Pharma code 28

40022546-07/15

PACKAGE LEAFLET: INFORMATION FOR THE USER

Proof Z

NlCOTINei

NICOTINE

Fruity Mint

2mg Compressed Lozenge

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 Fruity Mint 2 mg lozenge 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 lozenge 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.    What Nicotinell Fruity Mint lozenge is and what it is used for

2.    Before you take Nicotinell Fruity Mint lozenge

3.    How to take Nicotinell Fruity Mint lozenge

4.    Possible side effects

5.    How to store Nicotinell Fruity Mint lozenge

6.    Further information

1.    WHAT NICOTINELL FRUITY MINT LOZENGE IS AND WHAT IT IS USED FOR

Nicotinell Fruity Mint lozenge contains nicotine, which is one of the substances contained in tobacco.

This medicinal product belongs to a group of medicines which are used to help you to stop smoking.

When sucked, 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 FRUITY MINT LOZENGE

Do not take Nicotinell Fruity Mint lozenge

•    If you are allergic (hypersensitive) to nicotine or any of the other ingredients of Nicotinell Fruity Mint lozenge.

•    If you are a non-smoker.

Take special care with Nicotinell Fruity Mint lozenge

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,

•    overactive thyroid glands (hyperthyroidism),

•    overactive adrenal glands (pheochromocytoma),

•    kidney or liver disease,

•    oesophagitis, inflammation in the mouth or throat, gastritis or peptic ulcer.

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 Fruity Mint lozenge out of the reach and sight of children at all times.

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 lozenge 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 Fruity Mint lozenge with food and drink

Coffee, acidic and soft drinks may decrease the absorption of nicotine and should be avoided for 15 minutes before sucking a lozenge.

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 pre-mature 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 health-care 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 breastfeeding as nicotine may be found in breast milk. If your doctor has recommended you to use Nicotinell Fruity Mint lozenge during breast-feeding, the lozenge should be sucked 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 the lozenge 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 Fruity Mint lozenge

Nicotinell Fruity Mint lozenges contain sweeteners, including aspartame and maltitol.

Each Nicotinell Fruity Mint 2 mg lozenge contains aspartame (E951), a source of phenylalanine equivalent to 5 mg per piece and may be harmful for people with phenylketonuria. Because Nicotinell Fruity Mint 2 mg lozenge contains maltitol (E965), a source of fructose:

-    if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine,

-    patients may experience a mild laxative effect.

Calorific value 2.1 kcal/g maltitol. Nicotinell Fruity Mint lozenge ingredients are suitable for diabetics.

Nicotinell Fruity Mint 2 mg lozenge contains 9.81 mg of sodium per piece. To be taken into consideration by patients on a controlled sodium diet.

3. HOW TO TAKE NICOTINELL FRUITY MINT LOZENGE

Always take Nicotinell Fruity Mint lozenge 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 the lozenges and for the whole treatment period.

Nicotinell Fruity Mint lozenge is available in two strengths: 1 and 2 mg. The appropriate dose will depend on your previous smoking habits.

You should use the 2 mg Nicotinell Fruity Mint lozenge if:

•    you are a smoker with a strong or very strong nicotine dependency,

•    you have previously failed to stop smoking with the 1 mg lozenge,

•    your withdrawal symptoms remain so strong as to threaten relapse.

Otherwise 1 mg Nicotinell Fruity Mint lozenge should be used.

Do not swallow.

Select your optimal dosage from the following table:

If an adverse event occurs with the use of the high dose (2 mg lozenge), use of the low dose (1 mg lozenge) should be considered.

Instructions for use:

1.    Suck a lozenge until the taste becomes strong.

2.    Allow the lozenge to rest between your gum and cheek.

3.    Suck again when the taste has faded.

4.    Repeat this routine until the lozenge dissolves completely (about 30 minutes).

Dosage for adults over 18 years:

Suck one lozenge when you feel the urge to smoke. In general one lozenge should be taken every one or two hours. Normally 8-12 lozenges per day are sufficient. If you still experience an urge to smoke, you can suck additional lozenges. Do not exceed 15 lozenges per day of the 2 mg strength.

The treatment duration is individual. Normally, treatment should continue for at least 3 months. After 3 months, you should gradually reduce the number of lozenges used each day. Treatment should be stopped when you have reduced your use of the lozenge to 1-2 lozenges per day. It is generally not recommended to use Nicotinell Fruity Mint lozenge for longer than 6 months. However, some ex-smokers may need treatment with the lozenge longer to avoid returning to smoking. If you are still using the lozenge after 9 months, you should speak to your doctor or pharmacist.

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 Fruity Mint lozenges than you should

Sucking too many lozenges 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 and circulatory problems.

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.

Pharma code 28L

Proof Z

4.    POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions

In rare cases you might experience allergic reactions. These reactions may in very few cases be serious. You should stop taking the medicine straight away and seek urgent medical advice if you experience symptoms such as

-    swollen face, tongue and/or pharynx and/or

-    difficulty to swallow or

-    hives together with difficulty breathing (angioedema).

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

(affects 1 to 10 users in 100)

•    dizziness and headache.

•    dryness of the mouth, hiccups, stomach trouble such as nausea, flatulence, heartburn, increased saliva production and irritation of the mouth and throat may also occur, especially as a result of intense sucking. Slower sucking will usually overcome these problems.

Less common side effects

(affects 1 to 10 users in 1,000)

•    palpitations.

Rare side effects

(affects 1 to 10 users in 10,000)

•    disturbances in heart beat rhythm.

Mouth ulcers may occur when trying to quit smoking, but the relationship to the nicotine treatment is not clear.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 FRUITY MINT LOZENGE

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.

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 Fruity Mint lozenge contains

The active substance is nicotine.

Each piece of Nicotinell Fruity Mint lozenge contains 2 mg of nicotine (as 6.144 mg nicotine bitartrate dihydrate).

The other ingredients are

• maltitol (E965), sodium carbonate anhydrous, sodium hydrogen carbonate, polyacrylate, xanthan gum, colloidal anhydrous silica, levomenthol, peppermint oil, aspartame (E951), magnesium stearate and guarana flavour.

What Nicotinell Fruity Mint lozenge looks like and contents of the pack

Nicotinell Fruity Mint lozenge is a white, fruit mint flavoured, round biconvex compressed lozenge.

Nicotinell Fruity Mint lozenge is available in two strengths (1 and 2 mg). This package leaflet deals with Nicotinell Fruity Mint 2 mg lozenges. The tubes are packed in boxes containing 24, 72, 96 or 144 lozenges. Each tube contains 24 lozenges. Packs may contain 1,3, 4 or 6 tubes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Consumer Health,

Camberley GU15 3YL, UK

Manufacturer

Novartis Consumer Health GmbH Zielstattstrasse 40,

81379 Munich Germany

This leaflet was last revised on 2015-06-30

GB 933740

40022546-07/15    lb NOVARTIS

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