NICOTINELL MINT 1MG COMPRESSED LOZENGES

Active substance: NICOTINE BITARTRATE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MINT 1 mg

Production:
SwissCo - CH

Print Z
Reference SITE: 2.0708.1000-04
Ref. Market:

NICOTINE

Prepress

Read all of this leaflet carefully because it contains
important information for you.

la sooris s.à.r.l.: NIC LOZ MINT 1 MG GB_909767_Z_PIL - 24.08.2011

Compressed Lozenge

This medicine is available without prescription. However,
you still need to use Nicotinell Mint 1mg lozenge carefully
to get the best results from it.

Pharma code 1416

Proof Z

• 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.

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
b
 reast-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.

In this leaflet

Driving and using machines

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. Further information

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
Nicotinell Mint lozenge contains nicotine, which is one of
the substances contained in tobacco.
This medicinal product belongs to a group of medicines
w
 hich are used to help you to stop smoking.
When sucked, nicotine is released slowly and absorbed
through the lining of the mouth.
This medicinal product is used to relieve the nicotine
withdrawal symptoms in nicotine dependency, as an aid to
smoking cessation.
Patient counselling and support normally improve the
success rate.

2. BEFORE YOU TAKE NICOTINELL MINT
LOZENGE
Do not take Nicotinell Mint lozenge

Important information about some of the
ingredients of Nicotinell Mint lozenge
Nicotinell Mint lozenges contain sweeteners, including
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
i
ngredients are suitable for diabetics.
Nicotinell Mint 1 mg lozenge contains 9.8 mg of sodium
per piece. To be taken into consideration by patients on a
controlled sodium diet.

3. HOW TO 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.

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.

Take special care with Nicotinell Mint lozenge

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.

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.
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 the reach and sight of children at all times.

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 Nicotinell Mint lozenge with food and
drink

Pregnancy and breast-feeding
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

Nicotinell Mint 1 mg lozenge is recommended in low to
moderate nicotine dependent smokers.
Nicotinell Mint 1 mg lozenge is not recommended for
smokers with a strong or very strong nicotine dependency.
Do not swallow.
Select your optimal dosage from the following table:
Low to moderate
dependency

Moderate to strong
Strong to very
dependency
strong dependency

Low dosage forms acceptable
High dosage forms acceptable
Less than 20
cigarettes / day

1 mg lozenge
is preferable

From 20 to 30
cigarettes / day
Low (1 mg lozenge) or
high (2 mg
lozenge) dose forms
depending on patient
characteristics and
preference

Over 30 cigarettes /
day

2 mg lozenge
is preferable

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:
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.
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

80 mm

Coffee, acidic and soft drinks may decrease the
absorption of nicotine and should be avoided for
15 minutes before sucking a lozenge.

Nicotinell Mint Lozenge is available in two strengths:
1 and 2 mg.

Pharma code 1416

59544 - AWF 13502 - OTDC 232619
NIC LOZ MINT 1 MG GB_909767Z_PIL
145 x 400 mm – Recto - Verso
1416 (minicode)
P Reflex Blue U
Helvetica Neue Condensed

80 mm

Order DO
Reference:
Format:
Pharma code:
1 colour:
Fonts used:

lozenge for longer than 6 months. However, some exsmokers 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.

Prepress

Each piece of Nicotinell Mint lozenge contains 1 mg of
n
 icotine (as 3.072 mg nicotine bitartrate dihydrate).
The other ingredients are

Nicotinell should not be used by people under 18 years of
age without recommendation from a doctor.

• maltitol (E965), sodium carbonate anhydrous, sodium
hydrogen carbonate, polyacrylate, xanthan gum,
colloidal anhydrous silica, levomenthol, peppermint oil,
aspartame (E951), magnesium stearate.

If you take more Nicotinell Mint lozenges than
you should

la sooris s.à.r.l.: NIC LOZ MINT 1 MG GB_909767_Z_PIL - 24.08.2011

Pharma code 1416

Proof Z

Counselling may improve your chances of giving up
smoking.

Children and adolescents (<18 years)

Production:
SwissCo - CH

Print Z
Reference SITE: 2.0708.1000-04
Ref. Market:

6. FURTHER INFORMATION

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
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.

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).

What Nicotinell Mint lozenge contains
The active substance is nicotine.

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 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
Novartis Consumer Health,
Wimblehurst Road,
Horsham,
West Sussex,
RH12 5AB, UK.

Manufacturer
Novartis Consumer Health GmbH
Zielstattstrasse 40,
81379 Munich
Germany

This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria
Nicotinell Mint 1 mg Lutschtabletten
Denmark
Nicotinell Mint 1 mg Sugetablet
Finland
Nicotinell Mint 1 mg Imeskelytabletti
France
Nicotinell Menthe 1mg, 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
Italy
Nicotinell Mint 1 mg Pastiglia
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
Romania
Nicotinell Mint 1 mg, comprimate de supt
Spain
Nicotinell Mint 1 mg comprimidos para

chupar
Sweden
Nicotinell Mint 1 mg sugtablett
United Kingdom Nicotinell Mint 1 mg compressed Lozenge
This leaflet was last approved November 2010.

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.

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.

Pharma code 1416

59544 - AWF 13502 - OTDC 232619
NIC LOZ MINT 1 MG GB_909767Z_PIL
145 x 400 mm – Recto - Verso
1416 (minicode)
P Reflex Blue U
Helvetica Neue Condensed

80 mm

Order DO
Reference:
Format:
Pharma code:
1 colour:
Fonts used:

80 mm

GB_909767
2.0708.1000-04

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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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