NICORETTE 7CER TRANSD 10MG/16H

NICORETTE TRANSDERMICAL CEROTTS

active ingredients

NICORETTE Semi-transparent transdermal patches contain 1,75 mg of nicotine/cm2 and is available in 10 mg/16 hours (surface of 9 cm2), 15 mg/16 hours (surface of 13.5 cm2). For the full list of excipients, see paragraph 6.1.

Excellent

Nicotinic matrix: Mid-chain triglycerides, Basic butylated methacrylate copolymer, Polyethyleneterphthalate film (PET). Acrylic matrix: Acrylic Adhesive Solution Potassium Adhesive Hydroxide, Chroscaramellose Sodium, Acetylacetonate Aluminium, Polyethylethylte Film (PET), alluminized on one side and siliconed on both sides.

Therapeutic indications

NICORETTE transdermal patches is indicated in the treatment of nicotine dependence and promotes the disassuefation from smoking in motivated smokers to stop.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1; - Non-smokers or occasional smokers. Since the divesting effect of NICORETTE transdermal patches are explicated thanks to the absorption in nicotine blood, NICORETTE transdermal patches are contraindicated in patients in which tobacco smoke was prohibited by the doctor and in particular in: - subjects in pediatric age; - subjects that have had heart attacks or brain accidents; - subjects who have suffered or suffer from defects in circulation of any kind; - subjects suffering from palpitations, heart arrhythmias, heart disease, arterial hypertension; - subjects with skin disorders that can complicate therapy with patches; - Pregnancy and nursing (see paragraph 4.6).

Population

Population: During administration NICORETTE transdermal patches the patient should completely stop smoking. Consulting and support normally increase the chances of success. Start the treatment with the patch from 15mg/16 hours using a patch per day for 8 weeks. After 8 weeks the treatment should gradually be reduced using daily, for another 4 weeks, a patch of 10 mg/16 hours Treatment should last no more than 3 months. The duration of treatment, however, may vary depending on the individual response. We do not recommend the use of the patch over 6 months of therapy. Only some former smokers may need prolonged treatment to prevent smoking. The plaster must be applied on an intact surface of the skin just awake in the morning and removed in the evening before going to sleep. Pediatric population: NICORETTE transdermal patches should not be given to persons under 18 years of age. There is still no sufficient experience of using NICORETTE transdermal patches on this age group. Method of administration: NICORETTE transdermal patches must be applied on a clean, dry, intact and hairless skin surface, for example on anca, upper arm or breast. Apply the patch on the chosen cutaneous area, avoiding touching the adhesive part with your fingers and pressing with the palm of your hand for 10-20 seconds. It is necessary to change daily the skin surface on which to apply the patch and avoid applying it consecutively on the same area. DON'T OVERDO IT. The administration of nicotine must be temporarily interrupted if any symptom of overdose occurs (see paragraph 4.9). If nicotine overdose symptoms persist, nicotine intake must be decreased both for the frequency of administration and for lowering the dosage.

Conservation

Store at a temperature below 25°C

Warnings

Stop the treatment in case of severe or persistent skin reactions. No smoking and no other medicinal products containing nicotine; additional nicotine can be harmful. Nicotine is a highly toxic substance: doses of nicotine tolerated by adults can cause serious symptoms of poisoning in children and may be fatal. (see paragraph 4.9). Periodic medical checks are recommended, so as to check progress in smoking abandonment. It is important that therapy is supported by other activities to facilitate smoking suspension. The risk of nicotine administration in replacement therapy must be assessed against the risk of not stopping smoking. An assessment of the risk-benefit ratio by a competent physician for patients with the following conditions is required: • severe or moderate liver failure and/or severe kidney failure. Carefully use in such patients since nicotine clearance or metabolites can be reduced with a potential increase in adverse effects; • esophagitis, gastric or duodenal ulcers in acute form. Use carefully in such patients since nicotine can worsen the symptoms of these conditions; • uncontrolled hyperthyroidism or feocromocytoma. Nicotine, both produced by substitute therapy and produced by smoke, causes the emission of catecholamines from the adrenal midollar. • Diabetes mellitus. Such patients should be advised to monitor blood sugar levels more frequently than usual since, when smoking is stopped and nicotine-based replacement therapy (NRT), nicotine-induced catecholamine release is reduced and this can affect carbohydrates. A lower dose of insulin may be required as a result of smoking suspension. To prevent the risk of burns NICORETTE transdermal patches must be removed before being subjected to any Magnetic Resonance for Imaging (MRI). The suspension of smoking, with or without nicotine substitutes, may alter the pharmacokinetics of certain drugs administered in conjunction (see paragraph 4.5). There may be a permanent dependence on nicotine.

Interactions

No clinically relevant interactions have been definitively established between nicotine-based replacement therapy and other medicines. However nicotine can increase both the hemodynamic effects of adenosine, such as increased blood pressure, heart rate and plasma adrenaline, and increased pain response (such as chest pain, angina pectoris) and effects on conduction (block of the A-V node) caused by the administration of adenosine. Smoking (but not nicotine) is associated with an increase in the enzymatic activity of CYP1A2. After stopping smoking, a reduction of clearance of substrates of this enzyme may occur. This can lead to an increase in plasma levels of some medicines that may have a potential clinical importance for those drugs having a strict therapeutic index, such as phenacetin, caffeine, theophylline, tacrine, chlozapine and ropinirol. The cessation of smoking can increase the plasma levels of: • acetaminophen, caffeine, imipramine, oxazepam, pentazocin, propranolol, theophylline, due to the inhibition of liver enzymes; • insulin by increased subcutaneous absorption of insulin; • adrenergic antagonists (prazosin, labetalol) and adrenergic agonists (isoprenaline, phenylphrine), due to the decrease in the circulation of catecholamines caused by the suspension of smoking; • olanzapine, chlomipramine and fluvoxamine as partially metabolized by the CYP1A2 enzyme, although the data is poor and the possible unknown clinical meaning. In such cases a decrease in the dose to the suspension of smoking may be necessary. The suspension of smoking can also decrease: • the absorption of glutetimid; • phase I metabolism of propoxyphene. Both smoke and nicotine can increase the circulating levels of cortisol and cateculamine. It may be necessary to develop therapies with agonists or adrenergic blockers in relation to the stages of nicotine therapy or the amount of smoked cigarettes. Therefore in case of concomitant therapies it is necessary to consult the doctor. Limited data also indicates that smoking can induce the metabolism of flecainide and pentazocin.

Effects

Most of the undesirable effects manifested by subjects occur during the first stage of treatment and are mainly dose-dependent. These side effects are similar to those resulting from the use of nicotine administered by any other means. About 20% of users NICORETTE transdermal patches found slight skin reactions during the first week of treatment. Table 1 shows the undesirable effects of post-marketing experience and clinical studies for nicotine formulations in transdermal patches. The frequency was estimated on the basis of clinical studies data, according to the frequency categories using the following convention: Very common (≥ 1/10); Common (≥ 1/100 and Diseases of the nervous system Town Vertigo, headache, insomnia Not common Opinion^* Heart disease Not common Palpitations*, tachycardia* Gastrointestinal pathologies Town Nausea, vomiting Notable Gastrointestinal disorder*, Pathologies of skin and subcutaneous tissue Very common Itch Town Skin rash* Not common Hyperhidrosis Notable Erythema Vascular diseases Not common Redness*, hypertension* Respiratory, chest and mediastinic pathologies Not common dispnea* Psychiatric disorders Not common Abnormal dreams* Diseases of musculoskeletal system and connective tissue Not common Mialgia^a Notable Pain in the Arts Immune system pathologies Not common Hypersensitivity* Notable Anaphylactic reaction* Systemic pathologies and conditions for administration Not common Reactions in application, asthenia*, chest discomfort*, chest pain *, malaise*, fatigue*. ^a in the patch application area * systemic effects Some symptoms, such as dizziness, headache, insomnia, dysphora or depressed mood, irritability, frustration or anger, anxiety, difficulty of concentration, restlessness or impatience, bradycardia, increased appetite or body weight may be related to withdrawal symptoms associated with smoking suspension. Increased incidence of aftous ulcer may occur as a result of smoking suspension. The cause is unclear. Allergic reactions (including anaphylaxis symptoms) rarely occur when using NICORETTE transdermal patches. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address “www.agenziafarmaco.gov.it/it/responsabili”.

Overdosing

Overdose can be caused by the contemporary use of more patches, if the patient has a very light nicotine dependence or if, at the same time, uses other sources of nicotine including smoking. Excessive use of nicotine, both by therapeutic use and by smoke, can cause overdose symptoms. Symptoms of overdose are typical of nicotine acute poisoning and include nausea, vomiting, increased salivation, diarrhea, abdominal suffering, sweating, headaches, dizziness, hearing disorders and marked weakness. At high doses the symptoms described may be accompanied by hypotension, weak and irregular pulse, breathing difficulties, prostration, circulatory collapse and generalized seizures. Attention: Nicotine doses that are tolerated by adult smokers can cause severe poisoning symptoms in small children and can be fatal. A suspected nicotine poisoning in a child must be considered a medical emergency and treated immediately. Treatment of overdose: the intake of nicotine must be stopped immediately and the patient must be treated in a symptomatic way. Remove the plaster and rinse the application site with water. If excessive amount of nicotine is swallowed, activated carbon reduces nicotine gastrointestinal absorption. It is believed that the oral acute dose of nicotine in humans is between 40 mg and 60 mg.

Pregnant smoking is associated with serious health risks of women, fetus and child. Smoking can cause fetus damage such as intrauterine growth delay, premature birth or neonatal death. It is therefore desirable to stop as soon as possible.

Pregnancy

: Pregnant women should use NICORETTE transdermal patches only under medical control. Only in case the pregnant woman continues to smoke, can the use of NICORETTE, the use of which may lead to potential risks. The harmful effects of cigarette smoke during pregnancy and fetus health have been clearly identified and include low birth weight, increased risk of miscarriage, increased neonatal mortality. Specific effects of NICORETTE on the development of the fetus are unknown. Nicotine comes to the fetus and influences its cardiorespiratory apparatus. The effect is dose-dependent. Risks on the fetus arising from the use of NICORETTE transdermal patches are not known. Therefore, it should always be recommended for pregnant women to completely stop smoking without the use of nicotine replacement therapy. Cases of miscarriage were reported during therapy; as for smoking, it cannot be excluded that nicotine can contribute to the occurrence of this eventuality. Nicorette is not recommended during labor and childbirth. The effects of nicotine on the mother or fetus during labor are unknown.

Nursing:

Nicotine passes freely in breast milk in quantities that may have harmful effects on the infant even at therapeutic doses. The effect of the medicinal product in children who are breastfeeding has not been examined. The milk-plasm ratio is of the order of 2.9. A newborn eliminates nicotine through the first pass of the liver, however the efficiency of removal is lower at birth.It is assumed that with the correct use of NICORETTE nicotine concentrations in breast milk are lower than those obtained with cigarette smoking, since with replacement therapy nicotine concentrations in maternal plasma are generally reduced. NICORETTE transdermal patches should therefore be avoided during breastfeeding. In case you are unable to quit smoking, use of NICORETTE transdermal patches in women who are breastfeeding should be started only after consulting your doctor.

Source: Farmadati