Consumer medicine information

Nicabate Gum

Nicotine

BRAND INFORMATION

Brand name

Nicabate Gum

Active ingredient

Nicotine

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Nicabate Gum.

What is in this leaflet

This leaflet answers some common questions about NICABATE Gum. It does not contain all the available information.

It does not take the place of talking to your pharmacist or doctor.

All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you using NICABATE Gum against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine. You may need to read it again.

What is NICABATE Gum used for?

NICABATE Gum is a mint flavoured stop smoking aid. It can help you stop smoking over a few months. You can also use it to help you stop smoking more gradually over a longer period of time.

It helps you give up smoking by replacing some of the nicotine you are used to getting from cigarettes. It is the nicotine in cigarettes that can make you physically addicted to them. This type of treatment is called Nicotine Replacement therapy (NRT).

It contains a nicotine resin. When it is chewed, nicotine is released slowly from the resin and is absorbed through the lining of the mouth.

This medicine can reduce your urge to smoke by providing some of the nicotine previously inhaled from cigarettes and helps you resist cigarettes. This nicotine also relieves many of the withdrawal symptoms such as feeling ill or irritable and cravings that you may feel when you try to give up.

NICABATE Gum does not have the health dangers of tobacco because it does not contain the tar, carbon monoxide or other toxins present in cigarette smoke.

If possible, when giving up smoking, NICABATE Gum should be used with a stop smoking behavioural support programme.

NICABATE 2 mg Gum is suitable for smokers who smoke less than 20 cigarettes a day.

NICABATE 4 mg Gum is suitable for smokers who smoke more than 20 cigarettes a day.

Your pharmacist or doctor may have given you this medicine for another reason

If you need more information ask your pharmacist or doctor.

Before you use NICABATE Gum

When you must not use it

Do not use NICABATE Gum if:

  • You are allergic to nicotine or any of the ingredients listed at the end of this leaflet.
  • You are a non-smoker.
  • You are an occasional smoker.
  • You are under 12 years of age.

There are no health benefits to smoking. It is always better to give up smoking and using NRT can help. In general any possible side effects associated with NRT are far outweighed by the well established dangers of continuing to smoke.

If you are in hospital because of a heart attack, severe heart rhythm disturbances or a stroke you should try to quit smoking without using NRT unless your doctor tells you to use it. Once you are discharged from hospital you may use NRT in consultation with your doctor.

If you have diabetes, you should monitor your blood sugar levels more often than usual when starting NICABATE Gum as you may find your insulin or other medication requirements alter.

If you have epilepsy or are taking medicine to control seizures, you should not use NICABATE Gum unless your doctor has told you to.

If you have had allergic reactions that involve swelling of the lips, face and throat (angioedema) or itchy skin rash (urticaria), using NRT can sometimes trigger this type of reaction.

If you are pregnant or breastfeeding, it is best if you can give up smoking without the use of NRT. However, it is better to stop smoking using NRT than to continue smoking.

Do not use NICABATE Gum if you are under 12 years of age. The levels of nicotine in NRT are suitable for people who are giving up smoking but not for children under 12. Children are more likely to be affected by nicotine and it could cause severe toxicity which can be fatal. Make sure you keep nicotine containing products out of the reach and sight of children at all times and dispose of the gum carefully.

Do not use this medicine after the expiry date (EXP) printed on the pack. If you use it after the expiry date has passed, it may not work as well.

Do not use NICABATE Gum if the packaging is torn or shows signs of tampering.

Do not use this medicine to treat any other complaint unless your doctor or pharmacist says it is safe. Do not give this medicine to anyone else even if they have the same symptoms as you.

Before you start to use it

You must tell your pharmacist or doctor if:

  • You have an uncontrolled, overactive thyroid gland. Nicotine may make your symptoms worse.
  • You have a stomach or duodenal ulcer or inflammation of the oesophagus. Swallowing nicotine can make your symptoms worse. Some people have reported getting mouth ulcers. If your symptoms do get worse, you should talk to your doctor and you might want to use a non-oral type of NRT such as patches.
  • You have heart or circulation problems including heart failure or stable angina or high blood pressure
  • You have had a stroke
  • You have any serious liver or kidney disease. You may be more prone to side effects.
  • You are a diabetic
  • You have been diagnosed as having a tumour of the adrenal glands (phaeochromocytoma). Nicotine may make your symptoms worse.
  • You have hereditary fructose intolerance. Each piece of the 2 mg strength gum (1 dose) contains 149 mg of sorbitol. Each piece of the 4 mg strength gum (1 dose) contains 138 mg of sorbitol. Sorbitol is unsuitable for those with hereditary fructose intolerance. It can also cause stomach upset and diarrhoea.
  • You are on a low sodium diet. Each piece of the 2 mg strength gum contains 10.5 mg of sodium. The maximum daily dose of the 2mg strength NICABATE Gum (20 pieces) contains 210 mg sodium. Each piece of the 4 mg strength gum contains 14.0 mg of sodium. The maximum daily dose of the 4 mg strength NICABATE Gum (10 pieces) contains 140 mg sodium. The maximum daily dose may be harmful if you are on a low sodium diet.
  • You have any allergies to any other medicines.
  • You are pregnant or intend to become pregnant.
  • You are breastfeeding or planning to breastfeed.
  • You have ever experienced seizures.

If you have not told your pharmacist or doctor about any of the above, tell them before you use NICABATE Gum.

If you are pregnant or breastfeeding, then you should try to quit smoking without the use of NICABATE Gum if possible. However, it is better to stop smoking using NRT than to continue smoking.

If you are pregnant
Smoking during pregnancy has risks such as poor growth of your baby before birth, premature birth or still birth. Stopping smoking is the best way to improve both your health and that of your baby. The earlier you stop smoking, the better.

Ideally, if you are pregnant, you should stop smoking without using NRT. However, if you have tried and this hasn’t worked, NRT may be recommended to help you stop smoking. This is because it is better for your developing baby than if you carry on smoking. The decision to use NRT should be made as early on in your pregnancy as possible and you should aim to use it for only 2-3 months. Remember, the most important thing is to stop smoking.

Products that are taken intermittently, such as gum or mini lozenges are preferable to nicotine patches. However, patches may be preferred if you have nausea or sickness.

If you are breastfeeding
Tobacco smoke causes breathing difficulties and other problems in babies and children. If you need to use NRT to help you quit, the amount of nicotine your baby may receive is much smaller and less harmful than breathing in second hand smoke. Do not use patches if you are breastfeeding. You should use NRT products that are taken intermittently (eg gum or mini lozenges rather than patches) and to breastfeed just before you take the product. This allows as long a time as possible between NRT use and feeding and will help your baby to get the smallest amount of nicotine possible.

Using other medicines

Tell your pharmacist or doctor if you are using any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Stopping smoking, with or without nicotine replacement products such as NICABATE Gum, may alter the absorption of some medicines. The doses of the other medicines that you are using may need to be changed.

You should tell your pharmacist or doctor if you are using any other medicines. Other medicines may be affected by NICABATE Gum or affect how well NICABATE Gum works.

Your pharmacist or doctor can advise you what to do if you are using any of these medicines.

If you have not told your pharmacist or doctor about any of these things, tell him/her before you take any NICABATE Gum.

Things to be careful of

If you have false teeth that are poorly fitted or not clean you may have difficulty chewing the gum. If you experience this problem, another nicotine replacement product may be more suitable for you such as a patch or mini lozenge.

Chewing nicotine gum may loosen fillings or dental implants. The butylated hydroxytoluene in this product may cause irritation to the mouth or to the skin around it.

How to use NICABATE Gum

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

During any attempt to give up smoking using NICABATE Gum, it is important that you make every effort to stop smoking completely. However, if you do smoke a cigarette while you are using NRT, you should continue your quit attempt. Talking to your pharmacist or doctor may help.

For some people, the use of more than one NRT product may help them to identify the combination most appropriate for their individual quit attempt.

The method of chewing nicotine gum is not the same as for ordinary chewing gum.

You should chew it as follows:

  1. Chew the gum slowly until taste becomes strong (about 1 minute).
  2. Rest the gum against your cheek (about 1 minute).
  3. Chew the gum again when taste has faded.
  • Keep chewing like this for about half an hour.
  • When the gum has lost its strong taste, you should dispose of it carefully.

Chewing the gum continuously causes the nicotine to be released from the gum too quickly. When this happens, the nicotine tends to be swallowed instead of absorbed through the lining of your mouth. Swallowing the nicotine may irritate your throat, upset your stomach or give you hiccups.

You should not eat or drink while the gum is in your mouth as this may reduce the absorption of nicotine. Avoid drinking acidic beverages such as coffee, juices and fizzy drinks for 15 minutes before chewing the gum as this may also reduce the absorption of nicotine.

You should use the 2 mg strength gum if you smoke less than 20 cigarettes a day.

You should use the 4 mg strength gum if you smoke more than 20 cigarettes a day.

Dosage

For smokers who want to stop in a few months.
NICABATE Gum can be used according to the following schedule.

Adults (and young people aged over 12 years)

STEP 1
Initial treatment period
12 weeks
Chew 1 piece whenever there is an urge to smoke. Use 8-12 pieces/day of the 2 mg strength or 8-10 pieces/day of the 4 mg strength.

STEP 2
Step down treatment period
2 weeks
Gradually reduce gum use to 4-6 pieces/day.

STEP 3
Step off treatment period
2 weeks
Use 1-3 pieces /day. Reduce to zero over 2 weeks.

To help you stay smoke free, use 1 piece of gum when you are strongly tempted to smoke.

Do not use more than one piece of gum at a time.

Do not use more than one piece of gum per hour.

Do not use more than 20 pieces /day of the 2 mg strength or 10 pieces /day of the 4 mg strength.

For adult smokers who want to stop over several months.
Use a piece of gum whenever you have a strong urge to smoke instead of smoking a cigarette. When you have reduced the number of cigarettes you smoke each day to a level you feel you can quit completely then use the schedule in the section above for smokers who want to quit in a few months.

If you have not reduced the number of cigarettes you smoke each day after 6 weeks, then see your pharmacist or doctor.

If you still need to use the gum on a regular basis 6 months after the start of treatment and haven’t started a permanent quit attempt, you should seek help and advice from your healthcare professional.

Using Nicabate combination therapy

Combination therapy can be used by adult smokers who have been unsuccessful giving up smoking when they have used just one type of NRT.

Do not use combination therapy in young people aged 12 to 17 years.

If you want to use NICABATE Patches together with NICABATE Gum 2 mg or NICABATE Mini Lozenges 1.5 mg, you should start with the 21 mg patch and you should use at least 4 pieces of gum or Mini Lozenges each day. Most people use 4 to 5 pieces a day. Do not use more than 12 pieces of gum or Mini Lozenges a day.

Do not use NICABATE Gum 4 mg or NICABATE Mini Lozenges 4 mg together with NICABATE Patches.

If you are using NICABATE Patches together with NICABATE Gum or NICABATE Mini Lozenges, the combination treatment should be used for 12 weeks. After this time you should begin weaning yourself off NRT. You can do this by:

  1. Using the 14 mg patch for 2 weeks and then the 7 mg patch for 2 weeks while continuing to take the same number of mini lozenges or pieces of gum you routinely use. Once you are not using any patches, you can gradually reduce the number of mini lozenges or pieces of gum until you are not using any.

OR

  1. Stop using the 21 mg patch and then gradually reduce the number of mini lozenges or pieces of gum you are using.

How long to use it

Over a period of 3 months, you should use the gum to relieve the cravings to smoke. After 3 months, you should be able to reduce the use of the gum. You should try to use fewer pieces of gum each day. When you are using only one or two pieces per day, you should try to stop completely. However, you should remember that you might feel a sudden craving to smoke long after you’ve given up and you can use the gum again if this should happen.

Young people aged 12 to 17 years old should only use NICABATE Gum for 10 weeks in total. You can start off using 8-12 (maximum 15) pieces of the 2 mg gum or 8-10 (maximum 10) pieces of the 4 mg gum a day. Once you have broken the habit of smoking, start to reduce the number of pieces of gum you use a day until you are only using 1 or 2, then stop completely. If you think you may need to use it for longer, talk to your pharmacist or doctor.

NRT should only be used by those aged 12 to 17 years if a counselling programme is used at the same time. NRT is not likely to work in this age group if there is no counselling with it.

Children under 12 years of age should not use NICABATE Gum.

If you find it difficult to give up NICABATE Gum or you are worried that you may start smoking again, then speak to your pharmacist or doctor.

If you feel you need to use the gum for longer than 9 months, ask your pharmacist or doctor for advice.

If you do start smoking again, you may want to talk to your pharmacist or doctor about how to get the best results from further courses of NICABATE Gum.

The directions given to you by your pharmacist or doctor may be different from the information in this leaflet. If you are unsure how to use this medicine, ask your pharmacist or doctor for advice.

If you use too much (Overdose)

If you use too many nicotine gums you may start to feel sick, dizzy and unwell. Stop using the gums and immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) or go to accident and emergency at your nearest hospital if you think you or anyone else may have used too much NICABATE Gum.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

The gum is not suitable for children under 12 or for non-smokers. They may develop signs of nicotine overdose including headache, sickness, stomach pains and diarrhoea. Even small amounts of nicotine can be dangerous to children. If you think a child has used any, you must contact a doctor immediately.

While you are using NICABATE Gum

During any attempt to give up smoking using NICABATE Gum, it is important that you stop smoking completely. Smoking even one cigarette decreases your chances of success.

Things you must do

Use NICABATE Gum exactly as your pharmacist or doctor has told you to.

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

Side Effects

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are using NICABATE Gum. NICABATE Gum helps most people but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Stopping smoking itself can cause some symptoms such as dizziness, headache, sleep disturbances, cough and cold like symptoms, depression, irritability and insomnia. You may also get more mouth ulcers than usual.

Ask your pharmacist or doctor to answer any questions you may have.

This medicine contains the sugar alcohols, sorbitol and mannitol. These may have a laxative effect or cause diarrhoea.

Tell your pharmacist or doctor if you notice any of the following and they worry you:

  • Sore throat, mouth irritation
  • Nausea
  • Hiccups
  • Stomach upsets
  • Vomiting
  • Diarrhoea
  • Indigestion/heart burn
  • Flatulence
  • Constipation
  • Dry mouth
  • Insomnia
  • Cough
  • Excess saliva
  • Jaw muscle ache
  • Dizziness
  • Headache

These are the more common side effects of NICABATE Gum. Mostly these are mild and short-lived. You may experience these side effects as you decrease the number of pieces of gum that you use.

If you tend to suffer from indigestion, the 4 mg gum may cause mild indigestion or heartburn. Chewing the gum more slowly or using the 2 mg strength will usually help.

Tell your doctor immediately if you notice any of the following:

  • Changes from your normal heartbeat
  • Mouth ulcer
  • Red or itchy skin

These may be serious side effects of NICABATE Gum. These side effects are uncommon.

If any of the following happen, stop using NICABATE Gum and tell your doctor immediately or go to accident and emergency at your nearest hospital:

  • Fast or very irregular heartbeat
  • Severe allergic reaction symptoms of which include sudden wheeziness or tightness of the chest, rash and feeling faint.

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Other side effects not listed above may also occur in some people. Tell your pharmacist or doctor if you notice anything else that is making you feel unwell. Do not be alarmed by this list of possible side effects. You may not experience any of them.

Transferred dependence
Some people worry that they will quit smoking but become dependent on nicotine gum. This is very rare and, if it did happen, it is less harmful to you than continuing to smoke and an easier habit to break.

After using NICABATE Gum

Storage

Keep the gum in the blister pack inside the carton until you are ready to use it. If you take the gum out of its blister pack, it may not keep as well.

Keep it in a cool dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car on hot days. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your pharmacist or doctor tells you to stop using the gum or the gum has passed its expiry date, ask your pharmacist what to do with any gum that is left over.

This is not all the information that is available on NICABATE Gum. If you have any more questions or are not sure about anything, ask your pharmacist or doctor.

Product Description

What it looks like

NICABATE Gum comes in two strengths. Both strengths are an off-white, rectangular, pillow-shaped gum

Both strengths come in blister cartons of 24 pieces of gum.

Ingredients

Each piece of gum contains either 2 mg or 4 mg nicotine in the form of a resin complex called nicotine polacrilex. Nicotine polacrilex is also known as nicotine resinate. Amount based on 20% nicotine resinate.

The gum also contains the following inactive ingredients:

  • Gum contains Butylated hydroxytoluene (E321)
  • Sorbitol (E420)
  • Xylitol (E967)
  • Calcium Carbonate (E170)
  • Sodium Carbonate Anhydrous (E500)
  • Glycerol (E422)
  • Acesulfame Potassium (E950)
  • Sucralose (E995)
  • Mannitol (E421)
  • Acacia (E414)
  • Sucralose (E955)
  • Carnauba Wax (E903)
  • Titanium Dioxide (E171)
  • Talc-purified
  • Flavours: Optacool, Eucamenthol and Levomenthol

NICABATE Gum is mint flavoured and sugar-free.

Marketed by:

GlaxoSmithKline Consumer Healthcare
82 Hughes Avenue
Ermington NSW 2115 Australia
ACN: 603 310 292

AUST R 258232 NICABATE GUM (2 mg)

AUST R 258233 NICABATE GUM (4 mg)

Date of preparation:
June 2019

Trademarks are owned by or licensed to the GSK group of companies.

©2019 GSK group of companies or its licensor.

www.nicabate.com.au

Published by MIMS November 2020

BRAND INFORMATION

Brand name

Nicabate Gum

Active ingredient

Nicotine

Schedule

Unscheduled

 

1 Name of Medicine

Nicotine.

2 Qualitative and Quantitative Composition

Active ingredient.

Nicotine.
Nicotine is 3-[(2S)-1-methylpyrolidin-2-yl]pyridine and is the major pharmacologically active alkaloid of tobacco. The free alkaloid is absorbed rapidly through the skin and respiratory tract.
Nicotine 2 mg coated chewing gum.
Nicotine 4 mg coated chewing gum.

Excipients.

For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Off-white rectangular pillow-shaped coated chewing gum and is approximately 20 x 12 mm.

4 Clinical Particulars

4.1 Therapeutic Indications

For the relief of nicotine withdrawal symptoms including nicotine cravings associated with smoking cessation. It may also be used as part of a smoking reduction strategy by smokers who are unable or not ready to stop smoking abruptly as a step towards stopping completely. If possible, when stopping smoking, it should be used in conjunction with a behavioural support programme as this normally improves the success rate.

4.2 Dose and Method of Administration

Adults (18 years and over including the elderly).

Nicabate gum 2 mg is suitable for smokers who smoke fewer than 20 cigarettes a day.
Nicabate gum 4 mg is suitable for smokers who smoke more than 20 cigarettes a day.
Users should make every effort to stop smoking completely during treatment with Nicabate gum.
Behavioural therapy, advice and support will normally improve the success rate.
Nicabate gums should be chewed as directed whenever there is an urge to smoke, to maintain complete abstinence from smoking.
Users should follow the schedule of treatment in Table 1.
The user dose and duration of treatment is individual and dependent on how much nicotine you need to reduce the withdrawal symptoms. Clinical experience has shown that the treatment should last for at least 3 months. When daily use is 1-2 gums, use should be stopped. Any spare gums should be retained as cravings may suddenly return.
Users should not use more than one piece of gum at a time and should not exceed 20 pieces/day of the 2 mg strength or 10 pieces/day of the 4 mg strength.
Users should not use more than 1 gum per hour.
Absorption of nicotine is through the buccal mucosa and any nicotine that is swallowed is destroyed by the liver.

Directions for use.

Patients should be directed to chew each piece of gum slowly until the taste becomes strong (about 1 minute) then stop and rest the gum against the cheek. Once the taste fades, the gum should be chewed a few times until the taste gets strong then rested again against the cheek. This sequence should be repeated for about 30 minutes until the gum has lost its strength.
Acidic beverages e.g. coffee or soft drink interfere with the buccal absorption of nicotine.
The user should not eat or drink while using the chewing gum. Drinks that lower the pH in the mouth, e.g. coffee, fruit juice or sodas, may reduce the absorption of nicotine from the oral cavity. To achieve the maximum absorption of nicotine, these drinks should be avoided up to 15 minutes prior to using the chewing gum.
Those who use the gum beyond 9 months are recommended to seek additional help and advice from a healthcare professional who may consider alternate quit strategies such as combination therapy.

Children and adolescents.

The use of NRT in adolescents should only be used when the benefits of abstinence outweigh the risks of continued smoking.
Data are limited in relation to the value of NRT use in young people where the demand for cessation products and the motivation to quit is low. Nevertheless NRT is safe in this group. NRT should only be used by adolescents in conjunction with a counselling programme. Counselling is needed in this age group because NRT is likely to be ineffective in the absence of counselling.
Adolescents (12-17 years) should follow the schedule of treatment for adults in Table 1 for steps 1, 2 and 3 but, as data are limited, duration of NRT in this age group is restricted to 10 weeks. If longer treatment is required, advice from a healthcare professional should be sought who can then reassess the patient for their commitment to quitting and the benefits of continued treatment. If treatment is continued, it should not be extended for more than another four weeks.
Adolescents should not quit with a Combination NRT Regimen.
Nicabate gum is not recommended for use in children under 12 years of age.

Combination therapy.

In some instances, it may be beneficial to utilize more than one form of NRT concurrently. For example, combination therapy could be used by smokers who have relapsed with NRT monotherapy in the past, who experience breakthrough cravings or have difficulty controlling cravings for cigarettes using single therapy. This would allow users to identify the combination most appropriate for their individual quit attempt. If required, Nicabate gum 2 mg, or Nicabate 1.5 mg Mini lozenges may be combined with Nicabate 21 mg patches. Nicabate gum 4 mg and/or Nicabate 4 mg Mini lozenges should not be used with Nicabate patches.
When using Nicabate 21 mg patches in addition to Nicabate 2 mg gums or 1.5 mg Mini lozenges, it is recommended that a minimum of 4 pieces of gum/4 Mini lozenges are used daily. Most people will use 4-5 pieces. The maximum number of gums or Mini lozenges used in conjunction with the patch is 12 pieces per day.
Combination treatment should be used for 12 weeks after which weaning may be initiated. If required, weaning may be done by either:
1. Using Nicabate 14 mg patch for 2 weeks and then Nicabate 7 mg patch for 2 weeks while maintaining the number of pieces of 2 mg gum or 1.5 mg Mini lozenges that have been routinely used. Then, when a patch is no longer used, the number of pieces of gum or 1.5 mg Mini lozenges can be gradually reduced; or
2. Stopping use of Nicabate 21 mg patch and then gradually reducing the number of pieces of 2 mg gum or 1.5 mg Mini lozenges that are being used.
Users should stop smoking completely during treatment with Nicabate 2 mg gum or 1.5 mg Mini lozenges in combination with Nicabate 21 mg patches.

Harm reduction.

Gradual cessation of smoking.

Reduce to quit.

For smokers who are unwilling or unable to quit abruptly. Use a piece of gum whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. The number of pieces of gum a day is variable and depends on the patient's needs. Nonetheless it should not exceed 20 pieces per day of the 2 mg strength or 10 pieces per day of the 4 mg strength.
Users should not use more than 1 gum per hour.
If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, a healthcare professional should be consulted. Reduced tobacco consumption may help to lead to complete cessation of smoking. This should be attempted as soon as possible. When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then start on the schedule for 'abrupt cessation' as given above.
If an attempt to stop smoking completely has not been started within 6 months after the beginning of treatment, it is recommended to consult a healthcare professional.

4.3 Contraindications

Nicabate should not be used by non-smokers; children under 12 years of age; those with hypersensitivity to nicotine or any of the excipients.

4.4 Special Warnings and Precautions for Use

The risks associated with the use of NRT (Nicotine replacement therapy) are substantially outweighed in virtually all circumstances by the well-established dangers of continued smoking.

Patients hospitalised for myocardial infarction, severe dysrhythmia or CVA.

Patients hospitalised for myocardial infarction, severe dysrhythmia or CVA (cerebrovascular accident) who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicabate gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital, they can use NRT on medical advice. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the mini lozenges should be reduced or discontinued.
Use with caution in patients with recent or unstable cardiovascular disease. In patients with unstable cardiovascular disease, do not continue NRT if patient continues to smoke.
The combination NRT regimen should not be used in people with known cardiovascular disease without evaluation of the risk/benefit by a health care professional.

Seizures.

Potential risks and benefits of nicotine should be carefully evaluated before use in subjects taking anti-convulsant therapy or with a history of epilepsy as cases of convulsions have been reported in association with nicotine.

Diabetes mellitus.

Blood glucose levels may be more variable when stopping smoking, with or without NRT, so it is important for patients with diabetes mellitus to monitor their blood glucose levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism and vasoconstriction may delay/reduce insulin absorption.

Allergic reactions.

Susceptibility to angioedema and urticaria. NRT should be used with caution by patients who are susceptible to angioedema and/or urticaria.

Pheochromocytoma and uncontrolled hyperthyroidism.

Use with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma as nicotine causes release of catecholamines. A risk-benefit assessment should be made by an appropriate healthcare professional.

GI disease.

Swallowed nicotine may exacerbate symptoms in patients suffering from active oesophagitis, oral or pharyngeal inflammation, gastritis and gastric or peptic ulcers. Oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported. A risk-benefit assessment should be made by an appropriate healthcare professional.

Danger in small children.

Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children.

Transferred dependence.

Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking.

Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP1A2 (and possibly by CYP1A1). When a smoker stops smoking, this may result in a slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, tacrine, clozapine and ropinirole. The plasma concentration of other medicinal products metabolised in part by CYP1A2 e.g. imipramine, olanzapine, clomipramine and fluvoxamine may also increase on cessation of smoking, although data to support this are lacking and the possible clinical significance of this effect for these drugs is unknown. Limited data indicate that the metabolism of flecainide and pentazocine may also be induced by smoking.

Sorbitol (E420).

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Butylated hydroxytoluene (E321).

May cause irritation of mucous membranes.

Sodium.

Nicabate Gum contains 10.5 mg (2 mg gum) or 14.0 mg (4 mg gum) of sodium per piece of gum. To be taken into consideration by patients on a controlled sodium diet.
During a quit attempt, users should not interchange nicotine gums with nicotine lozenges since pharmacokinetic data indicate a higher availability of nicotine from some nicotine lozenges in comparison to the gum.

Dental.

Smokers who wear dentures or who have temporomandibular joint disease may experience difficulty in chewing Nicabate gum.
Nicotine gum may loosen fillings or dental implants.

Oral.

Use of Nicabate gum may exacerbate oral inflammation.

Use in hepatic impairment.

Use with caution in patients with moderate to severe hepatic impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects. A risk-benefit assessment should be made by an appropriate healthcare professional.

Use in renal impairment.

Use with caution in patients with severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects. A risk-benefit assessment should be made by an appropriate healthcare professional.

Use in the elderly.

No data available.

Paediatric use.

Do not use in children under 12 years of age.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine (i.e. increase in blood pressure and heart rate and also increase pain response (angina pectoris type chest pain) provoked by adenosine administration (see Section 4.4 Special Warnings and Precautions for Use).
Smoking cessation, with or without nicotine replacement, may alter the individual's response to concomitant medication and may require adjustment of dose.
Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP1A2 (and possibly by CYP1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.
The following drugs may require adjustment in dose at cessation of smoking: caffeine, theophylline, imipramine, pentazocine, tacrine, clomipramine, insulin, clozapine, olanzapine and fluvoxamine. In particular, anticonvulsants may require special monitoring and/or dosage adjustment.
Other reported effects of smoking include reduced analgesic efficacy of propoxyphene, reduced diuretic response to frusemide and altered pharmacological response to propranolol, as well as altered rates of ulcer healing with H2 antagonists. Both smoking and nicotine can increase levels of circulating cortisol and catecholamines. Dosages of nifedipine, adrenergic agonists or adrenergic blocking agents may need to be adjusted.

Insulin dependent diabetes.

Smoking cessation may lead to an increase in subcutaneous insulin absorption.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

In rats and rabbits, implantation can be delayed or inhibited by a reduction in DNA synthesis that appears to be caused by nicotine. Studies have shown a decrease in litter size in rats treated with nicotine during gestation.
(Category D)
Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby. The earlier abstinence is achieved the better.
Ideally smoking cessation during pregnancy should be achieved without NRT. However for women unable to quit on their own, NRT should only be used on the advice of a health care professional. Nicotine is harmful to the foetus. However, the risk of using NRT to the foetus is lower than that expected with tobacco smoking, due to lower maximal plasma nicotine concentration and no additional exposure to polycyclic hydrocarbons and carbon monoxide.
However, as nicotine passes to the foetus affecting breathing movements and has a dose dependent effect on placental/foetal circulation, the decision to use NRT should be made as early on in the pregnancy as possible. The aim should be to use NRT for only 2-3 months.
Intermittent dosing products may be preferable as these usually provide a lower daily dose of nicotine than patches. However patches may be preferred if the woman is suffering from nausea during pregnancy.
Nicotine from smoking and NRT is found in breast milk. However the amount of nicotine the infant is exposed to from NRT is relatively small and less hazardous than the second-hand smoke they would otherwise be exposed to.
Ideally smoking cessation during lactation should be achieved without NRT. However for women unable to quit on their own, NRT may be recommended to assist a quit attempt.
Using intermittent dose NRT preparations, compared with patches, may minimize the amount of nicotine in the breast milk as the time between administrations of NRT and feeding can be made as long as possible. Women should try to breastfeed just before they take the product.

4.7 Effects on Ability to Drive and Use Machines

Nicabate Gums have no or negligible influence on the ability to drive and use machines. However, users of nicotine replacement products should be aware that smoking cessation can cause behavioural changes.

4.8 Adverse Effects (Undesirable Effects)

Nicotine lozenges / gum / patches can cause adverse reactions similar to those associated with nicotine from tobacco. Many of the observed adverse reactions are consistent with the pharmacological effects of nicotine, which are dose dependent.
At recommended doses Nicabate gum has not been found to cause any serious adverse effects. Excessive consumption of Nicabate extra fresh gum by those who have not been in the habit of inhaling tobacco smoke, could possibly lead to nausea, faintness or headaches.
Certain symptoms that have been reported such as depression, irritability, anxiety, increased appetite and insomnia may be related to withdrawal symptoms associated with smoking cessation. Subjects quitting smoking by any means could expect to suffer from headache, dizziness, sleep disturbance, increased coughing or a cold.
Adverse reactions are listed by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000), not known (cannot be estimated from the available data). See Table 2.

Paediatric population (12-17 years inclusive).

There are no specific adverse event data for this population. However, the frequency, type and severity of adverse reactions in adolescents are expected to be the same as in adults, based upon the pharmacokinetic study demonstrating a similar pharmacokinetic profile in the adolescent age group to adults.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Overdosage can occur if many gums are taken simultaneously or in rapid succession. The consequences of an overdose are most likely to be minimised by the early nausea and vomiting known to occur with excessive nicotine intake. Nicotine is also subject to a significant first-pass metabolism.
Even small quantities of nicotine may be dangerous in children and may prove fatal. If poisoning is suspected in a child, a doctor must be consulted immediately.
The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60 mg. Signs and symptoms of an overdose from nicotine gum would be expected to be the same as those of acute nicotine poisoning including pallor, nausea, vomiting, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and vision, tremor, mental confusion and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, respiratory failure, prostration, circulatory collapse and terminal convulsions.

Treatment of overdose.

For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).
All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal may reduce absorption of the medicine if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicabate gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs.
The main pharmacological actions are central stimulation and/or depression, transient hyperpnoea, peripheral vasoconstriction (usually associated with a rise in systolic pressure), suppression of appetite and stimulation of peristalsis.
Withdrawal symptoms associated with the abrupt cessation of the use of nicotine include dysphoria, depressed mood, insomnia, irritability, frustration or anger, anxiety, difficulty concentrating, restlessness or impatience, decreased heart rate, increased appetite or weight gain and nicotine craving. These symptoms have been shown in clinical studies to be relieved by nicotine replacement products such as Nicabate gum.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5-7 minutes and reach a maximum about 30 minutes after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and have been shown never to exceed those obtained from smoking cigarettes.

Distribution.

As the plasma protein binding of nicotine is low (4.9%-20%), the volume of distribution of nicotine is large (2.5 L/kg). The distribution of nicotine to tissue is pH dependent, with the highest concentrations of nicotine found in the brain, stomach, kidney and liver. Nicotine crosses the blood brain barrier, the placenta and is detectable in breast milk.
Mean steady state trough levels of 9-10 nanogram/mL are achieved during standardised conditions i.e. chewing every four seconds for 30 minutes.
The volume of distribution following IV administration of nicotine is about 2 to 3 L/kg and the half-life approximately 2 hours.

Metabolism.

The metabolism of nicotine primarily occurs in the liver, but also in the lung and kidney. More than 20 metabolites of nicotine have been identified all of which are believed to be less active than the parent compound. Nicotine is metabolized primarily to cotinine but is also metabolized to nicotine N'-oxide. Cotinine has a half-life of 15 to 20 hours and its blood levels are 10 times higher than nicotine. Cotinine is further oxidized to trans-3'-hydroxycotinine, which is the most abundant metabolite of nicotine in the urine. Both nicotine and cotinine undergo glucuronidation.

Excretion.

The elimination half-life of nicotine is approximately 2 hours (range 1-4 hours). Total clearance for nicotine ranges from approximately 62 to 89 L/hr. Non-renal clearance for nicotine is estimated to be about 75% of total clearance. Nicotine and its metabolites are excreted almost exclusively in the urine. The primary urinary metabolites are cotinine (15% of the dose) and trans-3-hydroxy-cotinine (45% of the dose). The renal excretion of unchanged nicotine is highly dependent on urinary pH with greater excretion occurring at acidic pH. About 10% of nicotine is excreted unchanged in the urine. As much as 30% of nicotine may be excreted unchanged with high flow rates and acidification of the urine below pH 5.
Plasma protein binding of nicotine is less than 5%. Therefore, changes in nicotine binding, from use of concomitant drugs or alternatives, of plasma proteins by disease states would not be expected to have significant effects on nicotine kinetics.
Progressive severity of renal impairment is associated with decreased total clearance of nicotine. The pharmacokinetics of nicotine is unaffected in cirrhotic patients with mild liver impairment (Child score 5) and decreased in cirrhotic patients with moderate liver impairment (Child score 7). Raised nicotine levels have been seen in smoking patients undergoing haemodialysis.
There are no differences in nicotine kinetics between men and women.

5.3 Preclinical Safety Data

Genotoxicity.

Nicotine and cotinine were not mutagenic in the Ames Salmonella test. Nicotine induced repairable DNA damage in an E. coli test system. Nicotine was shown to be genotoxic in a test system using Chinese hamster ovary cells.

Carcinogenicity.

Nicotine itself does not appear to be a carcinogen in laboratory animals. However, nicotine and its metabolites increased the incidence of tumours in the cheek pouches of hamsters and forestomach of F344 rats, respectively, when given in combination with tumour initiators. One study, which could not be replicated, suggested that cotinine, the primary metabolite of nicotine, may cause lymphoreticular sarcoma in the large intestine in rats.
Studies in male rats have shown that nicotine can decrease testis weight, cause a reversible decrease in Sertoli cell numbers with impairment of spermatogenesis, and result in a variety of changes in the epididymis and vas deferens. However, similar effects have not been reported to occur in humans.

6 Pharmaceutical Particulars

6.1 List of Excipients

Gum Base 25048 (incl. 0.09% w/w Butylated hydroxytoluene (E321), calcium carbonate (E170), sorbitol (E420), glycerol (E422), acesulfame potassium (E950), eucamenthol flavour, mannitol, sodium carbonate anhydrous (E500), carnauba wax (E903), xylitol (E967), levomenthol flavour, optacool flavour, sucralose (E955), talc-purified, titanium dioxide (E171), acacia (E414).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Nicabate gum is available in two strengths: 2 mg and 4 mg in PVC/PVDC/Aluminium blister packs of 24, 30, 100, 200 and 300 gums.
Not all pack sizes may be marketed.
All presentations contain information on Nicabate gum and how to use it.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

54-11-5.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes