Consumer Medicine Information

NICORETTE^® Nasal Spray

Nicotine
10 mg/mL nasal spray

What is in this leaflet

This leaflet answers some common questions about Nicorette Nasal Spray. 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. Your doctor has weighed the risks of you using Nicorette Nasal Spray against the benefits it is expected to 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 Nicorette Nasal Spray is used for

Nicorette Nasal Spray 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 Nicorette Nasal Spray 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.
Nicorette Nasal Spray 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.
Nicorette Nasal Spray 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.

Nicorette Nasal Spray contains nicotine in a solution in a brown glass container with a spray pump. When you spray this medicine into your nose (make sure you do so correctly- see 'How to use Nicorette Nasal Spray') nicotine is rapidly absorbed through the lining of your nose into the bloodstream.

Unlike cigarettes Nicorette Nasal Spray does not contain harmful tar and carbon monoxide.

Before using Nicorette Nasal Spray

When you must not use Nicorette Nasal Spray

Do not use Nicorette Nasal Spray 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 Nicorette 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 Nicorette Nasal Spray 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 Nicorette Nasal Spray 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 Nicorette Nasal Spray in children.
  
  
• You are allergic to nicotine or may be sensitive to any components of Nicorette Nasal Spray (see 'Product description').

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

Do not give Nicorette Nasal Spray to anyone else.

This medicine is available only with a doctor's prescription.

Before you start to use Nicorette Nasal Spray

If you have had any of the following, you must tell your doctor before using Nicorette Nasal Spray:

• Asthma
• 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)
• Diabetes.

Taking other medicines

Tell your doctor 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)
• Insulin
• Imipramine (antidepressant)
• Pentazocine (pain medication).

Using Nicorette Nasal Spray

How much should I use and for how long?

A dose of Nicorette Nasal Spray is one spray into each nostril. It is recommended that you use 1 to 2 doses each hour to relieve your cravings to smoke. Do not have more than 3 doses in one hour.

You can continue this treatment for about 12 weeks, lessening your dependence on nicotine and allowing you to concentrate on breaking your smoking habit.

After 12 weeks you should be ready to reduce your use of Nicorette Nasal Spray. Over the next 6 to 8 weeks reduce your daily dose until you have stopped your course of Nicorette entirely.

Do not use Nicorette Nasal Spray for longer than 6 months.

How to use Nicorette Nasal Spray

It is very important that you use the spray correctly, using it at the correct angle.
Study the pictures below:

1. Remove the protective cap
   
   
2. If you are using the spray for the first time or if you have not used the spray for 2-3 days prime Nicorette Nasal Spray by placing the nozzle between your first and second finger with the thumb on the bottom of the bottle. Press several times firmly and quickly until a fine spray appears (up to 7-8 strokes).
   
   Important: Point the spray safely away from you when priming it. Do not prime near children or pets.
   
   
3. Insert the spray tip into one nostril, pointing the top towards the back of your nose. Press firmly and quickly.
   
   Give a spray into your other nostril.
   
   
4. Put on the protective cap and keep the container out of reach of children. Do not leave your nasal spray in the light.

Please note each priming reduces the number of doses in the bottle. When empty, or the spray is no longer needed, dispose of it carefully away from the reach of children or pets.

If you use too much (overdose) or in accidental poisoning

Overdose of nicotine can occur if nicotine is used excessively, either from too many doses of the Nicorette Nasal Spray used too often and/or smoking.

Symptoms 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.

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

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

Side effects

Nicotine like all other medicines may cause unwanted side effects in some people.

The majority of people using the Nasal Spray for the first time find that it may cause sneezing, running nose, watering eyes, and cough. These may be quite unpleasant at first. However, after a few days the body becomes accustomed to the spray and these effects will gradually disappear.

You may notice the following:

• Headache
• Nausea and/or vomiting
• Stomach upset
• Coughing
• Nose-bleed
• Running nose, sneezing, watering eyes
• Mouth ulcer.

These are not likely to be serious.
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 Nicorette Nasal Spray

Storage

Store Nicorette Nasal Spray at temperatures below 25°C.
Keep the pack out of the light.

KEEP NICORETTE NASAL SPRAY OUT OF REACH OF CHILDREN.
(See section on 'If you use too much (overdose) or in accidental poisoning').

Product description

What Nicorette Nasal Spray looks like

Nicorette Nasal Spray is a clear or slightly cloudy, colourless to light yellow solution filled in a 10 mL brown glass container with a spray pump.

Nicorette Nasal Spray is available only on a doctor's prescription.

Ingredients

The active ingredient in Nicorette Nasal Spray is nicotine.
Other non-active ingredients are: citric acid, dibasic sodium phosphate, disodium edetate, methyl hydroxybenzoate, monobasic sodium phosphate, perfume (NNS Aroma DZ-03226), polysorbate 80, propyl hydroxybenzoate, purified water and sodium chloride.

Supplier

Nicorette Nasal Spray is supplied in New Zealand by:

Pharmacia
PO Box 11-282
Ellerslie
Auckland

For medical enquiries call (09) 5804300

This leaflet was prepared in July 2001.