Skip to Content

UK Edition. Click here for US version.

NICOTINELL CLASSIC 4MG MEDICATED CHEWING GUM

Active substance(s): NICOTINE / NICOTINE / NICOTINE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

20 mm

63 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

NICOTINE

CLASSIC 2 mg
CLASSIC 4 mg

Medicated chewing-gums

Pharma code XXXX

Order DO
Reference
Format
Pharma code
Colour
Font
Min. font size
Reference MKT
Production site

3000539712 - AWF 18279 - OTDC 305651
NIC GUMS CLASSIC GB_307857A_PIL
155 x 385 mm – Recto/Verso
XXXX
P Reflex Blue U
Helvetica Neue LT Pro, Avant Garde Gothic, Berthold Akzidenz Grotesk
9 pt

Reference SITE

Famar Greece
(Print Z)
XXXXXXXX

Pre-press

la sooris s.à.r.l.: NIC GUMS CLASSIC GB_307857A_PIL – 18.07.2013

Draft A

Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to use Nicotinell chewinggum carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your doctor, nurse or pharmacist if you need
more information or advice.
• If any of the side effects gets serious, or if you
notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Nicotinell chewing-gum is and what it is
used for
2. Before you take Nicotinell chewing-gum
3. How to take Nicotinell chewing-gum
4. Possible side effects
5. How to store Nicotinell chewing-gum
6. Further information
1 What Nicotinell chewing-gum is and what it
is used for
Nicotinell medicated chewing-gum is a nicotine
replacement therapy (NRT) which is used to help
you to stop smoking. It is available in two strengths
(2 mg and 4 mg) and five flavours (Fruit, Mint,
Icemint, Liquorice and Classic). This leaflet is for
Nicotinell Classic 2 mg and 4 mg medicated
chewing-gums.
The chewing-gum contains nicotine, which is one of
the substances contained in tobacco. When chewed,
nicotine is released slowly and absorbed through the
lining of the mouth. Nicotinell chewing-gum does not
contain the other harmful substances found in
tobacco smoke such as tar and carbon monoxide.
Nicotinell 2 mg and 4 mg gums can be used to help you:
• stop smoking completely
• cut down the amount you smoke - perhaps
before you go on to stop completely.
In addition, they may be used when you:
• do not wish to smoke. For example in confined
spaces (in the car; in the house) or where others
(such as children) could be harmed by tobacco
smoke
• are unable to smoke
• develop cravings once you have stopped smoking
Reducing the number of cigarettes smoked can
increase the chances that you will move on to quit
completely.
Nicotinell 2 mg gum is for smokers smoking less
than 20 cigarettes per day.
If you smoke more than 30 cigarettes per day, or if
you have previously failed to stop smoking with the
aid of nicotine replacement therapy, you should use
Nicotinell 4 mg medicated chewing-gum.
If you smoke between 20 and 30 cigarettes per
day, you can use either strength of gum.
Smokers of more than 20 cigarettes per day, who
are reducing their smoking prior to a quit attempt,
should use Nicotinell 2 mg gums once they have
successfully reduced the number of cigarettes
smoked per day.
Nicotinell 2mg and 4mg gums can also be used to
relieve breakthrough cravings of smokers attempting to quit by following a patch programme.
You might feel a sudden craving to smoke long
after you have given up smoking and stopped using
Nicotinell gums.Remember you can use any
nicotine replacement therapy again if this should
happen.
If you need advice before starting to use Nicotinell
gum, talk to your doctor, nurse, pharmacist or
trained counsellor.

To help quit smoking you should also try to use a
behavioural support programme to increase your
chances of success. Talk to your doctor, nurse,
pharmacist or a trained counsellor about this.
2 Before you take Nicotinell chewing-gum
Do NOT take Nicotinell chewing-gum if you are
• allergic (hypersensitive) to nicotine or any of the
other ingredients of the chewing-gum
• a non-smoker or occasional smoker
• under 12 years of age, except on the advice of
a doctor.
Take special care with Nicotinell chewing-gum
Please speak with your doctor, nurse or pharmacist
before taking the chewing-gum if you:
• have heart disease, (e.g. heart attack, disorders
of the heart rate and/or rhythm)
• have or had a stroke
• have serious liver or kidney disease
• have or had a stomach ulcer
• have persistent indigestion
• have a severe sore throat or inflammation of
the mouth
• are diabetic (see next section)
• have an overactive thyroid gland
• have a tumour of the adrenal glands
(pheochromocytoma)
• have fructose intolerance
• are on a low-sodium diet
• are taking any other medicines (see next
section)
• are pregnant or breast-feeding (see
Pregnancy/Breast-feeding sections).
Some denture wearers may experience difficulty in
chewing the gum. If you do, it is recommended
that you use a different form of nicotine replacement
therapy, such as a patch or lozenge. Ask your
doctor or pharmacist for advice.
Using nicotine replacement therapy is better than
continuing to smoke.
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 effect of some medicines can be altered when
you stop smoking.
• If you are already taking regular medication
you should tell your doctor, nurse or pharmacist.
• Diabetics should monitor their blood sugar
levels more often than usual when taking
chewing gum because your insulin/medication
requirements may alter.
Taking Nicotinell chewing-gum with food and drink
Coffee, juices, acidic and fizzy drinks may reduce
the absorption of nicotine and should not be taken
for 15 minutes before chewing the gum.
Pregnancy
Smoking during pregnancy is associated with risks
such as poor growth of the baby before birth,
premature birth or still birth. Stopping smoking is
the single most effective way to improve both your
health and that of your baby. The earlier smoking
stops, the better.
Ideally, stopping smoking during pregnancy should
be done without nicotine replacement therapy.
However, if you have tried and this is not possible,
nicotine replacement therapy may be used
because the risk to the developing baby is less
than that expected from continued smoking.
The decision to use nicotine replacement therapy
should be made as early on in the pregnancy as

ON FOR THE USER

Driving and using machines
The chewing gum is unlikely to affect your ability
to drive or operate machinery.
Important information about some of the
ingredients of Nicotinell Medicated chewinggum
These chewing-gums contain some ingredients of
which you may need to be aware of:
• sorbitol and maltitol liquid: if you have been
told by your doctor that you have an intolerance
to some sugars, contact your doctor before
taking this medicine.
Each piece contains 0.2 g sorbitol and
0.03g maltitol liquid, a source of 0.04 g
fructose. Calorific value 0.1 kcal/2mg piece and
1.2 kcal/4mg piece.
• sodium: 11.50 mg per 2 mg piece and 11.52 mg
per 4 mg piece. To be taken into consideration by
those on a controlled sodium diet.
• butylhydroxytoluene (E321): may cause local
irritation to lining of the mouth.
For other ingredients see Section 6.

STOP using Nicotinell chewing gum and seek
medical attention immediately if you experience
the rare serious side effects listed below:
• allergic reactions which include swelling of the
skin, swelling of the face and mouth, low blood
pressure and difficulty in breathing.
Some effects you may notice in the first few days
are dizziness, headache and sleep disturbances.
These may be withdrawal symptoms in connection
with smoking cessation and may be caused by
insufficient administration of nicotine.
Common side effects (occur in 1 to 10 users in 100)
• dizziness and headache.
• Hiccups, stomach trouble such as nausea,
flatulence, vomiting, heartburn, increased saliva
production, irritation of the mouth and throat and
jaw muscle ache may also occur, especially as a
result of intense chewing. Check that you are
following the correct chewing technique if you
experience these effects.
Uncommon side effects (occur in 1 to 10 users in
1,000)
• palpitations.
• red skin rash (erythema) and itching of raised
bumps of the skin (urticaria).
Rare side effects (occur in 1 to 10 users in 10,000)
• disturbances in heart beat rhythm
The chewing-gum can stick to and very rarely
damage dentures or other dental work.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you can
call Freephone 0808 100 3352 (available from 10
a.m. to 2 p.m. Mondays to Fridays) or fill in a paper
form available from your local pharmacy.

3 How to take Nicotinell chewing-gum

5 How to store Nicotinell chewing-gum

possible with the aim of discontinuing use after
2-3 months.
Ask your doctor for advice before taking any
medicine.

LASSIC 2 mg
LASSIC 4 mg

edicated chewing-gums

Order DO

3000539712 - AWF 18279 - OTDC 305651

To help
smoking
you
should also try to use a
NIC quit
GUMS
CLASSIC
GB_307857A_PIL
behavioural
support
programme
to increase your
155 x 385 mm – Recto/Verso
Pharma code chances
XXXX of success. Talk to your doctor, nurse,
out prescription.
pharmacist
or a Utrained counsellor about this.
Colour
P Reflex Blue
Nicotinell chewingFont
Helvetica Neue LT Pro, Avant Garde Gothic, Berthold Akzidenz Grotesk
sults from it. Min. font size
9 pt
2 Before
you take Nicotinell chewing-gum
Reference MKT
ed to read it again.
Do NOT
take
Nicotinell chewing-gum if you are
Production site
Famar
Greece
armacist if you need
(Print Z)
• allergic (hypersensitive) to nicotine or any of the
Reference SITE
XXXXXXXX
other
ingredients of the chewing-gum
serious, or if you

a
non-smoker
smoker
ed in this leaflet,
Pre-press
la sooris s.à.r.l.: or
NICoccasional
GUMS CLASSIC
GB_307857A_PIL – 18.07.2013
• under 12 years of age, except on the advice of
rmacist.
a doctor.

lly because itReference
on for you. Format

DraftTake
Aspecial care with Nicotinell chewing-gum

m is and what it is

hewing-gum
ing-gum

wing-gum

gum is and what it

gum is a nicotine
ch is used to help
ble in two strengths
urs (Fruit, Mint,
This leaflet is for
mg medicated

tine, which is one of
acco. When chewed,
absorbed through the
ewing-gum does not
ances found in
carbon monoxide.
an be used to help you:

oke - perhaps
pletely.
when you:
ample in confined
se) or where others
armed by tobacco

ave stopped smoking
tes smoked can
will move on to quit

kers smoking less

arettes per day, or if
op smoking with the
rapy, you should use
wing-gum.
0 cigarettes per
h of gum.
ettes per day, who
r to a quit attempt,
ms once they have
er of cigarettes

can also be used to
f smokers attemptprogramme.
g to smoke long
g and stopped using
can use any
gain if this should

ng to use Nicotinell
pharmacist or

Please speak with your doctor, nurse or pharmacist
before taking the chewing-gum if you:
• have heart disease, (e.g. heart attack, disorders
of the heart rate and/or rhythm)
• have or had a stroke
• have serious liver or kidney disease
• have or had a stomach ulcer
• have persistent indigestion
• have a severe sore throat or inflammation of
the mouth
• are diabetic (see next section)
• have an overactive thyroid gland
• have a tumour of the adrenal glands
(pheochromocytoma)
• have fructose intolerance
• are on a low-sodium diet
• are taking any other medicines (see next
section)
• are pregnant or breast-feeding (see
Pregnancy/Breast-feeding sections).
Some denture wearers may experience difficulty in
chewing the gum. If you do, it is recommended
that you use a different form of nicotine replacement
therapy, such as a patch or lozenge. Ask your
doctor or pharmacist for advice.
Using nicotine replacement therapy is better than
continuing to smoke.
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 effect of some medicines can be altered when
you stop smoking.
• If you are already taking regular medication
you should tell your doctor, nurse or pharmacist.
• Diabetics should monitor their blood sugar
levels more often than usual when taking
chewing gum because your insulin/medication
requirements may alter.
Taking Nicotinell chewing-gum with food and drink
Coffee, juices, acidic and fizzy drinks may reduce
the absorption of nicotine and should not be taken
for 15 minutes before chewing the gum.
Pregnancy
Smoking during pregnancy is associated with risks
such as poor growth of the baby before birth,
premature birth or still birth. Stopping smoking is
the single most effective way to improve both your
health and that of your baby. The earlier smoking
stops, the better.
Ideally, stopping smoking during pregnancy should
be done without nicotine replacement therapy.
However, if you have tried and this is not possible,
nicotine replacement therapy may be used
because the risk to the developing baby is less
than that expected from continued smoking.
The decision to use nicotine replacement therapy
should be made as early on in the pregnancy as

Breast-feeding
It is better to use nicotine replacement therapy
products that can be taken intermittently (not
patches). Try to breast-feed at a time just before
you take the product to ensure that the baby gets
the smallest amount of nicotine possible.
If you need to use nicotine replacement therapy to
help you give up smoking, the amount of nicotine
that the baby may receive is considerably smaller
and less harmful than the second-hand smoke
they would otherwise be breathing in.

Chew one piece of gum when you feel the urge to
smoke. It is important to chew the gum correctly,
not like ordinary chewing-gum. Follow the
instructions below and do NOT swallow the gum:
Chewing technique:
1. Chew one piece of gum slowly until the taste
becomes strong.
2. Rest between your gum and cheek.
3. Chew again when taste has faded.
4. Repeat this chewing routine for about 30
minutes.
Most people use 8 – 12 pieces of gum a day.
Do NOT use more than 1 piece of gum at a time
or more than 25 pieces of 2 mg gum, or 15 pieces
of 4 mg gum a day.
Remember not to drink certain drinks 15 minutes
before chewing the gum (see Section 2).
The gum can stick to and very rarely damage
dentures or other dental work. You may prefer to
use a patch or lozenge.
After 3 months, you should try to gradually reduce
the number of pieces of gum chewed each day.
You should stop using the gum when you are only
taking 1-2 pieces of gum per day.
For the relief of breakthrough cravings:
If you are attempting to quite smoking using a
patch programme, you can use these gums to
relieve any breakthrough cravings your may
experience. Chew one piece of gum if you feel the
need to smoke. Counselling may improve your
chances of giving up smoking.
Children and adolescents (12 -18 years) should
only use the gum for 12 weeks. If longer is
required then talk to your doctor, nurse or
pharmacist.
Children under 12 years should not use the gum
unless advised by a doctor.
If you take more Nicotinell chewing-gums than
you should
If you accidentally take too many, or if a child has
eaten any, contact your doctor or nearest hospital
casualty department immediately, take the pack
or leaflet with you if possible.
The general symptoms of nicotine overdose
include:
• headache, sickness, diarrhoea and stomach
pains
If you forget to use Nicotinell chewing-gums
Only chew the gum when you need to. Do NOT
use more than 1 piece of gum at a time or more
than 25 pieces of 2 mg gum , or 15 pieces of 4 mg
gum a day.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, Nicotinell chewing-gums can
cause side effects, although not everybody gets them.

Keep out of the reach and sight of children.
Do not use Nicotinell gums after the expiry date
which is stated on the blister pack and box after
“EXP”. The expiry date refers to the last day of that
month.
Do not store above 25°C.
To dispose of used gum, wrap in paper before
putting into a waste bin. Ask your pharmacist how
to dispose of medicines no longer required. These
measures will help to protect the environment.
6 Further information
What Nicotinell chewing-gum contains
The active substance is nicotine.
Each piece of 2 mg gum contains 2 mg of nicotine
in a resin complex (as 10 mg nicotine polacrilin).
Each piece of 4 mg gum contains 4 mg of nicotine
in a resin complex (as 20 mg nicotine polacrilin).
The other ingredients are
• gum base, calcium carbonate (E170), sorbitol
(E420), sodium carbonate anhydrous, sodium
hydrogen carbonate (E500), glycerol (E422),
levomenthol, fruit flavouring, butylhydroxytoluene
(E321), xylitol (E967), mannitol (E421), gelatin,
titanium dioxide (E171), carnauba wax (E903),
talc (E553b) and water.
See section 2 for further ingredient information.
Nicotinell Classic medicated chewing gum contains
a reduced amount of flavourings and is specifically
recommended if you prefer the classic nicotine
taste.
Nicotinell gum is sugar-free.
What Nicotinell chewing-gum looks like and
contents of the pack
Each piece of chewing-gum is off-white in colour
and rectangular in shape.
The Classic 2 mg and 4 mg Gums are packed in
blisters inside boxes containing 24, 96 and 120
pieces of gum. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Consumer Health, Camberley, GU15 3YL, UK.
Manufacturer
FAMAR S.A., 48th km Athens-Lamia, 19011, Avlona,
Greece.
Help/Advice
You can also find additional information and support
@ www.smokefree.nhs.uk or by calling the NHS
helpline on 0800 0224322.
This leaflet was last approved in June 2013.

GB_307857 - xxxxxxxx

Expand Transcript

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.

Hide