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QuitX® Chewing Gum

(Nicotine)


Consumer Medicine Information

IMPORTANT - Please read this leaflet very carefully BEFORE you start to use the chewing gum. After reading, if you have any questions, consult your pharmacist or doctor.

QuitX Chewing Gum

1. Identification

QuitX Chewing Gum is available in 2 nicotine dosage strengths, with each dosage strength available in 2 flavours, namely Mint and Classic.

QuitX 2 mg Gum available in Classic or Mint flavour.

QuitX 4 mg Gum available in Classic or Mint flavour.

There are 2 pack sizes for each flavour, containing either 24 or 96 pieces of QuitX Chewing Gum.

QuitX Chewing Gum contains nicotine, acesulfame potassium, butylated hydroxytoluene, calcium carbonate, carnauba wax, chewing gum base, glycerol, menthol, polacrilin, saccharin, saccharin sodium, sodium bicarbonate, sodium carbonate anhydrous, sorbitol, talc - purified, water - purified. Flavour: Mint Gums - eucalyptus oil, peppermint oil, Classic Gums - fruit flavour.

The gums are sugar-free and have no added colour.

Each 2 mg gum contains 0.19 g sorbitol (equivalent to 3.8 g/ maximum dose of 20 gums). Each 4 mg gum contains 0.17 g sorbitol (equivalent to 1.7 g/maximum dose of 10 gums). Products containing sorbitol may have a laxative effect or cause diarrhoea.

Each gum contains 11.5 mg or 0.5 mmol sodium (for the 2 mg gum, this is equivalent to 230 mg or 10 mmol/ maximum dose of 20 gums; for the 4 mg gum, this is equivalent to 115 mg or 5 mmol/ maximum dose of 10 gums) which should be taken into account by those on a low sodium diet.

2. What QuitX Chewing Gum is used for

QuitX Chewing Gum can help you stop smoking. You probably know that smoking is a very difficult habit to break. There are two sides to quitting smoking. The first is the psychological dependence on cigarettes. You have probably smoked for many years and smoking has become an important part of your life.

The other side is a physical addiction to nicotine. Cigarettes contain nicotine, and your body has become dependent on nicotine. QuitX Chewing Gum can reduce your desire to smoke by providing some of the nicotine that you used to inhale from cigarettes. This helps you to resist smoking.

When chewed, nicotine is released slowly from the gum and absorbed through the lining of the mouth. The amount of nicotine in the gum can also reduce some of the unpleasant effects that often happen when giving up smoking, such as feeling ill or irritable. QuitX Chewing Gum does not act as quickly as smoking.

Nicotine can also be replaced using patches containing nicotine. The patches provide a constant level of nicotine by simply being applied each day. If you want to know more about nicotine patches, talk to your doctor or pharmacist.

QuitX Chewing Gum works most effectively when you have a strong personal commitment to stop smoking. You cannot rely on QuitX alone to break the habit. The QuitX Support Program has been designed to further assist you in this regard.

QuitX may be used in combination with personal counselling. Counselling is available from various groups such as Quit For life. To get the best out of QuitX, we encourage you to enrol in one of these groups.

3. Before you use QuitX Chewing Gum

When you must not use it

Do not use QuitX Chewing Gum if:

  • Your mouth or throat is sore
  • You are pregnant or breastfeeding
  • You are under 18 years old
  • You are a non-smoker
  • You are allergic to nicotine or any of the other ingredients in the gums
  • 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)
  • The expiry date printed on the carton or blister platform has passed
  • The packaging is torn or shows signs of tampering.

Before you use it

Tell your pharmacist if you have any of the following medical conditions and ask for his/her advice before using QuitX Chewing Gum:

  • Any type of heart disease, including angina
  • High blood pressure or any circulation disorder
  • Kidney or liver problems
  • Stomach ulcer or persistent stomach upset
  • Hyperthyroidism (a disorder of the thyroid gland)
  • Diabetes
  • Phaeochromocytoma (a tumour of the adrenal gland).

Tell your pharmacist if you are taking any other medicines, including medicines that you buy without a prescription. Your pharmacist will be able to advise you if stopping smoking may affect the way these medicines work.

Be careful if you have dentures, dental caps or partial bridges. As with other gums, QuitX Chewing Gum may stick to your dentures, dental caps or partial bridges and may damage them. You should stop using the gum if it sticks to your dental work and discuss further use with your dentist.

4. Using QuitX Chewing Gum

How to get started

QuitX Chewing Gum is not like ordinary chewing gum. You must stop smoking completely while you are using it.

It is probably best to nominate a specific day that you will stop smoking. It may be helpful for you to:

  • Try to choose a day when you will not be where others are smoking
  • Choose a day with as little stress as possible
  • Choose a day not too far in the future.

Tell your family and friends that you have set this target "quit day". This is the day you take control of your habit and become a non-smoker.

Prepare to stop smoking by trying to reduce the number of cigarettes you smoke each day.

How to commence using QuitX Chewing Gum

At the beginning of the "quit day", start to use QuitX Chewing Gum before any cigarettes have been smoked.

Chew one piece of gum when you feel the urge to smoke.

Follow these steps:

  • Chew slowly until the taste becomes strong
  • Rest the piece of chewing gum between your gum and cheek
  • Chew again when the taste has faded
  • Repeat the chewing routine for about 30 minutes
  • Do not chew more than one piece at a time.

Chew slowly.

The nicotine in QuitX Chewing Gum is released a little at a time and absorbed through the lining of your mouth into your bloodstream. If you chew too quickly or for too long, you will swallow the nicotine with your saliva. It will be broken down in your stomach and wasted.

Do not drink coffee or soft drinks for 15 minutes before chewing the gum. They may keep the nicotine in the gum from being absorbed properly.

Do not use more than 20 pieces of the 2 mg gum or 10 pieces of the 4 mg gum in a day. Most people use 8-12 pieces of the 2 mg gum or 4-6 pieces of the 4 mg gum in a day.

How long to use it

After about 3 months, gradually cut down the number of pieces of QuitX Chewing Gum you chew each day. When you are down to only 1-2 pieces of gum per day, you can stop using it. Stopping the gum completely should be possible within 6 months from the start of treatment.

5. While you are using QuitX Chewing Gum

Things you must do

Stop smoking completely while using QuitX Chewing Gum. You may have increased side effects if you continue to smoke while chewing the gum

Use QuitX Chewing Gum as instructed. If you follow these recommendations you should get the full benefit of the QuitX Support Program.

Tell your doctor or pharmacist if you continue to smoke while you are using QuitX Chewing Gum.

Stop using QuitX Chewing Gum immediately if you become pregnant. You should not use this program while you are pregnant or if you are breastfeeding.

Nicotine in any form may cause harm to your unborn baby.

Tell all of the doctors, dentists and pharmacists who are treating you that you are using QuitX Chewing Gum.

Things you must not do

Do not stop using QuitX Chewing Gum suddenly. You may get side effects similar to those you would get if you stopped smoking suddenly.

6. Side effects

Tell your pharmacist as soon as possible if you do not feel well while you are using QuitX Chewing Gum. Nicotine, like all other medicines, may cause unwanted side effects in some people.

If you get chest pain, irregular heartbeat or bad indigestion, do not smoke or use QuitX Chewing Gum or any other nicotine medication. See your pharmacist or doctor as soon as possible. Most of the undesirable effects reported by users of nicotine gums occur during the first few days or weeks and may be due to chewing incorrectly or to the effects of nicotine. Such effects include sore or irritated mouth or throat, jaw muscle ache, increased saliva, hiccups, mild indigestion or heartburn, nausea, dizziness and headache.

Less common side effects are palpitations (feeling of fast or irregular heartbeat), tingling in the fingers or toes, skin redness or rash.

Some common withdrawal symptoms from giving up smoking are irritability, sleep disturbances, dizziness or headache.

Tell your pharmacist or doctor if these effects do not go away, or if you notice anything else that is making you feel unwell.

7. Overdosage

Overdose with QuitX Chewing Gum could occur if many pieces are chewed at the same time or rapidly one after the other. The risk of overdose is small as nausea and vomiting usually occurs at an early stage with excessive nicotine intake.

The signs and symptoms of nicotine overdosage include pallor, sweating, nausea, salivation, vomiting, stomach upset, diarrhoea, headache, dizziness, hearing and vision disturbances, tremor, confusion, weakness, fainting and breathing difficulties.

In the event of overdose or suspected overdose, seek immediate medical advice or contact a Poisons Information Centre (Telephone: 13 11 26).

8. Storage

It is very important to keep QuitX Chewing Gum out of the reach of children, as doses of nicotine that are tolerated by adult smokers can cause severe poisoning in small children.

Store below 25°C.

9. Where to go for further information

This leaflet is only a summary of information about QuitX Chewing Gum.

Ask your pharmacist or doctor if you have any questions, or if you experience any difficulties before, during or after using QuitX Chewing Gum as they have more complete information.

QuitX Chewing Gum is supplied in Australia by:

Alphapharm Pty Limited
(ABN 93 002 359 739)
Chase Building 2
Wentworth Park Road
Glebe NSW 2037
Phone: (02) 9298-3999
Medical Information
Phone: 1800 028 365

® = Registered Trade Mark

This leaflet was prepared on 19 February 2007.

Published by MIMS/myDr September 2007

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