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NICOTINELL MINT 1MG COMPRESSED LOZENGES

Active substance: NICOTINE BITARTRATE DIHYDRATE

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Recto

45 mm

135 mm

Important information about some of the ingredients of Nicotinell
Mint lozenge
Nicotinell Mint lozenges contain sweeteners, including aspartame and
maltitol.

75 mm

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:

Calorific value 2.3 kcal/g maltitol. Nicotinell Mint lozenge ingredients are
suitable for diabetics.
Min 4 mm

13 mm

– 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.

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.

XXXXXXXX-mm/JJ

3. HOW TO TAKE NICOTINELL MINT LOZENGE

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

Draft C

Order – AWF
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Nicotinell Mint 1 mg lozenge is recommended in low to moderate nicotine
dependent smokers. It is not recommended for smokers with a strong
or very strong nicotine dependency.
Nicotinell Mint 1 mg lozenge can be used alone or in combination with
Nicotinell patches.

AWF 21621 – OTDC 358289
NICOTINELL MINT 1MG LOZENGE 0024 GB_315012_PIL
180 x 525 mm – Reference not available – Recto/Verso
XXX
Pantone Reflex Blue U
Helvetica Neue LT Pro
8 pts
XXXXXX
SwissCo - CH
XXXXXX

Pre-press

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

GSG412284 – AG – 16.04.2015

Adults over 18 years
Treatment with Nicotinell Mint lozenges only

Mint

Select your optimal dosage from the following table:

Nicotine
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.

WARNING: Wrong display / print > switch overprint ON

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.

• 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.

Instructions for use:
Do not swallow the lozenge.
1.
2.
3.
4.

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

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).

1. WHAT NICOTINELL MINT LOZENGE IS AND WHAT
IT IS USED FOR

Nicotinell lozenge should primarily be used for smoking 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.

Nicotinell Mint lozenge contains nicotine, which is one of the substances
contained in tobacco.
This medicine product belongs to a group of medicines which are used
to help you to stop smoking.
When sucked, nicotine is released slowly and absorbed through the lining
of the mouth.

525 mm

Suck a lozenge until the taste becomes strong.
Allow the lozenge to rest between your gum and cheek.
Suck again when the taste has faded.
Repeat this routine until the lozenge dissolves completely (about
30 minutes).

This medicinal product is used 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.
Patient counselling and support normally improve the success rate.
Nicotinell is indicated for smokers aged 18 years and above.

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.

2. BEFORE YOU TAKE NICOTINELL MINT LOZENGE

Smoking reduction:

Do not take Nicotinell Mint lozenge

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 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.

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 Nicotinell Mint 1 mg lozenge in combination with
Nicotinell transdermal patches
Smoking cessation:
If you have failed treatment with only Nicotinell lozenge you can use
Nicotinell patches together with Nicotinell 1 mg lozenge.

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.

NOTE: Read the package leaflet of Nicotinell transdermal patch prior
to use.

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

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.

Taking other medicines

The use of Nicotinell 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.

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.

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 1mg 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.

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

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

180 mm

Verso

5. HOW TO STORE NICOTINELL MINT LOZENGE

Recommended dosage:
Period

Patches

Keep out of the reach and sight of children.

Lozenge 1 mg

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.

Initial treatment (followed by alternative 1 or 2 below)
First
1 patch 21 mg/
6-12 weeks 24 hours

When necessary, 5-6 lozenges per day
is recommended

Reduction of nicotine dose – alternative 1
Next 3-6
weeks

1 patch 14 mg/
24 hours
1 patch 7 mg/
24 hours

Continue to use lozenges, when
necessary

Up to 9
months
in total

---

Reduce the number of lozenges
gradually

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).
– 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

Reduction of nicotine dose – alternative 2

Draft C

Up to 9
months
in total

---

Nicotinell Mint lozenge is a white, mint flavoured, round biconvex
compressed lozenge.

Continue to reduce the number
of lozenges gradually

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.
The tubes are packed in boxes containing 24, 72, 96 or 144 lozenges.
Each tube contains 24 lozenges. Packs may contain 1, 3, 4 or 6 tubes. Not
all pack sizes may be marketed.

If you are still using the lozenge and patches after 9 months, you
should speak to your doctor or pharmacist.
Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 21621 – OTDC 358289
NICOTINELL MINT 1MG LOZENGE 0024 GB_315012_PIL
180 x 525 mm – Reference not available – Recto/Verso
XXX
Pantone Reflex Blue U
Helvetica Neue LT Pro
8 pts
XXXXXX
SwissCo - CH
XXXXXX

Pre-press

GSG412284 – AG – 16.04.2015

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.

WARNING: Wrong display / print > switch overprint ON

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

Continue to use lozenges, when
necessary

Following
3-6 weeks

Do not store above 25 °C.

If you have any further questions on the use of this product, ask your
doctor or pharmacist.

Marketing Authorisation Holder
Novartis Consumer Health UK Ltd
Park View, Riverside Way
Watchmoor Park, Camberley
Surrey GU15 3YL
United Kingdom
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:

4. POSSIBLE SIDE EFFECTS

Austria

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.

Nicotinell Mint 1 mg Lutschtabletten

Denmark

Like all medicines, Nicotinell Mint lozenges can cause side effects,
although not everybody gets them.

Nicotinell Mint 1 mg Sugetablet

Finland

Nicotinell Mint 1 mg Imeskelytabletti

France

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
Nicotinell Mint 1 mg Zuigtablet

Norway

Nicotinell Mint 1mg sugetablett, komprimert

Uncommon side effects (affects 1 to 10 users in 1,000)
• palpitations.

Portugal

Nicotinell Mint 1 mg Pastilhas

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).

525 mm

Netherlands

Spain

Nicotinell Mint 1 mg comprimidos para chupar

Sweden

Nicotinell Mint 1 mg sugtablett

United
Kingdom

Nicotinell Mint 1 mg Lozenge

This leaflet was last revised in 15 April 2015.

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 315012 – XXXXXX

180 mm

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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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