Nicorette Icy White 2mg medicated chewing gum

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Nicotine
Available from:
McNeil Products Ltd
ATC code:
N07BA01
INN (International Name):
Nicotine
Dosage:
2mg
Pharmaceutical form:
Medicated chewing-gum
Administration route:
Oromucosal
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04100200; GTIN: 3574660446739 3574660446777 3574660478471 3574661012261 3574661591254 3574661591179
Authorization number:
PL 15513/0152

icy white 2 mg and 4 mg gum

Nicotine chewing gum

What you should know about

nicorette

®

icy white 2 mg gum

(2 mg nicotine chewing gum)

nicorette

®

icy white 4 mg gum

(4 mg nicotine chewing gum)

Please read this leaflet carefully before you start using

this medicine. It provides useful information on how to use it

safely. Keep the leaflet, you might need it again.

If you think you are having side-effects, have any questions

or are not sure about anything please ask your doctor,

nurse or pharmacist.

1 What this medicine is for

NICORETTE

gum is a nicotine replacement therapy

(NRT). It is used to relieve and/or prevent withdrawal

symptoms and reduce the cravings you get when you try

to stop smoking, or when cutting down the number of

cigarettes you smoke.

NICORETTE

gum can also be used when you are pregnant

or breast-feeding to help you stop smoking, as the risks to

your baby are far less than if you continue to smoke. For

more information, see ’If you are pregnant or breast-feeding’

section.

Ideally you should always aim to stop smoking. You can use

NICORETTE

gum to achieve this by using it to completely

replace all your cigarettes.

However NICORETTE

gum can also be used in other ways,

n if you feel unable to stop smoking completely, or wish to

replace certain cigarettes and therefore it can help you to

cut down the number of cigarettes you smoke,

n at those times when you can’t or do not want to smoke.

For example,

- Where you don’t want to smoke and avoid harm to others

e.g children or family.

- Smoke free areas e.g Pub, work, public transport e.g

aeroplanes.

It may also help increase your motivation to quit.

When making a quit attempt a behavioural support

programme will increase your chances of success.

If you smoke 20 or fewer cigarettes a day, the 2 mg nicotine

gum will help relieve your cravings.

If you smoke more than 20 cigarettes a day, the 4 mg

nicotine gum may be more appropriate.

What does nicorette

gum do?

When you stop smoking, or cut down the number of

cigarettes you smoke, your body misses the nicotine that you

have been absorbing. You may experience unpleasant

feelings and a strong desire to smoke (craving). This

indicates that you were dependent on nicotine.

When you chew NICORETTE

gum, nicotine is released

and passes into your body through the lining of your mouth.

The nicotine released from the gum is sufficient to relieve the

unpleasant withdrawal symptoms. It will also help to stop the

craving to smoke, but NICORETTE

gum will not give you

the “buzz’’ you get from smoking a cigarette.

The gum contains a number of ingredients which help

remove dental staining, chewing NICORETTE

gum will

help improve the whiteness of your teeth.

Benefits you can get from using NRT instead of

smoking

For the best effect, make sure you chew nicorette

correctly. See ‘How to chew NICORETTE

gum - the

NICORETTE

chewing technique.

The benefits of stopping smoking far outweigh any

potential risk from using nicotine from NRT. It is the

toxins in cigarette smoke such as tar, lead, cyanide and

ammonia that cause smoking related disease and death, not

the nicotine.

n You may think that smoking helps relieve feelings of

anxiety and stress, but it does not deal with the cause of

the stress and leads to a number of serious diseases.

In addition, the feeling of relaxation after smoking is

temporary, with withdrawal symptoms and cravings soon

returning.

Nicotine replacement therapy can help relieve nicotine

withdrawal symptoms such as irritability, low mood,

anxiety, restlessness and cravings when used in place of

cigarettes.

n NRT may benefit smokers who want to quit, by helping to

control weight gain that may be experienced when trying

to stop smoking.

Use of NRT is safer than smoking tobacco but as soon as

you are ready, you should aim to stop smoking completely.

2 Before using this medicine

Do not use nicorette

gum:

n If you are a child under 12 years of age.

n if you have an allergy to nicotine or any of the other

ingredients.

Talk to your doctor, nurse or pharmacist…

n if you are pregnant or breast-feeding – you may be able

to use nicotine replacement therapy (NRT) to help you

give up smoking but you should try to give up without it.

See “If you are pregnant or breast-feeding” section.

n if you are in hospital because of heart disease

(including heart attack, disorders of heart rate or rhythm,

angina, high blood pressure or stroke). In other heart

conditions not requiring you to be in hospital, using NRT is

better than continuing to smoke.

n if you have a stomach ulcer, duodenal ulcer, inflamma-

tion of the stomach or inflammation of the oesophagus

(passage between the mouth and stomach).

n if you have liver or kidney disease.

n if you have an overactive thyroid gland or have a

phaeochromocytoma (a tumour of the adrenal gland that

can affect blood pressure) - your doctor will have told you

this.

n if you have diabetes – monitor your blood sugar levels

more often when starting to use NICORETTE

gum as you

may find your insulin or medication requirements alter.

n if you are taking other medicines such as

theophylline, clozapine or ropinirole. Stopping smoking or

cutting down may require the dose of these medicines to

be adjusted.

➤ If any of these apply, talk to your doctor, nurse or

pharmacist.

Some of the ingredients can cause

problems

NICORETTE

icy white gums contain butylated hydroxy

toluene (E321), an anti-oxidant, which may irritate your

mouth.

If you are pregnant or breast-feeding

If you are pregnant:

1) Firstly, you should try to give up smoking without NRT.

Stopping completely is by far the best option. The

earlier and quicker you do this the better it is for you

and your baby.

2) Secondly, if you can’t manage this, you can use NRT

as a safer alternative to smoking as the risks to your

baby are far less than smoking, however you should talk to

your doctor, nurse or pharmacist for advice.

Products that are used intermittently, including NICORETTE

gum may be preferable to nicotine patches. However, patches

may be more suitable if you have nausea or sickness. If you

do use patches take them off before going to bed at night.

If you are breast-feeding:

1) Firstly, you should try to give up smoking without NRT.

2) Secondly, if you can’t manage this you are best to use

NRT products that are taken intermittently (not patches),

however you should talk to your doctor, nurse or

pharmacist for advice. Breast-feed just before you use

NICORETTE

gum to ensure that the baby gets the

smallest amount of nicotine possible.

If you do need to use NRT to help you quit, the amount of

nicotine that the baby may receive is considerably smaller

and less harmful than the second-hand smoke they would

inhale if you smoked. Tobacco smoke produces breathing

and other problems in babies and children.

3 How and when to use this medicine

When to use nicorette

gum

The table below contains the dosage information for

NICORETTE

gum. This shows the number of gums you

should be using, when and how you should take them.

Please read this information carefully and then go to the

“How to stop smoking:” section, which will help you decide

which method to use to give up smoking.

n Use the “How to chew NICORETTE

gum - the

NICORETTE

chewing technique” instructions which

follow. The method of chewing is NOT the same as that

for ordinary chewing gum. This way of chewing ensures

that the nicotine is correctly released from the gum.

n The number of NICORETTE

gums you use each day will

depend on how many cigarettes you smoked and how

strong they are.

n The 2 mg gums should be used by people who smoke

20 or fewer cigarettes each day or by heavier smokers

when they are cutting down the number and strength of

the NICORETTE

gums they are using.

n The 4 mg gums should be used by people who smoke

more than 20 cigarettes each day.

Children aged under 12 years

Do not give this product to children under 12 years.

Adults and Children 12 years and over

Number of

Dose of Gums

cigarettes you

smoke per day

20 cigarettes

One 2 mg gum as

or fewer

required to relieve cravings.

More than

One 4 mg gum as

20 cigarettes

required to relieve cravings.

Use only one piece of gum at a time.

Do not use more than 15 gums per day.

The frequency with which you use the gums will depend

on how many cigarettes you smoked and how strong

they were.

How to chew nicorette

gum – the

nicorette

chewing technique

The method of chewing NICORETTE

gum is not the same

as for ordinary chewing gum. NICORETTE

gum is chewed

to release nicotine then rested so that nicotine can be taken

in through the lining of the mouth.

If NICORETTE

gum is chewed continuously, the nicotine is

released too quickly and is swallowed. This may irritate your

throat, upset your stomach or give you hiccups.

If you have false teeth you may have difficulty chewing the

gum as NICORETTE

gum could stick to them and on rare

occasions, damage dentures. If you experience a problem,

other types of nicotine replacement therapy such as a skin

patch, inhalator or microtab may be more suitable for you.

The nicorette

chewing technique

1 Chew slowly until taste becomes strong.

2 Rest between gum and cheek.

3 Chew again when the taste has faded.

n Keep chewing like this for about half an hour.

After this time the gum will have lost its strength and you

should dispose of it carefully.

How to stop smoking:

If you are able to stop smoking you should use

NICORETTE

gum, when needed, in place of cigarettes. As

soon as you can (this could be after a number of weeks or

months) you should reduce the number of gums you use

until you have stopped using them completely.

If you are unable to stop smoking, or do not feel ready to quit

at this time, you should replace as many cigarettes as

possible with NICORETTE

gum. There are toxins in

cigarettes that can cause harm to your body. NICORETTE

gum provides a safer alternative to smoking, for both you

and those around you. Reducing the number of cigarettes

may also help you to become more motivated to stop

smoking. As soon as you are ready you should aim to stop

smoking completely.

You can also use NICORETTE

gum on those occasions

when you can’t or don’t want to smoke e.g. Social situations

such as a party, in the pub or when at work.

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When making a quit attempt behavioural therapy, advice and

support will normally improve the success rate. If you have

quit smoking and want to stop using nicorette

gum but are

finding this difficult you should contact your doctor, nurse or

pharmacist for advice.

If you have used too many gums

If you have used more than the recommended dosage you

may experience nausea (feeling sick), salivation, pain in your

abdomen, diarrhoea, sweating, headache, dizziness, hearing

disturbance or weakness.

n If you do get any of these effects contact a doctor or

your nearest hospital Accident and Emergency

department immediately. Take this leaflet and the

pack with you.

If a child has used or swallowed the gums

n Contact a doctor or your nearest hospital Accident and

Emergency department immediately if a child under

12 years uses, chews or swallows this medicine. Take this

leaflet and the pack with you.

Nicotine ingestion by a child may result in severe

poisoning.

4 Possible side-effects

Like all medicines, NICORETTE

gum can have side-effects.

As many of the effects are due to nicotine, they can also

occur when nicotine is obtained by smoking.

Effects related to stopping smoking

(nicotine withdrawal)

You may experience unwanted effects because by stopping

smoking you have reduced the amount of nicotine you are

taking. You may also experience these effects if you under

use NICORETTE

gum before you are ready to reduce your

nicotine intake.

These effects include:

n irritability or aggression

n feeling low

n anxiety

n restlessness

n poor concentration

n increased appetite or weight gain

n urges to smoke (craving)

n night time awakening or sleep disturbance

n lowering of heart rate

Effects of too much nicotine

You may also get these effects if you are not used to inhaling

tobacco smoke.

These effects include:

n feeling faint

n feeling sick (nausea)

n headache

n hiccuping (due to excessive swallowing of nicotine)

Side-effects of nicorette

gum

NICORETTE

gum can sometimes cause a slight irritation

of the throat at the start of the treatment. It may also cause

increased salivation.

Those who suffer from indigestion may suffer from heartburn

or indigestion and may benefit from slower chewing and use

of the 2 mg gum.

The gum may occasionally stick to dentures and in rare

cases damage them.

If you notice any of the following; fast heart rate/beat,

abnormal beating of the heart, chest palpitations, shortness

of breath or allergic reactions (swelling of the face, mouth,

lips, throat and tongue, itching of the skin, swelling of the

skin, ulceration and inflammation of the lining of the

mouth, difficulty in breathing and dizziness) stop taking

NICORETTE

gum and contact a doctor immediately.

Very common side-effects:

(may affect more than 1 in 10 people):

n headache

n cough

n throat irritation

n (feeling sick) nausea

n hiccups

n sore mouth or throat

Common side-effects:

(may affect up to 1 in 10 people):

n allergic reactions (hypersensitivity)

n dizziness

n taste disturbance or loss of taste

n tingling or numbness of the hands and feet

n stomach pain or discomfort

n diarrhoea

n dry mouth

n excessive gas or wind

n increased salivation

n sore and inflamed mouth

n sickness (vomiting)

n indigestion

n burning sensation in the mouth

n tiredness (fatigue)

Uncommon side-effects:

(may affect up to 1 in 100 people):

n abnormal dream

n sudden reddening of the face and/or neck

n high blood pressure

n sudden constriction of the small airways of the lung that

can cause wheezing and shortness of breath

n loss or damage to voice

n blocked nose, sneezing

n throat tightness

n burping (belching)

n swollen, red, sore tongue

n mouth ulcers or blisters

n numbness or tingling of the mouth

n unusual weakness

n chest discomfort and pain

n hives (urticaria)

n excessive sweating

n itching

n rash

n jaw-muscle ache

n general feeling of discomfort or being unwell or out of

sorts (malaise)

Rare side-effects:

(may affect up to 1 in 1,000 people):

n difficulty in swallowing

n decreased feeling or sensitivity, especially in the mouth

n feeling of wanting to be sick (vomit)

Other side-effects can include:

n blurred vision, watery eyes

n dry throat, lip pain

n stomach discomfort

n redness of the skin

n muscle tightness

➤ When you stop smoking you may also develop mouth

ulcers. The reason why this happens is unknown.

➤ If you get any side-effects, talk to your doctor,

pharmacist or nurse. This includes any possible

side-effects not listed in this leaflet. You can also

report side-effects directly via the Yellow Card

Scheme at: www.mhra.gov.uk/yellowcard

By reporting side-effects you can help provide more

information on the safety of this medicine.

5 Storing and disposal

n Keep NICORETTE

gum out of the sight and reach of

children and animals. Nicotine in high doses can be very

dangerous and sometimes fatal if taken by small children.

n Do not store NICORETTE

gum above 25°C.

n Do not use the gum after the ‘Use before’ date on the box

or blister strip.

n Dispose of NICORETTE

gum sensibly.

n Medicines should not be disposed of via waste water or

household waste. Ask your pharmacist how to dispose of

medicines no longer required. These measures will help to

protect the environment.

6 Further information

What’s in this medicine?

The active ingredient in NICORETTE

icy white 2 mg gum is

2 mg Nicotine.

The active ingredient in NICORETTE

icy white 4 mg gum is

4 mg Nicotine.

Other ingredients are: Chewing gum base, xylitol,

peppermint oil, anhydrous sodium carbonate, acesulfame

potassium, levomenthol, magnesium oxide, talc, winterfresh,

hypromellose, sucralose, polysorbate 80, starch, titanium

dioxide (E171) and carnauba wax. The chewing gum base

contains butylated hydroxy toluene (E321), an antioxidant.

The 2 mg gum also contains sodium hydrogen carbonate.

The 4 mg gum also contains quinoline yellow (E104) (yellow

colour).

None of the gums contain sugar (sucrose) or animal

products.

What the medicine looks like

NICORETTE

icy white 2 mg gum is a whitish square

coated piece of gum.

NICORETTE

icy white 4 mg gum is a crème square coated

piece of gum.

Pack types and pack sizes:

The gums are blister-packed in sheets of 6, 10 or 15 and

supplied in packs of 10, 12, 15, 30, 105 and 210 pieces.

The gums are loose-filled packed in a cardboard box,

wrapped in a transparent plastic film, containing 25 pieces

and supplied in packs of 25, 100 (4x25) and 200 (8x25).

Not all pack types and sizes may be marketed.

Who makes nicorette

gum?

The Product Licence holder is McNeil Products Ltd,

Maidenhead, Berkshire, SL6 3UG, UK.

The manufacturer is McNeil AB, Helsingborg, Sweden.

This leaflet was prepared in June 2017.

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Object 1

Nicorette Icy White 2mg Gum

Summary of Product Characteristics Updated 02-Jun-2016 | McNeil Products Ltd

1. Name of the medicinal product

Nicorette Icy White 2 mg Gum

Boots NicAssist Ice Mint 2 mg Gum.

2. Qualitative and quantitative composition

Chewing Gum containing 2 mg nicotine, as nicotine resinate.

For excipients, see 6.1.

3. Pharmaceutical form

Medicated Chewing Gum

A square, coated, white coloured piece of gum

4. Clinical particulars

4.1 Therapeutic indications

Nicorette Icy White 2 mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms

associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to

quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for

smokers and those around them.

Nicorette Icy White 2 mg Gum is indicated in pregnant and lactating women making a quit attempt.

4.2 Posology and method of administration

Adults and Children over 12 years of age

Nicorette Icy White 2 mg Gum should be chewed slowly according to the instructions.

The strength of gum to be used will depend on the smoking habits of the individual. In general, if the

patient smokes 20 or less cigarettes a day, 2 mg nicotine gum is indicated. If more than 20 cigarettes per

day are smoked, 4 mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine

levels from heavy smoking.

Nicorette Icy White 2 mg Gum should be used whenever the urge to smoke is felt or to prevent cravings

in situations where these are likely to occur.

Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the

Gum and as soon as they are able, reduce the number of gums used until they have stopped completely.

Smokers aiming to reduce cigarettes should use Nicorette Icy White 2 mg Gum, as needed, between

smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as

possible.

As soon as they are ready smokers should aim to quit smoking completely.

Maximum daily dose: 15 pieces per day.

When making a quit attempt behavioural therapy, advice and support will normally improve the success

rate. Those who have quit smoking, but are having difficulty discontinuing Nicorette Icy White 2 mg

Gum are recommended to contact their pharmacist or doctor for advice.

For those using the 4mg gum, switching to the 2 mg gum may be helpful when stopping treatment or

reducing the number of gums used each day.

The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest“

technique described on the pack. After about 30 minutes of such use, the gum will be exhausted.

Absorption of nicotine is through the buccal mucosa, any nicotine, which is swallowed being destroyed

by the liver.

4.3 Contraindications

Hypersensitivity to nicotine or any component of the chewing gum.

Nicorette Icy White 2mg Gum is contraindicated in children under the age of 12 years.

4.4 Special warnings and precautions for use

Any risks that may be associated with NRT are substantially outweighed by the well-established dangers

of continued smoking.

Underlying cardiovascular disease: In stable cardiovascular disease this product presents a lesser hazard

than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial

infarction, unstable or worsening angina including Prinzmetal's angina, severe dysrhythmia or CVA and

who are considered to be haemodynamically unstable and/or who suffer with uncontrolled hypertension

should be encouraged to stop smoking with non-pharmacological interventions. If this fails, this product

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.

GI 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.

Renal or hepatic impairment: This product should be used with caution in patients with moderate to

severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites

may be decreased with the potential for increased adverse effects.

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.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines,

this product 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.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs

metabolised by CYP 1A2 (and possibly by CYP 1A1). 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.

Excipients: This product also contains butylated hydroxy toluene (E321); this may cause irritation to the

mucous membranes.

Denture warning: Smokers who wear dentures may experience difficulty in chewing this product . The

chewing gum may stick to, and may in rare cases damage dentures.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs has 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.

4.6 Fertility, pregnancy and lactation

Fertility

In females tobacco smoking delays time to conception, decreases in-vitro fertilization success rates, and

significantly increases the risk of infertility.

In males tobacco smoking reduces sperm production, increases oxidative stress, and DNA damage.

Spermatozoa from smokers have reduced fertilizing capacity.

The specific contribution of nicotine to these effects in humans is unknown.

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant

smoker and her baby, and the earlier abstinence is achieved the better. Ideally smoking cessation during

pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to)

quit without pharmacological support, NRT may be used as the risk to the fetus is lower than that

expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable

this product may be used in pregnancy as a safer alternative to smoking. Because of the potential for

nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is

significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when

the fetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the

infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast

milk and permit feeding when levels were at their lowest.

4.7 Effects on ability to drive and use machines

This product has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Effects of Smoking Cessation

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can

include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration,

increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and

decreased heart rate.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Adverse Drug Reactions

This product may cause adverse reactions similar to those associated with nicotine given by other means,

including smoking, and these are mainly dose-dependent. At recommended doses this product has not

been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients

occur during the first 3-4 weeks after start of treatment.

Excessive consumption of this product by those who have not been in the habit of inhaling tobacco smoke

could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at

first, cause hiccupping.

Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and

may also cause increased salivation.

Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if

the 4 mg nicotine gum is used; slower chewing and the use of the 2 mg nicotine gum (if necessary more

frequently) will usually overcome this problem.

The chewing gum may stick to, and may in rare cases damage dentures.

The adverse reactions observed in patients treated with oral nicotine formulations during clinical trials

and post-marketing experience are listed below by system organ class (SOC). Frequencies are defined in

accordance with current guidance, as: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1

000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), Not known - cannot be estimated from

the available data.

System Organ Class

Reported Adverse Event

Incidence

Immune System Disorders

Hypersensitivity

Anaphylactic reaction

Common

Not known

Psychiatric disorders

Abnormal dreams

Uncommon

Nervous System Disorders

Headache

Burning sensation

Dizziness

Dysgeusia

Paraesthesia

Very Common

Common

Common

Common

Common

Eye Disorders

Blurred Vision

Lacrimation increased

Not known

Not known

Cardiac Disorders

Palpitations

Tachycardia

Reversible atrial fibrillation

Uncommon

Uncommon

Very Rare

Vascular Disorders

Flushing

Hypertension

Uncommon

Uncommon

Respiratory, Thoracic and

Mediastinal Disorders

Cough**

Sore mouth or throat

Throat irritation

Bronchospasm

Dysphonia

Dyspnoea

Nasal Congestion

Sneezing

Throat tightness

Very Common

Very Common

Very Common

Uncommon

Uncommon

Uncommon

Uncommon

Uncommon

Uncommon

Gastrointestinal Disorders

Nausea

Hiccups

Abdominal pain

Diarrhoea

Dry mouth

Flatulence

Salivary hypersecretion

Stomatitis

Vomiting

Dyspepsia

Eructation

Glossitis

Oral mucosal blistering and

exfoliation

Paraesthesia oral

Dysphagia

Hypoaesthesia oral

Retching

Dry throat

Gastrointestinal discomfort

Lip pain

Very Common

Very Common

Common

Common

Common

Common

Common

Common

Common

Common

Uncommon

Uncommon

Uncommon

Uncommon

Rare

Rare

Rare

Not known

Not known

Not known

Skin and Subcutaneous Tissue

Disorders

Urticaria

Hyperhidrosis

Pruritus

Rash

Erythema

Uncommon

Uncommon

Uncommon

Uncommon

Not known

Musculoskeletal and Connective

Tissue Disorders

Pain in jaw

Muscle tightness

Uncommon

Not known

General Disorders and

Administration Site Conditions

Fatigue

Asthenia

Chest discomfort and pain

Malaise

Allergic reactions including

angioedema

Common

Uncommon

Uncommon

Uncommon

Rare

Systemic effects;

Tightness of jaw and pain in jaw with nicotine gum formulation

At the application site

Identified only for formulations applied during the night

Higher frequency observed in clinical studies with inhaler formulation.

***Reported the same or less frequently than placebo

Although the frequency in the active group is less than that of the placebo group, the frequency in the

specific formulation in which the PT was identified as a systemic ADR was greater in the active group

than the placebo group.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard.

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to

60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea,

sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms

may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration,

circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be

treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal

reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in nicotine dependence

ATC code: N07B A01

The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette

2mg 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.

The gum contains a number of ingredients that are recognized as having properties for removal of dental

staining. Clinical studies have shown that the gum helps to improve tooth whiteness.

Increased appetite is a recognised symptom of nicotine withdrawal and post-cessation weight gain is

common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight

following a quit attempt.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.

There are no other findings derived from preclinical testing of relevance to the prescriber in determining

the safety of the product, which have not been considered in other relevant sections of this Summary of

Product Characteristics.

6. Pharmaceutical particulars

6.1 List of excipients

Core Gum

Chewing gum base, containing butylated hydroxy toluene (E321)

Xylitol

Peppermint oil

Sodium carbonate, anhydrous

Sodium hydrogen carbonate

Acesulfame Potassium

Levomenthol

Magnesium oxide, light

Talc

Sub coating

Winterfresh

Hypromellose

Sucralose

Polysorbate 80

Purified water

Hard Coating

Xylitol

Starch

Titanium dioxide (E171)

Winterfresh

Carnauba wax

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Blister: 3 years

Box: 2 years. Shelf life after opening 3 months.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

PVC/PVDC/Al Blister packed strips each containing 6,10 or 15 pieces supplied in packs of 10, 12, 15, 30,

105 and 210 pieces.

Laminated cardboard box, wrapped in a transparent plastic film, containing 25 pieces, supplied in packs

of 25, 100 and 200.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Dispose of Nicorette Gum sensibly.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorisation holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing authorisation number(s)

PL 15513/0152

9. Date of first authorisation/renewal of the authorisation

18/07/2006

10. Date of revision of the text

18 May 2016

Company Contact Details

McNeil Products Ltd

Address

Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG

Medical Information e-mail

[email

protected]

Medical Information Direct Line

01344 864042

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