Document: leaflet MAH BRAND 2_PL 00030-0146 change

• leaflet MAH BRAND 2_PL 00030-0146
• leaflet MAH BRAND_PL 00030-0146
• leaflet MAH BRAND_PL 44673-0118

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Leaflet 1

135 mm

XXXXXXXX-mm/JJ

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Mint 1 mg lozenge carefully to get the best results from it.

In this leaflet:

1.    What Nicotinell Mint lozenge is and what it is used for

2.    Before you take Nicotinell Mint lozenge

3.    How to take Nicotinell Mint lozenge

4.    Possible side effects

5.    How to store Nicotinell Mint lozenge

6.    Contents of the pack and other information

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

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

This medicine 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 help people to stop smoking. The nicotine in Nicotinell Mint relieves nicotine withdrawal symptoms and cravings when you stop smoking or temporarily reduce smoking in order to facilitate smoking cessation. By relieving the withdrawal symptoms and cravings Nicotinell Mint counteracts a smoking relapse in smokers who are motivated to stop smoking.

Patient counselling and support normally improve the success rate. Nicotinell is indicated for smokers aged 18 years and above.

2.    BEFORE YOU TAKE NICOTINELL MINT LOZENGE

Do not take Nicotinell Mint lozenge

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

If you are a non-smoker.

Take special care with Nicotinell 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 Mint lozenge out of reach and sight of children at all times.

Children and adolescents (below 18 years)

Nicotinell should not be used by people under 18 years of age without recommendation from a doctor.

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 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 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 you to use Nicotinell 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 Mint lozenge

Nicotinell Mint lozenges contain sweeteners, including aspartame and maltitol.

Each Nicotinell Mint 1 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 Mint 1 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 2.3 kcal/g maltitol. Nicotinell Mint lozenge ingredients are suitable for diabetics.

Nicotinell Mint 1 mg lozenge contains 9.8 mg of sodium per piece.

To be taken into consideration by patients on a controlled sodium diet.

3. HOW TO TAKE NICOTINELL MINT LOZENGE

Always take Nicotinell Mint Lozenge exactly as stated in this package leaflet. You should check with your doctor or pharmacist if you are not sure.

Nicotinell Mint Lozenge is available in two strengths: 1 and 2 mg.

Nicotinell Mint 1 mg lozenge is recommended in low to moderate nicotine dependent smokers. It is not recommended for smokers with a strong or very strong nicotine dependency.

Nicotinell Mint 1 mg lozenge can be used alone or in combination with Nicotinell patches.

Adults over 18 years

Treatment with Nicotinell Mint lozenges only

Select your optimal dosage from the following table:

	Low to moderate dependency	Moderate to strong dependency	Strong to very strong dependency
	„ Low dosage to	ms acceptable _
		" High dosage for	ns acceptable "
	Less than 20 cigarettes / day	From 20 to 30 cigarettes/day	Over 30 cigarettes / day
Treatment with Nicotinell Mint lozenge only	1 mg lozenge is preferable	Low (1 mg lozenge) or high (2 mg lozenge) dose forms depending on patient characteristics and preference	2 mg lozenge is preferable

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:

Do not swallow the lozenge.

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 30 lozenges per day of the 1 mg strength (applies for both smoking cessation and smoking reduction).

Nicotinell lozenge should primarily be used for smoking cessation. Smoking cessation:

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.

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 Mint lozenge for longer than 6 months. However, some ex-smokers may need treatment with the lozenge for longer to avoid returning to smoking.

180 mm

If you take more Nicotine!! 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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nicotinell Mint lozenges 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 (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.

Uncommon 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 and allergic reactions. These reactions may in very few cases be serious. You should see your doctor immediately if you experience symptoms such as swollen face, tongue and/or pharynx and/or difficulty to swallow or hives together with difficulty breathing (angioedema).

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

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.

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 Mint lozenge contains

-    The active substance is nicotine

Each piece of Nicotinell Mint lozenge contains 1 mg of nicotine (as 3.072 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.

What Nicotinell Mint lozenge looks like and contents of the pack

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

Nicotinell Mint lozenge is available in two strengths (1 and 2 mg). This package leaflet deals with Nicotinell Mint 1 mg lozenges.

The blisters are packed in boxes containing 12, 36, 72, 96, 144 or 204 lozenges. Not all pack sizes may be marketed.

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 UK Ltd Park View, Riverside Way Watchmoor Park, Camberley Surrey GU15 3YL United Kingdom

Manufacturer

Novartis Consumer Health GmbH Zielstattstrasse 40,

81379 Munich Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Nicotinell Mint 1 mg Lutschtabletten
Denmark	Nicotinell Mint 1 mg Sugetablet
Finland	Nicotinell Mint 1 mg Imeskelytabletti
France	Nicotinell Menthe 1 mg, comprime a sucer
Germany	Nicotinell Lutschtabletten 1 mg Mint
Hungary	Nicotinell Mint 1 mg Szopogato tabletta
Iceland	Nicotinell mint 1 mg Munnsogstafla
Ireland	Nicotinell Mint 1 mg compressed Lozenge
Luxembourg	Nicotinell Mint 1 mg, comprime a sucer
Netherlands	Nicotinell Mint 1 mg Zuigtablet
Norway	Nicotinell Mint 1mg sugetablett, komprimert
Portugal	Nicotinell Mint 1 mg Pastilhas
Spain	Nicotinell Mint 1 mg comprimidos para chupar
Sweden	Nicotinell Mint 1 mg sugtablett
United Kingdom	Nicotinell Mint 1 mg Lozenge

This leaflet was last revised in 15 April 2015.

GB 315012 - XXXXXX    & NOVARTIS

k-

I    180 mm

Leaflet 2

In this leaflet:

1.    What Nicotinell Mint lozenge is and what it is used for

2.    Before you take Nicotinell Mint lozenge

3.    How to take Nicotinell Mint lozenge

4.    Possible side effects

5.    How to store Nicotinell Mint lozenge

6.    Contents of the pack and other information

1. What Nicotinell Mint lozenge is and what it is used for

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

This medicine 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 help people to stop smoking. The nicotine in Nicotinell Mint relieves nicotine withdrawal symptoms and cravings when you stop smoking or temporarily reduce smoking in order to facilitate smoking cessation. By relieving the withdrawal symptoms and cravings Nicotinell Mint counteracts a smoking relapse in smokers who are motivated to stop smoking.

Patient counselling and support normally improve the success rate.

Nicotinell is indicated for smokers aged 18 years and above.

2. Before you take Nicotinell Mint lozenge

Do not take Nicotinell Mint lozenge

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

•    If you are a non-smoker.

Take special care with Nicotinell 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 Mint lozenge out of reach and sight of children at all times.

Children and adolescents (below 18 years)

Nicotinell should not be used by people under 18 years of age without recommendation from a doctor.

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 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 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

Because Nicotinell Mint 1 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 2.3 kcal/g maltitol. Nicotinell Mint lozenge ingredients are suitable for diabetics.

Nicotinell Mint 1 mg lozenge contains 9.8 mg of sodium per piece. To be taken into consideration by patients on a controlled sodium diet.

3. How to take Nicotinell Mint lozenge

Always take Nicotinell Mint lozenge exactly as stated in this package leaflet. You should check with your doctor or pharmacist if you are not sure.

Nicotinell Mint lozenge is available in two strengths:

1 and 2 mg.

Nicotinell Mint 1 mg lozenge is recommended in low to moderate nicotine dependent smokers. It is not recommended for smokers with a strong or very strong nicotine dependency.

Nicotinell Mint 1 mg lozenge can be used alone or in combination with Nicotinell patches.

Adults over 18 years

Treatment with Nicotinell Mint lozenges only

Select your optimal dosage from the following table:

	Low to moderate dependency	Moderate to strong dependency	Strong to very strong dependency
	. Low d forms ac	osage . ceptable
		. High d forms ac	osage . ceptable
	Less than 20 cigarettes / day	From 20 to 30 cigarettes / day	Over 30 cigarettes / day
Treatment with Nicotinell Mint lozenge only	1 mg lozenge is preferable	Low (1 mg lozenge) or high (2 mg lozenge) dose forms depending on patient characteristics and preference	2 mg lozenge is preferable

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:

Do not swallow the lozenge.

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 30 lozenges per day of the 1 mg strength (applies for both smoking cessation and smoking reduction).

Nicotinell lozenge should primarily be used for smoking cessation.

Smoking cessation:

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.

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 Mint lozenge for longer than 6 months. However, some ex-smokers may need treatment with the lozenge for 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.

Smoking reduction:

Nicotinell lozenge should be used between periods of smoking in order to prolong smoke-free intervals and

145 mm