NICOTINELL CLASSIC 4MG MEDICATED CHEWING GUM

Active substance: NICOTINE

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Novartis Consumer Health
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Nicotinell® Classic 4mg medicated chewing-gums

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicotinell Classic 4 mg medicated chewing-gum
Nicotine
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 Nicotinell
Classic 4 mg medicated chewing-gum 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 doctor if you still need to use Nicotinell after 9 months.
If any of the side effects gets serious, or if you notice any side effect not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Nicotinell medicated chewing-gum is and what it is used for
Before you take Nicotinell medicated chewing-gum
How to take Nicotinell medicated chewing-gum
Possible side effects
How to store Nicotinell medicated chewing-gum
Further information

1. WHAT NICOTINELL MEDICATED CHEWING-GUM IS AND WHAT
IT IS USED FOR
Nicotinell belongs to a group of medicines which are used to help you to stop smoking.
Nicotinell contains nicotine, which is one of the substances contained in tobacco.
When chewed, nicotine is released slowly and absorbed through the lining of the mouth.
This medicinal product is used to relieve the nicotine withdrawal symptoms in nicotine
dependency, as an aid to smoking cessation.
Patient counselling and support normally improve the success rate.

2. BEFORE YOU TAKE NICOTINELL MEDICATED CHEWING-GUM
Do not take Nicotinell medicated chewing-gum



If you are allergic (hypersensitive) to nicotine or any of the other ingredients of Nicotinell
If you are a non-smoker.

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Take special care with Nicotinell medicated chewing-gum
Please check with your doctor or pharmacist before taking Nicotinell if you have:
• heart disease, e.g. heart attack, heart failure, angina, Prinzmetal’s angina or abnormalities
in heart beat rhythm,
• had a “stroke” (cerebrovascular accident),
• high blood pressure (uncontrolled hypertension),
• problems with your circulation,
• diabetes (monitor your blood sugar levels more often when starting to use Nicotinell as
you may find your insulin or medication requirements alter)
• overactive thyroid glands (hyperthyroidism),
• overactive adrenal glands (pheochromocytoma),
• kidney or liver disease,
• oesophagitis, inflammation in the mouth or throat, gastritis or peptic ulcer,
• fructose intolerance.
Even small quantities of nicotine are dangerous in children and may result in severe
symptoms or death. It is therefore essential that you keep Nicotinell out of reach and sight of
children at all times
People having problems with the joint of the jawbone and some denture wearers may
experience difficulty in chewing the gum. If you do, it is recommended that you use a
different pharmaceutical form of nicotine replacement therapy. Ask your doctor or pharmacist
for advice.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. If you stop smoking and if
you are using other medicines, your doctor may want to adjust the dose.
No information is available on interactions between Nicotinell and other medicines. However,
apart from nicotine, other substances in cigarettes may have an effect on certain medicine.
Stopping smoking can affect the action of certain medicines e.g.:


theophyllin (a medicine used for the treatment of bronchial asthma)



tacrine (medicine used to treat Alzheimer's disease)



olanzapine and clozapine (for the treatment of schizophrenia)



Insulin dose (medicine used for the treatment of diabetes) may need to be adjusted

Taking Nicotinell medicated chewing-gum with food and drink
Coffee, acidic drinks (e.g. fruit juice) and soft drinks may decrease the absorption of nicotine
and should be avoided for 15 minutes before chewing Nicotinell.

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Nicotinell® Classic 4mg medicated chewing-gums

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. Ideally you should try to
give up smoking without the use of medicines. If you cannot manage this, Nicotinell may be
recommended to help as the risk to the developing baby is less than that expected from
continued smoking. Nicotine in any form may cause harm to your unborn baby. Nicotinell
should only be used after consulting the healthcare professional who is managing your
pregnancy, or a doctor that is specialised in helping people quit smoking.
Nicotinell like smoking itself should be avoided during breast-feeding as nicotine may be
found in breast milk. If your doctor has recommended that you should take this medicinal
product, the medicated chewing-gum should be taken just after breast-feeding and not during
the two hours before breast-feeding.
Driving and using machines
There is no evidence of risk associated with driving or operating machinery if Nicotinell is
taken according to the recommended dose but remember that smoking cessation can cause
behavioural changes.
Important information about some of the ingredients of Nicotinell medicated
chewing-gum
Because Nicotinell Classic contains sorbitol and maltitol liquid: if you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor before taking this
medicine.
The gum base contains butylhydroxytoluene (E321) which may cause local irritation to
mucous membranes.
Each piece of Nicotinell Classic 4 mg contains sweeteners, including sorbitol (E420) 0.2 g
and maltitol liquid (E965) 0.03 g, a source of 0.04 g fructose. Calorific value 1.1 kcal/piece.
Nicotinell Classic 4 mg contains 11.52 mg of sodium per piece. To be taken into
consideration by patients on a controlled sodium diet.

3. HOW TO TAKE NICOTINELL MEDICATED CHEWING-GUM
Always take Nicotinell exactly as stated in this package leaflet. You should check with your
doctor or pharmacist if you are not sure.
To improve your chances of giving up smoking you should stop smoking completely when
you start to use Nicotinell and for the whole treatment duration.
Nicotinell is available in two strengths: 2 and 4 mg. The appropriate dose will depend on your
previous smoking habits. You should use Nicotinell 4 mg if:




you are a smoker with a strong or very strong nicotine dependency,
you have previously failed to stop smoking with Nicotinell 2 mg,
your withdrawal symptoms remain so strong as to threaten relapse.

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Otherwise Nicotinell 2 mg should be used.
Select your optimal dosage from the following table:
Low to moderate
dependency

Moderate to strong dependency

Strong to very strong
dependency

Low dosage forms acceptable
High dosage forms acceptable
Less than 20 cigarettes / day
Nicotinell 2 mg is preferable)

From 20 to 30 cigarettes / day
Low (Nicotinell 2 mg) or high (Nicotinell
4 mg) dose forms depending on patient
characteristics and preference.

Over 30 cigarettes / day
Nicotinell 4 mg is
preferable)

If an adverse event occurs with the use of the high dose (Nicotinell 4 mg), use of the low
dose (Nicotinell 2 mg) should be considered.
Instructions for use:
1.
2.
3.
4.

Chew one piece of Nicotinell slowly until the taste becomes strong.
Allow Nicotinell to rest between your gum and cheek.
Chew again when taste has faded.
Repeat this routine for about 30 minutes, to get a gradual release of nicotine.

Do not swallow.
Dosage for adults over 18 years:
Chew one piece of Nicotinell when you feel the urge to smoke. In general one piece should be
chewed every one or two hours. Normally 8-12 pieces per day are sufficient. If you still
experience an urge to smoke, you can chew additional pieces of Nicotinell. Do not exceed 15
pieces per day of Nicotinell 4mg.
The treatment duration is individual. Normally, treatment should continue for at least 3
months. After 3 months, you should gradually reduce the number of pieces of Nicotinell
chewed each day. Treatment should be stopped when you have reduced your use of Nicotinell
to 1-2 pieces per day. It is generally not recommended to use Nicotinell for longer than 6
months. However, some ex-smokers may need treatment with Nicotinell for longer to avoid
returning to smoking.
If you are still using Nicotinell after 9 months, you should speak to your doctor or pharmacist.
Counselling may improve your chances of giving up smoking.

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Children and adolescents(< 18 yrs)
Nicotinell should not be used by people under 18 years of age without recommendation from
a doctor.
If you take more Nicotinell medicated chewing-gums than you should
Chewing too many Nicotinell pieces can result in the same symptoms as smoking too much.
The general symptoms of nicotine overdose include weakness, sweating, increased production
of saliva, dizziness, throat burn, nausea, vomiting, diarrhoea, pain in the abdomen,
disturbance of hearing and vision, headache, fast or other disturbance in heart beat
(tachycardia and cardiac arrhythmia), shortness of breath, prostration, circulatory problems,
coma and terminal convulsions.
You should consult your doctor or pharmacist if you experience any problems.
If poisoning is suspected in a child, a doctor must be consulted immediately. Even small
quantities of nicotine are dangerous in children and may result in severe symptoms or death.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Nicotinell can cause side effects, although not everybody gets them.
Some effects you may notice in the first few days are dizziness, headache and sleep
disturbances. These may be withdrawal symptoms in connection with smoking cessation and
may be caused by insufficient administration of nicotine.
Common side effects ( occur in 1 to 10 users in 100)


dizziness and headache.



Hiccups, stomach trouble such as nausea, flatulence, vomiting, heartburn, increased
saliva production, irritation of the mouth and throat and jaw muscle ache may also
occur, especially as a result of intense chewing.
Slower chewing will usually overcome these problems.

Uncommon side effects (occur in 1 to 10 users in 1,000)



palpitations.
red skin rash (erythema) and itching of raised bumps of the skin (urticaria).

Rare side effects (occur in 1 to 10 users in 10,000)


disturbances in heart beat rhythm and allergic reactions. These reactions may in very
few cases be serious and include swelling of the skin, swelling of the face and mouth,
low blood pressure and difficulty in breathing. .

Mouth ulcers may be related to quitting smoking and not to your treatment.
Nicotinell can stick to and very rarely damage dentures or other dental work.
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.

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Nicotinell® Classic 4mg medicated chewing-gums

5. HOW TO STORE NICOTINELL MEDICATED CHEWING-GUM
Keep out of the reach and sight of children.
Do not use Nicotinell after the expiry date which is stated on the label after “EXP”. The
expiry date refers to the last day of that month.
Do not store above 25°C.
Used Nicotinell should be disposed of with care.
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.

6. FURTHER INFORMATION
What Nicotinell medicated chewing-gum contains
The active substance is nicotine.
Each piece of Nicotinell medicated chewing-gum contains 4 mg of nicotine (as 20 mg
nicotine-polacrilin).
The other ingredients are


gum base (containing butylhydroxytoluene (E321)), calcium carbonate, sorbitol
(E420), maltitol liquid (E965), sodium carbonate anhydrous, sodium hydrogen
carbonate, polacrilin, glycerol (E422), purified water, levomenthol, tutti flavour,
xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax and
talc.

What Nicotinell medicated chewing-gum looks like and contents of the pack
Each piece of coated medicated chewing-gum is off-white in colour and rectangular in shape.
Nicotinell medicated chewing-gum is available in two strengths (2 and 4 mg) and four
flavours (Fruit, Mint, Liquorice and Classic). This package leaflet deals with Nicotinell
Classic 4 mg medicated chewing-gums.
Nicotinell medicated chewing-gum contains reduced amount of flavouring and is specifically
recommended if you prefer the classic nicotine taste.
The blisters are packed in boxes containing 2, 12, 24, 36, 48, 60, 72, 84, 96, 120 or 204 pieces
of medicated chewing-gum. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Consumer Health, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey,
GU15 3YL.
Manufacturer

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Nicotinell® Classic 4mg medicated chewing-gums

FAMAR S.A., 48th km National Road Athens-Lamia, 19011, Avlonas, Attiki, Greece.
This medicinal product is authorised in the Member States of the EEA under
the following names:

AT

Nicotinell 4 mg - Kaugummi

BE

Nicotinell Classic, 4 mg, kauwgom

DE

Nicotinell Kaugummi 4 mg Classic

DK

Nicotinell Classic

ES

Nicotinell 4 mg chicle medicamentoso

FI

Nicotinell 4 mg lääkepurukumi

FR

NICOTINELL CLASSIC 4 mg SANS SUCRE, gomme à
mâcher médicamenteuse
Nicotinell Classic 4mg Medicated Chewing Gum.

IE
IS

Nicotinell Classic 4 mg lyfjatyggigúmmí

LU

Nicotinell Classic, 4 mg, gomme à mâcher médicamenteuse

NL

Nicotinell Classic, 4 mg, kauwgom

NO

Nicotinell medisinsk tyggegummi med nøytral smak

PT

Nicotinell Classic 4mg

SE

Nicotinell 4 mg, medicinskt tuggummi

UK

Nicotinell Classic 4mg Medicated Chewing Gum

This leaflet was last approved in August 2009.

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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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