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NICOTINELL TROPICAL FRUIT 2MG MEDICATED CHEWING GUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicotinell Tropical fruit 2 mg and 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
Tropical fruit medicated chewing-gum carefully to get the best results from it.




Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.
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 Tropical fruit chewing-gum is and what it is used for
Before you take Nicotinell Tropical fruit chewing-gum
How to take Nicotinell Tropical fruit chewing-gum
Possible side effects
How to store Nicotinell Tropical fruit chewing-gum
Further information

1. WHAT NICOTINELL TROPICAL FRUIT CHEWING-GUM IS AND
WHAT IT IS USED FOR
Nicotinell belongs to a group of medicines which are used to help you stop smoking.
Nicotinell Tropical fruit chewing-gum contains nicotine. When chewed, nicotine is released
slowly and absorbed through the lining of the mouth. This medicinal product is used to relieve
nicotine craving and withdrawal symptoms in nicotine dependency. It thereby
- counteracts the relapse in smoking in smokers who are motivated to stop or
- facilitate smoking reduction in smokers who cannot or are reluctant to stop.

2. BEFORE YOU TAKE NICOTINELL TROPICAL FRUIT CHEWINGGUM
Do not take Nicotinell Tropical fruit chewing-gum if you are
• allergic (hypersensitive) to any of the ingredients of the chewing-gum
• a non-smoker.
Take special care with Nicotinell Tropical fruit chewing-gum
Please check with your doctor or pharmacist if you have
• recently had a heart attack or stroke,
• any heart disease,
• high blood pressure,

• diabetes,
• overactive thyroid glands,
• overactive adrenal glands (pheochromocytoma),
• impaired kidney and/or liver function,
• peptic ulcer
In these conditions it is not sure that it is suitable for you to use Nicotinell Tropical fruit.
People having problems with the joint of the jawbone and 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.
Do not smoke while taking Nicotinell Tropical fruit, since you may obtain so high a
concentration of nicotine that you will feel bad.
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 and that you are stopping
smoking.
No information is available on interactions between Nicotinell Tropical fruit chewing-gum
and other medicines. However, the action of some drugs may be affected if you stop smoking.
This is particularly important if you use drugs containing


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



tacrine (a medicine used to treat Alzheimer's disease),



olanzapine and clozapine (for the treatment of schizophrenia).

Taking Nicotinell Tropical fruit chewing-gum with food and drink
Coffee, acidic and soft drinks may decrease the absorption of nicotine and should be avoided
for 15 minutes before chewing a Nicotinell Tropical fruit chewing-gum.
Pregnancy and breast-feeding
Nicotine may affect your unborn baby. Nicotinell Tropical fruit should only be used during
pregnancy after prescription by a doctor.
Nicotine is transferred to breast milk and there is a risk that the breast-fed child will be
affected. Nicotinell Tropical fruit should only be used during breast-feeding after prescription
by a doctor.
Driving and using machines
There is no evidence of risk associated with driving or operating machinery if Nicotinell
Tropical fruit chewing-gum is taken according to the recommended dose but remember that
smoking cessation can cause behavioral changes.
Important information about some of the ingredients of Nicotinell Tropical fruit
chewing-gum
Because Nicotinell Tropical fruit chewing-gum contains sorbitol: if you have been told by
your doctor that you have an intolerance to some sugars, contact your doctor before taking
Nicotinell Tropical fruit chewing-gum.

The gum contains butylhydroxytoluene (E321) which may cause local irritation to mucous
membranes in the mouth.
Each piece of chewing-gum contains 0.1 g sorbitol, a source of 0.02 g fructose. Calorific
value 1.0 kcal/piece of chewing-gum (Nicotinell Tropical fruit 2 mg) and 0.9 kcal/piece
(Nicotinell Tropical fruit 4 mg) respectively.
Nicotinell Tropical fruit chewing-gum contains 11.4 mg of sodium per piece. To be taken into
consideration by patients on a controlled sodium diet.

3. HOW TO TAKE NICOTINELL TROPICAL FRUIT CHEWING-GUM
The appropriate dose will depend on your nicotine dependence. You should use the 4 mg
Nicotinell Tropical fruit chewing-gum if
• you are a smoker with a strong nicotine dependency,
• you have previously failed to stop smoking with the 2 mg chewing-gum.
Otherwise 2 mg Nicotinell Tropical fruit chewing-gum should be used.
Select your optimal dosage from the following table:
Moderate to strong dependency

Low to moderate
dependency

Strong to very strong
dependency

Low dosage forms acceptable
High dosage forms acceptable

Less than 20 cigarettes / day
Low dose (2 mg chewinggum) is preferable

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

Over 30 cigarettes / day
High dose (4 mg chewinggum) is preferable

If an adverse event occurs with the use of the high dose (4 mg), use of the low dose (2 mg)
should be considered.
It is important to chew the chewing-gum in a correct way to avoid discomfort (e.g. hiccups
and heart burn).
Instructions for use:
1.
2.
3.
4.

Chew one piece of chewing-gum slowly until the taste becomes strong.
Allow the chewing-gum to rest between your gum and cheek.
Chew again when taste has faded.
Repeat this routine for about 30 minutes.

Do not swallow the chewing-gum.
Dosage for adults over 18 years:
Chew one piece of gum when you feel the urge to smoke.

At the beginning of the treatment, in general, one piece of chewing-gum should be chewed
every one or two hours. Normally 8-12 pieces of chewing-gum per day are sufficient,
irrespective of strength. Do not exceed 25 pieces a day of 2 mg chewing-gum or 15 pieces per
day of 4 mg chewing-gum.
Smoking cessation:
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 gum chewed
each day. Treatment should be stopped when you have reduced your use of the gum to 1-2
chewing-gums per day.
It is generally not recommended to use Nicotinell Tropical fruit chewing-gum for longer than
1 year. However, some ex-smokers may need treatment with the chewing-gum for longer to
avoid returning to smoking.
Counselling may improve your chances of giving up smoking.
Smoking reduction:
Nicotinell Tropical fruit is used between periods of smoking in order to prolong smoke-free
intervals and with the intention to reduce smoking as much as possible. If a reduction in the
number of cigarettes per day has not been achieved after 6 weeks, professional advice should
be sought. A quit attempt should be made as soon as you feel ready, but not later than 6
months after start of treatment. If a quit attempt cannot be made within 9 months after starting
treatment, professional advice should be sought.
Counselling may improve your chances of giving up smoking.

Children and adolescents (<18 years)
Nicotinell should not be used by people under 18 years of age without recommendation from
a doctor.
If you take more Nicotinell Tropical fruit chewing-gums than you should
Chewing too many chewing-gum pieces can result in the same symptoms as smoking too
much. The general symptoms of nicotine overdose include weakness, sweating, increased
production of saliva, throat burn, nausea, vomiting, diarrhoea, pain in the abdomen,
disturbance of hearing and vision, headache, fast or other disturbance in heart beat, shortness
of breath.
If you have taken more of the drug than you should, or if a child has taken the drug by
mistake, contact a doctor or hospital for assessment of risk and advice.
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 forget to use Nicotinell Tropical fruit medicated chewing-gums
Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Nicotinell Tropical fruit chewing-gums 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
(affecting 1 to 10 people out of 100)


dizziness, headache and sleep disturbances



hiccups, stomach issues, nausea, vomiting, increased saliva production, and inflammation
of the mouth mucous. Mouth, 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
(affecting 1 to 10 people out of 1000)


palpitations,



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

Rare side effects
(affecting 1 to 10 people out of 10000)


disturbances in heart beat rhythm and allergic reactions, e.g. swelling of the face, mouth
and/or throat (angiooedema)

Stop taking Nicotinell Tropical fruit and contact immediately a doctor if swelling of face,
tongue, and/or throat and/or difficulties to swallow or urticaria appear together with
difficulties to breathe (angiooedma).
Mouth ulcers may be related to quitting smoking and not to your treatment.
The gum can stick to and 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.

5. HOW TO STORE NICOTINELL TROPICAL FRUIT CHEWINGGUM
Keep out of the reach and sight of children.
Do not use Nicotinell Tropical fruit after the expiry date which is stated on the label of the
package after “EXP”. The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Tropical fruit chewing-gum contains
Nicotinell Tropical fruit medicated chewing-gum is available in two strengths.
The active substance is nicotine.

Each piece of Nicotinell Tropical fruit chewing-gum contains 2 mg or 4 mg nicotine (as 10
mg or 20 mg nicotine polacrilin (1:4)).
The other ingredients are:
Gum base (containing butylhydroxytoluene (E321)), xylitol, calcium carbonate (E170),
sorbitol (E420), mannitol (E421), sodium carbonate anhydrous, sodium hydrogen carbonate,
natural mint flavouring, polacrilin, glycerol, sucralose, levomenthol, mango flavouring,
gelatine, titanium dioxide (E171), acesulfame potassium (E950), carnauba wax and talc.
Nicotinell Tropical fruit medicated chewing gum is sugar free.
What Nicotinell Tropical fruit chewing-gum looks like and contents of the pack
Each piece of coated chewing-gum is off-white in colour and rectangular in shape.
The chewing-gums are packed in blisters containing 12 chewing-gums. The blisters are
packed in boxes containing 12, 24, 48, 84, 96 or 204 pieces of chewing-gum.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Novartis Consumer Health, Camberley GU15 3YL
Manufacturer
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:
Sweden (RMS)
Denmark (CMS)

Finland (CMS)
France (CMS)

Iceland (CMS)

Ireland (CMS)
Norway (CMS)

UK (CMS)

Nicotinell Tropisk frukt 2 o 4 mg medicinskt
tuggummi
Nicotinell Tropical Fruit
2 mg & 4 mg
medicinsk tyggegummi
Nicotinell Tropical Fruit 2 mg & 4 mg
lääkepurukumi
NICOTINELL FRUIT EXOTIQUE 2 mg et
4mg SANS SUCRE, gomme à mâcher
médicamenteuse édulcorée au xylitol, au
sorbitol, au sucralose et à l'acésulfame
potassique
Nicotinell Tropical Fruit
2 mg & 4 mg
lyfjatyggigúmmí
Nicotinell Tropical Fruit 2 mg & 4 mg
medicated chewing-gum
Nicotinell 2 mg / 4mg medisinsk tyggegummi
Tropisk frukt
Nicotinell Tropical Fruit 2 mg & 4 mg
medicated chewing-gum

This leaflet was last approved in May 2012

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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