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NICOROL TOFFEE 4 MG PASTILLES
Active substance(s): NICOTINE
Nicorol Toffee 2 & 4 mg Pastilles
Nicorol Citrus 2 & 4 mg Pastilles
Nicorol Spearmint 2 & 4 mg Pastilles
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Nicorol
Pastilles carefully to get the best results from them.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if you cannot refrain from smoking after 6 months’ treatment
with Nicorol Pastilles.
• If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
What Nicorol Pastilles are and what they are used for
Before you take Nicorol Pastilles
How to take Nicorol Pastilles
Possible side effects
How to store Nicorol Pastilles
WHAT NICOROL PASTILLES ARE AND WHAT THEY ARE USED FOR
Nicorol Pastilles belong to a group of medicines which are used to help you stop smoking.
The nicotine in Nicorol Pastilles relieves withdrawal symptoms (including craving for
nicotine) when you stop smoking and counteracts thereby relapse into smoking in smokers
who are motivated to stop.
When you suddenly stop providing nicotine in the form of tobacco to your body, you get hit
by different kinds of discomfort, called withdrawal symptoms. By means of Nicorol Pastilles
you can prevent or at least reduce this discomfort, by continuing to provide a small amount of
nicotine to your body during a short period of time.
Advice and support normally improve the success rate.
BEFORE YOU TAKE NICOROL PASTILLES
Do not take Nicorol Pastilles
if you are allergic (hypersensitive) to nicotine or any of the other ingredients of
Nicorol Pastilles (see section 6, Further Information)
if you are a non-smoker
Take special care with Nicorol Pastilles
Talk to your doctor before using Nicorol Pastilles if any of the following apply to you:
• if you have untreated high blood pressure
• if you have any other cardio- or cerebrovascular disorders, such as
o chest pain due to angina
o recent heart attack or stroke
o problems with your blood circulation
o heart failure
o abnormalities in heart beat rhythm
• if you have diabetes
• if you have an overactive thyroid gland (hyperthyroidism)
• if you have a tumour of the adrenal gland (pheochromocytoma)
• if you have a stomach ulcer
• if you have inflammation of the mouth, throat or gullet
• if you have severe kidney or liver problems
People under 18 years of age should not use Nicorol Pastilles, unless prescribed by a doctor.
The correct dose for adults could seriously poison or even kill small children. It is therefore
essential that you keep Nicorol Pastilles out of reach and sight of children at all times.
You should stop smoking completely during treatment with Nicorol Pastilles.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without prescription. This is especially important if
you are taking any of the following medicines:
• caffeine (in some cough and cold medicines)
• theophylline, and salbutamol (for asthma)
• imipramine, clomipramine or fluvoxamine (for depression)
• pentazocine, phenacetin, propoxyphene or phenylbutazone (painkillers)
• tacrine (for Alzheimer’s disease)
• olanzapine or clozapine (for schizophrenia)
• flecainide (for heart rhythm problems)
• ropirinol (for parkinson’s disease)
• prazosin and propranolol (for high blood pressure).
• insulin (for diabetes)
• furosemide (“water tablets”)
• isoprenaline (for heart attacks)
• medicines used to treat stomach ulcers
Taking Nicorol Pastilles with food and drink
Do not eat or drink whilst you have a Nicorol pastille in your mouth.
You should also avoid drinking coffee, fruit juice and other soft drinks for at least 15 minutes
before taking a pastille because it may decrease the absorption of nicotine.
Pregnancy and Breast-feeding
It is very important to stop smoking during pregnancy because it can result in poor growth of
your baby. It can also lead to premature births and even stillbirths, if you continue smoking
during the third trimester. Ideally you should try to give up smoking without the use of
medicines containing nicotine. If you cannot manage this, Nicorol Pastilles should only be
used after consulting the healthcare professional who is managing your pregnancy, your
family doctor, or a doctor in a centre that is specialized in helping people quit smoking.
Nicorol Pastilles should be avoided during breast-feeding as nicotine is found in breast milk
and may affect your child. If your doctor has recommended you to use Nicorol Pastilles
during breast-feeding, the pastille should be taken just after breast-feeding and not during the
two hours before breast-feeding.
Driving and using machines
Nicorol Pastilles should not affect your ability to drive or use machines when used following
the recommended dose.
However, stopping smoking can cause changes in your behaviour such as irritability.
Important information about some of the ingredients of Nicorol Pastilles
These pastilles contain sorbitol (an artificial sweetener). If you have been told by your doctor
that you have intolerance to some sugars, contact your doctor before taking this medicine.
Each pastille contains 0.5 mmol (11.5mg) sodium. The maximum daily dose of 30 pastilles
for the 2 mg strength contains 15 mmol (345 mg) of sodium. To be taken into consideration
by patients on a controlled sodium diet.
HOW TO TAKE NICOROL PASTILLES
Always take Nicorol Pastilles exactly as stated in this package leaflet. You should check with
your doctor or pharmacist if you are not sure.
You should stop smoking completely during the treatment with Nicorol Pastilles.
How many Pastilles should I take?
Start your treatment by taking one pastille every 1-2 hours. In most cases 8-12 pastilles per
day is sufficient.
The following table provides an approximate guidance for selecting a proper dosage:
Number of cigarettes / day
around 20 - 30
about more than 30 cigarettes
The 4 mg pastilles should also be taken if you have previously failed to give up smoking after
using Nicorol 2mg pastilles.
If you feel that the Nicorol 2mg pastilles are too strong for you, take advice from your
pharmacist for reducing the dosage further.
For Nicorol 2 mg pastilles the maximum dose is 30 pastilles per day.
For Nicorol 4mg pastilles the maximum dose is 15 pastilles per day.
In addition to Nicorol Pastilles, professional counselling may help you quit smoking.
Instructions for proper use:
1. The pastille should be moistened in the mouth and then moved to either cheek cavity.
The pastille should not be aggressively sucked, chewed or swallowed whole.
2. At intervals, the pastille should be moved from one side of the mouth to the other until the
pastille is completely dissolved (20-30 minutes).
Different types of nicotine replacement products may release different amounts of nicotine at
different speeds and may therefore not be directly interchangeable.
For how long should I take Nicorol Pastilles?
How long you take Nicorol Pastilles will vary from person to person. The duration of
treatment is individual, but is normally 2 to 3 months and after that you should gradually
reduce the number or strength of the pastilles you are taking each day. You should stop using
Nicorol Pastilles when your dose has reduced to 1 or 2 pastilles of 4mg or 2mg per day. If you
wish to reduce the dose further ask your pharmacist.
It is recommended that you do not use Nicorol Pastilles for more than 6 months. Some exsmokers may need to take the pastilles for longer to avoid returning to smoking. Do not use
Nicorol Pastilles for more than 6 months without asking your doctor or pharmacist for advice.
People under 18 years of age should not use Nicorol Pastilles, unless prescribed by a
If you take more Nicorol Pastilles than you should
Even small amounts of nicotine are poisonous for children. If poisoning is suspected in a child
or if you (or someone else) have taken too many Nicorol Pastilles, contact your doctor or
hospital casualty department straight away.
If you have taken too many Nicorol Pastilles, you may experience stomach pain, diarrhoea,
headache, dizziness, increased saliva, feel or be sick and sweat excessively. In the case of a
large overdose you may experince extreme tiredness, a drop in your blood pressure, weak an
irregular pulse, difficullty breathing and convulsions.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Nicorol Pastilles can cause side effects, although not everybody gets them.
Nicorol Pastilles can give the same side effects as nicotine given in another way. The side
effects are generally dose-dependent.
Most of the side effects reported by patients generally occur during the first 3-4 weeks. If any
of the side effects get troublesome, talk to your doctor or pharmacist.
Very common side effects (affects more than 1 user in 10):
• bitter taste in the mouth
Common side effects (affects 1 to 10 users in 100):
• gas formation
• nausea (feeling sick)
inflammation of the throat
irritation of the mouth and/or gullet
Uncommon side effects (affects 1 to 10 users in 1,000):
• fast or irregular heartbeat
Rare side effects (affects 1 to 10 users in 10,000):
• reversible heart fibrillation (heart failure)
• allergic reactions, which can be serious
Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
Aphthous mouth ulcers may occur when trying to quit smoking, but the relationship to the
nicotine treatment is not clear.
Some symptoms such as dizziness, headache and sleeping disturbances may be caused by
withdrawal symptoms during smoking cessation and can depend on too low supply of
If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
HOW TO STORE NICOROL PASTILLES
Keep out of the reach and sight of children.
Do not use Nicorol Pastilles after the expiry date which is stated on the blister and the carton
Do not store above 30C.
Store in the original package in order to protect from moisture.
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
What Nicorol Pastilles contain
The active substance is nicotine. Each pastille contains 2 mg or 4 mg nicotine.
The other ingredients are spray-dried acacia, liquid sorbitol (non-crystallising) (E420),
xylitol, sodium dihydrogen phosphate dihydrate, tri-sodium phosphate dodecahydrate,
sodium hydroxide, talc, maize starch, Capol (contains white beeswax and vegetable oil).
Nicorol Toffee:, toffee flavour, which contains natural flavouring substance, propylene glycol,
ethyl alcohol 95%.
Nicorol Citrus: orange oil and lemon oil.
Nicorol Spearmint: spearmint flavour,.which contains anethole, cornmint oil (Mentha
arvensis), orange oil, spearmint oil, alpha-terpineol
What Nicorol Pastilles look like and the contents of the pack
Nicorol Pastilles are round and light brown to brown and marked N2 (2 mg) or N4 (4 mg) on
The pastilles are packaged in blisters with 2, 14, 20, 28, 42, 56, 60, 72, 100 Pastilles in each
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavikurvegur 76-78, IS – 220 Hafnarfjordur, Iceland
Jemedic AB, Lötängsgatan 7, S-803 01, Gävle, Sweden
This leaflet was last approved in: 04/2010
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.