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NICOTINE FRUIT 4 MG MEDICATED CHEWING GUM

Active substance(s): NICOTINE RESINATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Nicotine Fruit 2mg Medicated Chewing Gum
Nicotine Fruit 4mg Medicated Chewing Gum

(referred to as Nicotine Fruit Medicated Chewing Gum in this leaflet)
Read all of this leaflet carefully before you start to take this medicine.
• This medicine is available without prescription. However, you still need to take Nicotine Fruit
Medicated Chewing Gum carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Nicotine Fruit Medicated Chewing Gum is and what it is used for
2. Before you take Nicotine Fruit Medicated Chewing Gum
3. How to take Nicotine Fruit Medicated Chewing Gum
4. Possible side effects
5. How to store Nicotine Fruit Medicated Chewing Gum
6. Further information

1. What Nicotine Fruit Medicated Chewing Gum is and what it is used for

The name of your medicine is Nicotine Fruit Medicated Chewing Gum. The active ingredient is
nicotine (as resinate).
Nicotine belongs to a group of medicines which are used to help you stop smoking.
Nicotine Fruit Medicated Chewing Gum can be used for the symptoms of nicotine withdrawal and to
relieve and/or prevent the cravings for nicotine that you get when;




you stop smoking completely
you cut down on the number of cigarettes you smoke while you try to give up
you feel unable to stop smoking but you don’t want to smoke cigarettes or you want to avoid
causing harm to others, such as when you are in a public place or are with friends and family.

When you stop smoking, cut down, or are unable to smoke cigarettes, your body misses the nicotine
that you have been getting from the smoke. You may experience unpleasant feelings and a strong
desire to smoke (“cravings”). Nicotine Fruit Medicated Chewing Gum will help relieve and/or
prevent the unpleasant withdrawal symptoms such as irritability, low mood, anxiety, restlessness and
your craving to smoke.

You should always aim to stop smoking completely whilst using Nicotine Fruit Medicated Chewing
Gum. To help you should also try to use a behavioural support programme to increase your chances
of successfully stopping smoking.
The use of Nicotine Fruit Medicated Chewing Gum is safer than smoking tobacco but as soon as you
are ready, you should aim to stop smoking completely.

2. Before you take Nicotine Fruit Medicated Chewing Gum
You should not take Nicotine Fruit Medicated Chewing Gum if you:
• are allergic (hypersensitive) to nicotine or any of the other ingredients of the gum (see section 6
Further information).
• are a child under 12 years of age.
Talk to your doctor before taking Nicotine Fruit Medicated Chewing Gum if you:
• have a stable heart disease (such as chest pain), previously had a stroke, suffer from blockages in
your blood vessels, severe high blood pressure or heart failure
• have an overactive thyroid gland or a tumour of the adrenal glands (phaeochromocytoma)
• have moderate/severe liver and/or kidney disease
• are diabetic
• suffer from inflammation of your oesophagus (often caused by excess stomach acid) or have an
active ulcer in your stomach or small intestine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
The following medicines can affect or be affected by treatment with Nicotine Fruit Medicated
Chewing Gum:


adenosine (a drug used in the diagnosis and treatment of abnormal heart rhythms)

Taking Nicotine Fruit Medicated Chewing Gum with food and drink
This medicine does not interact with food or drink and may be taken with or without food at any time
of the day.
Pregnancy and breast-feeding
Pregnancy:
Pregnant women wishing to stop smoking for the health of their baby should ideally do so without
nicotine replacement therapy (NRT).
However if you still need help to stop smoking, you can use this product as the risk to the baby is far
less than if you continue to smoke. You should talk to your pharmacist, nurse or doctor for more
advice.

NRT products which are used intermittently, such as this product may be preferable to nicotine
patches. However if you feel sick or are suffering from morning sickness the patches may be better
for you. If you do use nicotine patches they should be taken off before bedtime.
Breast-feeding:
You should try to stop smoking without using NRT.
However if you still need help to stop smoking you should use NRT’s which are used intermittently,
not patches. You should talk to your pharmacist, nurse or doctor for more advice.
Breast-feeding your baby just before you use Nicotine Fruit Medicated Chewing Gum makes sure that
your baby gets the smallest amount of nicotine possible.
The amount of nicotine that your baby may receive when you are using Nicotine Fruit Medicated
Chewing Gum or other NRT products is much smaller and less harmful than the second hand smoke
they would inhale if you smoked. Tobacco smoke causes breathing and other health problems in
babies and children.
Driving and using machinery
Nicotine Fruit Medicated Chewing Gum does not affect your ability to drive or operate machinery.
Important information about some of the ingredients in Nicotine Fruit Medicated Chewing
Gum
Each chewing gum contains 0.36mmol (8.22mg) sodium. The maximum daily dose of 15 chewing
gum for the 2mg/4mg strengths contains 5.4mmol (123.3mg) of sodium. To be taken into
consideration by patients on a controlled sodium diet.
The Nicotine Fruit Medicated Chewing Gum contains Allura Red (E129) and Sunset Yellow FCF
(E110) which may cause allergic reactions.

3. How to take Nicotine Fruit Medicated Chewing Gum
When to use Nicotine Fruit Medicated Chewing Gum
The following sections contain the dosage information for Nicotine Fruit Medicated Chewing Gum.
This shows the number of gums you should be using, when you should take them, how you should
take them and the maximum amount of time you should be using NRT for.
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.




Use the “How to chew Nicotine Fruit Medicated Chewing Gum”. 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.
The number of Nicotine Fruit Medicated Chewing Gums you use each day will depend on how
many cigarettes you smoked and how strong they are. See table below to find out the dose you
should take.





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 Nicotine gums
they are using.
The 4 mg gums should be used by people who smoke more than 20 cigarettes per day.

Children under 12 years
Do not give this product to children under 12 years.
Adults and Children 12 years and Over

To remove
Gum, tear off
Singe unit.
Number of
cigarettes you
smoke per day
20 cigarettes or
fewer
More than 20
cigarettes





Peel off backing
starting at corner
with loose edge.

Push gum
through foil.

Dose of Gums

One 2mg gum as
required to relieve
cravings
One 4mg gum as
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 are.

How to chew Nicotine Fruit Medicated Chewing Gum
The method of chewing Nicotine Gum is not the same as for ordinary chewing gum.
Nicotine Gum is chewed to release nicotine then rested so that nicotine can be taken in through the
lining of the mouth. If Nicotine 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 Nicotine Gum could stick to them
and on rare occasions, damage dentures. If you experience a problem, other types of nicotine
replacement therapy may be more suitable for you.
How to chew Nicotine Fruit Medicated Chewing Gum
1. Chew slowly until taste becomes strong.
2. Rest between gum and cheek.
3. Chew again when the taste has faded.

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 Nicotine Fruit Medicated Chewing 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 Nicotine Gum. There are toxins in cigarettes that can cause harm to your
body. Nicotine 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 Nicotine 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. 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 Nicotine Gum but
are finding this difficult you should contact your doctor, nurse or pharmacist for advice.
If you take more Nicotine Fruit Medicated Chewing Gum than you should
If you (or someone else) consume a large amount of gum or if you think a child has swallowed any of
the gums, contact your nearest hospital casualty department or your doctor immediately. Always take
the container with you, if possible, even if empty.
Symptoms that may indicate you have taken too much are:

irregular heart beat

difficulty in breathing or an uncomfortable chest

complete exhaustion and inability to move

heart attack or low blood pressure

fits.

4. Possible side effects
Like all medicines, Nicotine Fruit Medicated Chewing Gum can cause side effects, although not
everybody will be affected by them.
As can happen with any medicine, a few people may develop an allergic reaction. If you experience
any of the following, seek medical help immediately:

rash, itching, difficulty breathing.
Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can
include;







dysphoria/depressed mood
irritability/aggression
anxiety
restlessness
poor concentration
increased appetite/weight gain






urges to smoke (cravings)
mouth ulcers
sleep disturbance
decreased heart rate.

Patients prone to indigestion may suffer initial heartburn if the 4mg gum is used. Slower chewing and
use of the 2mg gum (more frequently if necessary) will normally stop this problem.
Patients with dentures should be cautious as the gum can stick to and damage false teeth.
Side-effects reported with Nicotine Fruit Medicated Chewing Gum are:
Very Common (Occurs in more than 1 in 10 patients)

headache

hiccups

sore mouth and throat

stomach upsets

nausea

jaw-muscle ache
Common (Occurs in more than 1 in 100 patients)

dizziness

vomiting
Uncommon (Occurs in less than 1 in 100 patients)

skin reddening

palpitations (an increased awareness of the beating of your heart)

itchy rash
Rare (Occurs in less than 1 in 1000 patients)

allergic reactions
Very Rare (Occurs in less than 1 in 10,000 patients)

abnormal heart rhythm
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nicotine Fruit Medicated Chewing Gum


Keep out of sight and reach of children.








Do not use this medicine after the expiry date which is stated on the outer packing. The expiry
date refers to the last day of that month.
Do not store above 25°C. Store in the original blister in order to protect from moisture. Keep
the blister in the outer carton in order to protect from light. Do not transfer the gums to another
container.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.
Used gum should be disposed of with care as they can be toxic in small children.

6. Further information
What Nicotine Fruit Medicated Chewing Gum contains
The active ingredient in this medicine is Nicotine (as resinate). There are two different strengths of
gum available: a gum containing 2 mg of nicotine and a gum containing 4 mg of nicotine.
Other ingredients are:

Gum base (containing Butylhydroxytoluene(E321)

Xylitol(E967)

Sodium carbonate, anhydrous

Sodium hydrogen carbonate(E500)

Magnesium oxide (light)

Entrapped menthol flavour

Levomenthol

Acesulfame potassium(E950)

Sucralose

Brown lake (E110 Sunset Yellow, E129 Allura red and E132 Indigo)

Toothpaste flavour

Talc(E553b)

Acacia, spray-dried

Titanium dioxide(E171)

N & A Citrus/fruit flavour

Carnauba wax(E903)

Sunset yellow FCF (E110) (4mg gum only)
What Nicotine Fruit Medicated Chewing Gum looks like and the contents of the pack
Nicotine Fruit Medicated Chewing Gum is supplied in blister packs containing ten pieces of gums.
Cartons may contain 40 or 100 pieces of gum.
Marketing Authorisation Holder and Manufacturer:
Nicobrand Limited
189 Castleroe Road
Coleraine
BT51 3RPNorthern Ireland

For any information about this medicine, please contact the Marketing Authorisation Holder, details
provided above.
Nicotine Fruit Medicated Chewing Gum 2mg
PL10866/0009
Nicotine Fruit Medicated Chewing Gum 4mg
PL10866/0010

This leaflet was last revised in October 2014.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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