Skip to Content

NICOTINELL FRUIT 4 MG MEDICATED CHEWING-GUMS

Active substance(s): NICOTINE / NICOTINE / NICOTINE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
Nicotinell Fruit 4 mg medicated chewing-gum
Nicotine
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
This medicine is available without prescription. However, you still need to use Nicotinell Fruit 4 mg
medicated chewing-gum carefully to get the best results from it.
Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.
• 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
In this leaflet:
1. What Nicotinell is and what it is used for
2. What you need to know before you take Nicotinell
3. How to take Nicotinell
4. Possible side effects
5. How to store Nicotinell
6. Content of the pack and other information
1. What Nicotinell 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. What you need to know before you take Nicotinell
Do not take Nicotinell
• If you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6)
• If you are a non-smoker.
Warnings and precautions
Talk to 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.
Other medicines and Nicotinell
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
Nicotinell 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.
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 breastfeeding.
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.
Nicotinell contains sorbitol, butylhydroxyltoluene and sodium
Because Nicotinell Fruit contains sorbitol: 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 Fruit 4 mg contains sweeteners, including sorbitol (E420) 0.2 g, a source of 0.04
g fructose. Calorific value 0.9 kcal/piece.
Nicotinell Fruit 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

Always take this medicine exactly as described in this package leaflet or as your doctor or pharmacist
has told. 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.
Otherwise Nicotinell 2 mg should be used.
Select your optimal dosage from the following table:

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

Do not swallow.
The recommended dose for adults over 18 years and older people is:
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.
Use in 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 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 arrhyhtmia), 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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 (may affect up to 1 in 10 people)
• 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 (may affect up to 1 in 100 people)
• palpitations.
• red skin rash (erythema) and itching of raised bumps of the skin (urticaria).
Rare side effects (may affect up to 1 in 1,000 people)

• 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.
Reporting of side effects
If you get any side effects, talk to your pharmacist. 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.
5. How to store Nicotinell
Keep out of the sight and reach 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. Contents of the pack and other information
What Nicotinell contains
The active substance is nicotine.
Each piece of Nicotinell medicated chewing-gum contains 4 mg of nicotine (as 20 mg nicotinepolacrilin).
The other ingredients are
• gum base (containing butylhydroxytoluene (E321)), calcium carbonate, sorbitol (E420), sodium
carbonate anhydrous, sodium hydrogen carbonate, polacrilin, glycerol (E422), purified water,
levomenthol, tutti flavour, saccharin, sodium saccharin, acesulfame potassium, xylitol (E967), mannitol
(E421), gelatin, titanium dioxide (E171), carnauba wax and talc. See section 2 “Nicotinell contains
sorbitol, butylhydroxytoluene and sodium”

What Nicotinell 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 Fruit 2 mg medicated chewinggums.
The blisters are packed in boxes containing 2, 12, 24, 36, 48, 60, 72, 96, 120 or 204 pieces of medicated
chewing-gum. Not all pack sizes may be marketed.
Marketing Authorisation Holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
Brentford,
TW8 9GS,
U.K.
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:
AT
BE
DK
EE
EL
ES
FI
FR
HU
IE
LT
LU
LV
NL
NO
PT
SE
UK

Nicotinell Fruit 4 mg - wirkstoffhaltige Kaugummis zur
Raucherentwöhnung
Nicotinell Fruit, 4 mg, kauwgom
Nicotinell Fruit, medicinsk tyggegummi
Nicotinell Fruit
Nicotinell Fruit
Nicotinell fruit 4 mg chicle medicamentoso
Nicotinell Fruit 4 mg lääkepurukumi
NICOTINELL FRUIT 4 mg SANS SUCRE, gomme à mâcher
médicamenteuse
Nicotinell Fruit 4 mg gyógyszeres rágógumi
Nicotinell Fruit 4 mg Medicated Chewing Gum.
Nicotinell Fruit 4 mg vaistinė kramtomoji guma
Nicotinell Fruit, 4 mg, gomme à mâcher médicamenteuse
Nicotinell Fruit 4 mg ārstnieciskā košļājamā gumija
Nicotinell Fruit, 4 mg, kauwgom
Nicotinell medisinsk tyggegummi med fruktsmak
Nicotinell Fruit 4 mg
Nicotinell Fruit 4 mg medicinskt tuggummi
Nicotinell Fruit 4 mg Medicated Chewing Gum.

This leaflet was last revised in June 2016

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.

Hide