Nicorette - 7 semi-transparent transdermal patches 10 mg / 16h

Product Description

Semitransparent transdermal nicotine patches.

Indications

Nicorette is a drug used in nicotine addiction.
It promotes smoking cessation in smokers motivated to quit.

Composition

Active ingredients

This medicine contains 1.75 mg of nicotine/cm^2 in a 10 mg/16 hour formulation (surface area of ​​9 cm^2).

Excipients

Nicotine matrix: medium chain triglycerides, basic butylated methacrylate copolymer, polyethylene terephthalate film (PET).
Acrylic matrix: acrylic adhesive solution, potassium hydroxide, sodium croscarmellose, aluminium acetylacetonate, polyethylene terephthalate film (PET), aluminized on one side and siliconized on both sides.

Directions for use and Dosage

Dosage: While taking Nicorette transdermal patches the patient should stop smoking completely.
Counselling and support usually increase the chances of success.
Initiate therapy with the 15 mg/16 hour patch using one patch daily for 8 weeks.
After 8 weeks, treatment should be gradually reduced to using one 10 mg/16 hour patch daily for a further 4 weeks.
Treatment should last no longer than 3 months.
However, the duration of treatment may vary. vary depending on individual response.
Using the patch for more than 6 months is not recommended.
Only some former smokers may need prolonged treatment to avoid starting smoking again.
The patch should be applied to an intact area of ​​skin upon waking in the morning and removed in the evening before going to sleep.
Paediatric population: Nicorette transdermal patches should not be administered to persons under 18 years of age.
There is not yet sufficient experience with the use of Nicorette transdermal patches in this age group.
Method of administration: Nicorette transdermal patches should be applied to a clean, dry, intact and hairless area of ​​skin, for example on the hip, upper arm or chest.
Apply the patch to the chosen skin area, avoiding touching the adhesive side with your fingers and pressing with the palm of your 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 to the same area.
Do not exceed the recommended doses.
Nicotine administration must be temporarily interrupted if any symptoms of overdose occur.
If symptoms of nicotine overdose persist, nicotine intake must be reduced both by frequency of administration and by lowering the dosage.

Warnings

Discontinue treatment in case of severe or persistent skin reactions.
Do not smoke or take other medicinal products containing nicotine; additional nicotine can be harmful.
Nicotine is a highly toxic substance: doses of nicotine tolerated by adults can cause severe poisoning symptoms in children and can be fatal.
Periodic medical check-ups are recommended to monitor progress in smoking cessation.
The risk of administering nicotine in replacement therapy must be weighed against the risk of not quitting smoking.
A risk-benefit assessment by a competent physician is required for patients with the following conditions:

• severe or moderate hepatic insufficiency and/or severe renal insufficiency.
  Use with caution in these patients as the clearance of nicotine or its metabolites may be reduced with a potential increase in adverse effects;
• acute esophagitis, gastric or duodenal ulcers.
  Use with caution in these patients as nicotine may cause serious side effects. worsen the symptoms of these conditions;
• uncontrolled hyperthyroidism or pheochromocytoma.
  Nicotine, whether from replacement therapy or smoking, causes the release of catecholamines from the adrenal medulla.
• Diabetes mellitus. These patients should be advised to monitor their blood sugar levels more frequently than usual because, when smoking is stopped and nicotine replacement therapy (NRT) is initiated, nicotine-induced catecholamine release is reduced, which may affect carbohydrate metabolism.
  A lower insulin dose may be required as a result of smoking cessation.
  To prevent the risk of burns, Nicorette transdermal patches must be removed before undergoing any Magnetic Resonance Imaging (MRI).

Contraindications

Hypersensitivity to the active substance or to any of the excipients;
Non-smokers or occasional smokers.
Since the weaning effect of Nicorette transdermal patches is achieved through the absorption of nicotine into the blood, Nicorette transdermal patches is contraindicated in patients in whom tobacco smoking has been prohibited by the doctor and in particular in:

• pediatric subjects;
• subjects who have had heart attacks or strokes;
• subjects who have suffered or suffer from circulation problems of any kind;
• subjects suffering from palpitations, cardiac arrhythmias, heart disease, arterial hypertension;
• subjects with skin disorders that may complicate therapy with the patches.

Interactions

Clinically relevant interactions between nicotine replacement therapy and other medicinal products have not been definitively established.
However, nicotine can increase both the haemodynamic effects of adenosine, such as increased blood pressure, heart rate and plasma adrenaline, and the increased pain response (such as chest pain, angina pectoris) and the effects on conduction (A-V node block) caused by adenosine administration.
Smoking (but not nicotine) is associated with an increase in CYP1A2 enzyme activity.
After quitting smoking, you may experience a decrease in CYP1A2 enzyme activity. A reduction in the clearance of substrates of this enzyme may occur. This may lead to an increase in plasma levels of some drugs, which may be of potential clinical importance for those with a narrow therapeutic index, such as phenacetin, caffeine, theophylline, tacrine, clozapine, and ropinirole.
Smoking cessation may also increase the concentration of other drugs partially metabolized by the CYP1A2 enzyme, such as imipramine, pentazocine, olanzapine, clomipramine, and fluvoxamine, although data are limited and the possible clinical significance is unknown.
Smoking cessation may also decrease the absorption of glutethimide and the phase I metabolism of propoxyphene.
Both smoking and nicotine can increase circulating levels of cortisol and catecholamines.
It .... It may be necessary to adjust therapies with adrenergic agonists or 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 a doctor.
Limited data also indicate that smoking can induce the metabolism of flecainide and pentazocine.

Undesirable effects

Most of the undesirable effects experienced by subjects occur during the first phase of treatment and are mainly dose-dependent.
These undesirable effects are similar to those resulting from the use of nicotine administered by any other means.
Approximately 20% of users of Nicorette transdermal patches have observed mild skin reactions during the first week of treatment.
Some symptoms, such as dizziness, headache, insomnia, dysphoria or depressed mood, irritability, frustration or anger, anxiety, difficulty concentrating, restlessness or impatience, bradycardia, increased appetite or weight gain may be related to withdrawal symptoms associated with smoking cessation.
An increased incidence of aphthous ulceration may occur following smoking cessation.
The cause is unclear.
Allergic reactions (including symptoms of anaphylaxis) occur rarely during the use of Nicorette transdermal patches.
The table shows the adverse reactions collected from post-marketing experience and clinical studies, for nicotine formulations in transdermal patches.
The frequency has been estimated on the basis of clinical study data, according to frequency categories using the following convention: Very common (> 1/10); Common (> 1/100 and <1/10); Uncommon (> 1/1,000 and <1/100); Rare (> 1/10,000 and <1/1,000); Very rare (<1/10,000); Not known (frequency cannot be estimated from the available data).

^a in the area of ​​application of the patch
* systemic effects Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at “www.agenziafarmaco.gov.it/it/responsabili”.

Overdose

Overdose can be caused by the simultaneous use of multiple patches, if the patient has very mild nicotine dependence or if, at the same time, he uses other sources of nicotine, including smoking. Excessive use of nicotine, whether through therapeutic administration or through smoking, can cause symptoms of overdose.
Symptoms of overdose are typical of acute nicotine poisoning and include nausea, vomiting, increased salivation, diarrhea, abdominal pain, sweating, headache, dizziness, hearing problems, and marked weakness.
At high doses, the symptoms described may be accompanied by hypotension, a weak and irregular pulse, difficulty breathing, prostration, circulatory collapse, and generalized convulsions.
Warning: Doses of nicotine that are tolerated by adult smokers can cause severe poisoning symptoms in young children and can be fatal.
Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.
Treatment of overdose: Nicotine intake should be stopped immediately and the patient should be treated symptomatically.
Remove the patch and rinse the application site with water.
If excessive nicotine is swallowed, activated charcoal reduces the gastrointestinal absorption of nicotine.
The minimum acute lethal oral dose of nicotine in humans is believed to be between 40 mg and 60 mg.

Pregnancy and breastfeeding

Smoking during pregnancy is associated with serious health risks for the woman, the fetus and the child.
Smoking can cause harm to the fetus such as intrauterine growth retardation, premature birth or neonatal death.
It is therefore advisable to stop as soon as possible.
Pregnancy: Pregnant women should use Nicorette transdermal patches only under medical supervision.
Nicotine reaches the fetus and affects its cardiorespiratory system. The effect is dose-dependent.
The risks to the fetus resulting from the use of Nicorette transdermal patches are unknown.
Therefore, pregnant women should always be advised to stop smoking completely without the use of nicotine replacement therapy.
Breastfeeding: Nicotine passes freely into breast milk in quantities that can have harmful effects on the infant even at therapeutic doses.
Nicorette transdermal patches should therefore be avoided during breastfeeding.
If you are unable to stop smoking, the use of Nicorette transdermal patches in women who are breastfeeding should be started only after consulting your doctor.

Storage

Store below 25°C.

Format

7 patches of 10 mg