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NICOTINELL FRUITY MINT 1 MG COMPRESSED LOZENGE

Active substance(s): NICOTINE BITARTRATE DIHYDRATE

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Recto

45 mm

135 mm

Pregnancy and breast-feeding

75 mm

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.

Min 4 mm

13 mm

Pharma code 27

Nicotinell like smoking itself should be avoided during breastfeeding as nicotine may be found in breast milk. If your doctor
has recommended you to use Nicotinell Fruity Mint lozenge
during breast-feeding, the lozenge should be sucked just
after breast-feeding and not during the two hours before
breast-feeding.

40022545-07/15

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.
Important information about some of the ingredients
of Nicotinell Fruity Mint lozenge

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

AWF 23228 – NPL 9-311 – OTDC 380705
NIC LOZ FRUITY MINT 1 MG GB_933727_PIL
180 x 525 mm – Reference not available – Recto/Verso
27
P Reflex Blue U
Helvetica Neue LT Pro
Text body: 9 pts

SwissCo AG – CH
40022545-07/15

Pre-press

Ducommun sa – DO-15-E1400 – 01.10.2015

Nicotinell Fruity Mint lozenges contain sweeteners, including
aspartame and maltitol.
Each Nicotinell Fruity 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 Fruity Mint 1 mg lozenge contains maltitol (E965),
a source of fructose:

NICOTINE

–– 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.

Fruity Mint

1mg Compressed Lozenge

Calorific value 2.1 kcal/g maltitol. Nicotinell Fruity Mint lozenge
ingredients are suitable for diabetics.
Nicotinell Fruity Mint 1 mg lozenge contains 9.81 mg of sodium
per piece. To be taken into consideration by patients on a
controlled sodium diet.

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

3. HOW TO TAKE NICOTINELL FRUITY MINT LOZENGE

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

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

• 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.

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.

In this leaflet

Nicotinell Fruity Mint 1 mg lozenge is recommended in low
to moderate nicotine dependent smokers.

Nicotinell Fruity Mint lozenge is available in two strengths: 1 and
2 mg. The appropriate dose depends on your previous smoking
habits.

525 mm

1. What Nicotinell Fruity Mint lozenge is and what it is used for
2. Before you take Nicotinell Fruity Mint lozenge
3. How to take Nicotinell Fruity Mint lozenge
4. Possible side effects
5. How to store Nicotinell Fruity Mint lozenge
6. Further information

Nicotinell Fruity 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:

1. WHAT NICOTINELL FRUITY MINT LOZENGE IS AND
WHAT IT IS USED FOR
Nicotinell Fruity Mint lozenge contains nicotine, which is one
of the substances contained in tobacco.
This medicinal 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.
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.

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.

2. BEFORE YOU TAKE NICOTINELL FRUITY MINT
LOZENGE

Instructions for use:

• If you are allergic (hypersensitive) to nicotine or any of the other
ingredients of Nicotinell Fruity Mint lozenge.
• If you are a non-smoker.

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).

Take special care with Nicotinell Fruity Mint lozenge

Dosage for adults over 18 years:

Please check with your doctor or pharmacist before taking
Nicotinell if you have:

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.

Do not take Nicotinell Fruity Mint lozenge

• 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.

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 Fruity 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.
Counselling may improve your chances of giving up smoking.
Children and adolescents (<18 years)

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.

Taking Nicotinell Fruity 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.

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

180 mm

80 mm

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

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

Pharma code 27

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 Fruity Mint lozenge out of the reach and
sight of children at all times.

Verso

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Allergic reactions
In rare cases you might experience allergic reactions. These
reactions may in very few cases be serious. You should stop
taking the medicine straight away and seek urgent medical
advice if you experience symptoms such as
–– swollen face, tongue and/or pharynx and/or
–– difficulty to swallow or
–– hives together with difficulty breathing (angioedema).

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

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.

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 and guarana flavour.

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.
Less common side effects
(affects 1 to 10 users in 1,000)
Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 23228 – NPL 9-311 – OTDC 380705
NIC LOZ FRUITY MINT 1 MG GB_933727_PIL
180 x 525 mm – Reference not available – Recto/Verso
27
P Reflex Blue U
Helvetica Neue LT Pro
Text body: 9 pts

SwissCo AG – CH
40022545-07/15

Pre-press

Ducommun sa – DO-15-E1400 – 01.10.2015

• palpitations.

Nicotinell Fruity Mint lozenge is a white, fruit mint flavoured,
round biconvex compressed lozenge.
Nicotinell Fruity Mint lozenge is available in two strengths
(1 and 2 mg). This package leaflet deals with Nicotinell Fruity
Mint 1 mg lozenges. 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.

Marketing Authorisation Holder
Novartis Consumer Health,
Camberley
GU15 3YL, UK

• disturbances in heart beat rhythm.
Mouth ulcers may occur when trying to quit smoking, but the
relationship to the nicotine treatment is not clear.

Manufacturer

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. 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

Proof Z

What Nicotinell Fruity Mint lozenge looks like and contents
of the pack

Not all pack sizes may be marketed.

Rare side effects
(affects 1 to 10 users in 10,000)

By reporting side effects you can help provide more information
on the safety of this medicine.

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.

Novartis Consumer Health GmbH
Zielstattstrasse 40,
81379 Munich
Germany
This leaflet was last revised on 2015-06-30.

5. HOW TO STORE NICOTINELL FRUITY MINT LOZENGE
Keep out of the sight and reach 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.

GB 933727
40022545-07/15

525 mm

Do not store above 25 °C.

180 mm

Expand view ⇕

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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