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NICABATE CQ 2MG MINT GUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicabate CQ 2 mg Mint Gum
Nicotine
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 Nicabate CQ Mint
Gums 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 becomes serious, or if you notice any side effects not listed in
this leaflet, please tell a healthcare professional.
 Throughout this leaflet Nicabate CQ 2 mg Mint Gums are referred to as Nicabate CQ
Mint Gums.
In this leaflet:
1. What Nicabate CQ Mint Gums are and what they are used for
2. Before you use Nicabate CQ Mint Gums
3. How to use Nicabate CQ Mint Gums
4. Possible side effects
5. How to store Nicabate CQ Mint Gums
6. Further information

1.

What Nicabate CQ Mint Gums are and what they are used for

Nicabate CQ Mint Gums are used to help people stop smoking. This type of treatment is called
Nicotine Replacement Therapy or NRT.
It is the nicotine in cigarettes that can make you physically addicted to them.
 Nicabate CQ Mint Gums help you to give up smoking by replacing some of the nicotine you
get from cigarettes.
 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
smoke.
Nicabate CQ Mint Gums 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 gums 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.

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2.

Before you take Nicabate CQ Mint Gums

- x - Do not use Nicabate CQ Mint Gums if:
 you are allergic (hypersensitive) to nicotine or any of the other ingredients in the gum
(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 Nicabate CQ Mint Gums, 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 Nicabate CQ Mint Gum:
 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 Nicabate CQ Mint Gums. 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
reaction.
 If you wear dentures as you may experience difficulty in chewing.
 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 a severe poisoning in children which can cause death.
 Do not interchange between Nicabate CQ Mint Gums and nicotine lozenges during any
attempt to quit smoking.
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 and breastfeeding below for more information.)
- ! - Get help and advice from a healthcare professional if you have:
 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 ulcer or an inflamed oesophagus or gullet (the passage between the
mouth and the 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
Please tell your healthcare professional if you are taking or have recently taken any other
medicines, including medicine obtained without a prescription.
- ! - Pregnancy or 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

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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 gums may be preferable to nicotine patches. This is because with
gums, 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
need to 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 gums or lozenges, 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
possible.
- ! – Driving and using machines
There are no known effects of Nicabate CQ Mint Gums on your ability to drive or use machines.
However, you should be aware that giving up smoking can cause behavioural changes that could
affect your ability to drive or use machines.
- ! – Important information about some of the ingredients of Nicabate CQ Mint Gums:


Sodium - Each gum contains 11.4 mg sodium which should be taken into account if you are
on a controlled sodium diet.



Sorbitol (E420) and Maltitol Liquid (E965) – if you have rare hereditary problems of
fructose intolerance, do not take this medicine.



Butylated hydroxytoluene (E321) – this may cause irritation of mucous membranes.

3.

How to use Nicabate CQ Mint Gums

- i – Always use Nicabate CQ Mint Gums exactly as stated in this package leaflet. You should
check with your healthcare professional if you are not sure.
During any attempt to give up smoking using Nicabate CQ Mint Gums it is important that you
make every effort to stop smoking completely. However, if you do smoke a cigarette while you
are using NRT, you should continue your quit attempt. If you continue to have difficulty stopping
smoking talking to your doctor, nurse, smoking cessation advisor or pharmacist may help.
You should use Nicabate CQ Mint Gums by putting one gum in your mouth and chew slowly
until the taste becomes strong (about 1 minute) then stop and rest the gum against your cheek.
When the taste fades, chew a few times until the taste get strong then rest the gum again. After
about 30 minutes of such use, the gum will be exhausted. You should not eat or drink while a
gum is in your mouth as this may reduce the absorption of the nicotine. Do not use more that 15
gums a day. If you feel the need to use Nicabate CQ Mint Gums for longer than 9 months in total,
you should ask a healthcare professional for advice.
Nicabate CQ Mint Gums can be used according to the following timetable which is designed to
gradually reduce the number of pieces of gum you use.
Adults (18 years and over)
 Start by using 8 to 12 gums a day. Chew gum whenever you have an urge to smoke.

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Use the gums like this for up to 3 months, then gradually cut down number of gums you use a
day (see table below).
Once you are using only 1 or 2 gums 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
gum again if it happens.

STEP 1
STEP 2

Initial treatment
period
Chew 1 piece of
gum whenever there
is an urge to smoke.
Use 8-12 pieces/day
for 3 months.

Step down treatment
period
Gradually reduce
gum use to 1-2
pieces/day.
Then stop treatment.

STEP 3
Weeks 10 to 12
Support treatment
Chew a piece of
gum if sudden
cravings tempt you
to smoke.

Young people (12-17 years)
You should follow the instruction above for stopping smoking straightway but you should only
use the gums for 12 weeks in total. If you feel the need to use Nicabate CQ Mint Gums for
longer than 12 weeks or if you are not ready to stop smoking straightaway, you should talk to a
healthcare professional for advice.
Do not exceed the stated dose. Do not smoke or use any other nicotine containing product at
the same time. Follow the instructions carefully and do not use more than 15 gums in one
day (24 hours).
Children under 12 years of age should not use Nicabate CQ Mint Gums.
This product is for oromucosal use. This means that the nicotine in the gum is released slowly
into the mouth from where it is absorbed into the body.
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 gums 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 Nicabate CQ Mint Gums than you should
If you use too many Nicabate CQ Mint Gums you may start to feel sick, dizzy and unwell. Stop
using the gums and get advice straightaway from a doctor or hospital casualty department. If
possible, show them the packet or this leaflet.

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The gums are not suitable for children under 12 or non-smokers. If the gums 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 gums, contact your doctor or
nearest hospital casualty department straightaway. If possible show them the packet or this
leaflet.
If you have any further questions on the use of this product, ask your healthcare professional.
4.

Possible Side Effects

- ! - Like all medicines Nicabate CQ Mint Gums can cause side effects, although not everybody
gets them. At the recommended doses Nicabate CQ Mint Gums have not been found to cause any
serious side effects.
Stopping smoking itself can cause symptoms such as dizziness, headache, sleep disturbances,
cough, cold-like symptoms. Symptoms such as depression, irritability, anxiety 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
occur:
Common (affects between 1 in 10 and 1 in 100 people)
 feeling sick, gastro-intestinal discomfort,
 sore throat, sore mouth, mouth irritation or ulceration, pharyngitis, cough
 sleep disturbance, headache, irritability, dizziness
 being sick, hiccups, indigestion,
 jaw pain
None of the above effects are serious and often wear off after a few days treatment.
Less common side effects (affects between 1 in 100 and 1 in 1000 people)
 an increase in your heart rate or awareness of your heart beat
 feeling lightheaded
 difficulty breathing, chest pain
 taste disturbance/distortion
 itching or a rash, redness of the skin, increased sweating
 pain in muscles/joint or swelling
 inflammation of the mucous lining of the mouth
 tremor
 feeling unwell
Rare side effects (affects less than 1 in 1000 people)
 allergic reactions such as angio-oedema
Very rare effects (affects less than 1 in 10000 people)
 severe allergic reaction symptoms of which include sudden wheeziness or tightness of
chest, rash and feeling faint.

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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.
5.






6.

How to store Nicabate CQ Mint Gums
Keep all medicines out of the reach and sight of children.
Do not use the gums after the expiry date stated on the blister and carton. The expiry date
refers to the last day of that month.
Do not store above 25ºC.
Store in the original container.
Dispose of the pack 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 Nicabate CQ Mint Gums contain
The active substance is nicotine 2 mg (in the form of nicotine resinate). The other ingredients
are chewing gum base, calcium carbonate, butylhydroxytoluene (E321), sorbitol (E420), maltitol
liquid (E965), glycerol, acesulfame potassium, mint flavour, mannitol (E421), sodium carbonate
anhydrous, sodium hydrogen carbonate, carnauba wax and talc.
What Nicabate CQ Mint Gums look like and contents of the pack
Off-white rectangular pillow-shaped gum.
Packs contain 12, 24, 48 or 96 gums.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder to be completed nationally
*The manufacturer of Nicabate CQ Mint Gum is Fertin Pharma A/S, Industrivej 8, DK 7120
Vejle Øst, Denmark.
This medicinal product is authorised in the Member States of the EEA under the following
names:
Ireland: NiQuitin CQ 4mg Mint Gum
Portugal: NiQuitin CQ 4mg Gomas para Mascar Medicamentosas
Spain: NiQuitin 4mg Chicles Medicamentosos
UK: Nicabate CQ 4mg Mint Gum
This leaflet was last revised in 6 May 2011.

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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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