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Active substance(s): NICOTINE RESINATE

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Nicotine Mini 1.5 mg Lozenges
Please 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 Nicotine Minis
carefully to get the best results from them.
• Keep this leaflet. You may need to read it again.
• Ask a healthcare professional e.g. doctor, nurse, smoking cessation adviser or pharmacist
if you need more information or advice.
• If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell a healthcare professional.
• Throughout this leaflet Nicotine Mini 1.5 mg Lozenges are referred to as Nicotine Minis.
In this leaflet:
1. What Nicotine Minis are and what they are used for
2. Before you take Nicotine Minis
3. How to use Nicotine Minis
4. Possible side effects
5. How to store Nicotine Minis
6. Further information


What Nicotine Minis are and what they are used for

Nicotine Minis are used to help people stop smoking. This type of treatment is called Nicotine
Replacement Therapy or NRT.
This pack contains 1.5 mg Nicotine Minis which are for smokers who smoke 20 cigarettes or less
a day.
They can help you give up smoking straightaway. They can also help you cut down smoking
before stopping completely. If you think you can stop smoking straightaway, then you should
because this is usually best. However, if you feel this is too big a step, then you may wish to try
cutting down the amount of cigarettes you smoke as a first step before stopping completely. See
Section 3 “How to use Nicotine Minis” for further details.
It is the nicotine in cigarettes that can make you physically addicted to them.
• Nicotine Minis help you to give up smoking by replacing some of the nicotine you get from
• This nicotine relieves some of the unpleasant symptoms that smokers may have when they try
to give up. These include feeling ill or irritable.
• The nicotine can also relieve your cravings for a cigarette and help you to resist the urge to
Nicotine Minis do not have the health dangers of tobacco. This is because they do not contain the
tar, carbon monoxide or other toxins in cigarette smoke. Some people worry that after stopping
smoking, they may become dependent on nicotine lozenges instead. This is very rare, and if it did
happen, it is less harmful than continuing to smoke. It also an easier habit to break.
Your chances of stopping smoking will be improved if you take part in a support programme.
These “stop smoking programmes” are known as behavioural support. For information on stop
smoking programmes please talk to a healthcare professional.


Before you take Nicotine Minis

Do not use Nicotine Minis if:
• you are allergic (hypersensitive) to nicotine or any of the other ingredients in the
lozenge (See Section 6: Further information)
• you are a non-smoker or under the age of 12 years.
There are no health benefits to smoking. It is always better to give up smoking. Using Nicotine
Replacement Therapy (NRT), like Nicotine Minis, can help. In general, any possible side effects
associated with NRT are far outweighed by the well known dangers of continuing to smoke.
Take special care with Nicotine Minis:
• If you have had a recent heart attack or stroke, or you suffer from severe heart rhythm
problems, unstable or worsening angina (chest pain) or resting angina you should try to
quit smoking without using any NRT products unless your doctor tells you to use them.
• If you have diabetes you should monitor your blood sugar levels more often than usual when
you start using Nicotine Minis. Your insulin or medicine requirements may change.
• If you have ever had allergic reactions that involve swelling of the lips, face and throat
(angioedema) or itchy skin rash (urticaria). Using NRT can sometimes trigger this type of

If you have children under 12 years as the levels of nicotine in Nicotine Replacement
Therapy (NRT) are not suitable for children under 12. The effects of nicotine affect children
more than adults. It could cause severe poisoning in children which can cause death.
Do not interchange between Nicotine Minis and nicotine gums during any attempt to quit

If you are pregnant or breast feeding it is best if you can give up smoking without the use of
NRT. However, it is better to stop smoking using NRT than to continue smoking. (See the section
on pregnancy or breastfeeding below for more information.)
Get help and advice from a healthcare professional if you have:
• If you have heart or circulation problems including heart failure, stable angina, high
blood pressure or occlusive peripheral artery disease
• Serious liver or kidney problems because you may be more likely to get side effects.
• Uncontrolled overactive thyroid gland or phaeochromocytoma (a tumour of the adrenal
gland that can affect blood pressure) - your doctor will have told you this - because nicotine
may make your symptoms worse.
• Stomach or duodenal ulcers or an inflamed oesophagus or gullet (the passage between the
mouth and stomach) because swallowing nicotine can make your symptoms worse. It may
also cause mouth ulcers. If your symptoms do get worse you should talk to your doctor. You
might want to use a non-oral form of NRT instead, such as patches.
Taking other medicines
Stopping smoking may alter the effect of other medicines you may be taking. If you have any
questions or concerns about this, talk to a healthcare professional.
Pregnancy and breast feeding
Smoking during pregnancy has risks for the baby. These include poor growth before birth,
premature birth or stillbirth. Stopping smoking is the best way to improve both your health and
that of your baby. The earlier you stop smoking the better.
Ideally, if you are pregnant, you should stop smoking without using NRT. However, if you have
tried and this has not worked, NRT may be recommended by a healthcare professional to help

you stop smoking. This is because it is better for your developing baby than if you carry on
smoking. The decision to use NRT should be made as early on as possible in your pregnancy.
You should aim to use it for only 2-3 months. Remember, the most important thing is to stop
smoking. Products such as lozenges may be preferable to nicotine patches. This is because with
lozenges, you do not get the nicotine all the time. However, patches may be preferred if you have
nausea or sickness.
If you are breast feeding tobacco smoke causes breathing difficulties and other problems in
babies and children. Ideally you should stop smoking without using NRT. However if you have
tried and this has not worked, NRT may be recommended by a healthcare professional. If you do
use NRT to help you quit, the amount of nicotine your baby may get is small. It is much less
harmful than breathing in second hand smoke. It is best to use NRT products that are taken at
certain times of the day (such as gum or lozenge, rather than patches). It is also better to breast
feed just before you take the product. This helps your baby to get the smallest amount of nicotine
Driving and using machines
Stopping smoking can result in difficulties concentrating and increased irritability.

How to use Nicotine Minis

The instructions about how to use Nicotine Minis depend on whether you are:
(a) stopping smoking straightaway
(b) cutting down before stopping
Always use Nicotine Minis exactly as stated in this package leaflet. You should check with your
healthcare professional if you are not sure.
This product is for oromucosal use. That means that the nicotine in the tablets is released slowly
into the mouth from where it is absorbed into the body.
In all cases you should use Nicotine Minis by putting one lozenge in your mouth and from time to
time move it from one side of your mouth to the other, until it is completely dissolved. This
should take around 10 minutes. Do not chew the lozenge or swallow it whole. Do not use more
than 15 lozenges a day. If you feel the need to use Nicotine Minis for longer than 9 months in
total, you should ask a healthcare professional for advice.
(a) Stopping smoking straightaway
Adults (18 years and over)
• Start by using 8 to 12 lozenges a day. Suck a lozenge whenever you have an urge to
• Use the lozenges like this for up to 6 weeks, then gradually cut down the number of
lozenges you use a day.
• Once you are using only 1 or 2 lozenges a day, stop using them altogether.
After you have given up you may sometimes feel a sudden craving for a cigarette. You can
use a lozenge again if this happens.
(b) Cutting down before stopping smoking
Adults (18 years and over)
When you feel a strong urge to smoke, use a Nicotine Mini instead of a cigarette to help you
manage your cravings. Cut down the number of cigarettes you smoke per day by as many as
possible. If you have not been able to cut down the number of cigarettes you smoke each day
after 6 weeks, talk to a healthcare professional.

As soon as you feel able, you should give up cigarettes completely. Follow the instructions
for stopping smoking straightaway given above. Do this as soon as possible. If your attempt
to stop smoking completely has not been successful within 6 months of starting the use of
Nicotine Minis, speak to a healthcare professional.
Young people (12-17 years inclusive)
You should only use Nicotine Minis following advice from a healthcare professional.
Do not exceed the stated dose. Follow the instructions carefully and do not use more than 15
lozenges in one day (24 hours).
Children under 12 years of age should not use Nicotine Minis.
If you are tempted to start smoking again
If you are:
• worried that you may start smoking again
• finding it difficult to stop using the lozenges completely
talk to a healthcare professional.
If you do start to smoke again, they can advise you on how to get the best results from further
courses of Nicotine Replacement Therapy (NRT).
If you take more Nicotine Minis than you should
If you use too many Nicotine Minis you may start to feel sick, dizzy and unwell. Stop using the
lozenges and get advice straightaway from a doctor or hospital casualty department. If possible,
show them the packet or this leaflet.
The lozenges are not suitable for children under 12 or non-smokers. If the lozenges are used by
children or non-smokers they may show signs of nicotine overdose. These include headache,
sickness, stomach pains and diarrhoea. If a child has used or eaten any of the lozenges, contact
your doctor or nearest hospital casualty department straightaway. If possible show them the
packet or this leaflet.

Possible Side Effects

Like all medicines Nicotine Minis can cause side effects, some more common than others,
although it is possible you may not get any side effects at all. At the recommended doses Nicotine
Minis have not been found to cause any serious side effects.
Stopping smoking itself can cause symptoms such as dizziness, headache, sleep disturbance,
cough and cold-like symptoms. Symptoms such as depression, irritability, anxiety, restlessness,
increased appetite and insomnia may also be related to withdrawal symptoms associated with
giving up smoking.
Other Side effects are listed below - they are group based on the likelihood with which they can
Very common (affects more than 1 in 10 people)
• The lozenges may cause your mouth or tongue to be slightly sore or irritated. You may
also feel sick.
Common (affects between 1 in 10 and 1 in 100 people)
• Sore throat

Being sick
Stomach discomfort

Less common side effects (affects between 1 in 100 and 1 in 1000 people)
• Nervousness
• Depression
• Palpitations (feeling your heart beat)
• Increased heart beat
• Chest pain
• Rash
• Tiredness and generally feeling unwell
Very rare (affects less than 1 in 10,000 people)
• Severe allergic reaction symptoms of which include sudden wheeziness or tightness of
the chest, rash and feeling faint
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell a healthcare professional.


How to store Nicotine Minis
Keep out of the reach and sight of children.
Do not use the lozenges after the expiry date stated on the container and outer packaging.
The expiry date refers to the last day of the month.
Do not store above 30ºC.
Store in the original container in order to protect from moisture.
Do not use the container for anything else due to possible fine coating of tablet dust in the
Dispose of the container responsibly. 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.
Further Information

What Nicotine Minis contain
The active substance is nicotine 1.5 mg (in the form of a resin complex called nicotine resinate).
The other ingredients are mannitol (E421), sodium alginate, xanthan gum, potassium
bicarbonate, calcium polycarbophil, sodium carbonate anhydrous, acesulfame potassium,
flavours, magnesium stearate.
Nicotine Minis are sugar free.

What Nicotine Minis look like and contents of the pack
White to off-white oval compressed lozenges (lozenges) with convex surfaces.
The 1.5 mg lozenge has an “L” on one side.
Each container contains 20 lozenges. Packs may contain one or three containers.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Omega Pharma Ltd, 32 Vauxhall Bridge Road, London, SW1V 2SA,
UK and all enquiries should be sent to this address.

The manufacturer of Nicotine Minis is GlaxoSmithKline Dungarvan Limited
Knockbrack Dungarvan ,Co. Waterford, Ireland
Nicotine is a registered trademark of ELAN PHARMA INTERNATIONAL LTD.
This medicinal product is authorised in the Member States of the EEA under the following
This information to be included at the end of the procedure once all MS names have been agreed.
This leaflet was last approved in {10/2015}.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.