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GALPHARM NICOTINE REPLACE 2MG LOZENGES

Active substance(s): NICOTINE RESINATE

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4. What should you do if you
take too many lozenges?
If you take more than the recommended
number of lozenges per day, you may suffer a
nicotine overdose and need to get advice from
your doctor. Signs of overdose include
headache, sickness, stomach pains and
diarrhoea. In the event that a child has taken any
lozenges or if an accidental overdose occurs,
contact your doctor or nearest hospital casualty
department immediately as this could be fatal.
If possible show them the pack or this leaflet.

5. Possible side effects
Sometimes there can be some side effects
from giving up smoking or using the lozenges.
This medicine may cause allergic reaction,
which involves swelling of the face, lips and throat
(angioedema) or itchy skin rash (urticaria). If this
happens to you contact your doctor immediately.
Common side effects are:
• coughing, sore throat, mouth irritation or
difficulty swallowing, dry mouth/throat/lips,
ulcers in/around mouth
• sleep disturbances, including insomnia,
anxiety, irritability, dizziness, headache
• feeling sick (nausea), being sick (vomiting),
diarrhoea, constipation, hiccups, belching,
wind, feeling bloated
• increased appetite, heartburn and indigestion.
None of the above side-effects are serious, and
often wear off after a few days’ treatment.
Occasionally an increased heart rate may be
experienced. If this happens stop using the
lozenges and tell your doctor.
Uncommon side effects are:
• nightmares, abnormal dreaming, poor quality
sleep, tiredness, lack of energy, feeling
unwell, restlessness, alertness
• breathing problems, shortness of breath,
asthma or worsening asthma, chest pain,
tight chest
• throat irritation, taste disturbance, mouth
numbness or burning, bleeding gums, bad
breath, toothache, jaw pain, thirst
• migraine, mood swings and anger
• rash, itchy skin, skin irritation, hot flushes
• stomach pains, stomach ulcer, hiatus hernia,
changes in appetite, taste changes,
increased saliva
• irregular heartbeat (palpitations)
• sneezing, nasal congestion, catarrh, nasal
discomfort, nose bleed

Asda Nicotine 2 mg Lozenges

• increased sweating, sensory disturbance
• urgency to pass water at night
• painful and swollen legs.

PATIENT INFORMATION LEAFLET

If any of the side effects gets serious, or if you
notice side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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.

6. How to store your medicine
Keep all medicines out of the reach and
sight of children.
Do not use this medicine after the expiry date
printed on the pack.
Do not store above 25°C and keep in the
original carton.

7. What is in this medicine?
Your cream / white circular compressed
lozenge is embossed with L344 on one side
and has an odour of peppermint.
The active ingredient is nicotine 2 mg in the form
of a resin complex (nicotine resinate 13.33 mg).
The other ingredients are: mannitol (E421),
magnesium stearate, sodium alginate, xanthan
gum, potassium bicarbonate, sodium
carbonate anhydrous, aspartame (E951) and
peppermint flavour.

Read all of this leaflet carefully before you
take this medicine because it contains
important information you need to know.

This product can be used during pregnancy
and breastfeeding (see Pregnancy and
Breastfeeding below).

This medicine is available without prescription,
however, you still need to use this product
carefully to get the best results from it.
Keep this leaflet as you may need to read it
again. Ask your pharmacist if you need more
information or advice.

Some people worry that, when they have
stopped smoking, they may become dependent
on NRT instead. This is very rare, and if it were
to happen it is still safer than continuing to
smoke. It is also an easier habit to break.

This medicine contains:
• nicotine resin which when sucked, nicotine
is released slowly from the resin and absorbed
through the lining of the mouth. This nicotine
relieves some of the cravings and unpleasant
withdrawal symptoms, such as feeling ill or
irritable, that smokers frequently feel when
they try to give up. This type of treatment is
called Nicotine Replacement Therapy (NRT).

8. Who makes this medicine?

This product can be used to help:
• stop smoking straightaway (a quit attempt)
• cut down on smoking, perhaps before you
go on to stop completely (reducing to quit or
just reducing).

PL 12063/0068

2737333

4

2. Is this medicine suitable
for you?
Do not take this medicine if you:
• are allergic to nicotine or any of the other
ingredients
• are a non-smoker
• are under 12 years of age. The level of nicotine
in NRT is not suitable for children under 12.
Children are more susceptible to the effects
of nicotine, and it could cause severe toxicity,
which can be fatal.

This pack contains lozenges which are for
smokers who smoke their first cigarette more
than 30 minutes after waking up.
If possible, when giving up smoking these
lozenges should be used with a stop smoking
behavioural support programme.

Text Revised: June 2013.

Your chance of stopping smoking will be
improved if you also take part in a support
programme. These ‘Stop Smoking’
programmes are known as behavioural
support. For more information:
• call the NHS Free Smoking Helpline on
0800 022 4332 or visit http://smokefree.nhs.uk

Your lozenges are a stop smoking aid. They
can reduce your urge to smoke by providing
some of the nicotine previously inhaled from
cigarettes and helps you resist cigarettes.
Because the lozenges do not contain the tar or
carbon monoxide of cigarette smoke, they do
not have the health dangers of tobacco.

Your lozenges are available in pack sizes of 12,
36 and 72’s, although not all pack sizes may be
marketed.

The Marketing Authorisation holder and
manufacturer is Wrafton Laboratories Limited,
Wrafton, Braunton, Devon, EX33 2DL, UK.

It is always better to stop smoking
completely. Smoking is harmful and has no
health benefits. NRT products like these
lozenges can help you stop. Any risks or
possible side effects from NRT are much less
than the proven dangers of continuing to smoke.

1. What is this medicine and
what is it used for?

If you are in hospital because of a heart
attack, severe heart rhythm disturbances
or a stroke - you should try to quit smoking
without using nicotine lozenges, unless your
doctor tells you to use them - once you are
discharged from hospital, you can use these
lozenges as normal.

In addition, these lozenges can be used when you:
• do not wish to smoke or are unable to smoke,
for example in confined spaces (in the car, in
the house), where others (such as children)
could be harmed by tobacco smoke or in
places where smoking is prohibited
(temporary abstinence)
• develop cravings once you have stopped
smoking.

Please see your doctor or pharmacist
before taking this medicine if you:
• have heart or circulation problems including
heart failure or stable angina (episodes of
chest discomfort that are usually predictable)
• have high blood pressure
• have occlusive peripheral artery disease which is a narrowing of the blood vessels
outside of your heart
• suffer from phenylketonuria, a rare inherited
metabolic disorder
1

Reducing the number of cigarettes smoked can
increase the chances that you will go on to quit
completely.

Asda Nicotine 2 mg Lozenges
Leaflet

6613

2737333

Perrigo, Braunton

17/06/13

N/A

5

280x210mm (L156)

DH

1853

Black

N/A

N/A

N/A

N/A

N/A

Cutter

N/A

N/A

• have serious liver or kidney disease
• have a stomach ulcer or duodenal ulcer
• have inflammation of the oesophagus
(oesophagitis), which is the tube leading from
the mouth to the stomach
• have an uncontrolled, overactive thyroid
gland
• are diabetic, as diabetic patients need to
monitor blood sugar levels more closely as
nicotine from smoking or from taking these
lozenges may vary them more than usual
• have been diagnosed as having a tumour of
the adrenal glands (phaeochromocytoma)
• have had allergic reactions (see also
section 5 “Possible side effects”).
Other important information:
When you stop smoking your metabolism
slows down and this may alter the way your
body responds to certain medicines.
Pregnancy and breastfeeding
If you are pregnant or planning to become
pregnant
Smoking when you are pregnant is harmful
to your baby. The risks include poor growth
before birth, damage to the baby’s lungs,
premature birth and stillbirth. Stopping smoking
is the best way to improve your health and the
health of your baby and the earlier you stop
smoking the better.
It is best to give up smoking without
using NRT.
If that’s too difficult, using NRT is safer for you
and your baby than continuing to smoke. The
nicotine in NRT is less dangerous than the
more harmful substances in cigarette smoke,
such as tar and other toxins.
If you have tried to stop smoking without using
NRT, and haven’t been able to, your healthcare
advisor may recommend NRT to help you stop.
If you do use NRT during pregnancy:
• Start as early in your pregnancy as possible
• Aim if possible to use NRT for only 2 to 3
months. But remember – the most important
thing is not to smoke. It is safer to carry on
using NRT than to start smoking again.
If you are breastfeeding
Tobacco smoke is harmful to babies and
children, causing breathing difficulties and
other problems.
If you are breastfeeding, it is best if you stop
smoking without NRT. But if you do need to
use NRT, the nicotine that gets into breast milk
is less dangerous to your baby than breathing
in second-hand smoke.

If you do use NRT while breastfeeding:
• Try to breastfeed just before you take the
lozenge, when the nicotine levels in your
body are at their lowest. That way, your baby
gets as little nicotine as possible.
Driving and using machines
There are no known effects of these 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 you in this way.
Important information about some of the
ingredients in this medicine:
Each lozenge contains about 15 mg of
sodium and the maximum daily dose of these
lozenges (15 lozenges) contains 225 mg
sodium. To be taken into consideration if you
are on a controlled sodium diet.
Contains aspartame (E951) which is a source
of phenylalanine. May be harmful for people
with phenylketonuria.
Your lozenges are sugar free.

3. How to take this medicine
Adults and young people aged 12 years
and over
Instructions for use of these lozenges depend
on whether you are:
• stopping smoking straightaway
• cutting down on smoking before you stop
• cutting down with no immediate plans to stop
• going without cigarettes for a short time
or if you are having cravings after you have
stopped smoking.
If you are under 18 years old and not ready
to stop smoking straightaway, talk to a
healthcare professional for advice.
Important: These lozenges are suitable for
smokers who have their first cigarette of the
day more than 30 minutes after waking up.
How to take your lozenges:
• 1 lozenge should be placed in the side of the
mouth and allowed to dissolve
• At intervals, the lozenge should be moved from
one side of the mouth to the other; the action
should be repeated for 20 to 30 minutes until
the lozenge is completely dissolved
• The lozenge should not be chewed or
swallowed whole
• Users should not eat or drink while a lozenge
is in the mouth as this may reduce the
absorption of nicotine
• Do not use more than one lozenge at a time
and do not use more than 15 lozenges
per day.
2

Stopping smoking straightaway
Adults and young people aged 12 years
and over:
It is important to make every effort to stop smoking
completely. But if you do sometimes smoke a
cigarette while using NRT, don’t be discouraged –
just keep going with your quit attempt. It may
help to talk to a healthcare professional if you are
finding your quit attempt difficult.
Use the lozenges according to the 3-step
programme below, which is designed to
gradually reduce the number of lozenges you use.

STEP 1
Weeks 1 to 6

STEP 2
Weeks 7 to 9

STEP 3
Weeks 10 to 12

Initial
Step down
Step down
treatment period treatment period treatment period
1 lozenge every 1 lozenge every 1 lozenge every
1 to 2 hours
2 to 4 hours
4 to 8 hours
To help you stay smoke free over the next 12
weeks, take a lozenge in situations when you
are strongly tempted to smoke. During this
initial treatment period (weeks 1 to 6) use at
least 9 lozenges a day.
If you find it difficult to give up these lozenges
or if you are worried that you may start smoking
again then speak to your doctor or pharmacist.
It is important you complete the step down
programme in full. This is because urges to
smoke and withdrawal symptoms can occur for
weeks after stopping smoking. If you resume
smoking you may want to talk to your doctor or
pharmacist about how to get the best results
from your lozenges.
You are more likely to quit smoking
when using this product with help from
your pharmacist, doctor, a trained
counsellor, or a support programme.
Cutting down on smoking before you stop
Adults aged 18 years and over:
You may find it easier to quit completely later if
you use these lozenges to help you cut down
on smoking first.
When you feel a strong urge to smoke, have a
lozenge 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 ready to stop smoking
completely, follow the instructions above, under
‘Stopping smoking straightaway’. If you have
not felt able to make a quit attempt within 6
months of starting to use NRT, you may find it
helpful to talk to a healthcare professional.
Cutting down with no immediate plans to stop
Adults aged 18 years and over:
It is always best to stop smoking
completely, but using NRT to cut down is less
harmful than continuing to smoke heavily.
Cutting down the number of cigarettes you
smoke each day will make it easier to quit
completely in the future.
When you feel an urge to smoke, have a lozenge
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.
It is best to stop smoking completely as
soon as you feel able to. Follow the instructions
above, under ‘Stopping smoking straightaway’.
Going without cigarettes for a short time
Adults aged 18 years and over:
This product can help you manage your cravings
so that you can resist cigarettes in situations
where smoking is inappropriate, for example:
• where your second-hand smoke may
damage other people, such as children
• where smoking is not allowed, such as on a
flight or in a hospital
• when smoking should be avoided, such as
before surgery.
When you feel an urge to smoke, have a
lozenge instead of a cigarette to help manage
your cravings. Continue to use one lozenge
every 1-2 hours (maximum 15 a day) during the
period when you are avoiding smoking.
It is best to stop smoking completely as
soon as you feel able to. Follow the instructions
above, under ‘Stopping smoking straightaway’.
Once you have stopped smoking
After you have stopped smoking, you may
sometimes feel a craving for a cigarette. You
can use this product again to help you relieve
these cravings – using NRT is always better
than smoking again.
If you are worried that you may start smoking
again, talk to a healthcare professional. They
can advise you on how to get the best results
from further courses of NRT.
If you are finding it difficult to stop using NRT
completely, talk to a healthcare professional.

3

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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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