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GALPHARM NICOTINE REPLACE 4 MG GUM

Active substance(s): NICOTINE RESINATE

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Asda Nicotine Replace 4mg Gum
Nicotine
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you take
this medicine because it contains important
information you need to know.

Talk to your doctor, pharmacist or nurse before
taking this medicine if you:
• are in hospital because of a heart attack, severe
heart rhythm disturbances or a stroke.
If you have other heart conditions which do not
require you to be in hospital, using NRT is better
than continuing to smoke
• 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.
• have liver or kidney disease
• have a stomach ulcer, duodenal ulcer or have
inflammation of the oesophagus (oesophagitis),
which is the tube leading from the mouth to the
stomach
• have an uncontrolled, overactive thyroid gland or
have been diagnosed as having a tumour of the
adrenal glands (phaeochromocytoma)
• are diabetic, as diabetic patients need to monitor
blood sugar levels more closely as nicotine from
smoking or from taking the gum may vary them
more than usual
• are taking other medicines such as theophylline,
clozapine or ropinirole. When you stop smoking your
metabolism slows down and this may alter the way
your body responds to certain medicines.

This medicine is available without prescription,
however, you still need to use this product carefully to
get the best results from it. Keep this leaflet as you
may need to read it again. Ask your doctor, pharmacist
or nurse if you need more information or advice.
IN THIS LEAFLET:
1. What Asda Nicotine Replace 4mg Gum is and
what it is used for?
2. Before you take Asda Nicotine Replace
4mg Gum
3. How to take Asda Nicotine Replace 4mg Gum
4. Possible side effects
5. Storing Asda Nicotine Replace 4mg Gum
6. Further information
WHAT ASDA NICOTINE REPLACE 4MG GUM
IS AND WHAT IT IS USED FOR?
Nicotine 4mg Gum can reduce your urge to smoke by
providing some of the nicotine previously inhaled from
cigarettes. This type of treatment is called Nicotine
Replacement Therapy (NRT).

Important information about some of the
ingredients in this medicine:
This medicine contains maltitol and sucralose. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.

Nicotine 4mg Gum contains nicotine resin which
when chewed, releases nicotine which is absorbed
through the lining of the mouth. This nicotine relieves
some of the cravings and unpleasant withdrawal
symptoms, such as feeling ill, anxious and irritable,
that smokers frequently feel when they try to give up
smoking or cut down the number of cigarettes smoked.

This medicine contains butylated hydroxytoluene, which
may cause local skin reactions (e.g contact dermatitis),
and local irritation to the eyes and mucous membranes.

When you are pregnant or breast-feeding it is best if
Nicotine 4mg Gum is used to help you stop smoking.
Using NRT is safer for you and your baby than
continuing to smoke. See the ‘If you are Pregnant or
Breast-feeding’ section for more information.

If you are Pregnant or Breast-feeding
If you are pregnant
• Smoking when you are pregnant is harmful to
your baby. If you are pregnant it is best to give
up smoking without using NRT. Stopping smoking
completely is the best option, and the earlier you
stop smoking the better it is for the health of you
and your baby
• If you can’t manage stopping smoking, using NRT is
a safer alternative than continuing to smoke.
However, you should ask for advice from your doctor,
nurse or pharmacist. Nicotine 4mg Gum may be
more suitable for use than patches as it can be used
intermittently. If you have nausea or sickness, patches
may be more suitable, however, if you do use patches
take them off before going to bed at night.

Nicotine 4mg Gum can be used to stop smoking
completely by replacing all of your cigarettes.
However, it can also be used to help:
• cut down the number of cigarettes you smoke,
for example, if you are unable to stop smoking
completely or want to replace certain cigarettes
• in situations where you do not wish to smoke to
avoid harming others, such as children or family
• in situations where you are unable to smoke, such
as at work or on public transport.
If possible, when giving up smoking, this medicated
chewing gum should be used with a stop smoking
behavioural support programme which will increase
your chances of success.

If you are breast-feeding
• If you are breast-feeding it is best if you stop
smoking without NRT
• If you do use NRT while breast-feeding, products
that are taken intermittently such as gum are best.
However, you should talk to your doctor, pharmacist
or nurse for more advice.
Try to breast-feed just before you take the gum,
when nicotine levels in your body are at their lowest.
That way your baby gets as little nicotine as possible.
If you do need to use NRT to help you stop smoking,
your baby may receive a smaller amount of nicotine
and this is less dangerous than breathing in secondhand smoke.
Tobacco smoke is harmful to babies and children,
causing breathing difficulties and other problems.

This pack contains medicated chewing gum which is
for smokers who smoke more than 20 cigarettes a day.
It is always better to stop smoking completely.
Smoking is harmful and has no health benefits. NRT
products like this medicated chewing gum can help
you stop smoking.
Any risks or possible side effects from NRT are much less
than the proven dangers of continuing to smoke, because
the chewing gum does not contain the tar, carbon
monoxide or other toxic chemicals in cigarette smoke.
Some people worry that, when they have stopped
smoking, they may become dependent on NRT
instead. This is very rare, and if it were to happen it is
still safer than continuing to smoke. It is also an easier
habit to break.

HOW TO TAKE ASDA NICOTINE REPLACE
4MG GUM

BEFORE YOU TAKE ASDA NICOTINE
REPLACE 4MG GUM

• The following instructions for use depend on whether
you are stopping smoking completely, cutting down
the number of cigarettes you smoke per day or if
you are going without cigarettes for a short time
• The 4mg chewing gums are suitable for people
who smoke 20 or more cigarettes per day
• The chewing gum may not be suitable for use if you
have false teeth, as it could stick to them and more
rarely, damage the dentures.

Do not take this medicine if you:
• are allergic to nicotine or any of the other ingredients
• are under 12 years of age. The level of nicotine in
NRT is not suitable for children under 12. Children
are more susceptible to the effects of nicotine, and it
could cause severe toxicity, which can be fatal.

Please turn over ➥

Asda Nicotine Replace 4mg Gum

BLACK

MAGENTA

YELLOW

Chewbacca

3

10168

L161 G

03/02/16

4006390

180x360mm

DH

TBC

Fertin Pharma

BLACK

PANTONE

PANTONE

877

485

CUTTER

VARNISH

BRAILLE

Adults and young people aged 12 years and over
Number of cigarettes
smoked per day

Dose of Gums

At the start of treatment the chewing gum may cause
a slight throat irritation, it may also cause an increase
in salivation. Occasionally, the chewing gum may stick
to, and rarely, it may damage dentures.

20 cigarettes or more

One gum as required to
manage cravings

Other side effects include:

• Do not use more than one piece of chewing
gum at a time
• Do not use more than 15 gums per day
• How frequently you use the gums will depend on
how many cigarettes you smoked and how
strong they were
How to chew your chewing gum
This is a special type of gum and is not like ordinary
chewing gum. Use it as follows:
• Chew 1 piece of medicated chewing gum for about
30 minutes with regular pauses
• It is important to chew the medicated chewing gum
slowly and with regular pauses to allow the nicotine
to be taken in through the lining of the mouth, and
also so that the nicotine is not released too quickly
• After 30 minutes dispose of the chewing gum carefully.
Stopping Smoking Completely
If you are able to stop smoking completely, use a
medicated chewing gum in place of cigarettes when
needed. As soon as you feel ready, you should reduce
the number of chewing gums you use until you are
able to stop taking them completely. It is important to
make every effort to stop smoking completely. But if
you do sometimes smoke a cigarette while using NRT,
don’t be discouraged – just keep going with your quit
attempt. It may help to talk to a healthcare professional
if you are finding your quit attempt difficult.
Cutting down the number of cigarettes smoked
per day
If you are unable to stop smoking completely or want
to replace certain cigarettes you should use Nicotine
4mg Gum in place of as many cigarettes as possible.
You may find it easier to quit completely later if you use
this gum to help you cut down on smoking first.
You can also use Nicotine 4mg Gum to help manage
your cravings in situations where you can’t or do not wish
to smoke, for example, at work or on public transport.
You are more likely to quit smoking when
using this product with help from your
pharmacist, doctor, a trained counsellor,
or a support programme.
If you are worried that you may start smoking again, talk
to a healthcare professional. They can advise you on
how to get the best results from further courses of NRT.
If you are finding it difficult to stop using NRT
completely, talk to a healthcare professional.
What should you do if you use too many gums?
If you take more than the recommended number of
gums, you may suffer a nicotine overdose and need to
get advice from your doctor. Signs of overdose include
headache, sickness, stomach pains and diarrhoea.
If a child has used or swallowed the gums
Contact a doctor or your nearest hospital casualty
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.
POSSIBLE SIDE EFFECTS
Sometimes there can be some side effects from giving
up smoking or using this chewing gum.
Some symptoms may be withdrawal symptoms
connected with stopping smoking and reducing the
amount of nicotine you are taking. These can be;
irritability or aggression, feeling low, anxiety,
restlessness, poor concentration, increased appetite or
weight gain, urges to smoke, night-time awakening,
sleep disturbance and lowering of heart rate.
Nicotine side effects can generally occur when taking
this chewing gum. These effects include; feeling faint,
feeling sick, headache and hiccupping (due to
excessive swallowing of nicotine).

Very common side effects (more than 1 in every 10
people are affected)
• headache
• stomach discomfort, hiccups and feeling sick
• sore mouth or throat
• jaw-muscle ache
Common side effects (less than 1 in every 10 people
are affected)
• dizziness
• sickness (vomiting)
Uncommon side effects (less than 1 in every 100
people are affected)
• irregular heartbeat (palpitations)
• hives (rashes)
• redness or itching of the skin
Rare side effects (less than 1 in 1000 people are
affected)
• Allergic reactions (swelling of the face, lips and
throat (angioedema) which may cause difficulty in
swallowing or breathing).
Very rare side effects (less than 1 in 10,000 people
are affected)
• Abnormal heart beats
If any of the side effects get serious, or if you notice
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
After stopping smoking you may develop mouth
ulcers; it is not known why this happens.
Reporting of side effects
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.
STORING ASDA NICOTINE REPLACE
4MG GUM
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date printed
on the pack.
Do not store above 25°C and store in the original
package. Keep blister in the outer carton to protect
from light.
Dispose of this medicine sensibly.
FURTHER INFORMATION
Your medicated chewing gum is a white, rectangular
shaped and coated piece of chewing gum.
The active ingredient is nicotine 4mg in the form of
a resin complex (nicotine resinate 26.5mg).
The other ingredients are: Gum Base (containing
butylated hydroxytoluene [E321]), Calcium Carbonate,
Xylitol, Sodium Carbonate Anhydrous, Acesulfame
Potassium, Sucralose, Peppermint, Coolmix,
L-Menthol, Talc, Maltitol (E965), Titanium Dioxide,
Maltitol liquid and Carnauba wax.
The gums are available in pack sizes of 10, 12, 20, 24,
30, 36, 48, 50, 80, 96 and 108 pieces of chewing
gum, although not all pack sizes may be marketed.
The Marketing Authorisation holder is
Wrafton Laboratories Limited, Wrafton, Braunton,
Devon, EX33 2DL, UK.
The manufacturer is: Fertin Pharma A/S, Vejle,
Denmark.
Text revised: February 2016.

PL 12063/0134

4006390

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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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