Nicoretteicy 2mg Nicotine 20 Lozenges

Composition :

Each tablet contains 2 mg of nicotine (in the form of nicotine resin). For the full list of excipients, see section 6.1.

Excipients

Lozenge core: Mannitol (E421) Xanthan gum Winterfresh RDE4–149 Spray died (Gum arabic (E414) peppermint, menthol and eucalyptol flavors) Sodium carbonate anhydrous (E500) (i) Sucralose (E955) Acesulfame potassium (E950 ) Magnesium stearate (E470b) Coating: Hypromellose (E464) Winterfresh RDE4–149 (peppermint, menthol and eucalyptol flavors) Titanium dioxide (E171) Sucralose (E955) Sepifilm Gloss (Hypromellose (E464), Cellulose Microcrystalline (E460) , Aluminum – Potassium Silicate (E555), Titanium Dioxide (E171)) Acesulfame di Potassium (E950) Polysorbate 80 (E433)

Therapeutic indications

Nicoretteicy 2 mg lozenges are used to treat tobacco addiction by relieving nicotine withdrawal symptoms and cravings in smokers aged 18 years or older. The ultimate goal is the permanent cessation of tobacco use. Nicoretteicy 2 mg lozenges should preferably be used in conjunction with a behavioral support program.

Contraindications

• Hypersensitivity to nicotine or to one of the excipients of the lozenge. • Children under the age of 18. Non-Smoking

Dosage

Posology The dose of lozenges to be administered will depend on the individual's smoking habits. Adults Nicoretteicy 2 mg lozenges are suitable for smokers with low nicotine dependence, for example those who smoke their first cigarette of the day more than 30 minutes after waking up or who smoke fewer than 20 cigarettes per day. used for more than 6 months. If users still feel the need for treatment, consult a physician. Behavioral therapy advice and support will improve your success rate. Pediatric population Children and adolescents Nicoretteicy 2 mg lozenges are not recommended for use in individuals under the age of 18 years. Method of administration Oromucosal use Place a lozenge in the mouth and let it dissolve. From time to time move the lozenge from one part of the mouth to the other until it is completely dissolved (approximately 16–19 minutes). Do not chew or swallow the tablet whole. Do not take food or drinks at the same time as the tablet. Liquids that lower the oral pH such as coffee, fruit juices, and carbonated drinks can reduce the absorption of nicotine in the mouth. To achieve optimal absorption of nicotine, do not take such liquids within 15 minutes prior to taking the tablet. The patient should make a commitment to stop smoking completely while taking Nicoretteicy lozenges. The lozenges should be used whenever you feel the urge to smoke. Take a sufficient quantity of tablets every day; most smokers usually need 8-12 tablets, for a maximum of 15. The duration of treatment varies from one individual to another, but a maximum of 6 weeks treatment is recommended to quit smoking. The nicotine dose should be gradually reduced by decreasing the total number of tablets taken per day. When daily consumption is less than 1–2 tablets, discontinue treatment. Take one lozenge whenever you feel the urge to smoke to maintain complete abstinence from smoking. Save all leftover tablets for taking in case of a sudden desire to smoke. If you have been taking the tablets for more than 6 months it is advisable to seek medical attention for further support and assistance.

Warnings and Precautions

Usually, the benefits of quitting smoking far outweigh the risks associated with properly administered nicotine replacement therapy. An assessment of the risks and benefits by a competent physician is required for patients with the following conditions: • Addicted smokers with a recent myocardial infarction, unstable or aggravated angina, Prinzmetal's angina, severe cardiac arrhythmias, uncontrolled hypertension, recent cerebrovascular accident and / or subjects considered haemodynamically unstable should be encouraged to quit smoking through non-pharmacological interventions (such as counseling). If the latter are unsuccessful, Nicoretteicy 2 mg lozenges may be considered, but as safety data in this patient group are limited, treatment should only be initiated under close medical supervision. • Stable cardiovascular diseases such as hypertension, stable angina pectoris, cerebrovascular diseases, peripheral occlusive arterial disease and heart failure. • Diabetes mellitus. Patients with diabetes mellitus should monitor blood glucose levels more closely than usual when smoking cessation and initiation of nicotine replacement therapy, as nicotine-induced reduction in catecholamine may affect carbohydrate metabolism. • Allergic reactions: susceptibility to angioedema and urticaria. • Renal and hepatic insufficiency: Use with caution in patients with moderate to severe hepatic insufficiency and / or severe renal insufficiency as a decrease in clearance of nicotine or its metabolites may occur, with the possibility of an increase in side effects. • Pheochromocytoma and uncontrolled hyperthyroidism: Use with caution in case of uncontrolled hyperthyroidism or pheochromocytoma as nicotine causes the release of catecholamines. • Gastrointestinal pathology: Ingested nicotine can exacerbate symptoms in patients suffering from esophagitis, gastric or peptic ulcers; oral nicotine replacement therapy preparations should be used with caution in these conditions. Danger in young children: Nicotine doses tolerated by adult and adolescent smokers can produce severe toxicity in young children, with even fatal outcomes. Products containing nicotine should not be left in places where they could be misused, handled or ingested by children, see section 4.9 Overdose Smoking cessation: Polycyclic aromatic hydrocarbons present in tobacco smoke induce the metabolism of drugs metabolised by CYP1A2 (and probably from CYP1A1). When a smoker quits smoking, metabolism may slow down, resulting in increased blood levels of these drugs. Potentially clinically significant drugs are listed in section 4.5. Transmitted addiction: Transmitted addiction is unusual, less harmful, and easier to stop than smoking addiction.

Interactions

Smoking cessation, with or without nicotine substitutes, may alter the response to concomitant drug in former smokers. Dose adjustment of these drugs may be necessary and, for drugs with a narrow therapeutic margin, such as theophylline, smoking cessation must be accompanied by rigorous clinical and laboratory monitoring; in addition, the patient must be informed about the risks of overdose. Upon cessation of smoking, dose adjustments may be required for the following medications:

Dose reduction may be required upon smoking cessation Possible mechanism of action
Caffeine, theophylline, imipramine, pentazocine, phenacetin, phenylbutazone, tacrine, clomipramine, reduced induction of CYP1A2
olanzapine, fluvoxamine, flecainide, ropinirole.
Insulin Increase in subcutaneous insulin absorption

Adrenergic antagonists, eg. prazosin, propanolol. Reduction of catecholamines in circulation
Dose increase may be required upon smoking cessation Possible mechanism of action
Adrenergic agonists, eg. isoprenaline, salbutamol Decrease of catecholamines in circulation

Side effects

Nicotine replacement therapy can cause side effects similar to those associated with nicotine given in other ways, including smoking. These can be attributed to the pharmacological effects of nicotine, some of which are dose dependent. Excessive consumption of Nicoretteicy 2 mg lozenges by people who are not in the habit of inhaling tobacco smoke could lead to nausea, weakness or headache. Some symptoms that have been reported, such as depression, irritability, anxiety, increased appetite and insomnia, may be related to withdrawal symptoms associated with smoking cessation. People who stop habitual tobacco use in any way may suffer from an associated nicotine withdrawal syndrome which includes at least four of the following symptoms: dysphoria or moodiness; insomnia; irritability; frustration or anger; anxiety; difficulty concentrating; restlessness or impatience; decreased heart rate; increased appetite or weight. Nicotine cravings and the urge to smoke are also recognized as clinically relevant symptoms and an important additional element in nicotine withdrawal after smoking cessation. Nicoretteicy 2 mg lozenges cause unwanted reactions similar to those associated with nicotine taken in other ways and these depend mainly on the dose. After smoking abstinence, there may be an increased frequency of aphthous ulcer. The case history is unclear. Within each frequency group, undesirable effects are presented in descending order of severity: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 10) 1,000 to <1/100), rare (≥1 / 10,000 to <1 / 1,000) or very rare (<1 / 10,000). Immune system disorders Very rare: hypersensitivity (including allergic and anaphylactic reactions), angioedema Psychiatric disorders Common: irritability, anxiety, sleep disturbances, including abnormal dreams Uncommon: nervousness, depression Nervous system disorders: Common: dizziness, headache Heart disorders : Uncommon: palpitations, increased heart rate Rare: atrial arrhythmia Respiratory, thoracic and mediastinal disorders: Common: cough, sore throat Gastrointestinal disorders: Very common: nausea, mouth / throat and tongue irritation Common: vomiting, diarrhea, gastrointestinal disorders, flatulence, hiccups, heartburn, dyspepsia Skin and subcutaneous tissue disorders: Uncommon: rash, erythema, urticaria General disorders and administration site conditions: Uncommon: fatigue, malaise, chest pain

Pregnancy and breastfeeding

Women of childbearing potential / contraception in males and females In contrast to the well-known undesirable effects of tobacco smoking on conception and pregnancy in humans, the effects of therapeutic nicotine treatment are unknown. Consequently, although it has not been deemed necessary to give specific advice on female contraception to date, the most prudent condition for a woman seeking pregnancy is to be a non-smoker and not to use nicotine replacement therapies. Smoking may have adverse effects on male fertility, but special contraceptive measures have not been shown to be necessary during nicotine replacement therapy in males. Pregnancy The harmful effects of tobacco smoking on the health of the mother and the fetus or child. baby have been amply demonstrated. These effects include reduced birth weight, an increased risk of miscarriage and an increase in perinatal mortality. Stopping smoking is the single most effective intervention to improve the health of the pregnant smoker and the fetus and the shorter the time to achieve abstinence, the better the outcomes. Nicotine passes to the fetus and can cause dose-dependent changes in placental / fetal circulation and respiratory movements. Pregnant women or those planning to conceive should be advised to quit smoking without resorting to Nicoretteicy 2 mg lozenges. The use of Nicoretteicy lozenges by a highly dependent pregnant smoker should only be done on medical advice, following an assessment of the balance between risks and benefits. The decision to use nicotine replacement therapy must be made early in the pregnancy, as soon as possible. The goal is to use nicotine replacement therapy for only 2–3 months. Intermittent dosing products may be preferable as they usually provide a lower daily nicotine dosage than patches. However, if the woman experiences nausea during pregnancy, the patches may be preferable. Breastfeeding Nicotine passes freely into breast milk in such quantities as to affect the baby, even at therapeutic doses; consequently, patients should ideally quit smoking without the use of nicotine replacement therapy. If this is not possible, the use of Nicoretteicy lozenges to assist lactating women in trying to stop should only be done on the advice of a doctor, following a benefit-risk assessment. To minimize the nicotine content in breast milk, when using nicotine replacement therapy, women should try to breastfeed just before taking the product and allow as much time as possible (recommended time: 2 hours) between taking a tablet and breastfeeding afterwards. Nicotine and Fertility In women, tobacco smoking delays the time to conception, decreases in vitro fertilization success rates, and significantly increases the risk of infertility. In males, tobacco smoke reduces sperm production, increases oxidative stress and DNA damage. The spermatozoa of smokers have a reduced fertilizing capacity. The specific contribution of nicotine to these effects in humans is unknown.