Nicorette Icy White 2mg medicated chewing gum

Main information

  • Trade name:
  • Nicorette Icy White 2mg medicated chewing gum
  • Dosage:
  • 2mg
  • Pharmaceutical form:
  • Medicated chewing-gum
  • Administration route:
  • Oromucosal
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Nicorette Icy White 2mg medicated chewing gum
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 04100200; GTIN: 3574660446739 3574660446777 3574660478471 3574661013077

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 15513/0152
  • Last update:
  • 22-07-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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.

651532

turn over

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.

651532