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Usage instructions for Nicotrol patches and similar generic 16 hour nicotine patches.

Consumer Medicine Information

Usage instructions on this page also apply to all generic nicotine 5 mg/16h, 10 mg/16h, 15 mg/16h, transdermal patches.

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What is on this webpage ?
This webpage answers some common questions about the Nicotrol patch. It does not contain all the available information or take the place of professional advice such as talking to your doctor or pharmacist.

All medicines have risks and benefits. You need to weigh the risks of wearing the Nicotrol patch against the benefits it will have for you.

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

Please print this page and keep the printout with the medicine. You may need to read it again.

What is the Nicotrol patch used for?
The Nicotrol patch helps you to give up smoking by relieving the desire to smoke, as well as some of the unpleasant effects, which smokers experience when they stop smoking.

How does the Nicotrol patch work?
Smokers have both a physical reliance on nicotine (i.e. the body becomes dependent on nicotine) and a psychological reliance on the smoking habit itself.

When you give up smoking, your body will miss the effects of nicotine and you will miss the habit of smoking.

The Nicotrol patch helps you to tackle these two sides of the problem separately, instead of all at once.

It is your body's dependence on nicotine, which causes withdrawal symptoms when you suddenly stop smoking. Nicotine is an addictive substance. Symptoms may include irritability, restlessness, depression, weight gain, and craving for cigarettes.

The Nicotrol patch is intended to ease such withdrawal symptoms by providing your body with nicotine. This leaves your mind free to concentrate on overcoming your psychological desire to smoke.

Nicotrol patches have been designed to slowly allow nicotine to be absorbed through your skin. The amount of nicotine in the Nicotrol patch is sufficient to help overcome the withdrawal symptoms but is lower than the amount of nicotine which you get from smoking. Therefore, overcoming your reliance on the nicotine in the Nicotrol patch is much easier than overcoming your dependence on the nicotine you get from smoking.

The Nicotrol patch is intended to help you to give up smoking, but you will only be successful in becoming a non-smoker if you are determined to quit.

You will also need the support of others, your family, your friends, or specialised counselling organisations.


Before using the Nicotrol patch
When you must not use the Nicotrol patch

Do not use the Nicotrol patch if:
- You are pregnant or intend to become pregnant
There is medical evidence that nicotine in any form may be harmful to an unborn child. Therefore it is recommended that you do not use Nicotrol if you are pregnant or intend to become pregnant, unless you are unable to stop smoking without nicotine replacement. Talk to your doctor before using the Nicotrol patch during pregnancy.
- You are breast-feeding or intend to breast-feed
Nicotine passes freely into breast milk, and can affect the health of the baby. Therefore it is recommended that you do not use the Nicotrol patch if you are breast-feeding or intend to breast-feed.
- You have had a recent heart attack or stroke
- You have heart disease such as palpitations (fast or irregular heart beats) or uncontrolled angina (chest pain)
- You are a non-smoker
- You are under 18 years old
There is not enough information about the use of the Nicotrol patch in children.
- You are allergic to nicotine or are sensitive to any components of the chewing gum.

You should not use the Nicotrol patch if the expiry date printed on the carton has passed or the packaging is torn or shows signs of tampering.

Do not give the Nicotrol patches to anyone else to use as it is recommended that they seek professional advice prior to starting treatment.

Before you start using Nicotrol patches
If you have had any of the following, you should ask for your doctor or pharmacist's advice before using Nicotrol patches.

These medical conditions may need consideration by or discussion with your doctor or pharmacist. You and your doctor or pharmacist can then weigh up the risk of using Nicotrol patches against the benefits you will get if you stop smoking.

The medical conditions include:
Angina (chest pain) or any other problem with your heart or blood vessels such as pain in one or more legs when you walk
High blood pressure
Previous stroke
Kidney disease
Liver disease
Stomach ulcer or pain
Hyperthyroidism (a disorder of the thyroid gland)
Phaeochromocytoma (a tumour of the adrenal gland)
Any skin disease, rashes or allergies to adhesives

Taking other medicines
If you are taking any other medicines, including medicines that you buy without a prescription, in a pharmacy, supermarket or health food shop, the way these medicines work may be affected once you stop smoking.

These medicines may include:
Theophylline (asthma medication)
Imipramine (antidepressant)
Pentazocine (pain medication).
You may wish to seek professional advice from your doctor or a pharmacist before you start to use Nicotrol patches.


Using Nicotrol Patches
Which is the correct strength of Nicotrol patch to use and how long it should be used for?
Nicotrol patches come in three different strengths. The patch is applied on waking (usually in the morning) and removed 16 hours later (usually at bedtime). The patch is not intended to be worn while you are sleeping.

When you first start to use the Nicotrol patch you should use the highest strength. This is the 15 mg/16h Nicotrol patch. You should use this strength patch daily for 8 weeks.

Then you should reduce the amount of nicotine you are using by changing the strength of the patch you use. Use the next lower strength patch (10 mg/16h) applied daily for 2 weeks, then use the lowest strength patch (5 mg/16h) applied daily for two weeks.

This gradual reduction in the amount of nicotine will help your body get used to going without nicotine.

If you have been unable to quit smoking after this time, then further use of the Nicotrol patch may be considered after advice from your doctor or pharmacist.

How do I combine use of Nicotrol Patch with nicotine gum or inhaler?
Normally the Nicotrol patch, nicotine gum or inhaler alone would provide enough nicotine to help most people control their craving for cigarettes. However, some people may find that even though they are using nicotine replacement therapy (NRT) they still have intense or frequent cravings they find difficult to cope with. If you are one of these people you may benefit from combining a Nicotrol patch with either nicotine 2 mg gum or nicotine 10 mg inhaler.

Each morning apply a Nicotrol 15 mg/16 hour patch to an intact area of skin. The Nicotrol patch should be removed before going to bed. After applying the Nicotrol patch use nicotine 2 mg gum or nicotine inhaler whenever a craving occurs.

If you are using nicotine 2 mg gum try to chew at least 4 pieces of gum every day. Most people will use 5-6 pieces. If you are using nicotine inhaler try to use 4-5 cartridges every day.

The combination of a Nicotrol patch and nicotine gum or inhaler should be used in this way for 6-12 weeks. After this time if required you can wean yourself off NRT by either:

1. Using the Nicotrol 10 mg/16 hour patch for 3-6 weeks and then use the Nicotrol 5 mg/16 hour patch for 3-6 weeks while using the same number of pieces of nicotine gum or inhaler cartridges in a day that you have routinely used. Then when a patch is no longer needed, gradually reduce the number of pieces of gum or inhaler cartridges until you no longer need them.


2. Stop use of the Nicotrol 15 mg/16 hour patch and then gradually reduce the number of pieces of nicotine 2 mg gum or inhaler cartridges that are used until you no longer need them.


How to apply and use the Nicotrol patch

Choose and prepare an area of skin
Before you open the pouch choose an area of skin and make sure it is clean and dry. Any area of the body could be used, but preferably hairless skin is best to stick the patch on. Some examples may be the upper thigh, hip, the upper arm or the chest.

The patch should be placed on a different part of the body each day. This will help reduce skin irritation.

Each patch is sealed in a childproof pouch. You will need a pair of scissors to cut the pouch open. Cut along one edge of the pouch with the scissors and carefully remove the patch. Be sure to handle the patch carefully as the nicotine on the sticky side could come off on your hands. This can cause stinging and redness if it gets near your eyes or nose.

To apply the patch remove the clear plastic coating and press the sticky side onto the clean dry skin for about 10 seconds. Run your finger around the edge of the patch to ensure it sticks properly.

If you apply the patch correctly you can shower, bathe or swim without worrying about it coming off.

How to dispose of a used patch
After removal fold the used patch in half with the sticky side inward. Place the folded patch inside the opened pouch or wrap it in a piece of aluminium foil. The used patch should then be disposed of carefully where children or animals cannot get hold of it.

Important: Immediately after applying or removing a Nicotrol patch wash and dry your hands thoroughly so that you cannot get any nicotine into your eyes or nose.

If you use too much (overdose)
Overdosage can occur if more than one patch is used, or you smoke or use other nicotine containing products while you are wearing a patch.

There is a small risk that young children may be poisoned with nicotine if they put a patch in their mouth or apply them (especially more than one) to their own skin.
Anyone who swallows a patch needs immediate medical attention.

Signs of overdose or poisoning include:
- Nausea and vomiting
- Salivating
- Diarrhoea
- Abdominal pain
- Cold sweats
- Weakness
- Disturbed hearing
- Headache
- Breathing difficulties
- Weak, rapid or irregular pulse
- Loss of consciousness.

In the event of yourself or someone else showing symptoms seek medical advice.

Immediately telephone your doctor for advice, or go to Accident and Emergency at your nearest hospital.

You can also help by doing the following:
- Remove all the nicotine patches
- Flush the skin with water and dry it.


Side effects

What are possible side effects of using Nicotrol patches?
Nicotine like all other medicines may cause unwanted side effects in some people. Seek professional advice from your doctor or pharmacist as soon as possible if you do not feel well while you are using Nicotrol Patch.

Most of the undesirable effects reported by users of Nicotrol occur during the first weeks after beginning treatment. Some are minor and temporary but others may need medical attention.

You may notice the following:
- Redness or itching of the skin where the patch has been
- Headache
- Nausea and/or vomiting
- General skin redness and hives
- Dizziness
- Sleeplessness.

Some effects, such as dizziness, headache and sleeplessness may be withdrawal symptoms due to low nicotine levels.

If any of these effects do not go away, or you have any other undesirable effects during use, tell your doctor or pharmacist.


After using the Nicotrol patch

Do not use a patch if the pouch or patch is damaged. Keep all the pouches in the box until immediately before use.

Store Nicotrol Patch at temperatures below 25°C. Storage in a car in hot weather may cause damage to the patch.

Children have a greater risk of poisoning from nicotine, therefore it is important to keep Nicotrol patches out of reach of children.


Product description
What do Nicotrol patches look like?
Nicotrol patches are rectangular and beige-pink (skin-tone) in colour.

Each of the three strengths is a different size. The largest patch is the highest strength and contains the most nicotine.

Each strength of Nicotrol patch comes in packs of 7 patches.

The Nicotrol patch is a General Sales Medicine.

The active ingredient in a Nicotrol patch is nicotine.
Other non-active ingredients are: polyisobutylene, polybutene, polyester (nonwoven).

Nicotrol Patches are supplied in New Zealand by:
PO Box 11-282


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