Nicorette Fresh Fruit Chewing Gum 4mg, 30pcs

Composition

1 gum chewing medicinal contains:

Active ingredient: nicotine-polymer complex – 22 mg (the specified amount is equivalent to 4.4 mg of nicotine, including 10% excess). Auxiliary substances:  Core of chewing gum medicinal: chewing gum (base)* – 560 mg, xylitol-302 mg, peppermint oil-30 mg, sodium carbonate-30 mg, acesulfame potassium-2 mg, levomentol-2 mg, magnesium oxide-1 mg, quinoline yellow E 104-1 mg; Shell of chewing gum medicinal: xylitol – 294 mg, peppermint oil-9 mg, Arabian gum-9 mg, titanium dioxide-7 mg, Carnauba wax-1 mg, quinoline yellow E 104-0.06 mg. * The base of medicinal chewing gum is a mixture of various types of wax, resin and other hydrocarbons (about 60%) and calcium carbonate (up to 40%).

Pharmacological action

Pharmacodynamics : After abruptly quitting smoking, patients who have used tobacco-containing products daily for a long time may develop withdrawal symptoms, which include: dysphoria, insomnia, increased irritability, anxiety, impaired concentration, decreased heart rate, increased appetite, or weight gain. An important symptom of withdrawal syndrome is also the desire to smoke. In the treatment of tobacco dependence, nicotine replacement therapy reduces the need for the number of cigarettes smoked, reduces the severity of withdrawal symptoms that occur when completely quitting smoking in those who have decided to quit smoking; facilitates temporary abstinence from smoking, and also helps to reduce the number of cigarettes smoked in those who cannot or do not want to completely quit smoking. Pharmacokinetics:  Nicotine coming from chewing gum is rapidly absorbed through the cheek mucosa and is detected in the blood after 5-7 minutes. The maximum concentration of nicotine is reached 30 minutes after the start of chewing. The volume of distribution of nicotine with intravenous use is about 2-3 l / 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 that are less active than nicotine have been identified. The binding of nicotine to plasma proteins is less than 5%. In this regard, violations of nicotine binding with the simultaneous use of other drugs or changes in plasma protein levels in various diseases should not significantly affect the kinetics of nicotine. The primary metabolite of nicotine in plasma, cotinine, has a half-life of 15-20 hours, and its concentration exceeds that of nicotine by 10 times. Mainly cotinine (15% of the dose) and trans-3-hydroxy-cotinine (45% of the dose) are excreted in the urine. From 10% to 30% of the nicotine dose is excreted unchanged in the urine. Progressive deterioration of renal function is accompanied by a decrease in total nicotine clearance. Its pharmacokinetics do not change in patients with cirrhosis of the liver with slightly pronounced liver function disorders (Child-Pugh index 5) and decreases in patients with cirrhosis of the liver with moderate liver function disorders (Child-Pugh index 7). In smokers treated with hemodialysis, an increase in the concentration of nicotine in the blood plasma was noted. In elderly patients, there is 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 with complete smoking cessation in patients who have decided to quit smoking;• if you temporarily quit smoking; * reducing the number of cigarettes smoked by those who are unable or unwilling to quit completely.

Use during pregnancy and lactation

Smoking during pregnancy is associated with risks such as delayed fetal 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 passes through the placenta and is excreted in human milk, and therefore its use may pose a danger to the fetus or child. Patients should be informed about the need to attempt smoking cessation without nicotine replacement therapy. If such attempts are unsuccessful, the decision to conduct therapy is made after comparing the possible positive effect for the mother and the potential harm to the fetus. Nicotine in small amounts gets into breast milk even when taken in therapeutic doses, which can negatively affect the health of the child when taking the drug by a nursing mother. Therefore, you should refrain from using Nicorette® chewing gum during breastfeeding. If you can’t stop smoking, you should start using the drug only after consulting your doctor. In order to reduce the negative effect of nicotine on the child, Nicorette® chewing gum should be used immediately after feeding.

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 low mood, insomnia, irritability, dissatisfaction 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 craving, considered a clinically significant symptom, is an important manifestation of nicotine withdrawal after smoking cessation. Most of the adverse reactions were observed in the early phase of treatment and are mainly dose-dependent. In the first few days of treatment, irritation of the oral and pharyngeal mucosa may occur. Continuation of treatment leads to adaptation. When using gum chewing medicinal Fresh mint rarely develop allergic reactions (including symptoms of anaphylaxis).

How to take, course of use and dosage

Adults and adolescents over 18 years of age, the dosage is selected individually, depending on the intensity of smoking. As a rule: * Nicorette® 2 mg (moderate nicotine content) chewing gum should be used if you smoke less than 20 cigarettes a day, * Nicorette® chewing gum 4 mg (high nicotine content) should be used if you smoke more than 20 cigarettes a day or you have not been able to stop smoking when using chewing gum at a dose of 2 mg. How to use Nicorette®chewing gum Nicorette® should be used in all cases where there is an overwhelming desire to smoke, in accordance with the following scheme: 1. Chewing gum should be chewed for approximately 30 minutes at intervals. Slowly chew the chewing gum until it has a pronounced taste. 2. Stop chewing and leave the gum between the inside of your cheek and your gums. 3. When the taste is gone, start chewing the gum again. If symptoms of overdose occur (see section “Overdose”), the drug should be discontinued immediately. Complete smoking cessation Only one pad should be chewed at a time after stopping smoking. When completely quitting smoking, the dose of chewing gum per day is determined by the degree of dependence on nicotine, but usually amounts to 8-12 pieces per day and should not exceed 15 pieces per day. Use of chewing gum in the indicated dose should be up to 3 months, after which the daily number of gums should be gradually reduced until complete withdrawal. Chewing gum is canceled 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 longer therapy to avoid resuming smoking. Reduce the number of cigarettes smoked Chewing gum should be used as needed between smoking episodes in order to increase the time between smoking and to reduce smoking as much as possible. If within 6 weeks it was not possible to reduce the daily consumption of cigarettes, you should seek help from a specialist. An attempt to quit smoking should be made as soon as you feel that you are 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 quit smoking within 9 months of starting therapy, you should consult a specialist. After quitting smoking, you should follow the recommendations of therapy, gradual dose reduction and drug withdrawal indicated above for complete quitting. 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. Simultaneous medical counseling and psychological support usually increase the effectiveness of therapy. Temporary smoking cessation Chewing gum can be used during periods when it is necessary to refrain from smoking, for example, when you are in places where smoking is prohibited, or in other situations when you need to refrain from smoking.In combination with the transdermal patch, Nicorette® chewing gum Fresh fruit in a dosage of 2 mg can also be used together with the patch in situations where a person continues to periodically experience an irresistible urge to smoke against the background of using the patch, or if it was not possible to quit smoking using only chewing gums or only a patch. In combination with the patch, Nicorette® chewing gum Fresh fruit in a dosage of 2 mg allows you to quickly remove strong urges to smoke when necessary. Patients should 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. At the same time, at least 4 chewing gums of 2 mg per day are used; usually 5-6 chewing gums are enough. The number of chewing gums should not exceed 15 pieces per day. Usually, the general course of treatment 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 limbs or chest. You must change the overlay location every day: do not use the same area for two consecutive days. After applying the patch, wash your hands thoroughly to avoid eye irritation from possible nicotine ingestion. Discontinuation of combination therapy:There are two ways to cancel combination therapy. Method 1: during the next 2 weeks, it is necessary to switch from the 25 mg/16 hours patch (stage 1) to the 15 mg/16 hours patch (stage 2), and then during the next 2 weeks to the 10 mg/16 hours patch (Stage 3), while maintaining the amount of Nicorette® chewing gums used Fresh fruit with a dosage of 2 mg, as with the Initial therapy. Then gradually reduce the amount of chewing gum until complete withdrawal during the time that a person needs, depending on his needs, but not later than 12 months after the start of combination therapy. Method 2: consists in complete cancellation of the patch immediately after the end of the Initial therapy stage. Then gradually reduce the amount of Nicorette® chewing gums Fresh fruit with a dosage of 2 mg until complete withdrawal during the time that a person needs, depending on his needs, but not later than 12 months after the start of combination therapy.

Overdose

Excessive intake of nicotine during substitution therapy and / or smoking can 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 severe weakness. Hypotension, weak and irregular pulse, difficulty breathing, circulatory collapse, and generalized seizures may occur when high doses of nicotine are used. Nicotine in doses tolerated by adult smokers can cause severe symptoms of intoxication in young children, including fatal ones. Treatment of overdose: you should immediately stop using nicotine and prescribe symptomatic treatment. Activated charcoal reduces the absorption of nicotine in the gastrointestinal tract. If necessary, artificial respiration and oxygen are prescribed.

Description

Nicorette® – a wide range of nicotine replacement therapy products to combat smoking cravings. Nicorette® helps to reduce cravings for smoking and relieve various manifestations of withdrawal syndrome: cravings, irritability, bad mood, anxiety, poor concentration and increased appetite. The safety and efficacy of nicotine replacement therapy as an approach to tobacco addiction treatment has been studied in 150 clinical studies1 and recommended by the World Health Organization 2. KEY BENEFITS Keep the habit under control-Clinically proven to help fight cravings 3, including physical and psychological nicotine addiction. Flexible withdrawal plan-Nicorette® chewing gum helps to fight the craving for smoking both by completely quitting smoking and by reducing the number of cigarettes smoked. Calmness and composure – The chewable format helps control anxiety and irritability. Fight cravings on the go-Nicorette® Chewing Gum helps you fight cravings and take your mind off smoking in any place you want 7. Helps reduce cravings and relieve various withdrawal symptoms 4-cravings, irritability, bad mood, anxiety, poor concentration, and increased appetites Helps control weight gain 5-Nicorette® Chewing Gum helps keep your appetite under control when quitting smoking. In addition, all Nicorette®chewing gums they do not contain sugar. Fresh Way to Quit Smoking-Nicorette® Anti-smoking Gum has a pleasant taste of fresh Peppermint How does Nicorette®work?Nicorette® chewing gum is specifically designed to allow your body to gradually adjust to nicotine withdrawal. The drug to combat smoking cravings contains medical nicotine, which is released when chewing 6. At the same time, the level of nicotine 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, contributing to the treatment of tobacco addiction 7. How to choose Nicorette®chewing gum?* Do you smoke less than 20 cigarettes a day? Try Nicorette® 2 mg chewing gum (moderate nicotine content)• Do you smoke more than 20 cigarettes a day, or have you failed to quit using 2 mg of chewing gum? Try chewing gum 4 mg• * Nicorette® chewing gum can also be used in conjunction with a patch in situations where a person continues to periodically experience an irresistible urge to smoke while using the patch, or if it was not possible to quit smoking with only chewing gum or only a patch. In combination with the patch, Nicorette® chewing gum allows you to remove strong urges to smoke when necessary. Patients should completely stop smoking during therapy. Combination therapy increases the chances of quitting smoking by 2.5 times. 8 How to use Nicorette®chewing gum?Step 1-Slowly chew Nicorette® chewing gum until you taste nicotine and feel a tingling sensation in your mouth 7. Usually, one or two bites are necessary. Step 2-Stop chewing and leave Nicorette® chewing gum between your cheek and gums. Step 3 – After about a minute, when the tingling sensation is almost gone, start chewing again. Repeat this process until the tingling sensation disappears. Step 4-Repeat this pattern for about 30 minutes. Important:Use Nicorette® gum whenever you feel like smoking, up to a maximum of 15 pieces per day. Gradually reduce the number of drug applications until complete discontinuationhow to use Nicorette® when choosing combination therapy?Step 1: Use a 25 mg patch along with 2 mg chewing gum or spray. Apply this dosage for 8 weeks Step 2: you can choose one of two ways to complete the therapy. Method 1: for the first 2 weeks, apply a patch with a dosage of 15 mg, and in the next 2 weeks-a patch with a dosage of 10 mg. Continue to apply the same amount of chewing gum or spray as at the beginning of therapy. Method 2: completely discard the patch immediately after the first stage is completed, and gradually reduce the amount of chewing gum or spray. Complete therapy no later than 12 weeks. Choose your smoking cessation path:The Nicorette® range includes spray, chewing gums and a patch. Nicorette® spray helps reduce cravings for smoking. Activation of the spray occurs in 60 seconds 9. Fights cravings for smoking in cases when you decide to give up cigarettes both immediately and gradually. Nicorette® chewing gum fights cravings and helps to distract yourself. To combat the craving for smoking in cases where you decide to give up cigarettes both immediately and gradually. The Nicorette® translucent patch does not require replacement for 16 hours 10. A format designed for those who have decided to give up cigarettes from the first application. REFERENCES 1-Stead LF, Perera R, Ballen S, Mant D, Hartmann-Boyce J, Cahill K, Lancaster T. Nicotine replacement therapy in quitting smoking. The Cochrane Library. Systematic Review 2012, Issue 11.2-Policy Recommendation on Smoking Cessation and Treatment of Tobacco Dependence. WHO 2003; WHO Indicative List of Essential Medicines 18th edition (April 2013). Compared to willpower. ” Stead et al. 2012. Nicotine replacement therapy for smoking cessation (Review). Cochrane Library. 5-Doherty K et al. dosage of nicotine gum and weight gain after quitting smoking. Journal of Counseling and Clinical Psychology,1996; 64: 799-8076-Instructions for use 7-With a full description of the methods of use and doses, see the instructions 8-In comparison with willpower. Cahill K., Steven 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 the instructions for use. 10-Form of production 10 mg/16 h,15 mg/16 h,25 mg/16 h.

Special instructions

Patients with diabetes mellitus may need to reduce their insulin doses after quitting smoking. Nicotine doses that are easily tolerated by adult and adolescent smokers can cause severe intoxication in children, which can lead to death. It is important not to leave nicotine-containing products unattended, as this may lead to improper use and ingestion by children. Polycyclic aromatic hydrocarbons found in tobacco smoke induce the metabolism of drugs metabolized by the CYP1A2 isoenzyme (and possibly CYP1A1). Stopping smoking can cause your metabolism to slow down and, as a result, increase the concentration of these drugs in your blood. This has potential clinical implications for drugs with a narrow therapeutic index, such as theophylline, tacrin, clozapine, and ropinirole. People with impaired chewing function are recommended to use other dosage forms. People who use dentures may have difficulty chewing Nicorette®chewing gum. Chewing gum can stick to your dentures and, in rare cases, damage them. If the medicine has fallen into disrepair or the expiration date has expired, do not throw it into the sewer or on the street! Place the medicine in a plastic bag and put it in the trash can. These measures will help protect the environment!

Form of production

Medicinal chewing gum Fresh fruit

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf life

3 years

Active ingredient

Nicotine

Purpose

Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, For adults

Indications

Smoking Cessation