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NICOTINELL MINT 2MG COMPRESSED LOZENGES

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

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Recto

Pre-press

Diadeis Suisse S.A. – DO-16-E0908 – 27.04.2016

Package leaflet: Information for the user

NICOTINE

MINT 2 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 2 mg lozenge carefully to get the best results from it.

Proof Z
Pharma code 2561

• 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

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.

1. What Nicotinell Mint lozenge is and
what it is used for

Important information about some of the ingredients
of Nicotinell Mint lozenge

Nicotinell Mint lozenge contains nicotine, which is one
of the substances contained in tobacco.

Nicotinell Mint lozenges contain sweeteners, including
aspartame and maltitol.

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

Each Nicotinell Mint 2 mg lozenge contains aspartame
(E951), a source of phenylalanine equivalent to 5 mg
per piece and may be harmful for people with phenylketonuria.

When sucked, nicotine is released slowly and absorbed
through the lining of the mouth.
This medicinal product is used to to help people to stop
smoking. The nicotine in Nicotinell 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.

400 mm

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
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.

Patient counselling and support normally improve the
success rate.

Because Nicotinell Mint 2 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.
Nicotinell Mint 2 mg lozenge contains 9.8 mg of sodium
per piece. To be taken into consideration by patients on
a controlled sodium diet.

Nicotinell is indicated for smokers aged 18 years and
above.

2. Before you take Nicotinell Mint lozenge
Do not take Nicotinell Mint lozenge
• If you are allergic (hypersensitive) to nicotine or any
of the other ingredients of Nicotinell Mint lozenge.
• If you are a non-smoker.
Take special care with Nicotinell Mint lozenge
Please check with your doctor or pharmacist before
taking Nicotinell 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.

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.
Nicotinell Mint lozenge is available in two strengths:
1 and 2 mg. The appropriate dose will depend on your
previous smoking habits. You should use the 2 mg
­Nicotinell Mint lozenge if:
• you are a smoker with a strong or very strong nicotine
dependency,
• you have previously failed to stop smoking with the
1 mg lozenge,
• your withdrawal symptoms remain so strong as to
threaten relapse.
Otherwise 1 mg Nicotinell Mint lozenge should be used.
Adults over 18 years
Select your optimal dosage from the following table:
Low to moderate
dependency

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.

Strong to very strong
dependency

Low dosage forms acceptable
High dosage forms acceptable

Children and adolescents (below 18 years)
Nicotinell should not be used by people under 18 years
of age without recommendation from a doctor.

Less than
20 cigarettes / day

From 20 to
30 cigarettes / day

Over 30 cigarettes /
day

1 mg lozenge
is preferable

Low (1 mg lozenge) or
high (2 mg lozenge)
dose forms
depending on patient
characteristics and
preference

2 mg lozenge
is preferable

Taking other medicines

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.
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).

Pregnancy and breast-feeding

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 15 lozenges per day
of the 2 mg strength (applies for both smoking cessation
and smoking reduction).

It is very important to stop smoking during pregnancy
because it can result in poor growth of your baby. It can

Nicotinell lozenges should primarily be used for smoking
cessation.

Taking Nicotinell 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.

145 mm

80 mm

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.

Moderate to strong
dependency

Pharma code 2561

AWF 25118 – OTDC 410854
NIC LOZ MINT 2 MG GB_936256_PIL
145 x 400 mm – Recto/Verso
2561 (mini)
P Reflex Blue U
Helvetica Neue LT Pro – ITC Avant Garde Gothic – Akzidenz Grotesk Pro
Text body: 8 pts

SwissCo AG – CH
2.0742.1031-01

80 mm

Order – AWF
Reference
Format
Pharma code
Colour
Font
Min. fonte size
Reference MKT
Production site
Reference Site

AWF 25118 – OTDC 410854
NIC LOZ MINT 2 MG GB_936256_PIL
145 x 400 mm – Recto/Verso
2561 (mini)
P Reflex Blue U
Helvetica Neue LT Pro – ITC Avant Garde Gothic – Akzidenz Grotesk Pro
Text body: 8 pts

SwissCo AG – CH
2.0742.1031-01

Pre-press

Diadeis Suisse S.A. – DO-16-E0908 – 27.04.2016

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 longer to avoid returning to smoking.
If you are still using the lozenge after 9 months, you
should speak to your doctor or pharmacist

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.

What Nicotinell Mint lozenge contains

Pharma code 2561

Smoking reduction:
Nicotinell lozenge should be used between periods of
smoking in order to prolong smoke-free intervals and
with the intention to reduce smoking as much as possible. The number of cigarettes should be gradually
replaced by Nicotinell 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 Nicotinell 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.

The active substance is nicotine.
Each piece of Nicotinell Mint lozenge contains 2 mg
nicotine (as 6.144 mg nicotine bitartrate dihydrate).
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
Nicotinell Mint lozenge is a white, mint flavoured, round
biconvex compressed lozenge.
Nicotinell Mint lozenge is available in two strengths
(1 and 2 mg). This package leaflet deals with Nicotinell
Mint 2 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

If you take more Nicotinell Mint lozenges than you
should
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.

400 mm

Keep out of the reach and sight of children.

6. Contents of the pack and other
information

Counselling may improve your chances of giving up
smoking.

Proof Z

5. How to store Nicotinell Mint lozenge

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 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.

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

Nicotinell Mint 2 mg Lutschtabletten
Nicotinell Mint 2 mg Sugetablet
Nicotinell Mint 2 mg Imeskelytabletti
Nicotinell Menthe 2 mg, comprimé
à sucer
Germany
Nicotinell Lutschtabletten 2 mg Mint
Iceland
Nicotinell mint 2 mg Munnsogstafla
Ireland
Nicotinell Mint 2 mg compressed
Lozenge
Netherlands
Nicotinell Mint 2 mg Zuigtablet
Norway
Nicotinell Mint 2 mg sugetablett,
komprimert
Portugal
Nicotinell Mint 2 mg Pastilhas
Spain
Nicotinell Mint 2 mg comprimidos
para chupar
Sweden
Nicotinell Mint 2 mg sugtablett
United Kingdom Nicotinell Mint 2 mg Lozenge
This leaflet was last revised in April 2016

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 1000)
• palpitations.
Rare side effects (affecting 1 to 10 people out of 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.

GB 936256
2.0742.1031-01

Pharma code 2561

Order – AWF
Reference
Format
Pharma code
Colour
Font
Min. fonte size
Reference MKT
Production site
Reference Site

80 mm

Verso

80 mm

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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