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NICOTINELL MINT 1MG COMPRESSED LOZENGES

Active substance(s): NICOTINE BITARTRATE DIHYDRATE / NICOTINE BITARTRATE DIHYDRATE / NICOTINE BITARTRATE DIHYDRATE

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Package leaflet: Information for the user

MINT 1 mg

Compressed Lozenge

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
­­
Mint 1 mg lozenge carefully to get the best results from it.

Pharma code 2538

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or
advice.
• You must contact a doctor if you still need to use
­­Nicotinell lozenge after 9 months.
• 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 Mint lozenge is and what it is used for
2. Before you take Nicotinell
­­
Mint lozenge
3. How to take Nicotinell
­­
Mint lozenge
4. Possible side effects
5. How to store Nicotinell
­­
Mint lozenge
6. Contents of the pack and other information

1. What ­Nicotinell Mint lozenge is and
what it is used for
­ icotinell Mint lozenge contains nicotine, which is one of
N
the substances contained in tobacco.
AWF 25136 – OTDC 410926
NIC LOZ MINT 1 MG GB_936287_PIL
145 x 400 mm – Recto/Verso
2538 (Mini)
P Reflex Blue U
Helvetica Neue LT Pro – Avant Garde Gothic ITC – Akzidenz Gothic
Text body: 8 pts

SwissCo AG – CH
2.0708.1031-01

Pre-press

Diadeis Suisse S.A. – DO-16-E0923 – 28.04.2016

Proof Z

Important information about some of the ingredients
of ­Nicotinell Mint lozenge
­ icotinell Mint lozenges contain sweeteners, including
N
aspartame and maltitol.
Each ­Nicotinell Mint 1 mg lozenge contains aspartame
(E951), a source of phenylalanine equivalent to 5 mg per
piece and may be harmful for people with phenylketonuria.
Because ­Nicotinell Mint 1 mg lozenge contains maltitol
(E965), a source of fructose:
–– if you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine,
–– patients may experience a mild laxative effect.
Calorific value 2.3 kcal/g maltitol. ­Nicotinell Mint lozenge
ingredients are suitable for diabetics.
­ icotinell Mint 1 mg lozenge contains 9.8 mg of sodium
N
per piece. To be taken into consideration by patients on a
controlled sodium diet.

3. How to take ­Nicotinell Mint lozenge
Always take ­Nicotinell Mint lozenge exactly as stated in
this package leaflet. You should check with your doctor
or pharmacist if you are not sure.

When sucked, nicotine is released slowly and absorbed
through the lining of the mouth.
This medicinal product is used to help people to stop
smoking. The nicotine in N
­ icotinell Mint relieves nicotine
withdrawal symptoms and cravings when you stop
smoking or temporarily reduce smoking in order to facilitate smoking cessation. By relieving the withdrawal
symptoms and cravings ­Nicotinell Mint counteracts a
smoking relapse in smokers who are motivated to stop
smoking.

­ icotinell Mint lozenge is available in two strengths:
N
1 and 2 mg.
­ icotinell Mint 1 mg lozenge is recommended in low to
N
moderate nicotine dependent smokers. It is not recommended for smokers with a strong or very strong nicotine dependency.
­ icotinell Mint 1 mg lozenge can be used alone or in
N
combination with ­Nicotinell patches.

Patient counselling and support normally improve the
success rate.

Adults over 18 years
Treatment with ­Nicotinell Mint lozenges only

­ icotinell is indicated for smokers aged 18 years and
N
above.

Select your optimal dosage from the following table:
Strong
Moderate
Low
to strong to very strong
to moderate
dependency dependency dependency
Low dosage
forms acceptable

2. Before you take ­Nicotinell Mint lozenge
400 mm

Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

This medicine product belongs to a group of medicines
which are used to help you to stop smoking.

Driving and using machines
There is no evidence of risk associated with driving or
operating machinery if the lozenge is taken according to
the recommended dose but remember that smoking
cessation can cause behavioural changes.

Do not take ­Nicotinell Mint lozenge
• If you are allergic (hypersensitive) to nicotine or any of
the other ingredients of N
­ icotinell Mint lozenge.
• If you are a non-smoker.
Take special care with N
­ icotinell Mint lozenge
Please check with your doctor or pharmacist before taking N
­ icotinell if you have:
• heart disease, e.g. heart attack, heart failure, angina,
Prinzmetal’s angina or abnormalities in heart beat
rhythm,
• had a “stroke” (cerebrovascular accident),
• high blood pressure (uncontrolled hypertension),
• problems with your circulation,
• diabetes,
• overactive thyroid glands (hyperthyroidism),
• overactive adrenal glands (pheochromocytoma),
• kidney or liver disease,
• oesophagitis, inflammation in the mouth or throat,
gastritis or peptic ulcer.
Even small quantities of nicotine are dangerous in children and may result in severe symptoms or death. It is
therefore essential that you keep ­Nicotinell Mint lozenge
out of reach and sight of children at all times.
Children and adolescents (below 18 years)
­Nicotinell should not be used by people under 18 years
of age without recommendation from a doctor.
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. If you stop smoking and if you are using other medicines, your doctor
may want to adjust the dose.
No information is available on interactions between
­Nicotinell lozenge and other medicines. However, apart
from nicotine, other substances in cigarettes may have
an effect on certain medicine.
Stopping smoking can affect the action of certain medicines e.g.:
• theophyllin (a medicine used for the treatment of bronchial asthma)
• tacrine (medicine used to treat Alzheimer’s disease)
• olanzapine and clozapine (for the treatment of schizophrenia)
• Insulin dose (medicine used for the treatment of diabetes) may need to be adjusted.
Taking N
­ icotinell Mint lozenge with food and drink
Coffee, acidic and soft drinks may decrease the absorption of nicotine and should be avoided for 15 minutes
before sucking a lozenge.
It is very important to stop smoking during pregnancy
because it can result in poor growth of your baby. It can
also lead to premature births and even stillbirths. Ideally
you should try to give up smoking without the use of
medicines. If you cannot manage this, ­Nicotinell may be
recommended to help as the risk to the developing baby
is less than that expected from continued smoking. Nicotine in any form may cause harm to your unborn baby.
­Nicotinell should only be used after consulting the

Over
From 20 to
Less than
20 cigarettes / 30 cigarettes / 30 cigarettes /
day
day
day
Treatment 1 mg lozenge Low (1 mg 2 mg lozenge
is preferable lozenge) or is preferable
with
high (2 mg
­Nicotinell
lozenge) dose
Mint
forms
lozenge
depending on
only
patient characteristics and
preference
If an adverse event occurs with the use of the high dose
(2 mg lozenge), use of the low dose (1 mg lozenge)
should be considered.
Instructions for use:
Do not swallow the lozenge.
1. Suck a lozenge until the taste becomes strong.
2. Allow the lozenge to rest between your gum and
cheek.
3. Suck again when the taste has faded.
4. Repeat this routine until the lozenge dissolves completely (about 30 minutes).
Dosage for adults over 18 years:
Suck one lozenge when you feel the urge to smoke. In
general one lozenge should be taken every one or two
hours. Normally 8-12 lozenges per day are sufficient. If
you still experience an urge to smoke, you can suck
additional lozenges. Do not exceed 30 lozenges per day
of the 1 mg strength (applies for both smoking cessation
and smoking reduction).
­ icotinell lozenge should primarily be used for smoking
N
cessation.
Smoking cessation:
To improve your chances of giving up smoking you
should stop smoking completely when you start to use
the lozenges and for the whole treatment period.
The treatment duration is individual. Normally, treatment
should continue for at least 3 months. After 3 months,
you should gradually reduce the number of lozenges
used each day. Treatment should be stopped when you
have reduced your use of the lozenge to 1-2 lozenges
per day. It is generally not recommended to use
­Nicotinell Mint lozenge for longer than 6 months. However, some ex-smokers may need treatment with the
lozenge for longer to avoid returning to smoking.
If you are still using the lozenge after 9 months, you
should speak to your doctor or pharmacist.
Counselling may improve your chances of giving up
smoking.
Smoking reduction:
­ icotinell lozenge should be used between periods of
N
smoking in order to prolong smoke-free intervals and

145 mm

80 mm

Pregnancy and breast-feeding

High dosage
forms acceptable

Pharma code 2538

80 mm

NICOTINE

healthcare professional who is managing your pregnancy, or a doctor that is specialised in helping people
quit smoking.
­Nicotinell like smoking itself should be avoided during
breast-feeding as nicotine may be found in breast milk. If
your doctor has recommended you to use ­Nicotinell Mint
lozenge during breast-feeding, the lozenge should be
sucked just after breast-feeding and not during the two
hours before breast-feeding.

with the intention to reduce smoking as much as possible. The number of cigarettes should be gradually
replaced by N
­ icotinell lozenge. If, after 6 weeks, you
have not succeeded in reducing the number of cigarettes
per day to at least half of your consumption you should
seek professional help. You should try to stop smoking as
soon as you feel ready, but not later than 4 months after
you started using N
­ icotinell lozenges. After that the number of lozenges should be gradually reduced, for example
by quitting one lozenge every 2-5 days.
If you do not succeed in making a serious attempt to
stop smoking within 6 months you should seek professional help. Regular use of ­Nicotinell lozenge beyond
6 months is generally not recommended. Some exsmokers may need treatment with the lozenges for longer to avoid returning to smoking.
Counselling may improve your chances of giving up
smoking.
Treatment with N
­ icotinell Mint 1 mg lozenge in combination with N
­ icotinell transdermal patches

Pharma code 2538

Smoking cessation:
If you have failed treatment with only ­Nicotinell lozenge
you can use N
­ icotinell patches together with ­Nicotinell
1 mg lozenge.
NOTE: Read the package leaflet of N
­ icotinell transdermal patch prior to use.
To improve your chances of giving up smoking you
should stop smoking completely when you start to use
the lozenges in combination with ­Nicotinell patches and
for the whole treatment period.
The use of N
­ icotinell patches together with ­Nicotinell
1 mg lozenge is recommended for smokers with moderate to very strong dependency, i.e. over 20 cigarettes per
day. It is strongly recommended that the combination
therapy is carried out with the advice and support from a
health care professional.

Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 25136 – OTDC 410926
NIC LOZ MINT 1 MG GB_936287_PIL
145 x 400 mm – Recto/Verso
2538 (Mini)
P Reflex Blue U
Helvetica Neue LT Pro – Avant Garde Gothic ITC – Akzidenz Gothic
Text body: 8 pts

SwissCo AG – CH
2.0708.1031-01

Pre-press

Diadeis Suisse S.A. – DO-16-E0923 – 28.04.2016

The combination therapy should only be used in smoking
cessation.
Initial combination therapy:
Begin the treatment with one patch 21 mg/24 hours in
combination with ­Nicotinell 1 mg lozenge. Use at least
4 lozenges (1 mg) per day. In most cases, 5-6 lozenges
are enough. Do not use more than 15 lozenges a day. In
normal cases, the treatment may last for 6-12 weeks.
Thereafter, you should reduce the nicotine dose gradually.
Apply the patch on a clean, dry, hairless, intact area of
skin on the trunk, arms or hips and press it against the
skin with your hand for 10-20 seconds.

400 mm

Like all medicines, ­Nicotinell Mint lozenges can cause
side effects, although not everybody gets them.
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 (affects 1 to 10 users in 100)
• dizziness and headache.
• dryness of the mouth, hiccups, stomach trouble such
as nausea, flatulence, heartburn, increased saliva
production and irritation of the mouth and throat may
also occur, especially as a result of intense sucking.
Slower sucking will usually overcome these problems.
Uncommon side effects (affects 1 to 10 users in 1,000)
• palpitations.
Rare side effects (affects 1 to 10 users in 10,000)
• disturbances in heart beat rhythm and allergic reactions. These reactions may in very few cases be serious. You should see your doctor immediately if you
experience symptoms such as swollen face, tongue
and/or pharynx and/or difficulty to swallow or hives
together with difficulty breathing (angioedema).
Mouth ulcers may occur when trying to quit smoking,
but the relationship to the nicotine treatment is not clear.
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.
Reporting of side effects
If you get any side effects, talk to your pharmacist. 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. How to store ­Nicotinell Mint lozenge
Keep out of the reach and sight of children.
Do not use ­Nicotinell after the expiry date which is stated
on the label after “EXP”. The expiry date refers to the last
day of that month.
Do not store above 25 °C.
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.

6. Contents of the pack and other
information

To minimize the risk of local irritation the placement of
­Nicotinell patches, alternate between different application sites.

Proof Z

4. Possible side effects

What ­Nicotinell Mint lozenge contains
–– The active substance is nicotine
Each piece of ­Nicotinell Mint lozenge contains 1 mg of
nicotine (as 3.072 mg nicotine bitartrate dihydrate).

Wash your hands thoroughly after application of transdermal patches to avoid irritation of the eyes with nicotine from the fingers.
Reduction of nicotine dose after the initial 6-12 weeks:
This can be done in two ways.
Alternative 1:
Use patches of a lower strength, i.e. 14 mg/24 hours
patches for 3-6 weeks followed by 7 mg/24 hours for
another 3-6 weeks together with the initial dose of
­Nicotinell 1 mg lozenge. Thereafter, reduce the number of
lozenges gradually. It is generally not recommended to
use N
­ icotinell Mint lozenge for longer than 6 months.
However, some ex-smokers may need treatment for
longer to avoid returning to smoking but it should not be
more than 9 months.
Alternative 2:
Discontinue the use of the patch and reduce the number
of 1 mg lozenges gradually. It is generally not recommended to use N
­ icotinell Mint lozenge for longer than
6 months. However, some ex-smokers may need treatment for longer to avoid returning to smoking but it
should not be more than 9 months.
Recommended dosage:
Period
Patches
Lozenge 1 mg
Initial treatment
(followed by alternative 1 or 2 below)
First
1 patch
When necessary, 5-6 loz6-12 weeks 21 mg/24 hours enges per day is recommended
Reduction of nicotine dose – alternative 1
Next
1 patch
Continue to use lozenges,
3-6 weeks 14 mg/24 hours when necessary
Following 1 patch
Continue to use lozenges,
3-6 weeks 7 mg/24 hours when necessary

Reduce the number
Up to
of lozenges gradually
9 months
in total
Reduction of nicotine dose – alternative 2

Continue to reduce
Up to
the number
9 months
of lozenges gradually
in total

–– The other ingredients are maltitol (E965), sodium carbonate anhydrous, sodium hydrogen carbonate, polyacrylate, xanthan gum, colloidal anhydrous silica, levomenthol, peppermint oil, aspartame (E951),
magnesium stearate.
What ­Nicotinell Mint lozenge looks like and contents
of the pack
­ icotinell Mint lozenge is a white, mint flavoured, round
N
biconvex compressed lozenge.
­ icotinell Mint lozenge is available in two strengths
N
(1 and 2 mg). This package leaflet deals with ­Nicotinell
Mint 1 mg lozenges.
The blisters are packed in boxes containing 12, 36, 72,
96, 144 or 204 lozenges. Not all pack sizes may be marketed.
Marketing Authorisation Holder
GlaxoSmithKline Consumer Healthcare (UK)
Trading Limited, Brentford, TW8 9GS, U.K.
Manufacturer
GlaxoSmithKline Consumer Healthcare (UK)
Trading Limited, Brentford, TW8 9GS, U.K.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria
Denmark
Finland
France

If you are still using the lozenge and patches after
9 months, you should speak to your doctor or pharmacist.
If you take more N
­ icotinell Mint lozenges than you
should

This leaflet was last revised in March 2016.
80 mm

Sucking too many lozenges can result in the same symptoms as smoking too much. The general symptoms of
nicotine overdose include weakness, sweating, increased
production of saliva, throat burn, nausea, vomiting, diarrhoea, pain in the abdomen, disturbance of hearing and
vision, headache, fast or other disturbance in heart beat,
shortness of breath and circulatory problems.
You should consult your doctor or pharmacist if you
experience any problems.
If poisoning is suspected in a child, a doctor must be
consulted immediately. Even small quantities of nicotine
are dangerous in children and may result in severe
symptoms or death.
If you have any further questions on the use of this pro­
duct, ask your doctor or pharmacist.

­ icotinell Mint 1 mg Lutschtabletten
N
­Nicotinell Mint 1 mg Sugetablet
­Nicotinell Mint 1 mg Imeskelytabletti
­Nicotinell Menthe 1 mg, comprimé à
sucer
Germany
­Nicotinell Lutschtabletten 1 mg Mint
Hungary
­Nicotinell Mint 1 mg Szopogató tabletta
Iceland
­Nicotinell mint 1 mg Munnsogstafla
Ireland
­Nicotinell Mint 1 mg compressed Lozenge
Luxembourg
­Nicotinell Mint 1 mg, comprimé à sucer
Netherlands
­Nicotinell Mint 1 mg Zuigtablet
Norway
­Nicotinell Mint 1 mg sugetablett, komprimert
Portugal
­Nicotinell Mint 1 mg Pastilhas
Spain
­Nicotinell Mint 1 mg comprimidos para
chupar
Sweden
­Nicotinell Mint 1 mg sugtablett
United Kingdom ­Nicotinell Mint 1 mg Lozenge

Pharma code 2538

80 mm

Verso

GB 936287
2.0708.1031-01

145 mm

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.

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