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PACKAGE LEAFLET

Package leaflet: Information for the user

Nicotinell Fruktmint 1 mg compressed lozenge

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 Fruktmint 1 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. See section 4.

To be completed nationally for ES:

• 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 6 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. See section 4.

In this leaflet:

1. What Nicotinell Fruktmint is and what it is used for

2. What you need to know before you take Nicotinell Fruktmint

3. How to take Nicotinell Fruktmint

4. Possible side effects

6. Contents of the pack and other information

Nicotinell Fruktmint 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 Fruktmint 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 Fruktmint 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.

Do not take Nicotinell Fruktmint

• 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,

• overactive thyroid glands (hyperthyroidism),

• overactive adrenal glands (pheochromocytoma),

• kidney or liver disease,

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

Children

The correct dose for adults or even small quantities could seriously poison or be fatal to small children. It is therefore essential that you keep Nicotinell Fruktmint out of sight and reach of children at all times.

Other medicines and Nicotinell Fruktmint

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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

Nicotinell Fruktmint 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 Fruktmint 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.

Nicotinell Fruktmint contains aspartame, maltitol, sodium and sulphites

Nicotinell Fruktmint lozenges contain sweeteners, including aspartame and maltitol.

Each Nicotinell Fruktmint contains aspartame (E951), a source of phenylalanine equivalent to 5 mg per piece and may be harmful for people with phenylketonuria.

Because Nicotinell Fruktmint 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 2.1 kcal/g maltitol. Nicotinell Fruktmint lozenge ingredients are suitable for diabetics.

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

Nicotinell Fruktmint contains sulphites that may rarely cause sever hypersensitivity reactions and bronchospasm.

Always take this medicine exactly as described in this package leaflet or as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

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

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

Adults over 18 years

Treatment with Nicotinell Fruktmint lozenges only

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:

Do not swallow the lozenge.

Dosage for adults over 18 years:

Suck one lozenge when you feel the urge to smoke. In general one lozenge should be takenevery 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 30lozenges 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 Fruktmint for longer than 6 months. However, some ex-smokers may need treatment with the lozenge for longer to avoid returning to smoking.

To be nationally completed for all CMS except ES:

If you are still using the lozenge after 9 months, you should speak to your doctor or pharmacist.

To be nationally completed for ES:

If you are still using the lozenge after 6 months, you should speak to your doctor or pharmacist.

Counselling may improve your chances of giving up smoking.

Smoking reduction:

Nicotinell should be used between periods of smoking in order to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. The number of cigarettes should be gradually replaced by Nicotinell. If, after 6 weeks, you have not succeeded in reducing the number of cigarettes per day to at least half of your consumption you should seek professional help. You should try to stop smokingas soon as you feel ready, but not later than 4 months after you started using Nicotinell. After that the number of lozenges should be gradually reduced, for example by quitting one lozenge every 2-5 days.

If you do not succeed in making a serious attempt to stop smoking within 6 months you should seek professional help. Regular use of Nicotinell beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the lozenges for longer to avoid returning to smoking.

Counselling may improve your chances of giving up smoking.

Treatment with Nicotinell Fruktmint 1 mg lozenge in combination with Nicotinell transdermal patches

Smoking cessation:

If you have failed treatment with only Nicotinell lozenge you can use Nicotinell patches together with Nicotinell 1 mg lozenge.

NOTE: Read the package leaflet of Nicotinell transdermal patch prior to use.

To improve your chances of giving up smoking you should stop smoking completely when you start to use the lozenges in combination with Nicotinell patches and for the whole treatment period.

The use of Nicotinell patches together with Nicotinell 1 mg lozenge is recommended for smokers with moderate to very strong dependency, i.e. over 20 cigarettes per day. It is strongly recommended that the combination therapy is carried out with the advice and support from a health care professional.

The combination therapy should only be used in smoking cessation.

Initial combination therapy:

Begin the treatment with one patch 21 mg/24 hours in combination with Nicotinell 1mg lozenge. Use at least 4 lozenges (1 mg) per day . In most cases, 5-6 lozenges are enough. Do not use more than 15 lozenges a day. In normal cases, the treatment may last for 6-12 weeks. Thereafter, you should reduce the nicotine dose gradually.

Apply the patch on a clean, dry, hairless, intact area of skin on the trunk, arms or hips and press itagainst the skin with your hand for 10- 20 seconds.

To minimize the risk of local irritation the placement of Nicotinell patches, alternate between different application sites.

Wash your hands thoroughly after application of transdermal patches to avoid irritation of the eyes with nicotine from the fingers.

Reduction of nicotine dose after the initial 6-12 weeks:

This can be done in two ways. .

Alternative 1:

Use patches of a lower strength, i.e. 14 mg/24 hours patches for 3-6 weeks followed by 7 mg/24 hours for another 3-6 weeks together with the initial dose of Nicotinell 1 mg lozenge. Thereafter, reduce the number of lozenges gradually. It is generally not recommended to use Nicotinell Fruktmint lozenge for longer than 6 months. However, some ex-smokers may need treatment for longer to avoid returning to smoking but it should not be more than 9 months.

Alternative 2:

Discontinue the use of the patch and reduce the number of 1 mg lozenges gradually. It is generally not recommended to use Nicotinell Fruktmint lozenge for longer than 6 months. However, some ex-smokers may need treatment for longer to avoid returning to smoking but it should not be more than 9 months.

Recommended dosage:

Period	Patches	Lozenge 1 mg
Initial treatment(followed by alternative 1 or 2 below)
First 6-12 weeks	1 patch 21 mg/24 hours	When necessary, 5-6 lozenges per day is recommended
Reduction of nicotine dose – alternative 1
Next 3-6 weeks	1 patch 14 mg/24 hours	Continue to use lozenges, when necessary
Following 3-6 weeks	1 patch 7 mg/24 hours	Continue to use lozenges, when necessary
Up to 9 months in total	---	Reduce the number of lozenges gradually
Reduction of nicotine dose – alternative 2
Up to 9 months in total	---	Continue to reduce the number of lozenges gradually

To be nationally completed for all CMS except ES:

If you are still using the lozenge and patches after 9 months, you should speak to your doctor or pharmacist.

To be nationally completed for ES:

If you are still using the lozenge and patches after 6 months, you should speak to your doctor or pharmacist.

Use in children and adolescents

Adolescents (12-17 years inclusive)

You should only use Nicotinell Fruktmint following advice from a doctor.

Children under 12 years

Children under 12 years of age must not use Nicotinell Fruktmint

If you take more Nicotinell Fruktmint 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, 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.

• 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( may affect up to 1 in 100 people)

Rare side effects ( may affect up to 1 in 1,000 people)

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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nicotinell Fruktmint 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. Contents of the pack and other information

What Nicotinell Fruktmint lozenge contains

Each piece of Nicotinell Fruktmint lozenge contains 1 mg of nicotine (as 3.072 mg nicotine bitartrate dihydrate).

What Nicotinell Fruktmint lozenge looks like and contents of the pack

Nicotinell Fruktmint lozenge is a white, fruit-mint flavoured, round biconvex compressed lozenge.

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

with Nicotinell Fruktmint 1 mg lozenges.

Bottle (polypropen) in folding box containing 24 or 72 (3 x 24) lozenges.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

To be completed nationally

Manufacturer

GSK Consumer Healthcare GmbH & Co. KG

Barthstraße 4

80339 München

Germany

GlaxoSmithKline Consumer Healthcare A/S

Nykær 68

2605 Brøndby

Denmark

GlaxoSmithKline Consumer Healthcare S.A.

Site Apollo - Avenue Pascal 2-4-6

1300 Wavre

Belgium

GlaxoSmithKline Santé Grand Public

100 route de Versailles

78164 Marly Le Roi Cedex

France

GSK-Gebro Consumer Healthcare GmbH

Bahnhofbichl 13

6391 Fieberbrunn

Austria

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

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

Austria
Denmark
Finland
France
Germany
Iceland
Ireland
Luxembourg
Netherlands
Norway
Portugal
Spain
Sweden
United Kingdom

This leaflet was last revised in 31 October 2016