NICORETTE INVISI Transdermal patch Ref.[9897] Active ingredients: Nicotine

When making a quit attempt behavioural therapy, advice and support will normally improve the success rate.

It is intended that the patch is worn through the waking hours (approximately 16 hours) being applied on waking and removed at bedtime.

Smoking Cessation

Adults (over 18 years of age)

For best results, most smokers are recommended to start on 25 mg / 16 hours patch (Step 1) and use one patch daily for 8 weeks. Gradual weaning from the patch should then be initiated. One 15 mg/16 hours patch (Step 2) should be used daily for 2 weeks followed by one 10 mg/16 hours patch (Step 3) daily for 2 weeks.

Lighter smokers (i.e. those who smoke less than 10 cigarettes per day) are recommended to start at Step 2 (15 mg) for 8 weeks and decrease the dose to 10 mg for the final 4 weeks.

Those who experience excessive side effects with the 25 mg / 16 hours patch (Step 1), which do not resolve within a few days, should change to a 15 mg / 16 hours patch (Step 2). This should be continued for the remainder of the 8 week course, before stepping down to the 10 mg / 16 hours patch (Step 3) for 4 weeks. If symptoms persist the advice of a healthcare professional should be sought.

Adolescents (12 to 18 years)

The dose and method of use are as for adults however as data are limited in this age group, the recommended treatment duration is 12 weeks. If longer treatment is required, advice from a healthcare professional should be sought.

Smoking Reduction/Pre-Quit

Smokers are recommended to use the Patch to prolong smoke-free intervals and with the intention to reduce smoking as much as possible.

The starting dose should follow the smoking cessation instructions above i.e. 25mg (Step 1) is suitable for those who smoke 10 or more cigarettes per day and for lighter smokers (i.e. those who smoke less than 10 cigarettes per day) are recommended to start at Step 2 (15 mg).

Smokers starting on 25mg patch (Step 1) should transfer to 15mg patch (Step 2) as soon as cigarette consumption reduces to less than 10 cigarettes per day.

A quit attempt should be made as soon as the smoker feels ready. When making a quit attempt smokers who have reduced to less than 10 cigarettes per day are recommended to continue at Step 2 (15 mg) for 8 weeks and decrease the dose to 10 mg (Step 3) for the final 4 weeks.

Temporary Abstinence

Use a Nicorette Invisi Patch in those situations when you can’t or do not want to smoke for prolonged periods (greater than 16 hours).

For shorter periods then an alternative intermittent dose form would be more suitable (e.g Nicorette inhalator or gum).

Smokers of 10 or more cigarettes per day are recommended to use 25mg patch and lighter smokers (i.e. those who smoke less than 10 cigarettes per day) are recommended to use 15mg patch.

How to apply the patches

Nicorette Invisi Patch should be applied to clean, dry intact areas of hairless skin, for example on the hip, upper arm, or chest. These areas should be varied each day and the same site should not be used on consecutive days.

1. Wash your hands before applying the patch.
2. Cut open the pouch with scissors along the side, as indicated. Select a clean, dry, hairless intact area of skin, such as the hip, upper arm or chest.
3. Peel one part of the silvery aluminium backing away. Avoid touching the sticky surface of the patch with your fingers.
4. Apply the sticky part of the patch carefully onto the skin and peel off the remaining half of the silvery aluminum backing.
5. Press the patch firmly onto the skin with your palm or finger-tips.
6. Rub your fingers firmly round the edge to ensure that the patch sticks firmly.

Use of skin oils or talc can prevent proper adhesion of the patch.

After removal, used patches should be disposed of carefully.

Symptoms

Symptoms of overdose with nicotine from this product may occur in smokers who have previously had a low nicotine intake from cigarettes or if other sources of nicotine are used concomitantly with this product.

Acute or chronic toxicity of nicotine in man is highly dependent on mode and route of administration. Adaptation to nicotine (e.g. in smokers) is known to significantly increase tolerability compared with non-smokers

The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, vomiting, increased salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose

All nicotine intake should stop immediately and the patient should be treated symptomatically. Remove the patch and rinse the application site with water. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in children and may prove fatal. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.

Shelf life: 36 months.

Do not store above 25°C.

Package sizes: 10 mg/16 h 7 and 14 patches.

All pack sizes may not be marketed.

Each patch is packed in a heat-sealed laminate pouch consisting of paper, PET film, aluminium acrylnitrilcopolymer or cyclo olefine copolymer coextrudate.

Nicotine residues in the used patches may present a hazard to children and pets, thus used patches should be folded, sticky sides together, put back in an empty pouch and placed in household rubbish.