine development, premature birth or stillbirth. Quitting smoking is the single most effective intervention to improve the health of both the pregnant woman and her baby.

Early smoking cessation is the best option.

Nicotine penetrates the placenta and is excreted with the woman’s milk, so its use may pose a risk to the fetus or baby.

Patients should be informed to attempt smoking cessation without nicotine replacement therapy. If such attempts are unsuccessful, the decision to undergo therapy is made after weighing the possible positive effect on the mother against the potential harm to the fetus.

Nicotine passes in small amounts into breast milk even when taken in therapeutic doses, which may have adverse effects on the baby when the drug is taken by a nursing mother. That is why you should refrain from using Nicorette® chewing gum while breastfeeding.

If you can not give up smoking, the drug should be started only after consulting your doctor. In order to reduce the negative effects of nicotine on the baby nicorette® chewing gum should be used immediately after feeding.

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