FULL CMI

Nicotinell^® Patch

Active ingredient(s): Nicotine 21mg/24 hours; 14mg/24 hours; 7mg/24 hours

Consumer Medicine Information (CMI)

This leaflet provides important information about using Nicotinell Patches. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Nicotinell Patches.

Where to find information in this leaflet:

1. Why am I using Nicotinell Patches?
2. What should I know before I use Nicotinell Patches?
3. What if I am taking other medicines?
4. How do I use Nicotinell Patches?
5. What should I know while using Nicotinell Patches?
6. Are there any side effects?
7. Product details

1. Why am I using Nicotinell Patches?

Nicotinell Patches contains the active ingredient nicotine [either 21mg/24 hours; 14mg/24 hours or 7mg/24 hours]. 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 aspects to quitting smoking. The first is the psychological dependence on cigarettes. You may have smoked for many years and smoking has become a routine part of your life.

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 health dangers of continuing to smoke.

The other side is the physical addiction to nicotine. Cigarettes supply nicotine, and your body has become dependent on nicotine.

Nicotinell Patches deliver nicotine into your bloodstream through your skin. Using Nicotinell Patches will help to gradually reduce the amount of nicotine your body craves each day.

Counselling is available from various support groups. To get the best out of Nicotinell Patches, we encourage you to enroll in one of these groups.

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

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

2. What should I know before I use Nicotinell Patches?

Warnings

Do not use Nicotinell Patches if:

• you are under 12 years old
• you are a non-smoker or occasional smoker
• you have a generalised skin disorder that may complicate patch therapy (e.g. generalised psoriasis or chronic 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

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.

Check with your doctor or pharmacist if you:

• 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)
• you have uncontrolled high blood pressure
• you have a history of epilepsy (fits)
• take any medicines for any other condition, including medicines that you buy without a prescription
• you are aged 12-17 years
• you are pregnant or breastfeeding
• you have severe high blood pressure
• you have other heart or blood vessel disease
• you have diabetes
• you have kidney or liver disease
• you have hyperthyroidism (an overactive thyroid)
• you have phaeochromocytoma (a tumour of the adrenal gland).

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Ideally, you should try to stop smoking without using NRT. Nicotine in any form may cause harm to your unborn baby. However, if you have tried and this has not worked, NRT may be recommended to help you stop smoking.

Seek advice from your pharmacist or doctor before starting NRT. 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. NRT products that are used intermittently, such as Nicotinell Gum, are preferable to nicotine patches. However, patches may be preferred if you have nausea or sickness. If you use Nicotinell Patches, make sure you remove the patch before bed.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

Nicotine is excreted in breast milk in quantities that may affect the child even in therapeutic doses. Like smoking, NRT should be avoided during breastfeeding. However, if you are unable to quit without the use of NRT, seek advice from your pharmacist or doctor before starting a program. Do not use Nicotinell Patches if you are breastfeeding.

Intermittent NRT products such as Nicotinell Gum may be used instead, and should be used immediately after breastfeeding, to ensure that the baby gets the smallest amount of nicotine possible from breast milk.

Take special care:

• If you have stomach or duodenal ulcers or inflamed oesophagus or gullet (the passage between the mouth and stomach) because nicotine replacement therapy can make your symptoms worse.
• When taking this medicine there is a risk of dependence.

Nicotinell Patches contain aluminium: you should not wear Nicotinell Patches during MRI (Magnetic Resonance Imaging) procedures.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Smoking cessation and/or Nicotinell Patches may change the way that other medicines work and you may not get the benefit from one or both products; for example, some medicines used for treatment of asthma, diabetes, schizophrenia, Parkinson's disease, high blood pressure, gastric ulcer, strong pain or angina pectoris may need dose adjustment. Your doctor or pharmacist will be able to advise you if stopping smoking or NRT may affect the way these medicines work.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Nicotinell Patches.

4. How do I use Nicotinell Patches?

How much to take / use

• Follow the instructions provided with the medicine.
• Do not exceed the recommended dosage.

Nicotinell Quit Now program

The Nicotinell Quit Now program lasts for 9-12 weeks. One patch is used each day for the duration of the program. Each patch is worn for one full day (24 hours). As the program progresses, a lower strength (smaller size) patch is used as your body's desire for nicotine decreases. Nicotinell Patches are available in three nicotine dosage strengths: Nicotinell Patch Step 1 (21 mg/24 hours), Nicotinell Patch Step 2 (14 mg/24 hours) and Nicotinell Patch Step 3 (7 mg/24 hours). Your correct starting strength depends on how many cigarettes you usually smoke each day.

If you smoke during your course of treatment, consult your doctor or pharmacist.

Nicotinell Pre-Quit program

If you smoke 20 or more cigarettes per day and are not sure you are able to give them all up at once, Nicotinell Pre-Quit program may be suitable for you. This involves wearing Nicotinell Patch Step 1 while gradually reducing the number of cigarettes you smoke over 2 weeks leading up to your quit date. After 2 weeks, stop smoking and start on the Nicotinell Quit Now program. You may also use Combination Therapy after the initial 2 week Pre-Quit program.

Combination Therapy

If you have relapsed in the past or if you experience cravings while using a single form of NRT, you can combine the use of Nicotinell Patches with Nicotinell Gum 2 mg.

A combination of NRT types 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 Patch Step 1, chew one piece of Nicotinell Gum 2 mg if you experience cravings. Use at least four pieces of gum but not more than 12 pieces in a day. Continue for 12 weeks.

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

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

Adolescents 12-17 years old

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

Adolescents should not quit using the Nicotinell Pre-Quit program or Combination Therapy.

Do not use for children under 12 years old.

How to apply Nicotinell Patches

1. Cut open the sachet along the dotted line.
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 red, 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 move.
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 10-20 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. An area of the skin used for a patch should not be used again for a new patch for at least seven days.
9. Avoid areas with skinfolds or where the skin creases.
10. The patch should be applied immediately after opening sachet.
11. Once applied, do not remove and re-apply elsewhere as the patch will not re-adhere well.
12. When replacing Nicotinell Patches after 24 hours, choose a different location for the new patch.
13. Remove the used patch, fold it in half, sticky side inwards. Discard the used patch carefully, keeping it out of reach of children or pets.
14. When applying the patch, avoid touching the eyes and nose.
15. When you have finished, always wash your hands with water only.

Additional information

• You can shower while wearing Nicotinell Patches. However, avoid spraying the shower jet directly onto the patch.
• Do not use bath or shower products with oily ingredients, either before or after application of the patch, as this could affect patch adhesion.
• When swimming for a long period in the sea or pool, you have two options:
  a. before swimming, remove the patch and immediately replace it on its packaging. You will be able to stick it back onto your dry skin later on.
  b. cover the patch with a waterproof adhesive dressing for the entire time that you swim.
• 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.
• 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.
• It is best not to use soap on the patch or skin immediately surrounding the patch.
• 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.

If you use too much Nicotinell Patches

If you think that you have used too much Nicotinell Patches, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

The signs and symptoms of nicotine overdose include sweating, nausea (feeling sick) salivation, vomiting, stomach upset, diarrhoea, headache, dizziness, reduced hearing, vision disturbances or general weakness. More serious nicotine poisoning may include the following symptoms: irregular heartbeat, breathing difficulties or an uncomfortable chest, prostration (completely exhausted and unable to move), cardiovascular collapse (possible heart attack or decreased blood pressure) or convulsions (its).

If overdose 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.

You should do this even if there are no signs of discomfort or poisoning.

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

5. What should I know while using Nicotinell Patches?

Things you should do

• Use Nicotinell Patches exactly as instructed.
• If you follow these recommendations, you should get the full benefit of the Nicotinell Patches program.

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

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

Things you should not do

• Do not wear more than one Nicotinell Patch at a time.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Nicotinell Patches affects you.

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

Looking after your medicine

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 the patch in the refrigerator, even in hot weather, as this could lead to a loss of adhesion.

Follow the instructions in the carton on how to take care of your medicine properly.

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 young children cannot reach it.

A locked cupboard at least 1.5 meters above the ground is a good place to store medicines.

When to discard your medicine (as relevant)

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

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

Like all medicines Nicotinell Patches can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Very common /common /uncommon side effects

In the event of a severe skin reaction that persists, stop treatment and consult your doctor or pharmacist to and another form of NRT to help you quit smoking. These effects are usually caused by not changing the site of application each day. Changing the site each day will allow any irritation to disappear naturally and cause you very little discomfort.

Mouth ulcers may be related to quitting smoking and not to your treatment.

Serious/rare side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Keep Nicotinell Patches out of reach of children at all times.

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.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What Nicotinell Patches contain

Do not take this medicine if you are allergic to any of these ingredients.

What Nicotinell Patches look like

Nicotinell Patches are available in three nicotine dosage strengths, each corresponding to a different patch size.

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

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

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

Who distributes Nicotinell Patches

Perrigo Australia
Suite 7, Level 1, 13a Narabung Way
Belrose NSW 2085
Customer Service: 1800 805 546
Visit our website: www.nicotinell.com.au

® Registered Trademark

This leaflet was prepared in August 2013

Date of amendment: March 2025

ACC03683P:6

Published by MIMS May 2025

Name of the medicine

Nicotine.

Excipients.

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.

Pharmacodynamics.

Pharmacokinetics.

Absorption.

Distribution.

Metabolism.

Elimination.

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.

Use in lactation.

Use in children and adolescents.

Use in the elderly.

Genotoxicity, carcinogenicity and effects on fertility.

Effects on ability to drive or use machines.

Danger in small children.

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.

Adults (18 years and over).

Nicotinell abrupt quit patch therapy.

Nicotinell pre-quit patch therapy.

Combination therapy.

Use in adolescents (12-17 years).

Use in children.

PBS listing.

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.

Overdose from topical exposure.

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.