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BOOTS NICASSIST 1MG COMPRESSED LOZENGE

Active substance(s): NICOTINE BITARTRATE DIHYDRATE / NICOTINE BITARTRATE DIHYDRATE / NICOTINE BITARTRATE DIHYDRATE

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145mm

145mm

Information for the user

:/"How to use this medicine

NicAssist 1 mg Lozenge
(Nicotine)
Read all of this leaflet carefully
because it contains important
information for you.
This medicine is available without
prescription to help you stop smoking.
However, you still need to use it carefully
to get the best results from it.
• Keep this leaflet, you may need to read
it again
• Ask your pharmacist if you need more
information or advice
• You must contact a pharmacist or
doctor for advice if you need to use
the lozenges for longer than 9 months

What this medicine is for

This medicine contains nicotine which
belongs to a group of medicines called
nicotine replacement therapy (NRl). It
acts to substitute the nicotine that you
nom,ally get from cigarettes and can
help you stop smoking.
It can be used to relieve the symptoms
of nicotine withdrawal and reduce the
cravings for nicotine that you get when
you try to stop smoking. When you suck
the lozenge, nicotine is released slowly
and taken into the body through the
lining of the mouth.
To help you quit smoking you should
also try to use a behavioural support
programme or counselling to increase
your chances of success.
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 known
smoking related diseases, not the nicotine.

Before you use this medicine

E
E

ij

This mediane can be used by adults of 18
years and over. However, some people
should not use this medicine or should
seek the advice of their pharmacist or
doctor first.

,X Do not use:

• If you are allergic to any of the
ingredients in this medicine (see "What
is in this medicine1
• If you are a non-smoker
• If you have phenylketonuria (this
medicine contains aspartame (E951), a
source of phenylalanine equivalent to
5 mg per lozenge, which may be harmful
to you)
• If you have an intolerance to some
sugars, unless your doctor tells you to
(this medicine contains maltitol, a source
of fructose)

! Talk to your pharmacist or doctor:

• If you have heart problems including a
previous heart attack, heart failure,
problems with your heart rate or rhythm,
angina, have had a stroke, or high blood
pressure not controlled by medication try to give up smoking first without using
NRT. However, if you still need help to
stop smoking you can use this medicine
but your doctor may want to monitor
you more closely
• If you have high blood pressure
• If you have problems with your circulation
• If you have a tumour near your kidney
(your doctor may have told you that you
have a condition called
phaeochromocytoma)
• If you have an ulcer in your stomach, or
problems such as pain or swelling of the
stomach or oesophagus (the passage
between your mouth and your stomach)
• If your liver or kidneys do not work properly
• If you have an overactive thyroid gland
• If you have diabetes - monitor your
blood sugar levels more often when you
start using this medicine. You may find
that you need to adjust the amount of
insulin that you use, or the amount of
tablets that you take (ask your doctor or
diabetes nurse about this)
• If you are on a low salt (sodium) diet
(each lozenge contains 9.8 mg of sodium,
which may be ham,ful to you)
• If you are pregnant or breastfeeding (see
"Other important information")

Other important information

Driving and using machines: Using
this medicine is not known to affect your
ability to drive or use machines. However
you should bear in mind that giving up
smoking can change your behaviour.
Using this medicine with food and
drink: Coffee, acidic and soft drinks may
decrease the absorption of nicotine. Do
not drink them for 15 minutes before
sucking a lozenge.
Information about some of the
ingredients in this medicine: Maltitol
(E965) may have a mild laxative effect.
Each lozenge contains 0.9 g maltitol.
This provides 2 kcal per lozenge. This
may need to be taken into account if
you have diabetes.
If you are pregnant: You should try to
stop smoking without using NRT.
However, if you still need help to stop
smoking, you can use this product as
the risk to your baby is far less than if
you continue to smoke. You should talk
to your pharmacist or doctor for more
advice.
If you are breastfeeding: You should
try to stop smoking without using NRT.
However, if you still need help to stop
smoking, you can use this medicine. You
should talk to your phamiacist or doctor
for more advice.
Do not use the lozenges in the 2 hours
before you feed your baby. Then
breastfeed your baby just before you use
the lozenge, to make sure that your baby
gets the smallest amount of nicotine
possible.
The amount of nicotine that your baby
may receive when you are using the
lozenges or other NRT products is much
smaller and less harmful than the
second-hand smoke they would inhale if
you smoked. Tobacco smoke causes
breathing and other health problems in
babies and children. If your husband,
partner or other household members
smoke too, try to get them to give up
with you.
Nicotine products and children:
Nicotine can be very dangerous to
children. The amount of nicotine
tolerated by adults and adolescents can
make children very ill, and can
sometimes be fatal. Do not leave your
lozenges where children may get hold
of them.

If you take other medicines

Before you use this medicine, make sure
that you tell your doctor or pharmacist
about ANY other medicines you might
be using at the same time, particularly
the following:
• Theophylline (for breathing problems)
• Tacrine (for Alzheimer's disease)
• Olanzapine or clozapine (used to treat
schizophrenia)
• Insulin (for diabetes)
When you stop smoking your metabolism
slows down. This can mean that some
medicines may stay in your body longer
than usual.
If you take any medicine on a regular
basis, tell your doctor that you intend to
stop smoking and follow his or her
advice about these medicines. This
includes medicines prescribed by your
doctor and medicine you have bought
for yourself, including herbal and
homeopathic remedies.

N
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Check the foil is not broken before use.
If it is, do not use that lozenge.
Read all of the following infom,ation
carefully before starting to use the
lozenges. Ask your pharmacist or doctor
if you need any advice.
• To improve your chances of successfully
giving up smoking you should stop
smoking completely when you start to
use the lozenges and when you are using
the lozenges
• Use the "How to suck the lozenge"
instructions to make sure that you suck
the lozenge correctly to release the
nicotine
The lozenges are available in two strengths.
Use the information and table below to
decide which strength of lozenge to use.
• The 1 mg lozenges should be used for
low or moderate nicotine dependent
smokers. They are not recommended for
strong or very strong nicotine dependency
Suck the lozenge. Do not chew or
swallow it.
Low to
Moderate to Strong to
very strong
strong
moderate
dependency dependency dependency
11 mg lozenge acceptable r ·�
v•==i 2 mg lozer-ge acceptable c:=v'
Over30
Less than 20 From20 to
cigarettes 30 cigarettes �es
/day
/day
Use the
1 mg
lozenge

Use the 1
mg or 2 mg
lozenge
depending
on how
strong your
cravings are
and your
preference

Use the2
mg lozenge

If you use the 2 mg lozenge and find that
you get side effects, try using the 1 mg
lozenge instead.
How to suck the lozenge
1. Suck a lozenge until the taste becomes
: strong.
:2.Rest the lozenge between your gums
, and cheek.
:3.Suck again when the taste has faded.
, 4. Repeat this routine until the lozenge
dissolves completely (about 30 minutes).
How many to use:
Adults over 18 years: Suck one
lozenge every one to two hours when
you feel the urge to smoke.
Most people use between 8 to 12
lozenges per day. However, if you still
have an urge to smoke you can use
more lozenges.
Don't use more than thirty 1 mg
lozenges per day.
Normally you should use the lozenges
for at least 3 months, but this may vary
from person to person. After 3 months,
you should gradually reduce the number
of lozenges used each day.
When you are using only one or two
lozenges per day you should stop
completely.
In general you should not use Boots
NicAssist 1 mg Lozenges for more than
6 months. However, some people may
need to use them for longer to stop
them smoking again.
If you need to use the lozenges for
longer than 9 months, ask your
phamiacist or doctor for advice.
Counseling may improve your chances
of gMng up smoking.
Children and adolescents under 18
years: Do not use the lozenges, unless
your doctor tells you to.
If you use too many: Sucking too
many lozenges can result in the same
symptoms as smoking too much. The
general symptoms of too much nicotine
include weakness, sweating, increased
production of saliva, throat burn, feeling
sick, being sick, diarrhoea, pain in the
abdomen, disturbance of hearing and
vision, headache, fast, slow or irregular
heart beat, shortness of breath and
circulatory problems.
If this happens talk to your doctor or
phamiacist for advice.

r lozenges:
If a child uses or swallows any
Talk to a doctor straight

away. Take the child to the nearest
casualty department. Take the medicine
and this leaflet with you. Even small
quantities of nicotine are dangerous in
children and may result in severe
symptoms or death.

Possible side effects

Most people will not have problems, but
some may get some of these:
If you get any of these serious side
effects, stop using the lozenges and
do not smoke. See a doctor at once:
• Fast, slow or irregular heart beat
• Difficulty breathing, swelling of the lips,
face, throat or tongue (signs of severe
allergic reaction)
These serious effects are rare, affecting
only 1 to 1O people out of 1 0,000.
If you get any of the following side
effects see your pharmacist or doctor:
In the first few days you may feel
dizzy, get headaches or have difficulty
sleeping. These may be withdrawal
symptoms from stopping smoking and
may be caused because you are not
getting enough nicotine.
Common side effects (affecting 1 to
1 O people out of 100)
• Dizziness and headache
• Dryness of the mouth, hiccups, stomach
trouble such as feeling sick, flatulence,
heartburn, increased saliva production
and irritation of the mouth and throat this may happen because you are
sucking the lozenge too fast, try to suck
more slowly
Uncommon side effects (affecting 1 to
1 0 people out of 1000)
• Palpitations
r When you stop smoking you may also
develop mouth ulcers. The reason why
this happens is unknown.

r

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

How to store this
medicine
°
Do not store above25 C.

Keep this medicine in a safe place out of
the sight and
of cupboard.
children,
preferably
in areach
locked
Use by the date on the end flap of the
carton or edge of the blister strip. If you
have out of date medicine or you no
longer need the lozenges take them to
your nearest pharmacy for safe disposal.

What is in this medicine

Each compressed lozenge contains
nicotine 1 mg (as nicotine bitartrate
dihydrate 3.072 mg), which is the active
ingredient.
As well as the active ingredient, the
lozenge also contains maltitol (E965),
sodium carbonate anhydrous, sodium
hydrogen carbonate, polyacrylate,
xanthan gum, colloidal anhydrous silica,
levomenthol, peppemiint oil,
aspartame (E951), magnesium stearate.
The pack contains36, 72, 96, 144 or 204
white, round, mint flavoured lozenges.
Not all pack sizes may be marketed.

Who makes this medicine

Manufactured for The Boots Company PLC
Nottingham NG2 3AA by
GlaxoSmithKline Consumer Healthcare
(UK) Trading Limited, Brentford, TW8
9GS, UK. Marketing Authorisation held by
GlaxoSmithKline Consumer Healthcare
(UK) TradingLimited, Brentford, TWB 9GS,
UK. This leaflet was last revised in April
2016
If you would like any further infom,ation
about this medicine, please contact The
Boots Company PLC Nottingham
NG23AA

Other formats

To request a copy of this leaflet in Braille,
large print or audio please call, free of
charge:

,

Expand Transcript

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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