Nicorette Transdermal Patches 10mg/16H 7 Patches

NAME
NICORETTE TRANSDERMAL PATCHES

PHARMACOTHERAPEUTIC CATEGORY
Drugs used in nicotine addiction.

ACTIVE PRINCIPLES
The transdermal patches are available in the formulations of 5 mg / 16 hours (surface of 10 cm ^ 2), 10 mg / 16 hours (surface of 20 cm ^ 2), 15mg / 16 hours (surface of 30 cm ^ 2) and contains 0 , 83 mg of nicotine / cm ^ 2 The semi-transparent transdermal patches are available in formulations of 10 mg / 16 hours (surface of 9 cm ^ 2), 15 mg / 16 hours (surface of 13.5 cm ^ 2) and contains 1 , 75 mg of nicotine / cm ^ 2.

EXCIPIENTS
Transdermal patches: non-woven polyester, siliconized polyester, low molecular weight polyisobutylene, medium molecular weight polyisobutylene, polybutene. Semi-transparent transdermal patches. Nicotine matrix: medium chain triglycerides, basic butylated methacrylate copolymer, polyethylene terephthalate film (PET); acrylic matrix: acrylic adhesive solution, potassium hydroxide, croscarmellose sodium, aluminum acetylacetonate, polyethylene terephthalate film (PET), aluminized on one side and siliconized on both sides.

INDICATIONS
Treatment of nicotine addiction and promotes smoking cessation in smokers motivated to quit.

CONTRAINDICATIONS / SECONDARY EFFECT
Non-smokers or occasional smokers. The drug is contraindicated in pregnancy and lactation. Since the weaning effect is expressed thanks to the absorption of nicotine into the blood, it is contraindicated in patients in whom tobacco smoking has been prohibited by the doctor and in particular in: pediatric subjects; people who have had heart attacks or brain accidents; subjects who have suffered or suffer from circulation defects of any kind; subjects suffering from palpitations, cardiac arrhythmias, heart disease, arterial hypertension, hyperthyroidism, diabetes and pheochromocytoma; people with skin disorders that can complicate patch therapy; known hypersensitivity to nicotine.

DOSAGE
During administration the patient should completely stop smoking. Advice and support usually increase the chances of success. Begin therapy with the 15mg / 16 hour patch using one patch per day for 8 weeks. After 8 weeks, the treatment should be gradually reduced by using a 10 mg / 16 hour patch daily for another 2/3 weeks and continuing for another 2/3 weeks with a 5 mg / 16 hours daily patch. The treatment should last no more than 3 months. The duration of treatment, however, may vary depending on the individual response. It is not recommended to use the patch beyond 6 months of therapy. Only some former smokers may need prolonged treatment to avoid resuming smoking. The patch should be applied to an intact surface of the skin as soon as you wake up in the morning and removed in the evening before going to sleep. How to apply the patch: Apply to a clean, dry, intact and hairless skin surface, such as hip, upper arm or chest. Apply the patch on the chosen skin area, avoiding touching the adhesive part with the fingers and pressing with the palm of the hand for 10-20 seconds It is necessary to change the skin surface on which to apply the patch daily and avoid applying it consecutively on the same area . The medicine should not be administered to people under 18 years of age 'unless under medical supervision. There is not yet sufficient experience of using the drug in this age group. Do not exceed the recommended dose.

STORAGE
Transdermal Patches: Store at a temperature not exceeding 30 degrees C. Semi-transparent Transdermal Patches: Store at a temperature not exceeding 25 degrees C.

WARNINGS
Discontinue treatment in case of severe or persistent skin reactions. Do not smoke and do not take other medicinal products containing nicotine; the extra nicotine can be harmful. Nicotine is a highly toxic substance: doses of nicotine tolerated by adults can cause severe symptoms of poisoning in children and can be fatal. Periodic medical check-ups are advised to check progress in quitting smoking. The risk of nicotine administration in replacement therapy must be weighed against the risk of not quitting smoking. The medicine should be used under medical supervision in patients with cardiovascular disease or who have had a serious cardiovascular problem or hospitalization for cardiovascular problems within 4 weeks before starting treatment (e.g. stroke, myocardial infarction, unstable angina pectoris, cardiac arrhythmia, coronary artery bypass graft and angioplasty) or in those suffering from uncontrolled hypertension. Careful use of Nicorette Transdermal Patches is suggested in patients with severe or moderate hepatic insufficiency, severe renal insufficiency, acute gastric or duodenal ulcers. Nicotine, whether produced by substitution therapy or produced by smoking, causes the release of catecholamines from the adrenal medulla. Therefore, Nicorette Transdermal Patches should also be used with caution in patients with hyperthyroidism or pheochromocytoma. In patients with diabetes mellitus a lower dose of insulin may be required as a result of stopping smoking.

INTERACTIONS
Smoking (but not nicotine) is associated with an increase in the enzyme activity of CYP1A2. After smoking cessation, a reduction in the clearance of substrates of this enzyme may occur. This may lead to an increase in the plasma levels of some medicinal products which may have potential clinical importance for those drugs with a narrow therapeutic index, such as phenacetin, caffeine, theophylline, tacrine, and clozapine and ropinirole. Smoking cessation may also increase the concentration of other drugs partially metabolised by the CYP1A2 enzyme, such as imipramine, pentazocine, olanzapine, clomipramine and fluvoxamine, although data are scarce and possible clinical significance unknown. Furthermore, smoking cessation may decrease the absorption of glutethymide and the phase I metabolism of propoxyphene. Both smoking and nicotine can increase circulating levels of cortisol and catecholamines. It may be necessary to fine-tune the therapies with agonists or adrenergic blockers in relation to the phases of nicotine therapy or the quantity of cigarettes smoked. Therefore in case of concomitant therapies it is necessary to consult the doctor. Limited data also indicate that smoking can induce the metabolism of flecainide and pentazocine.

SIDE EFFECTS
It can cause dose-dependent adverse reactions similar to those resulting from the use of nicotine administered by any other means. About 20% of users experienced mild skin reactions during the first week of treatment. Some symptoms, such as dizziness, headache, and insomnia, may be related to the withdrawal symptoms associated with quitting smoking. There may be an increased incidence of aphthous ulcer following cessation of smoking, the cause is not clear. Very common (> 1/10); common (> 1/100, <1/10); uncommon (> 1/1000, <1/100); rare (> 1/10000, <1/1000); very rare (<1/10000), including isolated cases. Nervous system disorders. Common; dizziness, headache and insomnia. Heart ailments. Uncommon: palpitations; very rare: reversible atrial fibrillation. Gastrointestinal pathology. Common: gastrointestinal disturbances, nausea, vomiting. Skin and subcutaneous manifestations. Uncommon: urticaria. General disorders and administration site conditions. Very common: itching; common: erythema.

PREGNANCY AND BREASTFEEDING
Smoking during pregnancy is associated with serious health risks for women, fetuses and babies. Smoking can cause fetal harm such as intrauterine growth retardation, premature birth or neonatal death. It is therefore advisable to stop as soon as possible. The risk of nicotine administration in replacement therapy must be weighed against the risk of not quitting smoking. Pregnant or lactating women should use the product only under medical supervision. Nicotine reaches the fetus and affects its cardiorespiratory system. The effect is dose-dependent. The risks to the fetus from using the drug are not known. Nicotine passes freely into breast milk in quantities that can have harmful effects on the infant even at therapeutic doses.