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INFORMATION FOR CONSUMERS

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Consumer Medicine Information

NICOTROL® Patch

Nicotine
5 mg/16h, 10 mg/16h, 15 mg/16h, transdermal patch

What is in this leaflet

This leaflet answers some common questions about 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 using Nicotrol Patch against the benefits it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again.

What Nicotrol Patch is used for

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 Nicotrol Patch works

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.

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.

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 Patch has 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 Nicotrol Patch is much easier than overcoming your dependence on the nicotine you get from smoking.

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 Nicotrol Patch

When you must not use Nicotrol Patch

Do not use Nicotrol Patch if:

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

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

Before you start to use Nicotrol Patch

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

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 Patch against the benefits you will get if you stop smoking.

The medical conditions include:

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:

You may wish to seek professional advice from your doctor or a pharmacist before you start to use Nicotrol Patch.

Using Nicotrol Patch

Which strength of Nicotrol Patch to use and how long it should be used for

There are three different strengths of Nicotrol Patch. 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 to combine use of Nicotrol Patch with nicotine gum or inhaler

Normally Nicotrol Patch or 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 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 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. Use 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. OR
  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 use 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:

In the event of yourself or someone else showing symptoms seek medical advice.
Immediately telephone your doctor or the National Poisons Information Centre (0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at your nearest hospital.

You can also help by doing the following:

Side effects

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:

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 Nicotrol Patch

Storage

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.

KEEP NICOTROL PATCH OUT OF REACH OF CHILDREN.

Product description

What 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.

Nicotrol Patch is a General Sales Medicine.

Ingredients

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

Supplier

Nicotrol Patch is supplied in New Zealand by:

Pharmacia
PO Box 11-282
Ellerslie
Auckland

For medical enquiries call (09) 5804300

This leaflet was prepared in September 2002.