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NICABATE 2MG MINT LOZENGE

Active substance: NICOTINE RESINATE

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PACKAGE LEAFLET

Package leaflet: Information for the user
Nicabate 2 mg Mint Lozenges
Nicotine
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your healthcare professional has told
you.
• 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 you get any side effects talk to your healthcare professional. This includes any side effects not
listed in this leaflet.
• Throughout this leaflet Nicabate 2 mg Mint Lozenges are referred to as Nicabate Mint Lozenges.
What is in this leaflet:
1. What Nicabate Mint Lozenges are and what they are used for
2. What you need to know before you use Nicabate Mint Lozenges
3. How to use Nicabate Mint Lozenges
4. Possible side effects
5. How to store Nicabate Mint Lozenges
6. Contents of the pack and other information

1.

What Nicabate Mint Lozenges are and what they are used for

Nicabate Mint Lozenges 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 Mint Lozenges 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 Mint Lozenges 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.
There are no health benefits to smoking. It is always better to give up smoking. Using NRT like Nicabate
can help. In general any possible side effects associated with NRT are far outweighed by the well known
dangers of continuing to smoke.

2.

What you need to know before you use Nicabate Mint Lozenges

Do not use Nicabate Mint Lozenges:
• if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to peanut or soya
• if you are a non-smoker or under the age of 12 years.
Warnings and precautions
Talk to your healthcare professional before using Nicabate Mint Lozenges:
• 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 Mint Lozenges. 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 have children under 12 years as the levels of nicotine in NRT are not suitable for children under
12.
Do not interchange between Nicabate Mint Lozenges and nicotine gums 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 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 nicotine patches.
• been told by your doctor that you have an intolerance to some sugars.
Children (under 12 years)
Do not give this medicine to children under the age of 12 years because it could cause severe poisoning in
children and cause death.
Other medicines and Nicabate Mint Lozenges
Tell your healthcare professional if you are using or have recently used or might use any 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 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 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 possible.
Driving and using machines
There are no known effects of Nicabate Mint Lozenges 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.
Nicabate Mint Lozenges contain:
• Sodium - Each lozenge contains about 17 mg sodium which should be taken into account if you are
on a controlled sodium diet.
• Aspartame - A source of phenylalanine. May be harmful to you if you suffer from phenylketonuria.
• Mannitol – Nicabate Mint Lozenges may have a mild laxative effect.
• Lactose - If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking Nicabate Mint Lozenges.

3.

How to use Nicabate Mint Lozenges

Always use this medicine exactly as described in this leaflet or as your healthcare professional has told
you. Check with your healthcare professional if you are not sure.
During any attempt to give up smoking using Nicabate Mint Lozenges 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 Mint Lozenges by putting one lozenge in your mouth and periodically move it
from one side of your mouth to the other, until it’s completely dissolved. This should take 20 to 30
minutes. Do not chew the lozenge or swallow it whole. You should not eat or drink while a lozenge is in
your mouth as this may reduce the absorption of the nicotine.
Do not use more that 15 lozenges a day. If you feel the need to use Nicabate Mint Lozenges for longer
than 9 months in total, you should ask a healthcare professional for advice.
Adults (18 years and over)





For the first 6 weeks use at least 9 lozenges a day
To help you stay smoke free over the next 12 weeks, you can take 1-2 lozenges per day in
situations where you are strongly tempted to smoke.
Once you are using only 1-2 lozenges a day, stop using them altogether.
STEP 1
Weeks 1 to 6

Initial treatment
period
1 lozenge every
1 to 2 hours

STEP 2
Weeks 7 to 9
Step down treatment
period
1 lozenge every
2 to 4 hours

STEP 3
Weeks 10 to 12
Step down treatment
period
1 lozenge every
4 to 8 hours

Do not exceed the stated dose.
Use in children and adolescents
Adolescents (12-17 years inclusive)
You should follow the instruction above for stopping smoking straightaway but you should only use the
lozenges for 12 weeks in total. If you feel the need to use Nicabate Mint Lozenges 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. Follow the instructions carefully and do not use more than 15 lozenges in
one day (24 hours).
Children under 12 years
Children under 12 years of age should not use Nicabate Mint Lozenges.
This product is for oromucosal use. This means that the nicotine in the lozenges is released slowly into the
mouth from where it is absorbed into the body.
Talk to a healthcare professional if you are:
• worried that you may start smoking again
• finding it difficult to stop using the lozenges completely.
If you do start to smoke again, they can advise you on how to get the best results from further courses of
NRT.
If you use more Nicabate Mint Lozenges than you should
If you use too many Nicabate Mint Lozenges 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.
If you have any further questions on the use of this product, ask your healthcare professional.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. At the
recommended doses Nicabate Mint Lozenges have not been found to cause any serious side effects.
Stopping smoking itself can cause symptoms such as headache, dizziness, increased coughing or a cold.
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 based on the likelihood with which they can occur:
Very common: may affect more than 1 in 10 people
• feeling sick.
Common: may affect up to 1 in 10 people
• sore throat, mouth/tongue irritation or ulceration
• sleep disturbance, headache, anxiety, irritability
• being sick, belching, hiccups, flatulence, diarrhoea, increased appetite, indigestion, heartburn.
None of the above effects are serious and often wear off after a few days treatment.
Uncommon: may affect up to 1 in 100 people
• an increase in your heart rate or awareness of your heart beat
• abnormal dreams, mood changes, worsening anxiety, feeling angry, wakefulness, feeling
lightheaded, abnormal hunger
• worsening asthma or difficulty breathing, difficulty swallowing, chest infections, coughing, nose
and throat irritation, nasal congestion
• dry lips, dry throat, jaw or tooth pain, bleeding gums, taste disturbance/distortion, local numbness
• stomach rumbling, worsening indigestion, acid regurgitation, gut irritation, stomach ulcer, hiatus
hernia
• itching or a rash, redness of the skin, localized skin reaction, increased sweating, skin flushes,
nosebleed
• pain, leg pain or swelling
• frequent urination at night
• symptoms of overdose.
Very rare: may affect up to 1 in 10,000 people
• Severe allergic reaction symptoms of which include sudden wheeziness or tightness of the chest,
rash and feeling faint.
If you get any side effects, talk to your healthcare professional. This includes any possible side
effects not listed in this leaflet.

5.

How to store Nicabate Mint Lozenges







Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Nicabate Mint Lozenges contain



The active substance is nicotine 2 mg (in the form of nicotine resinate).
The other ingredients are mannitol (E421), sodium alginate (E401), xanthan gum (E415),
potassium hydrogen carbonate (E501), polycarbophil calcium, anhydrous sodium carbonate
(E500i), aspartame (E951), magnesium stearate (E470b) and mint flavour (contains lactose and
soya protein).

What Nicabate Mint Lozenges look like and contents of the pack
White, round compressed lozenges with convex surfaces.
Nicabate Mint Lozenges have “NL2S” on one side.
Packs contain 12, 24, 36 or 72 lozenges (blister pack) or 24 or 72 lozenges (tube pack).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Consumer Healthcare, 980 Great West Road, Brentford, TW8 9GS, United Kingdom.
Manufacturer: Famar A.V.E ANTHOUSSA PLANT, Anthoussa Avenue 7, Anthoussa Attiki, 15344
Greece
GlaxoSmithKline Dungarvan Ltd, Knockbrack, Dungarvan, Co. Waterford, Ireland.
Catalent UK Swindon Zydis Limited, Frankland Road, Blagrove, Swindon, Wiltshire, SN5 8RU, UK.
This medicinal product is authorized in the Member States of the EEA under the following names:
Belgium, Luxembourg - NiQuitin Mint 2mg
Hungary - NiQuitin Mentolos 2 mg Szopogató Tabletta
Ireland - NiQuitin 2 mg Mint Lozenges
Italy – NiQuitin 2mg Pastiglie Gusto Menta
Portugal - Niquitin 2 mg Comprimidos para chupar
United Kingdom - Nicabate 2 mg Mint Lozenges
This leaflet was last revised in August 2013
Other sources of information
If you have any questions or comments about Nicabate Mint Lozenges, please FREEPHONE our
Information Line on 0500 100 222 or e-mail customer.relations@gsk.com.

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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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