NICORETTE FRESHMINT 2MG LOZENGE

Active substance: NICOTINE BITARTRATE DIHYDRATE

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650959
Details of Nicorette ActiveStop are at the end of this
leaflet.






freshmint 2mg lozenge
nicotine
compressed lozenge
What you should know about
nicorette® freshmint 2mg lozenge

(2mg nicotine compressed lozenge)
Please read this leaflet carefully before you start
using this medicine. It provides useful information
on how to use it safely. Keep the leaflet, you might
need it again.
If you think you are having side-effects, have any
questions or are not sure about anything please ask
your doctor, nurse or pharmacist.

1 What this medicine is for

Nicorette freshmint 2mg lozenge is a nicotine
replacement therapy (NRT).
It is used to relieve and /or prevent withdrawal
symptoms and reduce the cravings you get when
you try to stop smoking or when cutting down the
number of cigarettes you smoke.
Ideally you should always aim to stop smoking. You can
use nicorette freshmint 2mg lozenge to achieve this
by using it to completely replace all your cigarettes.
However nicorette freshmint 2mg lozenge can also
be used in other ways,
 if you feel unable to stop smoking completely, or
wish to replace certain cigarettes and therefore
it can help you to cut down the number of
cigarettes you smoke,
 at those times when you can’t or do not want to
smoke. For example,
- Where you don’t want to smoke and avoid
harm to others e.g children or family.
- Smoke free areas e.g Pub, work, public
transport e.g aeroplanes.
It may also help increase your motivation to quit.
When making a quit attempt a behavioural support
programme will increase your chances of success.

What does nicorette freshmint 2mg
lozenge do?

When you stop smoking or cut down the number of
cigarettes you smoke, your body misses the nicotine
that you have been absorbing. You may experience
unpleasant feelings and a strong desire to smoke
(craving). This indicates that you were dependent on
nicotine.
When you use nicorette freshmint 2mg lozenge,
nicotine is released and passes into your body
through the lining of your mouth. The nicotine
released is sufficient to relieve the unpleasant
nicotine withdrawal symptoms. It will also help to
stop your craving to smoke but will not give you the
“buzz” you get from smoking a cigarette.
Benefits you can get from using NRT instead of
smoking
For the best effect, ensure that you use nicorette
freshmint 2mg lozenge correctly – see “How to Use
Nicorette Freshmint 2mg Lozenge”.
The benefits of stopping smoking far outweigh any
potential risk from using nicotine from NRT. It is the
toxins in cigarette smoke such as tar, lead, cyanide
and ammonia that cause smoking related disease
and death, not the nicotine.
 You may think that smoking helps relieve
feelings of anxiety and stress, but it does not
deal with the cause of stress and leads to a
number of serious diseases. In addition, the
feeling of relaxation after smoking is temporary,
with withdrawal symptoms and cravings soon
returning. Nicotine replacement therapy can
help relieve nicotine withdrawal symptoms such
as irritability, low mood, anxiety, restlessness
and cravings when used in place of cigarettes.
 NRT may benefit smokers who want to quit, by
helping to control weight gain that may be
experienced when trying to stop smoking.
Use of NRT is safer than smoking tobacco but as
soon as you are ready, you should aim to stop
smoking completely.

2 Before using this medicine
X Do not use Nicorette Freshmint 2mg
Lozenge:

 if you have an allergy to nicotine or any of the
other ingredients.
 if you are a child under 12 years of age.

! Talk to your doctor, nurse or

pharmacist…

 If you are pregnant or breast-feeding – you may
be able to use nicotine replacement therapy
(NRT) to help you give up smoking but you
should try to give up without it. See ”If you are
pregnant or breast-feeding” section.
 if you are in hospital because of heart disease
(including heart attack, disorders of heart rate or
rhythm, or stroke).
In other heart conditions not requiring you to be
in hospital, using NRT is better than continuing
to smoke.
 if you have a stomach ulcer, duodenal ulcer,
inflammation of the stomach or inflammation of
the oesophagus (passage between the mouth
and stomach).
 if you have liver or kidney disease.
 if you have an overactive thyroid gland or have
a phaeochromocytoma (a tumour of the adrenal
gland that can affect blood pressure) – your
doctor will have told you this.
 if you have diabetes – monitor your blood sugar
levels more often when starting to use nicorette
freshmint 2mg lozenge as you may find your
insulin or medication requirements alter.
 if you are taking any other medicines such as
theophylline, clozapine or ropinirole. Stopping
smoking may require the dose of these medicines
to be adjusted.
If any of these applies, talk to your doctor, nurse or
pharmacist.

! If you are pregnant or breast-feeding
If you are pregnant:
1) Firstly, you should try to give up smoking
without NRT. Stopping completely is by far the

best option. The earlier and quicker you do this
the better it is for you and your baby.
2) Secondly, if you can’t manage this, you can use
NRT as a safer alternative to smoking as the risks
to your baby are far less than smoking, however
you should talk to your doctor, nurse or
pharmacist for advice.
Products that are used intermittently, including
nicorette freshmint 2mg lozenge, may be preferable
to nicotine patches. However, patches may be more
suitable if you have nausea or sickness. If you do use
patches take them off before going to bed at night.
If you are breast-feeding:
1) Firstly, you should try to give up smoking
without NRT.
2) Secondly, if you can’t manage this you are best
to use NRT products that are taken intermittently (not patches), however you should talk to
your doctor, nurse or pharmacist for advice.
Breast-feed just before you use nicorette lozenge
to ensure that the baby gets the smallest amount
of nicotine possible.
If you do need to use NRT to help you quit, the
amount of nicotine that the baby may receive is
considerably smaller and less harmful than the
second-hand smoke they would inhale if you
smoked. Tobacco smoke produces breathing and
other problems in babies and children.

3 How and when to use this
medicine
i How to use Nicorette Freshmint 2mg

Lozenge

Place the lozenge in the mouth. Allow it to slowly
dissolve. This will release nicotine, which you will
absorb through the lining of your mouth. Nicorette
freshmint 2mg lozenge should NOT be chewed or
swallowed. You should not eat or drink while a
lozenge is in the mouth.
The number of lozenges you use each day will
depend on how many cigarettes you smoked and
how strong they were. See dosing information over
the page to find out the dose you should use.

650959

i When to use Nicorette

Freshmint 2mg Lozenge

If you smoke 20 or fewer cigarettes a day, the 2 mg
nicotine lozenge will help relieve your cravings.
If you are able to stop smoking you should use the
lozenge, when needed, in place of cigarettes. As soon
as you can (this could be after a number of weeks or
months) you should reduce the number of lozenges
until you have stopped using them completely.
If you are unable to stop smoking or do not feel ready
to quit at this time, you should replace as many
cigarettes as possible with the lozenge. There are toxins
in cigarettes that can cause harm to your body. Nicorette
freshmint 2mg lozenge provides a safer alternative to
smoking, for both you and those around you. Reducing
the amount of cigarettes may also help you to become
more motivated to stop smoking. As soon as you are
ready you should aim to stop smoking completely.
You can also use the lozenge on those occasions
when you can’t or don’t want to smoke e.g. Social
situations such as a party, in the pub or when at work.
When making a quit attempt behavioural therapy,
advice and support will normally improve the success
rate. If you have quit smoking and want to stop
using nicorette freshmint 2mg lozenge but are
finding this difficult you should contact your doctor,
nurse or pharmacist for advice.
Below is the dosage information for the nicorette
freshmint 2mg lozenge. This shows the number of
lozenges you should be using, when you should take
them, how you should take them and the maximum
amount of time you should be using Nicotine
Replacement Therapy (NRT) for.

i Children under 12 years

Do not give this product to children under 12 years.

i Adults and children aged

12 years and over
Age

Dosage of lozenge

One lozenge to be
Adults and
taken as required to
children aged 12
relieve cravings.
years and over
 Most people take between 8 to 12 lozenges per day.
 Do not take more than 15 lozenges per day.
 Do not exceed the stated dose.

! If you have used too much Nicorette



Freshmint 2mg Lozenge

If you have used more than the recommended
amount of nicorette freshmint 2mg lozenge you
may experience nausea (feeling sick), salivation, pain
in your abdomen, diarrhoea, sweating, headache,
dizziness, hearing disturbance or weakness.
 If you do get any of these effects contact a doctor
or your nearest hospital Accident and Emergency
department immediately. Take this leaflet and the
pack with you.




a Nicorette Freshmint 2mg lozenge

 Contact a doctor or your nearest hospital Accident
and Emergency department immediately if a child
under 12 years uses, chews or swallows this
medicine. Take this leaflet and the pack with you.
Nicotine ingestion by a child may result in severe
poisoning.
Like all medicines, nicorette freshmint 2mg lozenge
can have side-effects. As many of the effects are due
to nicotine, they can also occur when nicotine is
obtained by smoking.



Effects related to stopping
smoking (nicotine withdrawal)

You may experience unwanted effects because by
stopping smoking you have reduced the amount of
nicotine you are taking. You may also experience
these effects if you under use nicorette freshmint
2mg lozenge before you are ready to reduce your
nicotine intake.

! These effects include:
 irritability or aggression
 feeling low
 anxiety
 restlessness
 poor concentration
 increased appetite or weight gain
 urges to smoke (craving)
 night time awakening or sleep disturbance
 lowering of heart rate

 Do not use the product after the ’Use before’
date on the box or blister strip.
 Dispose of lozenges sensibly away from children
and animals. 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.

You may also get these effects if you are not used to
inhaling tobacco smoke.

! These effects include:
 feeling faint
 feeling sick (nausea)
 headache

! If a child has used or swallowed

4 Possible side-effects

Effects of too much nicotine



Side-effects for Nicorette
Freshmint 2mg Lozenge
Common side-effects:

(less than 1 in every 10 people are affected)
 dizziness
 headache
 feeling sick (nausea)
 stomach discomfort
 hiccups
 sore mouth or throat
 coughing
 chest palpitations
 increased salivation

6 Further information


What’s in this medicine?



What the medicine looks like



Who makes Nicorette Freshmint 2mg
Lozenge?

Uncommon side-effects

(less than 1 in every 100 people are affected)
 redness or itching of the skin
 hives (urticaria)

Rare side-effects:

(less than 1 in 1,000 people are affected)
 abnormal beating of the heart
 allergic reactions (swelling of the mouth, lips,
throat and tongue, itching of the skin, swelling
of skin, ulceration and inflammation of the
lining of the mouth).
➤ If you notice these or any other unwanted effects
not listed in this leaflet tell your doctor, nurse or
pharmacist.
➤ When you stop smoking you may also develop
mouth ulcers. The reason why this happens is
unknown.

5 Storing and disposal
 Keep nicorette freshmint 2mg lozenge out of the
reach and sight of children and animals. Nicotine
in high doses can be very dangerous and
sometimes fatal if taken by small children.
 Do not store nicorette freshmint 2mg lozenge
above 25°C.

The active ingredient is nicotine. Each lozenge
contains 2 milligrams of nicotine (as nicotine
bitartrate dihydrate).
Other ingredients are: Mannitol (E421), Xanthan
gum (E415), Sucralose (E955), Acesulfame potassium
(E950), Magnesium stearate (E470b), Peppermint
Flavour including Gum Arabic (E414).
Nicorette freshmint 2mg lozenge is white to off
white, oval, with a mint flavour.
The lozenges are blister packed in sheets of 12 and
supplied in packs of 24 or 96 lozenges. Not all pack
sizes may be marketed.

The Product Licence holder is McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
The manufacturer is McNeil AB,
Helsingborg, Sweden.
This leaflet was prepared in September 2010 ©.



Information about Nicorette ActiveStop
Nicorette ActiveStop is a personalised support
programme which works with Nicorette to support
you, with the aim of helping you give up smoking.
All you need is internet access and a mobile
telephone.
Call 0800 244 838 for information.

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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