Nicotine Oral Spray (10ml Nicotine Oral Spray 10mg/ml)

Please read this information carefully before you start using this medicine. It provides useful information on how to use it safely. The information applies only to this product. If you have any questions, or you are not sure about anything, please ask your doctor.

Remember: This medicine is for you. Never give it to others. It may harm them even if their symptoms are the same as yours.

What is in your medicine?

Nicotine Oral Spray consists of a glass bottle of solution, attached to a pump spray unit designed to be put in front of your mouth. When the pump is used it delivers 0.5 milligrams of nicotine into the mouth. Besides the active ingredient, nicotine, the solution contains disodium phosphate, sodium dihydrogen phosphate, sodium chloride, citric acid, polysorbate 80, beta-ionine (aroma), methyl and propyl parahydroxybenzoate (preservatives), disodium edetate (stabiliser) and water. There are about 200 sprays in each bottle.

What kind of medicine is it?

Nicotine Nasal Spray is one of a group of medicines called Nicotine Replacement Therapy (NRT). It is used to relieve withdrawal symptoms and to reduce the cravings for nicotine which people get when they stop smoking.

What does this medicine do?

When you stop smoking, your body misses the nicotine which you have been absorbing from the smoke. You may experience unpleasant feelings and a desire to smoke (“craving”). This shows that you were dependent on nicotine. When you spray this medicine into your mouth (make sure you do so correctly – see How to use the Spray), Nicotine is rapidly absorbed through the lining of the mouth into the bloodstream. The amount of nicotine absorbed is sufficient to relieve the unpleasant withdrawal symptoms such as restlessness, irritability, headaches, inability to concentrate, light-headedness and dizziness. It will also help to calm the cravings and urges to smoke, but will not give you the “buzz” that you get from a cigarette.

As well as the effects of Nicotine, you could be very attached to the habit of smoking, for example lighting up after a meal or in certain situations or when you are with particular people. These rituals are part of your smoking habit which you may have been doing for many years. To succeed in giving up, you should try to avoid situations where you may be tempted to smoke.

Think about the times when you are likely to miss smoking most and try to plan how you will cope on these occasions. Changing your routine will help you to break the habit of smoking.

Encouragement and support from your doctor, friends and family can make giving up less stressful and more successful.

You must not use the spray if:

  • You are a non-smoker, or think you may be allergic to any ingredient in the spray.
  • You are pregnant or breast feeding. You should avoid nicotine in all forms if you are pregnant.
  • You are under 18 years of age.
  • You continue to smoke or use other products containing nicotine.

Before you use the spray, you should ask your doctor for advice if:

  • You have stomach ulcers or other stomach problems.
  • You suffer from persistent indigestion or pains in the chest.
  • You suffer from diabetes, overactive thyroid gland or have a tumour of the adrenal gland.
  • You have had or still have angina pectoris (chest pain) or any other problem with your heart or blood vessels (such as pain in one or both legs when you walk).
  • You have liver or kidney disease.
  • You are regularly taking other medicines. Stopping smoking may require the dose to be adjusted.

How to use the spray:

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

The bottle delivers on average 200 sprays each containing 0.5mg of nicotine.

    1. Point the spray safely away from you and any other adults, children or pets that are near you
    2. Press the top of the spray with your index finger 3 times until a fine spray appears. (Note: priming reduces the number of sprays you may get from the bottle)
    3. Do not eat or drink while using the mouth spray
    4. Press the top of the dispenser to release spray onto the inside of your cheek or under your tongue
    5. Do not spray on your lips or directly into your throat
    6. Do not inhale while spraying
    7. Nicotine mouth sprays are designed for nicotine to be absorbed through the mouth lining, so it is best not to swallow for a few seconds after spraying
    8. Care should be taken not to spray the eyes whilst administering the mouth spray

What dose should I use and for how long?

The frequency with which you use the spray will depend on how many cigarettes you smoked and how strong they were.

  1. Use 1 or 2 sprays when cigarettes normally would have been smoked or if cravings emerge. If after the first spray cravings are not controlled within a few minutes, a second spray should be used. If 2 sprays are required, future doses may be delivered as 2 consecutive sprays
  2. Most smokers will require 1-2 sprays every 30 minutes to 1 hour. You may use up to 4 sprays per hour. Do not exceed 2 sprays per dosing episode and 64 sprays (4 sprays per hour over 16 hours) in any 24-hour period.
  3. Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with theNicotine Nasal Spray and as soon as they are able, reduce the number of sprays used until they have stopped completely. Smokers aiming to reduce cigarettes should use the Spray, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible.
  4. As soon as they are ready smokers should aim to quit smoking completely
  5. You can continue this treatment for up to eight weeks, lessening your dependence on nicotine and allowing you to concentrate on breaking your smoking habit.
  6. After eight weeks you should be ready to reduce your use of Nicotine Oral Spray. Over the next two weeks reduce your use by half, and over the following two weeks reduce your use to none at all.

If at any time you are tempted to smoke, seek support from friends, relatives, or your doctor and try to fill the gap in your lifestyle once occupied by smoking. Do not exceed the stated dose or smoke whilst using the spray. Be on your guard once you have given up as urges to smoke can return long afterwards, and in a few minutes you undo your hard work.

What should I do if I have overdosed or a child has used or ingested the spray?

If you have taken too many sprays or a child has used the spray, promptly contact your doctor or Accident and Emergency Department. Have this information or the pack with you.

Are there any unwanted effects from the spray?

The majority of people using the spray for the first time find that it may cause sneezing, sore throat, runny nose or runny eyes, so it is important not to use it when driving or operating machinery. 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.

If you get palpitations, chest pain, leg pain or bad indigestion do not smoke. Do not use the spray but see your doctor as soon as possible.

Unwanted effects can be due to too much nicotine, especially if you continue to smoke (nausea, headache, dizziness)

OR

the effects of a reduction in your nicotine intake (restlessness, headache, irritability, etc).

If you have a nose disorder, and the spray makes it worse, talk to your doctor.

Less commonly indigestion, nosebleed and tingling sensations may occur.

If you find it difficult to cut down the dose of spray or are worried that without it you will start smoking again, talk to your doctor. If you have any side effects not listed here, tell them about these also.

MORE DETAILED INFORMATION IS AVAILABLE WITH YOUR DOCTOR. PLEASE HAVE ALL YOUR QUERIES ANSWERED BEFORE YOU START USING THE SPRAY