Consumer medicine information

Nicotinell Patches

Nicotine

BRAND INFORMATION

Brand name

Nicotinell Patch

Active ingredient

Nicotine

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Nicotinell Patches.

What is in this leaflet

This leaflet answers some common questions about Nicotinell Patches.

It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor.

All medicines have risks and benefits. Your pharmacist or doctor will be able to advise you about the risks and benefits of using Nicotinell Patches.

If you have any concerns about using this medicine, ask your pharmacist or doctor.

Keep this leaflet with the medicine.

You may need to read it again.

What are Nicotinell Patches used for?

Nicotinell Patches can help you stop smoking over a few months. You probably know that smoking is a very difficult habit to break. There are two sides to quitting smoking. The first is the psychological dependence on cigarettes. You have probably smoked for many years and smoking has become an important part of your life.

The other side is the physical addiction to nicotine. Cigarettes contain nicotine, and your body has become dependant on nicotine. The Nicotinell patch delivers nicotine into your bloodstream through your skin. Using Nicotinell will help to gradually reduce the amount of nicotine your body craves each day.

Counselling is available from various groups such as Quit For Life. To get the best out of Nicotinell, we encourage you to enrol in one of these groups.

Nicotinell is not intended for short periods, e.g. plane trips or other times when you cannot smoke. It is designed to help you quit smoking, not as a substitute for smoking.

Nicotinell works most effectively when you have a strong personal commitment to stop smoking. You cannot rely on Nicotinell alone to break the habit. Each nicotine patch helps relieve many nicotine withdrawal symptoms and cravings (such as early morning), which would otherwise have when you stop smoking.

Before you use Nicotinell Patches

When you must not use it

Do not use Nicotinell Patch if:

  • you are under 12 years old
  • you are a non-smoker
  • you have a generalised skin disorder such as psoriasis or dermatitis
  • you have an allergy to nicotine or to any component of the patch
  • the expiry date printed on the carton or sachet has passed
  • the packaging is torn or shows signs of tampering

There are no health benefits to smoking. It is always better to give up smoking and using Nicotinell can help. In general, any possible side effects associated with nicotine replacement therapy (NRT) are far outweighed by the well established dangers of continuing to smoke.

If you are in hospital because of a heart attack, severe heart rhythm disorders or a stroke, you should try to quit smoking without using NRT unless your doctor tells you to use it. Once you are discharged from the hospital, you may use NRT in consultation with your doctor.

If you have had allergic reactions that involve swelling of the lips, face and throat (angioedema) or itchy skin rash (urticaria), using NRT can sometimes trigger this type of reaction.

Before you start to use it

Talk to your doctor and ask for his/her advice before using Nicotinell Patch if:

  • you have had a recent heart attack or stroke
  • you have angina (chest pain) that is not well controlled or is getting worse
  • you have severe arrhythmia (irregular heartbeat)

Talk to your doctor or pharmacist and ask for his/her advice before using Nicotinell Patch if:

  • you have severe high blood pressure
  • you have other heart or blood vessel disease
  • you have diabetes
  • you have kidney or liver problems
  • you have hyperthyroidism (a disorder of the thyroid gland)
  • you have phaeochromocytoma (a tumour of the adrenal gland)
  • you are pregnant or breast-feeding
  • you are aged 12 to 17 years

If you require further advice, you should talk with your doctor or pharmacist.

Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription.

Your doctor or pharmacist will be able to advise you if stopping smoking may affect the way these medicines work.

Driving or operating machinery.

There is no evidence of any risk associated with driving or operating machinery if Nicotinell Patch is used according to the recommended dose but remember that smoking cessation can cause behavioural changes.

If you are pregnant.

Ideally you should not use this program while you are pregnant, and you should stop smoking without using nicotine replacement therapy. Nicotine in any form may cause harm to your unborn baby. However, if you are unable to quit without the use of nicotine replacement therapy, seek advice from your pharmacist or doctor before starting a program. The decision to use NRT should be made as early on in your pregnancy as possible and you should aim to use it for only 2-3 months. Products that are taken intermittently, such as gum, are preferable to nicotine patches. However, patches may be preferred if you have nausea or sickness.

If you are breast-feeding.

Nicotine is excreted in breast milk in quantities that may affect the child even in therapeutic doses. Like smoking, nicotine replacement therapy should be avoided during breast-feeding. However, if you are unable to quit without the use of nicotine replacement therapy, seek advice from your pharmacist or doctor before starting a program. Do not use Nicotinell Patch if you are breast-feeding. Intermittent NRT products such as Nicotinell nicotine chewing gums may be used instead, and should be used immediately after breast-feeding, to ensure that the baby gets the smallest amount of nicotine possible.

Patch should be removed prior to undergoing any MRI (Magnetic Resonance Imaging) procedures.

How to use Nicotinell Patches

How to get started

It is probably best to nominate a specific day that you will stop smoking. It may be helpful to:

  1. Try to choose a day when you will not be where others are smoking.
  2. Choose a day with as little stress as possible.
  3. Choose a day not too far in the future.

Tell your family and friends that you have set this target “quit day”.

This is the day you take complete control of your habit and become a non-smoker.

Prepare to stop smoking by trying to reduce the number of cigarettes you smoke each day. You should stop smoking completely while using Nicotinell.

How much to use

The Nicotinell course lasts for 9 to 12 weeks and one patch is used each day for the duration of use. Each patch is worn for one day (24 hours). As your course progresses, the aim is to use a lower strength (smaller size) patch as your body’s desire for nicotine decreases. Nicotinell Patches come in 3 nicotine dosage strengths, Nicotinell Step 1 (21mg/24 hours), Nicotinell Step 2 (14mg/24 hours) and Nicotinell Step 3 (7mg/24 hours). The correct strength for you to start on depends on how many cigarettes you smoke each day.

Instructions are provided below for each of the two programs. Program A is for people who smoke 20 or more cigarettes each day and Program B is for people who smoke less than 20 cigarettes each day. Choose the correct program for you.

If you have a previous medical condition your doctor may choose to vary the dosage as appropriate.

Choose the program that is right for you.

Program A: If you smoked more than 20 cigarettes each day

Weeks 1 - 4:

  1. Stop cigarette smoking and use one Nicotinell Step 1 patch each day for 3 to 4 weeks.
  2. After 3 to 4 weeks you should no longer be smoking cigarettes and can move on to Nicotinell Step 2. However if you are still smoking, consult your doctor or pharmacist.

Weeks 5 - 8:

  1. Use one Nicotinell Step 2 patch each day for another 3 to 4 weeks.
  2. After week 3, if you are still a non-smoker, you can move on to Nicotinell Step 3. But if you have smoked during weeks 5 – 8, consult your doctor or pharmacist.

Weeks 9 - 12:

  1. Use one Nicotinell Step 3 patch each day for another 3 to 4 weeks.
  2. After week 9 to 12 you should stop using the patches. You have become a non-smoker. Congratulations!

Program B: If you smoked less than 20 cigarettes each day

Weeks 1 - 4:

  1. Stop cigarette smoking and use one Nicotinell Step 2 patch each day for 3 to 4 weeks.
  2. After 3 to 4 weeks you should no longer be smoking cigarettes and can move on to Nicotinell Step 3. But if you are still smoking consult your doctor or pharmacist.

Weeks 5 - 12:

  1. Use one Nicotinell Step 3 patch each day for 5 to 8 weeks.
  2. If you have smoked during your course of treatment in weeks 5 – 8, please consult your doctor or pharmacist before proceeding further.
  3. Similarly, if you have smoked during your course of treatment in weeks 9 – 12, please consult your doctor or pharmacist.
  4. After week 9 to 12 you should stop using the patches. You have become a non-smoker. Congratulations!
Program Weeks 1-4 Weeks 5-8 Weeks 9-12 End program
A. If you smoked more than 20 cigarettes a day Use Nicotinell Step 1 Patch 21 mg Move to Nicotinell Step 2 Patch 14 mg Move to Nicotinell Step 3 Patch 7 mg Congratulations!
You have successfully become a non-smoker
B. If you smoked less than 20 cigarettes a day Use Nicotinell Step 2 Patch 14 mg Move to Nicotinell Step 3 Patch 7 mg Continue with Nicotinell Step 3 Patch 7 mg Congratulations!
You have successfully become a non-smoker
View as image

Combination therapy
If you have relapsed in the past or if you experience cravings while using a single form of nicotine replacement therapy (NRT), you can combine the use of Nicotinell patch with Nicotinell chewing gum 2 mg.

The combination is more effective than either product alone in people who have been unable to quit smoking using a single NRT method, increasing your chances of successfully quitting.

When using Nicotinell Step 1 patch, chew one piece of Nicotinell chewing gum 2 mg if you get a craving. Use at least 4 pieces of gum and not more than 12 pieces in a day. Continue for 12 weeks.

After 12 weeks, you can wean yourself off therapy by either of the following methods:

  1. Stop use of Nicotinell Patch and gradually reduce the number of gums used until they are no longer needed.
  2. a. Use Nicotinell Step 2 patch for 3-4 weeks, while using the same number of pieces of Nicotinell chewing gum 2 mg in a day that you have routinely used.
    b. Then use Nicotinell Step 3 for a further 3-4 weeks, while using the same number of pieces of Nicotinell chewing gum 2 mg in a day that you have routinely used.
    c. When patch use is no longer needed, gradually reduce the number of gums you use until you no longer need them.

Children 12 to 17 years old

Do not use for longer than 12 weeks. If you think you need to use for longer than 12 weeks, talk to your doctor or pharmacist.

Do not use for children under 12 years.

How to use Nicotinell Patches

  1. Cut open the sachet along the dotted line. Keep the sachet for the future disposal of the patch.
  2. Remove the protective liner from the sticky side of the patch.
  3. Apply the Nicotinell patch to a clean, dry, non-hairy area of skin free from creams, lotions) including sunscreen products or insect repellents), ointments, oil or powder. Wash and clean the area thoroughly before application. After a warm bath or shower, wait until the skin is cool and dry before application of the patch (especially important in hot and humid weather, so as to maximise initial adhesion).
  4. Do not shave the skin as this could cause irritation.
  5. The skin should not be broken or inflamed in any way (this includes e.g. sunburn, rash, eczema).
  6. You may use your chest, back, upper arm or hip. Try to avoid areas where your skin folds when you sit or exercise.
  7. Place the sticky side of the patch onto the area of skin you have chosen and press firmly with the palm of your hand for at least 20 seconds. Then run your fingers around the edge pressing firmly. Do not try to check if the patch has stuck by lifting the edge. This may make it come loose.
  8. Once applied, do not remove and re-apply elsewhere as the patch will not re-adhere well
  9. When replacing the Nicotinell patch after 24 hours, choose a different location for the new patch.
  10. Remove the used patch, fold it in half, sticky side inwards, replace in the original sachet and discard of carefully, keeping it out of reach of children or pets.
  11. Do not flush down the toilet.

Additional Information

  1. You can swim, bath or shower with the patch on. However, wait at least one hour after you apply the patch before undertaking any sweaty or wet activity. This will help maximise patch adhesion.
  2. Do not use bath oils or shower gels with oily ingredients, either before or after application of the patch, as this could affect patch adhesion.
  3. Despite using all the precautionary measures noted in this leaflet, be aware that excessive sweating or oily skin can lead to poor patch adhesion. Very hot or humid conditions can also affect adhesion.
  4. If the patch should fall off, secure it back in place with a medicinal adhesive tape or apply a fresh patch and continue. Change the patch at the usual time the following day.
  5. It is best not to use soap on the patch or skin immediately surrounding the patch.
  6. Do not smoke while using the patch – remember there is nicotine in your system for several hours after removing the patch.
  7. If you forget to change the patch at the usual time, change it when you remember and then change the patch at the usual time the following day.
  8. It is recommended that you do not apply the patch to a previously used skin site for three days.
  9. You should wear no more than one Nicotinell patch at a time.
  10. Nicotinell Patches should not be used for periods longer than three months.

While you are using Nicotinell Patches

Things you must do

Use Nicotinell exactly as instructed.

If you follow these recommendations you should get the full benefit of this Nicotinell program.

Stop smoking completely while using Nicotinell.

You may have increased side effects if you continue to smoke while wearing the patch.

Tell your doctor or pharmacist if you continue to smoke while you are using Nicotinell.

Tell all of the doctors, dentists and pharmacists who are treating you that you are using Nicotinell Patches.

Things you must not do

Do not stop using Nicotinell Patches suddenly.

You may get side effects similar to those you would get if you stopped smoking suddenly.

Side effects

The nicotine in Nicotinell Patches can cause reactions like those caused by smoking. These reactions include dizziness, headache, nausea (feeling sick) or sleep disturbances. These reactions are usually mild but tell your doctor or pharmacist if they worry you.

The patch can cause skin irritation. Using a different area of skin to apply the patch each day can reduce this. However, if you have severe redness, swelling, itching, burning sensation or blisters at the patch site, or a rash (e.g. itchy red rash or hives) you should remove the patch and tell you doctor immediately or go to the Accident & Emergency at your nearest hospital. This could be an allergic reaction to Nicotinell.

Keep Nicotinell Patches out of reach of children at all time

Nicotine is a highly toxic substance and could be life threatening to children. Each Nicotinell patch is sealed in a child-resistant sachet. Please take particular care to dispose of the used patches carefully.

If you use too much (overdose)

If you smoke or use other products containing nicotine while wearing a Nicotinell patch, you may suffer an overdose of nicotine. However if used correctly, nicotine overdose is unlikely.

The signs and symptoms of nicotine overdosage include pallor, sweating, nausea, salivation, vomiting, stomach upset, diarrhoea, headache, dizziness, hearing and vision disturbances, tremor, confusion, weakness, fainting and breathing difficulties.

If overdosage is suspected, remove the patch immediately, wash the area liberally with water (do not use soap) and dry. Depending on the severity of the symptoms, seek advice from your pharmacist, doctor or hospital casualty department.

Children: It is very important to keep both used and unused Nicotinell Patch out of the reach and sight of children, as doses of nicotine that are tolerated by adult smokers can cause severe poisoning in small children and can be fatal.

In the event of overdose or suspected overdose, seek immediate medical advice or contact a Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766).

After use

Storage

Keep the patch in the sachet pack inside the carton until you are ready to use it.

If you take the patch out of its sachet, it may not keep well.

Store the patches below 30°C.

Do not store patch in the refrigerator, even in hot weather, as this could lead to a loss of adhesion.

Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on windowsills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your pharmacist or doctor tells you to stop using the patch or you find that it has passed the expiry date, ask your pharmacist what to do with any patches that are left over.

Product description

Nicotinell is available in 3 nicotine dosage strengths, each corresponding to a different patch size.

Nicotinell Step 1 (30cm2 patch) 52.5mg nicotine patch (release rate 21mg nicotine per 24 hours)

Nicotinell Step 2 (20 cm2 patch) 35mg nicotine patch (release rate 14mg nicotine per 24 hours).

Nicotinell Step 3 (10cm2 patch) 17.5mg nicotine patch (release rate 7mg nicotine per 24 hours).

For more information

Ask your pharmacist or doctor if you have any questions, or if you experience any difficulties before, during or after using Nicotinell Patches.
Nicotinell Patches are supplied in Australia by:

Novartis Consumer Health Australasia Pty Ltd
ABN 46 004 535 513
327 – 333 Police Road
Mulgrave Vic 3170
Australia

NZ Office: Auckland, New Zealand

Toll Free Phone:
Australia: 1800 069 643
New Zealand: 0800 700 222

Visit our website: www.nicotinell.com.au

This leaflet was prepared in April 2009.

BRAND INFORMATION

Brand name

Nicotinell Patch

Active ingredient

Nicotine

Schedule

Unscheduled

 

Name of the medicine

Nicotine.

Excipients.

Coconut oil - fractionated, Durotak 280-2516, methacrylic acid copolymer.

Description

Chemical name: S-3-(1-methyl-2- pyrrolidinyl) pyridine. Molecular formula: C14H16N2. Molecular weight: 162.26. CAS Number: 54-11-5.
Nicotine is S-3-(1-methyl-2-pyrrolidinyl) pyridine and is the major pharmacologically active alkaloid of tobacco. The free alkaloid is absorbed rapidly through the skin and respiratory tract.
Nicotinell Patch is a round, multi-layered matrix patch. It consists of an external layer which protects the patch during storage, an adhesive layer, which is necessary for the contact between the transdermal patch and the skin during application, several matrix layers, a pad with the active ingredient solution and a backing foil for protection of the patch during wearing. Each patch is packaged in a heat sealed multilaminate sachet. Nicotine is the active ingredient; other components of the system are pharmacologically inactive. Nicotine penetrates the skin by diffusion and thus becomes directly bioavailable to the systemic circulation.
The following three systems are available as shown in Table 1.
To sustain the concentration gradients for diffusion, more nicotine is contained in the Nicotinell Patch than is actually delivered over 24 hours. Nicotinell Patch releases approximately 0.7 mg/cm2/24 hours of nicotine. Therefore, the average daily dose administered is determined largely by the size of the contact area of the system.
List of excipients: Coconut oil - fractionated, Durotak 280-2516, Methacrylic acid copolymer.

Pharmacology

Pharmacological action.

Nicotine acts primarily on cholinergic receptors of the nicotine type in the peripheral and in the central nervous system. Nicotine, the chief alkaloid in tobacco products, bind stereoselectively to acetylcholine receptors at the autonomic ganglia, in the adrenal medulla, at neuromuscular junctions and in the brain. Two types of central nervous system effects are believed to be the basis of nicotine's positively reinforcing properties. A stimulating effect, exerted mainly in the cortex via the locus ceruleus, produces increased alertness and cognitive performance. A "reward" effect via the "pleasure system" in the brain is exerted in the limbic system. At low doses the stimulant effects predominate while, at high doses, the reward effects predominate.

Pharmacodynamics.

Nicotine, the primary alkaloid in tobacco products and a naturally occurring autonomous substance, is a nicotine receptor agonist in the peripheral and central nervous systems. On consumption of tobacco products, nicotine has proven to be addictive.
Quitting smoking abruptly after prolonged, daily consumption induces a withdrawal syndrome consisting of at least four of the following symptoms: dysphoria or depressive mood, insomnia, irritability, feelings of frustration or anger, anxiety, difficulty concentrating, agitation or impatience, slowed cardiac rhythm, increased appetite and weight gain. The craving for nicotine is considered as a recognized clinical symptom of the withdrawal syndrome.
Clinical trials have shown that nicotine replacement therapy (NRT) may help smokers refrain from smoking or reduce their smoking habits by decreasing the withdrawal symptoms.

Pharmacokinetics.

Absorption.

Nicotine is readily absorbed through the skin into the systemic circulation.
The absorption profile after single application of Nicotinell Patch to healthy abstinent smokers (patients undergoing a course of smoking cessation therapy with the patch) shows an initial 1-2 hours delay followed by a progressive rise in plasma concentrations, plateaus being attained at about 8-10 hours after application.
After the patch is removed, plasma concentrations decline more slowly than would be predicted by the 2-hour elimination half-life for this agent after an intravenous infusion.
About 10% of the total amount of nicotine that reaches the circulation is delivered from the skin after Nicotinell Patch is removed. This is likely due to the existence of a cutaneous deposit of nicotine. The absolute bioavailability of the patch, compared to intravenous nicotine perfusion, is about 77%.
The area under the plasma concentration curve (0-24 h) increases in proportion to the dose of nicotine delivered by the patches: Nicotinell Patch 7 mg, 14 mg and 21 mg per 24 h. With repeated application of the patches 14 mg/24 h and 21 mg/24 h , the mean plasma concentration at steady state ranges from 7.1-12.0 nanogram/mL and 10.3-17.7 nanogram/mL, respectively.

Distribution.

Nicotine is distributed widely in the body with a volume of distribution of approximately 2-3 L/kg following intravenous (IV) administration. It crosses the blood-brain barrier and the placenta. Plasma protein binding of nicotine is negligible, less than 5%. Therefore changes in nicotine binding from use of concomitant drugs or alternations of plasma proteins by disease states would not be expected to have significant consequences.

Metabolism.

Nicotine is metabolised mainly in the liver to cotinine and nicotine-N-oxide. More than 20 metabolites of nicotine have been identified, all of which are believed to be less active than the parent compound. The primary metabolite of nicotine in plasma, cotinine, has a half-life of 15-20 hours and concentrations that exceed nicotine by tenfold. The kidneys and lungs also metabolise nicotine.

Elimination.

Nicotine and its metabolites are excreted in the urine. The primary urinary metabolites are cotinine (15% of the dose) and trans-3-hydroxycotinine (45% of the dose). About 10% of nicotine is excreted unchanged in the urine. Renal excretion of unchanged nicotine is pH-dependent and minimal under alkaline conditions.
Nicotine is excreted in breast milk.

Indications

Treatment of nicotine dependence, as an aid to smoking cessation. The Nicotinell Step 1 Patch may also be used by people who smoke 20 or more cigarettes per day for two weeks prior to quitting smoking.

Contraindications

Nicotinell Patch should not be used by non-smokers, occasional smokers, children under 12 years or those with generalised diseases of the skin which may complicate patch therapy (e.g. psoriasis or chronic dermatitis), or with hypersensitivity to nicotine or any of the excipients.

Precautions

Nicotine is a toxic and addictive drug and milligram doses are potentially fatal if rapidly absorbed. For any smoker, with or without concomitant disease or pregnancy, the risk of NRT in a smoking cessation program should be weighed against the hazard of continued smoking while using Nicotinell and the likelihood of achieving cessation of smoking without NRT.
Any risks that may be associated with NRT are substantially outweighed by the well-established dangers of smoking.
Treatment with Nicotinell Patch should be discontinued if symptoms of nicotine overdosage appear. Mild intoxication produces nausea, vomiting, abdominal pain, diarrhoea, headache, sweating, and weakness (see Overdosage).
Occasional smokers are not expected to benefit from the use of Nicotinell.
Dependent smokers with a recent myocardial infarction, unstable or worsening angina pectoris including Prinzmetal’s angina, severe cardiac arrhythmias, uncontrolled hypertension or recent cerebrovascular accident should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicotinell may be considered but as data on safety in these patient groups are limited, initiation should only be under close medical supervision.
Nicotinell should be used with caution in patients with:
severe hypertension, stable angina pectoris, cerebrovascular disease, occlusive peripheral arterial disease, heart failure;
diabetes mellitus, hyperthyroidism or pheochromocytoma;
moderate to severe hepatic and/or severe renal impairment.
Smokers with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated because catecholamine release can affect carbohydrate metabolism and vasoconstriction may delay or reduce insulin absorption.
Nicotinell Patch should be used with caution in patients who are susceptible to angioedema and/or urticaria. Patients with generalised dermatological disorders such as psoriasis or chronic dermatitis should not use the patch (see Contraindications).
In the event of a severe or persistent skin reaction, discontinue treatment and use another pharmaceutical form.
The Nicotinell Patch contains aluminium. The patch should therefore be removed prior to undergoing any MRI (Magnetic Resonance Imaging) procedures.

Use in pregnancy.

(Category D)
Ideally, complete smoking cessation during pregnancy should be achieved without NRT. However, for women unable to quit without pharmacological treatment, NRT may be recommended to assist a quit attempt. Nicotine is harmful to the fetus. However, the risk to the fetus with NRT is probably less than that expected with continued smoking due to:
Lower maximal plasma concentrations compared with inhaled nicotine, resulting in a nicotine exposure less or not more than that associated with smoking.
No exposure to polycyclic hydrocarbons and carbon monoxide.
As nicotine does pass to the fetus, the decision to use NRT should be made as early on in pregnancy as possible with the aim of discontinuing after use for 2-3 months.
If NRT is used during pregnancy, intermittent dosing products (Nicotinell Gum) should preferably be used as they usually provide a lower daily dose of nicotine than patches. However, if the woman suffers from nausea and/or vomiting, the patch may be preferred but should be removed before going to bed.

Use in lactation.

Even at therapeutic doses, nicotine is excreted in breast milk in quantities that may affect the child. Like smoking, NRT should be avoided during breastfeeding. Nicotinell Patch should not be used while breastfeeding. Intermittent NRT products such as Nicotinell Gum may be used. Women should breastfeed just before using the product to allow the time between NRT use and feeding to be as long as possible.

Use in children and adolescents.

Data on the use of NRT in adolescents under the age of 18 years are limited.
NRT should only be used in adolescents 12-17 years after consultation with a healthcare professional and use should be restricted to 12 weeks. If treatment is required for longer than 12 weeks, this should be discussed with a healthcare professional. Do not use in children under 12 years.

Use in the elderly.

Experience in the use of Nicotinell Patch in smokers over the age of 65 years is limited.

Genotoxicity, carcinogenicity and effects on fertility.

Nicotine was positive in some in vitro genotoxicity tests but there are also negative results with the same test systems. Nicotine was negative in standard in vivo tests.
Animal experiments have shown that nicotine induces post-implantation loss and may reduce the growth of fetuses.
Studies have shown a decrease in litter size in female rats treated with nicotine during gestation. Nicotine reduced fertility in male rats.
The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine.

Effects on ability to drive or use machines.

When Nicotinell is used as recommended there are minimal risks for driving vehicles or operating machinery. Nevertheless, one should take into consideration that smoking cessation can cause behavioural changes.

Danger in small children.

Nicotine is a toxic substance. Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small children and may prove fatal. Even used nicotine patches contain enough residual nicotine to be harmful to children. Nicotinell must be kept out of the reach and sight of children. As soon as a patch is removed from the skin, it should be folded firmly in half, with sticky sides together, and disposed of with care.

Interactions

No clinically-relevant interactions between NRT and other drugs have definitely been established. However, nicotine may enhance the haemodynamic effects of adenosine.
Cessation of smoking, with or without NRT, may alter the individual’s response to concomitant medication and may require adjustment of dose. In particular, anticonvulsants may require special monitoring and/or dosage adjustment.
Smoking, but not nicotine, is associated with increased CYP1A2, and possibly CYP1A1, activity. After cessation of smoking there may be reduced clearance of substrates for these enzymes and increased plasma levels of some medicinal products. This is of potential clinical importance in products with a narrow therapeutic window e.g. theophylline, ropinirole, clozapine and olanzapine.
Smoking may lead to reduced analgesic effects of opioids (e.g. dextropropoxyphene, pentazocine), reduced diuretic response to furosemide, reduced effect of beta-adrenergic blockers (e.g. propranolol) on blood pressure and heart rate decrease and reduced responder rates in ulcer healing with H2-antagonists.
Both smoking and nicotine may raise the blood levels of cortisol and catecholamines, i.e. may lead to a reduced effect of nifedipine or adrenergic antagonist, and to an increased effect of adrenergic agonists.
The increased subcutaneous absorption of insulin that occurs upon smoking cessation may necessitate a reduction in insulin dose.

Adverse Effects

In principle, Nicotinell can cause adverse reactions similar to those associated with nicotine administered by smoking. Since the maximum plasma concentrations of nicotine that are produced by Nicotinell are lower than those produced by smoking and fluctuate less, nicotine-related adverse reactions occurring during treatment with Nicotinell can be expected to be less marked than during smoking.
Clinical trial experience has shown that skin reactions at the application sites are the most frequent adverse reactions. This led to premature discontinuation of Nicotinell in about 6% of clinical trial participants. These reactions include application site burning, oedema, erythema, irritation, pruritus, rash, urticaria and vesicles. Most of the skin reactions resolved within 48 hours, but in more severe cases the erythema and infiltration lasted from 1-3 weeks. The onset of significant skin reactions occurred between 3 and 8 weeks from the start of therapy.
Upper respiratory tract infection and cough reported as adverse reactions may be linked to a chronic bronchitis induced by long term smoking in the past.
Aphthous stomatitis may develop in connection with smoking cessation, but any relation with the nicotine treatment is unclear.
Adverse reactions (from both clinical and post-marketing experience) are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Dosage and Administration

Instructions for use.

Nicotinell should be applied as soon as it has been removed from the see-through child-resistant pouch. The sachet has a pre-cut edge to facilitate removal of the Nicotinell Patch contents. Following removal of the metallic backing, the Nicotinell Patch should be immediately applied to a clean non-hairy, dry area of intact skin on the trunk or upper arm. The patch should be held in position for 10-20 seconds with the palm of the hand. A different site of application should be chosen each day. Several days should be allowed to elapse before using the same area again.

Adults (18 years and over).

Nicotinell abrupt quit patch therapy.

During an abrupt quit attempt, the patient should be advised to stop smoking completely when starting treatment with Nicotinell Patch.
For those smoking 20 or more cigarettes a day it is recommended that treatment be started with Nicotinell Patch Step 1. Those smoking less than 20 cigarettes a day should start with Nicotinell Patch Step 2.
Patients starting on Nicotinell Patch Step 1 should use this strength for 3-4 weeks, before moving onto Step 2 for 3-4 weeks, and finally Step 3 for 3-4 weeks.
Patients starting on Nicotinell Patch Step 2 may switch to Step 3 after 3-4 weeks, or continue to use Step 2 for 6-8 weeks before moving onto Step 3 for 3-4 weeks.
How quickly the patient moves through the program will vary depending on individual response, and maintaining or increasing the dose may be necessary if abstinence is not maintained or if withdrawal symptoms are experienced.
The treatment duration is about 3 months but may vary as a function of individual response. Intermittent dosing products (such as Nicotinell Gum) may be used beyond 3 months if necessary, but those using NRT for more than 9 months should seek advice from a healthcare professional.

Nicotinell pre-quit patch therapy.

For smokers of 20 or more cigarettes a day who choose to smoke while preparing to quit, Nicotinell Patch Step 1 should be applied once daily for the first 2 weeks of the quit attempt. After the 2 week Pre-Quit course is completed, the patient should stop smoking completely and continue their quit attempt using Nicotinell Patch Step 1, 2, then 3 (see directions for Nicotinell abrupt quit patch therapy).
Combination therapy may also be used once smoking has ceased (see Combination therapy).

Combination therapy.

If smokers have previously relapsed with use of one form of NRT, Combination Therapy could be beneficial. Smokers who experience breakthrough cravings or have difficulty controlling cravings using a single form of NRT may combine the use of Nicotinell Patch Step 1 with another form of NRT such as Nicotinell Gum 2 mg. Nicotinell Gum 4 mg should not be used with Nicotinell Patch.
When using Nicotinell Patch Step 1 in addition of Nicotinell Gum 2 mg, it is recommended that 4-12 pieces of the gum are used each day. Most people will use 5-6 pieces. Do not exceed 12 pieces a day.
Combination Therapy should be used for 12 weeks, after which one of the two following programs should be followed:
1. Stop use of Nicotinell Patch and gradually reduce the number of gums used until they are no longer needed.
2. Continue with Nicotinell Patch Step 2 for 3-4 weeks, then Nicotinell Patch Step 3 for a further 3-4 weeks while maintaining the number of Nicotinell Gum 2 mg that is used each day. After use of patches is ceased, gradually reduce the number of gums used until they are no longer needed.

Use in adolescents (12-17 years).

Adolescents aged 12-17 years should only use Nicotinell Patch under the advice of a healthcare professional. Treatment should not exceed 12 weeks without consultation with a healthcare professional, who can reassess the patient for their commitment to quit and the benefits of continued treatment. If treatment is continued, it should not be extended for more than another 4 weeks.
Adolescents aged 12-17 years should not use Combination or Pre-Quit therapy.

Use in children.

Do not use in children under 12 years.

PBS listing.

Nicotinell Patch Steps 1, 2 and 3 are available on the Pharmaceutical Benefits Scheme (PBS). A maximum of 12 weeks of PBS-subsidised NRT will be authorised per year.

Overdosage

In overdose, symptoms corresponding to heavy smoking may be seen.
The acute lethal oral dose of nicotine in a non-smoker is about 0.5-0.75 mg per kg body weight, corresponding in an adult to 40-60 mg. Even small quantities of nicotine are dangerous in children, and may result in severe symptoms of poisoning which may prove fatal. If poisoning is suspected in a child, a doctor must be consulted immediately.
Overdose with Nicotinell Patch may occur when many patches are applied simultaneously on the skin.
General symptoms of nicotine poisoning may include: weakness, sweating, salivation, nausea, vomiting, abdominal pain, diarrhoea, hearing and vision disturbances, headache, tachycardia and cardiac arrhythmia, dyspnoea, prostration, circulatory collapse, coma and terminal convulsions.

Treatment of overdose.

For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia). Treatment of overdose should be immediate as symptoms may develop rapidly. Immediately discontinue nicotine administration and institute symptomatic treatment. Monitor vital signs.

Overdose from topical exposure.

In the case of an overdose from topical exposure, the patch should be removed immediately. The skin surface may be flushed with water and dried. No soap should be used, since it may increase nicotine absorption.
Nicotine will continue to be delivered into the blood stream for several hours after removal of the patch from a depot of nicotine in the skin.

Presentation

Nicotinell Step 1 contain 52.5 mg nicotine with a 30 cm2 release area; release rate 21 mg/24 h (approx); branding EME.
Nicotinell Step 2 contain 35 mg nicotine with a 20 cm2 release area; release rate 14 mg/24 h (approx); branding FEF.
Nicotinell Step 3 contain 17.5 mg nicotine with a 10 cm2 release area; release rate 7 mg/24 h (approx); branding CWC.
All three presentations are round with a yellowish-ochre backing foil. All presentations contain information on Nicotinell and how to use it. They are available in boxes of 3, 7, 14, 21, 28 or 35 patches (not all pack sizes may be marketed).

Storage

Store below 30°C. Do not refrigerate.

Poison Schedule

Unscheduled.