Consumer medicine information

QuitX Chewing Gum

Nicotine

BRAND INFORMATION

Brand name

QuitX Chewing Gum

Active ingredient

Nicotine

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using QuitX Chewing Gum.

What is in this leaflet

This leaflet answers some common questions about QuitX gums.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist, or a counsellor experienced with helping smokers to quit.

All medicines have risks and benefits. You need to weigh the benefits and risks of taking QuitX gum against the expected benefits it will have for you.

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

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

What QuitX Gum is used for

QuitX Gum helps you to give up smoking by reducing cravings for nicotine thereby relieving the desire to smoke, as well as some of the unpleasant withdrawal effects which smokers experience when they stop smoking.

Dependence on nicotine can in some cases be transferred from cigarettes to QuitX Gum but it is less harmful and easier to break than smoking.

How QuitX Gum works

To successfully become a non-smoker it is important to understand how QuitX Gum works. Smokers have both a physical dependence on nicotine (i.e. the body becomes dependent on nicotine) and a psychological (i.e. mental) dependence 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.

QuitX Gum helps your body to tackle the problem of missing nicotine. However, you will still need to work on breaking your habit of smoking.

It is your body's dependence on nicotine which causes withdrawal symptoms when you suddenly stop smoking.

Nicotine is an addictive. When you stop smoking, you may experience withdrawal symptoms such as:

  • irritability, frustration or anger
  • restlessness
  • sleeplessness
  • difficulty concentrating
  • depression
  • hunger or weight gain
  • craving for cigarettes
  • decreased heart rate

QuitX Gum is intended to ease nicotine withdrawal symptoms by providing your body with nicotine.

QuitX Gum releases nicotine into your saliva. The nicotine is absorbed through the lining of your mouth and enters your blood stream.

Any nicotine that is swallowed in saliva is broken down in your stomach. It is therefore wasted. So it is important to chew QuitX Gum slowly so that the nicotine is released a little at a time and absorbed through the lining of the mouth.

This nicotine is sufficient to decrease the cravings for smoking. Unlike cigarettes, QuitX Gum does not contain harmful tar and carbon monoxide.

QuitX can help you to stop smoking

QuitX Gum helps you give up smoking by relieving nicotine craving, but you will only be successful in becoming a non-smoker if you are determined to quit.

You will need to plan your stop smoking program.

You will also need the support of others, your family, your friends, your pharmacist, family doctor or any one of a number of "quit smoking" organisations.

Do not be afraid to seek support or advice.

QuitX can help you to cut down your smoking

If you are not ready to stop smoking completely, QuitX can help you to give up smoking gradually by reducing cravings for nicotine and thus relieving the desire to smoke. It will help reduce some of the unpleasant withdrawal effects which smokers experience when they give up smoking.

Before using QuitX Gum

When you must not use QuitX Gum

Do not use QuitX Gum if:

You are allergic to nicotine or to any of the ingredients listed under the Product Description at the end of this leaflet.

You are pregnant or intend to become pregnant. Nicotine in any form may be harmful to an unborn child. If you are pregnant or intend to become pregnant, you should try to quit smoking without using nicotine products.

However, if this is not possible, your doctor may advise you to use QuitX Gum.

You are breastfeeding or intend to breastfeed. Nicotine passes into breast milk and can affect the health of the baby. If you are breastfeeding or intend to breastfeed, you should try to quit smoking without using nicotine products. However, if this is not possible, your doctor may advise you to use QuitX Gum.

You have heart disease such as palpitations (fast or irregular heart beats) or angina.

You have had a recent heart attack or a stroke.

You are a non-smoker, or only smoke occasionally.

You are under 12 years of age.

There is not enough information about the use of QuitX Gum in children.

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

If you are uncertain whether you can use QuitX Gum, speak to your doctor or pharmacist.

Do not give QuitX Gum to anyone else to use without professional advice from a doctor or pharmacist.

Before you start to use QuitX Gum

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

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 QuitX Gum against the benefits you will get if you stop smoking.

  • any type of heart disease, including angina, heart failure
  • high blood pressure
  • any blood circulation disorder
  • kidney disease
  • stomach ulcer or pain
  • hyperthyroidism (a disorder of the thyroid gland)
  • diabetes controlled with insulin
  • phaeochromocytoma (a tumour of the adrenal gland)
  • liver disorder.

If you have dentures, dental caps or partial bridges. QuitX Gum may stick to your dentures, dental caps or partial bridges and may cause damage to your dental work. It is important that your dental work is kept clean. You should stop chewing QuitX Gum if it is sticking to your dental work and discuss further use of QuitX Gum with your doctor and dentist.

Taking other medicines

Tell your doctor or pharmacist if you are taking any of other medicines before you start to use QuitX Gum.

This includes medicine that you buy without a prescription, in a pharmacy, supermarket or health food shop.

The following medicines may affect how QuitX works or may be affected by QuitX.

  • theophylline, a medicine used for asthma
  • imipramine, clomipramine and fluvoxamine (medicines used for depression)
  • pentazocine, a medicine for pain relief
  • clozapine, olanzapine and tacrine (medicines used for mental conditions)
  • flecainide, a medicine used for irregular and/or rapid heartbeat
  • ropinirole, a medicine used for restless legs syndrome
  • caffeine

Using QuitX Gum

What is the proper chewing method?

Do not chew QuitX Gum when eating or drinking. This causes excessive swallowing of nicotine, reducing the effectiveness of QuitX Gum. Do not drink acidic beverages, such as coffee or soft drinks, for 15 minutes before chewing as they can interfere with the absorption of nicotine.

To get the full effect from QuitX Gum these steps should be followed carefully:

  1. CHEW
    Place one piece of QuitX Gum in your mouth and chew it slowly until you feel a slight tingling sensation.
  2. PARK
    When you feel the tingling (usually after about 10 chews), place the piece of gum under your tongue or between your cheek and gums until the tingling has gone. This will take about one minute.
  3. CHEW
    When the tingling has gone, continue to chew the gum slowly until the tingling returns. Then again place the gum under your tongue or between your cheek and gums.
  4. Chew each piece of QuitX Gum in this way (CHEW, PARK, CHEW) until you no longer experience the tingling sensation. Each piece of gum will usually last about 30 minutes.
  5. Dispose of the chewed pieces of gum neatly.

Proper chewing is important

QuitX Gum releases nicotine into your saliva. This nicotine is absorbed through the lining of your mouth and enters your bloodstream.

Any nicotine that is swallowed in saliva is broken down in your stomach. It is therefore wasted.

So it is important to chew QuitX Gum slowly so that the nicotine is released a little at a time and absorbed through the lining of the mouth. If QuitX Gum is chewed too quickly or for too long, a lot of saliva is produced and swallowed which reduces QuitX's ability to work effectively. Too much chewing may also produce an unpleasant strong taste, which is a useful sign that you should slow down or stop chewing. Chewing too quickly may at first irritate the throat or cause hiccups or make you feel sick. So remember that if the taste is too strong you are chewing too fast!

Which strength of QuitX Gum should I use?

You should discuss which strength of QuitX Gum you should use with your pharmacist. QuitX Gum is available from a pharmacy in 2mg and 4mg strengths.

Usually, the 4mg strength is recommended if you smoke 20 or more cigarettes in a day or are a smoker who has not been able to quit smoking using the 2mg strength.

Otherwise, you should use the 2mg strength.

How much QuitX Gum should I use?

The amount of QuitX Gum you chew each day depends on your former smoking habits. Usually, it is recommended that a piece of QuitX Gum should be used when the urge to smoke is felt.

Because nicotine is released from QuitX Gum at a slower rate than from a cigarette, it is important that you do not try to delay chewing in the hope that the urge to smoke will go away. QuitX Gum needs extra time to work and be effective.

Adolescents (12 years and over)

QuitX gums should not be used in adolescents unless they are under the supervision of a doctor or pharmacist.

The recommended duration of QuitX treatment is 12 weeks.

Weeks 1 to 8
Chew 1 piece of 2mg or 4mg gum when there is an urge to smoke or every 2 to 3 hours.

Do not use more than 20 pieces of the 2mg QuitX gum or more than 10 pieces of the 4mg QuitX gum a day.

Weeks 8 to 12
Gradually reduced to 1 to 2 pieces a day and then stop use.

If the adolescent continues to smoke after 12 weeks, continue to seek advice from a pharmacist or doctor.

Adults (18 +)

A) IF YOU HAVE DECIDED TO STOP SMOKING IMMEDIATELY

Use QuitX 2mg gum if you smoke less than 20 cigarettes per day.

Weeks 1 to 12
Chew 1 piece of gum when there is an urge to smoke or every 1 to 2 hours (maximum 20 gums/day).

Most smokers need about 8 to 12 pieces a day.

After 12 weeks
Gradually reduce to 1 to 2 pieces of gum a day and then stop use.

Use QuitX 4mg gum if you smoke 20 or more cigarettes per day.

Weeks 1 to 12
Chew 1 piece of gum when there is an urge to smoke or every 1 to 2 hours (maximum 10 gums/day).

Most smokers need about 4 to 6 pieces a day.

After 12 weeks
Gradually reduce to 1 to 2 pieces of gum a day and then stop use.

B) IF YOU HAVE DECIDED TO CUT DOWN SMOKING

Use QuitX 2mg gum if you smoke less than 20 cigarettes per day. Gradually increase gum use (maximum 20 gums/day) for up to 6 months, while cutting down smoking. Stop smoking completely when you are ready. Continue using gum as per directions for Instruction 1) IF YOU HAVE DECIDED TO STOP SMOKING IMMEDIATELY.

If you have not cut down smoking in 6 weeks or quit smoking after 9 months, contact your doctor or pharmacist for advice.

Use QuitX 4mg gum if you smoke 20 or more cigarettes per day. Gradually increase gum use (maximum 10 gums/day) for up to 6 months, while cutting down smoking. Stop smoking completely when you are ready. Continue using gum as per directions for Instruction 1) IF YOU HAVE DECIDED TO STOP SMOKING NOW.

If you have not cut down smoking in 6 weeks or quit smoking after 9 months, contact your doctor or pharmacist for advice.

C) COMBINATION TREATMENT

If you have previously relapsed with use of one form of nicotine replacement therapy (NRT), combination use with a nicotine patch NRT may help.

You should discuss the use of combination therapy (nicotine gum and nicotine patches) with your doctor or pharmacist before starting combination therapy.

Your doctor or pharmacist can advise you on which products (and strength) to use.

When to start using QuitX Gum

Set a Stop Smoking Day so that you can plan to be ready. This allows you to:

  • Pick the right day - set a quit date that is likely to be stress free.
  • Quit with a friend - you can help each other stick to your plan.
  • Remove any temptation - make home and work cigarette-free zones.
  • Take one day at a time - everyday without a cigarette makes you a winner.
  • Keep yourself busy - do something you enjoy.
  • Think cash, not ash - your money will no longer be going up in smoke.
  • Avoid putting on weight - start a gentle exercise regimen.

If at first you don't succeed don't give up. Successful quitters keep trying.

When your Stop Smoking Day arrives, stop smoking completely on that day and begin your QuitX treatment.

When to stop using QuitX Gum

It is recommended that QuitX Gum be used for 12 weeks to help you get over your psychological desire to smoke. After 12 weeks, you should gradually reduce the number of pieces of QuitX Gum chewed each day. It should take another 4 weeks to step down to using 1 to 2 pieces per day. Don't be discouraged by this, it is all part of the quitting process.

When you reach this stage you can call yourself an ex-smoker, but there is still the chance that you may lapse back to your smoking habit, so always carry some QuitX Gum just in case you feel an urge to smoke. The use of QuitX Gum beyond one year is not recommended.

If you take too much (overdose)

Stop smoking completely when you start using QuitX Gum. Symptoms of nicotine overdose can occur if you smoke at the same time as you use QuitX Gum or if many pieces of QuitX Gum are chewed at the same time or rapidly one after the other.

Signs of overdose or poisoning include:

  • nausea and vomiting
  • salivating
  • diarrhoea
  • abdominal pain
  • sweating
  • headache
  • dizziness
  • disturbed hearing
  • weakness, faintness and fatigue
  • breathing difficulties
  • loss of consciousness
  • weak, rapid or irregular pulse

Keep QuitX Gum out of the reach of children. Seek medical advice immediately if a young child chews, swallows or sucks any quantity of QuitX Gum.

Children have a greater risk of poisoning from QuitX Gum if accidentally chewed, swallowed or sucked.

Young children can be poisoned by small amounts of nicotine.

In the event of yourself or another adult chewing or swallowing large quantities of QuitX Gum, seek medical advice.

Immediately telephone your doctor or Poisons Information Centre for advice (telephone 13 11 26) 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.

Seek professional advice from your doctor or pharmacist as soon as possible if you do not feel well while you are using QuitX Gum.

Do not smoke or use QuitX Gum or other nicotine medicines and see your doctor as soon as possible if you get:

  • chest pain or
  • bad indigestion or
  • an irregular (uneven) heart beat

Most of the undesirable effects reported by users of QuitX Gum occur during the first weeks after beginning treatment and may be due to chewing incorrectly or to the effects of nicotine. Some are minor and temporary but others may need medical attention.

The most common side effects are:

  • headache
  • nausea and vomiting
  • indigestion
  • hiccups
  • sore mouth or throat
  • jaw muscle ache
  • skin irritation, itching or redness

These may diminish during the first weeks of using QuitX Gum.

Seek professional advice if you are not sure. Some effects, such as dizziness, headache, sleeplessness and mouth ulcer 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 pharmacist or doctor.

REMEMBER - that QuitX Gum is not intended as an alternative to smoking and that your aim is to overcome your need for nicotine by the end of the treatment period.

After using QuitX Gum

Storage

The expiry date of QuitX Gum is on the label of the carton and on the foil of the blister strip.

Do not use QuitX Gum if the expiry date has passed. Leave all pieces in the blister pack until immediately before use.

Store QuitX Gum in a cool place where the temperature stays below 25°C. Exposure to temperatures greater than 25°C (e.g. if carried in a shirt pocket or stored in a car glove box for long periods) may cause deterioration of the Gum.

KEEP QuitX GUM OUT OF REACH OF CHILDREN.

Disposal

When QuitX Gum is no longer needed, dispose of it carefully, where children or animals cannot get it.

Product Description

What QuitX Gum looks like

QuitX Gum is available in two flavours; freshmint flavour and classic flavour.

Freshmint coated gums

  • The freshmint coated gums are square, biconvex shaped pieces of chewing gum available in two strengths; 2mg and 4mg.
  • The 2mg gums are white and the 4mg gums are light peach in colour.
Both are available in packs of 30 and 100 pieces.

Classic uncoated gums

  • The classic uncoated gums are square, biconvex shaped pieces of chewing gum available in two strengths; 2mg and 4mg.
  • The 2mg gums are off white to tan and the 4mg gums are yellowish in colour.
Both are available in packs of 30 and 100 pieces.

Each pack of QuitX gum are labelled with the Australian Registration Numbers:

  • Freshmint 2mg: AUST R 192915
    Freshmint 4mg: AUST R 192914
  • Classic 2mg: AUST R 225886
    Classic 4mg: AUST R 225888

Ingredients

The active ingredient in QuitX Gum is nicotine polacrilex.

Other ingredients in the Freshmint gum are:

  • chewing gum base
  • xylitol
  • sodium carbonate anhydrous
  • sodium bicarbonate
  • magnesium oxide light
  • menthol
  • menthol flavour
  • natural toothpaste flavour
  • acacia
  • hydroxypropylcellulose
  • acesulfame potassium
  • titanium dioxide
  • carnauba wax
  • sunset yellow (4mg strength only)

Other ingredients in the Classic gum are:

  • chewing gum base
  • sorbitol
  • sodium carbonate
  • sodium bicarbonate
  • acesulfame potassium
  • butylated hydroxytoluene
  • menthol
  • carnauba wax
  • mint fruit flavour
  • talc
  • quinolone yellow (4mg strength only)
  • Brown Lake Blend colour (4mg strength only)

Distributor

QuitX is distributed in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au

Date of Preparation:
21 July 2014

® Registered Trade Mark

Published by MIMS June 2015

BRAND INFORMATION

Brand name

QuitX Chewing Gum

Active ingredient

Nicotine

Schedule

Unscheduled

 

Name of the medicine

Nicotine.

Excipients.

Freshmint flavour (coated gum).

Sodium carbonate, sodium bicarbonate, chewing gum base, xylitol, menthol, menthol flavour, natural toothpaste flavour, magnesium oxide light, acacia, hydroxypropylcellulose, acesulfame potassium, titanium dioxide, carnauba wax, and sunset yellow (4 mg strength only).

Classic Flavour.

Sodium carbonate, sodium bicarbonate, chewing gum base, sorbitol, menthol, acesulfame potassium, butylated hydroxytoluene, mint fruit flavour, talc, carnauba wax, quinolone yellow (4 mg strength only), and brown lake blend colour (4 mg strength only).

Description

Chemical name: (S)- 3- (1- methyl-2-pyrrolidinyl) pyridine. Molecular formula: C10H14N2. MW: 162.26. CAS: 54-11-5.

Pharmacology

Nicotine is a natural alkaloid which has ganglion stimulating properties and produces a wide range of pharmacological actions.
The use of nicotine is widespread in the form of tobacco products, chronic use of which is causally linked to a variety of serious diseases. Many smokers develop a dependence due to an interaction of pharmacological, social and psychological factors.

Pharmacodynamics.

QuitX Chewing Gum is a treatment aid in smoking cessation. Clinical studies have shown that nicotine replacement from nicotine containing products can help people give up smoking by relief of abstinence symptoms associated with smoking cessation.
Abrupt cessation of the use of tobacco containing products following a prolonged period of daily use results in a characteristic withdrawal syndrome that includes four or more of the following: dysphoria or depressed mood; insomnia; irritability; frustration or anger; anxiety; difficulty concentrating, restlessness or impatience; decreased heart rate; and increased appetite or weight gain. Nicotine craving, which is recognised as a clinically relevant symptom, is also an important element in nicotine withdrawal.
Clinical studies have shown that nicotine replacement products can help smokers abstain from smoking by relieving these withdrawal symptoms.

Pharmacokinetics.

There are no differences in nicotine kinetics between men and women.

Absorption.

Nicotine administered in chewing gums is readily absorbed from the oral mucosa membranes. Demonstrable blood levels are obtained within five to seven minutes after starting chewing and reach a maximum about five to ten minutes after chewing is stopped. Blood levels are roughly proportional to the amount of nicotine released by chewing and are unlikely to exceed those obtained from smoking cigarettes. The amount of nicotine extracted from one chewing gum depends on how vigorously and for how long it is chewed. The amount of nicotine absorbed depends on the amount extracted and the loss from the oral cavity due to swallowing or expectoration.
The systemic availability of swallowed nicotine is lower due to first-pass hepatic metabolism. The high and rapidly rising nicotine concentration seen after smoking is rarely produced by treatment with the gum. Normally approximately 1.4 and 3.4 mg of nicotine will be extracted from the 2 and 4 mg gum, respectively. Steady state trough levels of 10 to 14 nanogram/mL for 2 mg and 24 to 29 nanogram/mL for 4 mg nicotine gum are achieved during standardised conditions, i.e. chewing every two seconds for 30 minutes. A twelve week study found that nicotine chewing gum 2 mg produced nicotine plasma levels of about 9 nanogram/mL, while 4 mg gum produced nicotine plasma levels of about 23 nanogram/mL. Afternoon peak plasma levels after cigarette smoking are about 35 nanogram/mL.

Distribution.

The volume of distribution following intravenous (IV) administration of nicotine is about 2 to 3 L/kg and the half-life approximately two hours.

Metabolism.

The major eliminating organ is the liver, and average plasma clearance is about 70 L/hour. The kidney and lung also metabolise nicotine. More than 20 metabolites of nicotine have been identified, all of which are believed to be less active than the parent compound. The primary metabolite of nicotine in plasma, cotinine, has a half-life of 15 to 20 hours and concentrations that exceed nicotine by ten-fold. The primary urinary metabolites are cotinine (15% of the dose) and trans-3-hydroxy-cotinine (45% of the dose).

Elimination.

About 10% of nicotine is excreted unchanged in the urine. As much as 30% of nicotine may be excreted unchanged in the urine with high flow rates and acidification of the urine below pH 5.

Special populations.

Plasma protein binding of nicotine is less than 5%. Therefore, changes in nicotine binding from use of concomitant drugs or alterations 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.
Raised nicotine levels have been seen in smoking patients undergoing haemodialysis.
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).

Clinical Trials

Smoking reduction studies.

Placebo controlled double blind, randomised clinical studies in healthy smokers who did not intend to quit smoking but who were motivated to reduce their smoking have shown that nicotine chewing gum (4 studies) and nicotine inhaler (2 studies) is effective at helping smokers reduce the number of cigarettes smoked, and that reducing smoking leads to the increased likelihood of smoking cessation.
Pooled data from 4 nicotine gum smoking reduction studies showed that 12.8% of subjects using nicotine gum had achieved a sustained reduction (by at least 50%) in smoking at 4 months, compared to 5.7% of placebo treated subjects. Pooled data from the four nicotine gum studies and two similarly designed nicotine inhaler studies showed that a total if 193/1215 (15.9%) subjects in the nicotine treatment groups in the six studies managed to reduce their cigarette consumption by at least 50% from week 6 to month 4 compared to 81/1209 (6.7%) in the placebo treated groups. The point prevalence (PP) quit rates at month 12 for these individuals was 58/193 (30.1%) in the nicotine treatment groups compared to 15/81 (18.5%) in the placebo treated groups.
The corresponding figures for smokers who were unable to reduce their cigarette consumption by at least 50% from week 6 to month 4 with regards to PP abstinence at month 12 were 47/1022 (4.6%) in the nicotine treated groups and 39/1128 (3.5%) in the placebo treated groups.
Overall, at 1 year, 8.15% of subjects treated with nicotine gum or inhaler were abstinent, compared to 4.05% of placebo treated subjects, giving an odds ratio of 2.10 (95% confidence interval 1.48, 2.99). As regular smokers are generally adept at self regulating their nicotine intake within a narrow range it is unlikely that concomitant use of nicotine gum or inhaler and smoking will result in overdose or plasma nicotine levels higher than those achieved with smoking alone.
During the smoking reduction studies no clinically significant treatment related adverse events were observed during the concomitant use of gum or inhaler and cigarettes for up to 12 to 18 months. The adverse event profile did not differ markedly from that in smoking cessation studies.
In a 3 way open tolerability study in 19 healthy smokers investigating the concurrent use of 4 mg chewing gum and smoking during physical exercise subjects were administered each of the following treatments: placebo gum + smoking one cigarette; 4 mg gum + one unlit cigarette; 4 mg gum + smoking one cigarette. Each treatment was repeated 7 times during 7 consecutive hours on one day. During multiple submaximal exercise tests, no signs of myocardial ischemia with any of the 3 treatments or differences between the 3 treatments in the number of extra systoles, episodes of two or more systoles or other arrhythmias were observed. Changes in mean heart rate and systolic blood pressure during exercise, and diastolic blood pressure at rest, tended to be higher in the smoking + gum group; however, the differences between treatments were minor. Of 3,094 smokers with chronic obstructive pulmonary disease (COPD) participating in a 5 year lung health study, 25% of subjects were smoking and using gum, and 40% were abstinent and continued to use gum after 1 year. No increase in the incidence of cardiovascular events in the abstainers who used gum or in those who used gum and continued to smoke were observed.

Indications

Treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit.
In smokers currently unable or not ready to stop smoking abruptly, QuitX Chewing Gum may also be used as part of a smoking reduction strategy as a step towards stopping completely.

Contraindications

QuitX Chewing Gum should not be administered to:
nonsmokers;
patients with known hypersensitivity to nicotine or any of the excipients of the gum;
children under 12 years of age (see Dosage and Administration, Children).

Precautions

Any risks that may be associated with the use of nicotine replacement therapy (NRT) are substantially outweighed by the well established dangers of continued smoking.

Denture warning.

Smokers who wear dentures may experience difficulty in chewing nicotine chewing gum. The chewing gum may stick to, and may in rare cases, damage dentures.

Underlying cardiovascular disease.

In stable cardiovascular disease nicotine gum presents a lesser hazard than continuing to smoke. However, dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or cerebrovascular accident (CVA) and who are considered to be haemodynamically unstable should be encouraged to stop smoking with nonpharmacological interventions. If this fails, nicotine gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.

Diabetes mellitus.

Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Gastrointestinal disease.

Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.
Nicotine chewing gum should be avoided if oral or pharyngeal inflammation is present.

Phaeochromocytoma and uncontrolled hyperthyroidism.

Nicotine, from both NRT and smoking, causes the release of catecholamines from the adrenal medulla. Therefore, nicotine chewing gum should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.

Transferred dependence.

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

Continued smoking while using nicotine replacement therapy.

Nicotine chewing gum can safely be used while smoking. The adverse event profile (incidence and severity of events) of nicotine chewing gum in studies to reduce smoking did not differ markedly from that in smoking cessation studies. Intermittent use of nicotine chewing gum and cigarettes does not appear to produce more side effects than use of NRT alone. Most regular smokers are adept at self titration of their nicotine intake in order to maintain their plasma nicotine levels within a narrow range.

Impaired renal function.

Nicotine chewing gum should be used 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.

Impaired hepatic function.

Nicotine chewing gum should be used 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.

Use in the elderly.

A minor reduction in total clearance of nicotine has been demonstrated in healthy elderly patients, however, not justifying an adjustment of dosage.

Carcinogenesis, mutagenesis, impairment of fertility.

Literature reports indicate that nicotine is neither an initiator nor a tumour promoter in mice. There is inconclusive evidence to suggest that cotinine, an oxidised metabolite of nicotine, may be carcinogenic in rats.
Neither nicotine nor cotinine was mutagenic in the Ames Salmonella test.
Studies have shown a decrease of litter size in rats treated with nicotine during the time of fertilisation.

Use in pregnancy.

(Category D)
Nicotine is harmful to the foetus. The harmful effects of cigarette smoking on maternal and foetal health are clearly established. Short-term exposure during the first trimester is unlikely to cause a hazard to the foetus. NRT is not contraindicated in pregnancy.
The decision to use NRT should be made on a risk benefit assessment as early on in the pregnancy as possible with the aim of discontinuing use as soon as possible. Smoking during pregnancy is associated with risks such as intrauterine 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 may be recommended to assist a quit attempt.
Nicotine passes to the foetus affecting breathing movements and has a dose dependent effect on placental/ foetal circulation. 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. 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. If patches are used they should be removed before going to bed.

Use in lactation.

NRT is not contraindicated in lactation. Nicotine from smoking and NRT is found in breast milk. However, the amount of nicotine the infant is exposed to is relatively small and less hazardous than the second hand smoke they would otherwise be exposed to.
Using intermittent dose NRT preparations such as nicotine chewing gum, may minimise the amount of nicotine in the breast milk as the time between administrations of NRT and feeding can be more easily prolonged. Women should breastfeed just before using the product.

Paediatric use.

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. Nicotine gum should be disposed of with care.

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.

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 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, clozapine and ropinirole.
The plasma concentration of other drugs metabolised in part by CYP1A2, e.g. imipramine, olanzapine, clomipramine, fluvoxamine and caffeine may also increase on cessation of smoking, although data to support this are lacking and the possible clinical significance of this effect is unknown.
Limited data indicate that the metabolism of flecainide and pentazocine may also be induced by smoking.

Adverse Effects

Nicotine chewing gum may cause adverse reactions similar to those associated with nicotine administered by other means and are mainly dose dependent.
Most of the undesirable effects reported by the patients occur during the first three to four weeks after start of treatment. The chewing gum may stick to and, in rare cases, may damage dentures.
The frequency of the more common reactions include the following.

Common (1/10 to 1/100).

Central nervous system.

Headache.

Gastrointestinal system.

Gastrointestinal discomfort, hiccups, nausea, vomiting.

Local.

Sore mouth or throat, jaw muscle ache.

Less common (1/100 to 1/1,000).

Circulation.

Palpitations.

Skin.

Erythema, urticaria.

Rare (1/1,000 to 1/10,000).

Cardiovascular system.

Reversible atrial fibrillation.

Other.

Allergic reactions such as angioedema.
Some symptoms, such as dizziness, headache and sleeplessness may be related to withdrawal symptoms associated with abstinence from smoking. Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Dosage and Administration

Smoking cessation.

The initial dosage should be individualised on the basis of the patient's nicotine dependence. QuitX Chewing Gum should be used when the urge to smoke is felt. Most smokers require about 8 to 12 pieces of the 2 mg gum or four to six pieces of the 4 mg gum. Not more than 20 pieces of the 2 mg gum or ten pieces of the 4 mg gum (equivalent to a daily dose of 40 mg) should be chewed in one day.
Highly dependent smokers (smoke > 20 cigarettes/day) or patients who have failed to stop smoking with the 2 mg gum should receive the 4 mg dosage initially. Other patients should begin treatment with the 2 mg dosage strength. Advice and support normally improve the success rate.
The following points should be observed.
Due to their nicotine content, QuitX Chewing Gum has an unusual taste. QuitX Chewing Gum should be chewed slowly until a strong taste or a slight tingling sensation is felt. When the tingling sensation occurs the smoker should stop chewing and the gum should be placed under the tongue or between the cheek and gums until the taste or tingling sensation has disappeared. Chewing should then be resumed slowly and the procedure repeated. QuitX Chewing Gum should be chewed in this manner until the nicotine effect is no longer experienced (about 30 minutes).
The nicotine effects are not experienced until after a few minutes of chewing, the rapid satisfaction supplied by smoking is hence not to be expected. Rapid chewing may initially irritate the throat or cause hiccups or nausea. Adapting to the proper chewing technique takes a few days. Acidic beverages, e.g. coffee or soft drinks interfere with the buccal absorption of nicotine. Use of such beverages should therefore be avoided for 15 minutes before and during chewing.

Children.

QuitX Chewing Gum should not be administered to children under 12 years of age.

Adults and elderly.

QuitX Chewing Gum should be used for at least 3 months. Gradual weaning from the gum should then be initiated. Treatment should be stopped when the dose is reduced to 1 to 2 chewing gums per day. Any spare gum should be retained, as craving may suddenly occur.
Regular use of the gum beyond 12 months is generally not recommended. Some exsmokers may need longer treatment with the gum to avoid returning to smoking.

Adolescents (12 to 18 years).

When deciding whether to recommend NRT an assessment should be made on the individual's nicotine dependence, motivation to quit and willingness to accept counselling. Counselling is considered to be vitally important in the effective treatment of tobacco dependence in this age group. Use for up to 8 weeks to break the habit of smoking, and then gradually reduce gum use over a 4 week period. When daily use is 1 to 2 gums, use should be stopped.
For those using 4 mg nicotine gum, the 2 mg nicotine gum will be helpful during withdrawal from treatment.
As data are limited in this age group, the recommended duration of treatment is 12 weeks. If longer treatment is required, advice should be sought from a healthcare professional.
Before a recommendation to extend treatment beyond 12 weeks is made the patient should be reassessed for commitment to quitting, expected benefit of continued treatment and maturity. Treatment should not be extended by more than a further 4 weeks.

Combination treatment.

If smokers have previously relapsed with use of one form of nicotine replacement therapy (NRT), combination therapy could be beneficial. Smokers who experience breakthrough cravings or have difficulty controlling cravings using one form of NRT alone could combine the use of QuitX nicotine patch step 1 (21 mg/24 hours) with another form of NRT such as QuitX chewing gum 2 mg. QuitX chewing gum 4 mg should not be used with nicotine patches.
When using QuitX nicotine patch step 1 (21 mg/24 hours) in addition to QuitX chewing gum 2 mg, it is recommended that 4 to 12 pieces are used each day. Most people will use 5 to 6 pieces. Do not exceed 12 pieces a day.
Combination therapy should be used for 12 weeks, after which one of the two following programs should be followed.
1. Stop use of QuitX nicotine patch and gradually reduce the number of gums used until they are no longer needed.
2. Continue with QuitX nicotine patch step 2 (14 mg/24 hours) for 3 to 4 weeks, then QuitX nicotine patch step 3 (7 mg/24 hours) for a further 3 to 4 weeks while maintaining the number of QuitX chewing gum 2 mg that is used each day. After use of patches is ceased, gradually reduce the number of gums used until they are no longer needed.

Smoking reduction (reducing to stop).

The smoker should use QuitX Chewing Gum between smoking episodes in order to prolong intervals between cigarettes, with the aim of reducing smoking as much as possible. Highly dependent smokers (smoke > 20 cigarettes/day) or patients who have failed to stop smoking with the 2 mg gum should use the 4 mg dosage.
Other patients should begin treatment with the 2 mg dosage. Not more than 20 pieces of the 2 mg gum or 10 pieces of the 4 mg gum (equivalent to a daily dose of 40 mg) should be chewed in one day. If the smoker has not achieved a reduction in the number of cigarettes per day after 6 weeks, he or she should consult a healthcare professional. This six week time period is given to the smoker to allow them to familiarise themselves with nicotine chewing gum and to deal with craving symptoms while they attempt to reduce their smoking. Smokers who do reduce their smoking with nicotine chewing gum should make a cessation attempt as soon as they feel ready, but not later than 6 months after they start using nicotine chewing gum.
When making a cessation attempt, the smoking cessation instructions above, can be followed. If the smoker has not made a cessation attempt within 9 months of commencing treatment he or she should consult a healthcare professional.

Overdosage

Excessive use of nicotine from either NRT and/or smoking might cause symptoms of an overdose. The risk of poisoning as a result of swallowing the gum is very small, as absorption in the absence of chewing is slow and incomplete.

Symptoms.

Symptoms of overdosage are those of acute nicotine poisoning and include nausea, salivation, vomiting, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. At high doses, these symptoms may be followed by hypotension, weak and irregular pulse, breathing difficulties, prostration, circulatory collapse and general convulsions.
Overdosage with nicotine can occur if the patient has a very low pretreatment nicotine intake or uses other forms of nicotine. The acute minimum lethal oral dose of nicotine in nonsmokers is believed to be 40 to 60 mg. Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small children and may prove fatal. The lethal dose of nicotine in a small child is approximately 10 to 15 mg.

Treatment.

Contact the Poisons Information Centre (131 126) for advice on the management of an overdose.
If chewing gum is ingested, activated charcoal should be given as soon as possible.
The administration of nicotine should be stopped immediately and the patient should be treated symptomatically. Activated charcoal reduces gastrointestinal absorption of nicotine.

Presentation

Freshmint.

Chewing gum (square, biconvex, coated), 2 mg (white); 4 mg (light peach): 30's, 100's (blister pack).

Classic.

Chewing gum (square, biconvex, uncoated), 2 mg (off white to tan); 4 mg (yellowish): 30's, 100's (blister pack).

Storage

Store below 25°C.

Poison Schedule

Unscheduled.