Nicoretteicy 2mg - 40 nicotine lozenges to quit smoking

Product Description

Nicoretteicy 2 mg are nicotine lozenges used to treat tobacco dependence by relieving withdrawal symptoms and cravings, with the goal of permanent cessation.

Indications

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

Composition

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

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

Directions for Use and Dosage

The dose of lozenges to be administered will depend on the individual's smoking habits.

Adults

Nicoretteicy 2 mg lozenges are suitable for smokers who have a low dependence on nicotine, 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 a day. The lozenges should not be used for a period longer than 6 months. If users still feel the need for treatment, consult a doctor. Counseling and support from behavioral therapy will improve the success rate.

Paediatric population

Children and adolescents: Nicoretteicy 2 mg lozenges are not recommended for use in individuals under 18 years of age.

Method of administration

• Oromucosal use.
• Place one lozenge in the mouth and allow it to dissolve.
• Occasionally move the lozenge from one side of the mouth to the other until it is completely dissolved (approximately 16–19 minutes).
• Do not chew or swish. Swallow the lozenge whole.
• Do not consume any food or drink at the same time as the lozenge.
• Liquids that lower oral pH such as coffee, fruit juices, and carbonated drinks can reduce the absorption of nicotine in the mouth. To achieve optimal nicotine absorption, do not consume such liquids within 15 minutes before taking the lozenge.

The patient must commit to stopping smoking completely during treatment with Nicoretteicy lozenges. The lozenges should be used whenever the craving occurs. Take a sufficient number of lozenges each day; Most smokers usually need 8–12 lozenges, with a maximum of 15. The duration of treatment varies from one individual to another, but a maximum of 6 weeks of treatment is recommended to quit smoking. The nicotine dose should be gradually reduced by reducing the total number of lozenges taken per day. When daily consumption is less than 1–2 lozenges, stop treatment. Take one lozenge each time you feel the urge to smoke to maintain complete abstinence from smoking. Keep any remaining lozenges for use in case of a sudden craving. If you take the lozenges for more than 6 months, you may need to stop smoking. It is advisable to seek medical advice for further support and assistance.

Warnings

Usually, the benefits of quitting smoking far outweigh the risks associated with properly administered nicotine replacement therapy. A risk-benefit assessment by a competent physician is necessary for patients with the following conditions:

• Dependent smokers with a recent myocardial infarction, unstable or worsening angina, Prinzmetal's angina, severe cardiac arrhythmias, uncontrolled hypertension, recent cerebrovascular accident, and/or those considered hemodynamically unstable should be encouraged to quit smoking through non-pharmacological interventions (such as counseling). If these are unsuccessful, it is recommended to discontinue smoking. Nicoretteicy 2 mg lozenges may be considered, but as safety data in this patient group are limited, treatment should be initiated only under close medical supervision.Stable cardiovascular disease such as hypertension, stable angina pectoris, cerebrovascular disease, peripheral arterial occlusive disease, and heart failure.Diabetes mellitus. Patients with diabetes mellitus should be monitored more closely. Blood glucose levels should be monitored more carefully than usual when stopping smoking and starting nicotine replacement therapy, as the nicotine-induced reduction in catecholamines may affect carbohydrate metabolism.Allergic reactions: Susceptibility to angioedema and urticaria.Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment, as a decrease in clearance of nicotine or its metabolites may occur, with the possibility of nicotine deficiency. of an increase in side effects.
• Pheochromocytoma and uncontrolled hyperthyroidism: Use with caution in cases of uncontrolled hyperthyroidism or pheochromocytoma as nicotine causes the release of catecholamines.
• Gastrointestinal disease: Ingested nicotine may exacerbate symptoms in patients with esophagitis, gastric or peptic ulcers; Oral nicotine replacement therapy preparations should be used with caution in these conditions.

Danger in young children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in young children, including fatal outcomes. Products containing nicotine should not be left 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 metabolized by Cyp1A2 (and probably by Cyp1A1). When a smoker stops smoking, a slowing of metabolism may occur, resulting in increased levels of these drugs in the blood. Potentially clinically significant drugs are listed in section 4.5.

Transmitted dependence: Transmitted dependence is unusual, less harmful, and easier to break than smoking dependence.

Contraindications

• Hypersensitivity to nicotine or to any of the excipients of the lozenge.
• Children aged 18 years and over: under 18 years of age.
• Non-smokers.

Side effects

Nicotine replacement therapy may cause side effects similar to those associated with nicotine administered by other methods, including smoking. These may be attributed to the pharmacological effects of nicotine, some of which are dose-dependent. Excessive consumption of Nicoretteicy 2 mg lozenges by individuals who are not accustomed to inhaling tobacco smoke may result in 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 by any means may experience an associated nicotine withdrawal syndrome that 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 gain. Nicotine craving and 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 adverse reactions similar to those associated with nicotine taken in other ways and these are mainly dose-dependent. After smoking withdrawal, an increased frequency of aphthous ulcers may occur. Case reports are not conclusive. clear.

Within each frequency grouping, undesirable effects are presented in descending order of seriousness: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000, <1/1,000), or very rare (<1/10,000).

Overdose

The minimum acute lethal oral dose of nicotine in humans is believed to be 40 to 60 mg. Direct symptoms of nicotine overdose may occur in patients with low pre-treatment nicotine intake or if nicotine is consumed simultaneously from multiple sources. Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in young children, which may be fatal. Suspected nicotine poisoning in a child should be treated as a medical emergency requiring immediate intervention.

Symptoms of overdose coincide with those of acute nicotine poisoning and include nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disturbances, and marked weakness. At high doses, these symptoms may be followed by hypotension, weak and irregular heartbeat, difficulty breathing, and sickness. Respiratory problems, prostration, circulatory collapse, and terminal convulsions.

Management of overdose: Discontinue nicotine administration immediately and treat the patient symptomatically. Activated charcoal reduces the gastrointestinal absorption of nicotine.

Pregnancy and breastfeeding

Women of childbearing age/contraception in males and females

In contrast to the well-known adverse effects of tobacco smoking on conception and pregnancy in humans, the effects of treatment with therapeutic nicotine are unknown. Consequently, although specific advice on female contraception has not been deemed necessary to date, the most prudent option for a woman seeking pregnancy is to be a non-smoker and not using nicotine replacement therapy. Smoking may have adverse effects on male fertility, but it has not been demonstrated that special contraceptive measures are necessary during nicotine replacement therapy in men.

Pregnancy

The harmful effects of tobacco smoking on the health of the mother and the fetus or child have been widely demonstrated. These effects include lower birth weight, an increased risk of spontaneous abortion, and an increased mortality. Perinatal. Smoking cessation 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 intending to conceive should be advised to stop smoking without using Nicoretteicy 2 mg lozenges. The use of Nicoretteicy lozenges by a highly dependent pregnant smoker should only occur under medical advice, following an assessment of the risks and benefits. The decision to use nicotine replacement therapy should be made as early as possible in the early stages of pregnancy. The aim is to use nicotine replacement therapy for only 2–3 months. Intermittent-dosing products may be preferable, as they typically provide a lower daily dose of nicotine than patches. However, if a woman experiences nausea during pregnancy, patches may be preferable.

Breastfeeding

Nicotine passes freely into breast milk in quantities sufficient to affect the baby, even at therapeutic doses; therefore, patients should ideally stop smoking without the use of nicotine replacement therapy. If this is not possible, the use of Nicoretteicy lozenges to assist breastfeeding women in their attempt to quit should only occur under the advice of a physician, following a risk-benefit assessment. To minimize the nicotine content in breast milk, when using nicotine replacement therapy, women should try to breastfeed immediately before taking the product and allow as much time as possible (recommended: 2 hours) between taking a lozenge and the next breastfeeding.

Nicotine and Fertility

In females, tobacco smoking delays the time to conception, decreases the success rate of in vitro fertilization, and significantly increases the risk of infertility. In males, tobacco smoking reduces sperm production, increases oxidative stress, and increases DNA damage. Smokers' sperm have a reduced fertilizing capacity. The specific contribution of nicotine to these effects in humans is unknown.

Storage

Polypropylene container: Store lozenges in the original container, protected from moisture.Blister pack: This medicine does not require any special storage conditions.

Format

40 Lozenges