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.    What Nicotinell Tropical fruit chewing-gum is and what it is used for

2.    Before you take Nicotinell Tropical fruit chewing-gum

3.    How to take Nicotinell Tropical fruit chewing-gum

4.    Possible side effects

5.    How to store Nicotinell Tropical fruit chewing-gum

6.    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 CHEWING-GUM

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:

Low to moderate dependency			Moderate to strong dependency		Strong to very strong dependency
__--	Low dosage fo rms acceptable
1
			= High dosage fo		rms acceptable
Less than 20 cigarettes / day		From 20 to 30 cigarettes / day			Over 30 cigarettes / day
Low dose (2 mg chewing-gum) is preferable			Low (2 mg chewing-gum) or high (4 mg chewing-gum) dose forms depending on patient characteristics and preference.		High dose (4 mg chewing-gum) 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.    Chew one piece of chewing-gum slowly until the taste becomes strong.

2.    Allow the chewing-gum to rest between your gum and cheek.

3.    Chew again when taste has faded.

4.    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 CHEWING-GUM

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)	Nicotinell Tropisk frukt 2 o 4 mg medicinskt tuggummi
Denmark (CMS)	Nicotinell Tropical Fruit 2 mg & 4 mg medicinsk tyggegummi
Finland (CMS)	Nicotinell Tropical Fruit 2 mg & 4 mg laakepurukumi
France (CMS)	NICOTINELL FRUIT EXOTIQUE 2 mg et 4mg SANS SUCRE, gomme a macher medicamenteuse edulcoree au xylitol, au sorbitol, au sucralose et a l'acesulfame potassique
Iceland (CMS)	Nicotinell Tropical Fruit 2 mg & 4 mg lyfjatyggigummi
Ireland (CMS)	Nicotinell Tropical Fruit 2 mg & 4 mg medicated chewing-gum
Norway (CMS)	Nicotinell 2 mg / 4mg medisinsk tyggegummi Tropisk frukt
UK (CMS)	Nicotinell Tropical Fruit 2 mg & 4 mg medicated chewing-gum

This leaflet was last approved in May 2012