PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicotine Mint 2mg Medicated Chewing Gum Nicotine Mint 4mg Medicated Chewing Gum

(referred to as Nicotine Fruit Medicated Chewing Gum in this leaflet)

Read all of this leaflet carefully before you start to take this medicine.

•    This medicine is available without prescription. However, you still need to take Nicotine Mint Medicated Chewing Gum 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.

•    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Nicotine Mint Medicated Chewing Gum is and what it is used for

2.    Before you take Nicotine Mint Medicated Chewing Gum

3.    How to take Nicotine Mint Medicated Chewing Gum

4.    Possible side effects

5.    How to store Nicotine Mint Medicated Chewing Gum

6.    Further information

1. What Nicotine Mint Medicated Chewing Gum is and what it is used for

The name of your medicine is Nicotine Mint Medicated Chewing Gum. The active ingredient is nicotine (as resinate).

Nicotine belongs to a group of medicines which are used to help you stop smoking.

Nicotine Mint Medicated Chewing Gum can be used for the symptoms of nicotine withdrawal and to relieve and/or prevent the cravings for nicotine that you get when;

•    you stop smoking completely

•    you cut down on the number of cigarettes you smoke while you try to give up

•    you feel unable to stop smoking but you don’t want to smoke cigarettes or you want to avoid causing harm to others, such as when you are in a public place or are with friends and family.

When you stop smoking, cut down, or are unable to smoke cigarettes, your body misses the nicotine that you have been getting from the smoke. You may experience unpleasant feelings and a strong desire to smoke (“cravings”). Nicotine Mint Medicated Chewing Gum will help relieve and/or prevent the unpleasant withdrawal symptoms such as irritability, low mood, anxiety, restlessness and your craving to smoke.

You should always aim to stop smoking completely whilst using Nicotine Mint Medicated Chewing Gum. To help you should also try to use a behavioural support programme to increase your chances of successfully stopping smoking.

2. Before you take Nicotine Mint Medicated Chewing Gum

You should not take Nicotine Mint Medicated Chewing Gum if you:

•    are allergic (hypersensitive) to nicotine or any of the other ingredients of the gum (see section 6 Further information).

•    are a child under 12 years of age.

Talk to your doctor before taking Nicotine Mint Medicated Chewing Gum if you:

•    have a stable heart disease (such as chest pain), previously had a stroke, suffer from blockages in your blood vessels, severe high blood pressure or heart failure

•    have an overactive thyroid gland or a tumour of the adrenal glands (phaeochromocytoma)

•    have moderate/severe liver and/or kidney disease

•    are diabetic

•    suffer from inflammation of your oesophagus (often caused by excess stomach acid) or have an active ulcer in your stomach or small intestine.

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.

The following medicines can affect or be affected by treatment with Nicotine Mint Medicated Chewing Gum:

•    adenosine (a drug used in the diagnosis and treatment of abnormal heart rhythms)

Taking Nicotine Mint Medicated Chewing Gum with food and drink

This medicine does not interact with food or drink and may be taken with or without food at any time of the day.

Pregnancy and breast-feeding Pregnancy:

Pregnant women wishing to stop smoking for the health of their baby should ideally do so without nicotine replacement therapy (NRT).

However if you still need help to stop smoking, you can use this product as the risk to the baby is far less than if you continue to smoke. You should talk to your pharmacist, nurse or doctor for more advice.

NRT products which are used intermittently, such as this product may be preferable to nicotine patches. However if you feel sick or are suffering from morning sickness the patches may be better for you. If you do use nicotine patches they should be taken off before bedtime.

Breast-feeding:

You should try to stop smoking without using NRT.

However if you still need help to stop smoking you should use NRT’s which are used intermittently, not patches. You should talk to your pharmacist, nurse or doctor for more advice.

Breast-feeding your baby just before you use Nicotine Fruit Medicated Chewing Gum makes sure that your baby gets the smallest amount of nicotine possible.

The amount of nicotine that your baby may receive when you are using Nicotine Mint Medicated Chewing Gum or other NRT products is much smaller and less harmful than the second hand smoke they would inhale if you smoked. Tobacco smoke causes breathing and other health problems in babies and children.

Driving and using machinery

Nicotine Mint Medicated Chewing Gum does not affect your ability to drive or operate machinery.

Important information about some of the ingredients in Nicotine Mint Medicated Chewing Gum

Each chewing gum contains 0.36mmol (8.22mg) sodium. The maximum daily dose of 15 chewing gums for the 2mg/4mg strengths contains 5.4mmol(123.3mg) of sodium. To be taken into consideration by patients on a controlled sodium diet.

The Nicotine Mint 4mgMedicated Chewing Gum contains Sunset Yellow FCF (E110) and may cause allergic reactions.

3. How to take Nicotine Mint Medicated Chewing Gum

When to use Nicotine Mint Medicated Chewing Gum

The following sections contain the dosage information for Nicotine Mint Medicated Chewing Gum.

This shows the number of gums you should be using, when you should take them, how you should

take them and the maximum amount of time you should be using NRT for.

Please read this information carefully and then go to the “How to stop smoking” section, which will

help you decide which method to use to give up smoking.

•    Use the “How to chew Nicotine Mint Medicated Chewing Gum”. The method of chewing is NOT the same as that for ordinary chewing gum. This way of chewing ensures that the nicotine is correctly released from the gum.

•    The number of Nicotine Mint Medicated Chewing Gums you use each day will depend on how many cigarettes you smoked and how strong they are. See table below to find out the dose you should take.

•    The 2 mg gums should be used by people who smoke 20 or fewer cigarettes each day or by heavier smokers when they are cutting down the number and strength of the Nicotine gums they are using.

•    The 4 mg gums should be used by people who smoke more than 20 cigarettes per day.

Children under 12 years

Do not give this product to children under 12 years.

Adults and Children 12 years and Over

To remove    Peel off backing    Push gum

Gum, tear off    starting at corner    through foil.

Singe unit.    with loose edge.

Number of cigarettes you smoke per day	Dose of Gums
20 cigarettes or fewer	One 2mg gum as required to relieve cravings
More than 20 cigarettes	One 4mg gum as required to relieve cravings

•    Use only one piece of gum at a time

•    Do not use more than 15 gums per day

•    The frequency with which you use the gums will depend on how many cigarettes you smoked and how strong they are.

How to chew Nicotine Mint Medicated Chewing Gum

The method of chewing Nicotine Gum is not the same as for ordinary chewing gum.

Nicotine Gum is chewed to release nicotine then rested so that nicotine can be taken in through the lining of the mouth. If Nicotine Gum is chewed continuously, the nicotine is released too quickly and is swallowed. This may irritate your throat, upset your stomach or give you hiccups.

If you have false teeth you may have difficulty chewing the gum as Nicotine Gum could stick to them and on rare occasions, damage dentures. If you experience a problem, other types of nicotine replacement therapy may be more suitable for you.

How to chew Nicotine Mint Medicated Chewing Gum

1.    Chew slowly until taste becomes strong.

2.    Rest between gum and cheek.

3.    Chew again when the taste has faded.

Keep chewing like this for about half an hour. After this time the gum will have lost its strength and you should dispose of it carefully.

How to stop smoking

If you are able to stop smoking you should use Nicotine Mint Medicated Chewing Gum, when needed, in place of cigarettes. As soon as you can (this could be after a number of weeks or months) you should reduce the number of gums you use until you have stopped using them completely. If you are unable to stop smoking, or do not feel ready to quit at this time, you should replace as many cigarettes as possible with Nicotine Gum. There are toxins in cigarettes that can cause harm to your body. Nicotine Gum provides a safer alternative to smoking, for both you and those around you. Reducing the number of cigarettes may also help you to become more motivated to stop smoking. As soon as you are ready you should aim to stop smoking completely. You can also use Nicotine Gum on those occasions when you can’t or don’t want to smoke e.g. Social situations such as a party, in the pub or when at work. When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. If you have quit smoking and want to stop using Nicotine Gum but are finding this difficult you should contact your doctor, nurse or pharmacist for advice.

If you take more Nicotine Mint Medicated Chewing Gum than you should

If you (or someone else) consume a large amount of gum or if you think a child has swallowed any of the gums, contact your nearest hospital casualty department or your doctor immediately. Always take the container with you, if possible, even if empty. Symptoms that may indicate you have taken too much are:

•    irregular heart beat

•    difficulty in breathing or an uncomfortable chest

•    complete exhaustion and inability to move

•    heart attack or low blood pressure

•    fits.

4. Possible side effects

Like all medicines, Nicotine Mint Medicated Chewing Gum can cause side effects, although not everybody will be affected by them.

As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, seek medical help immediately:

•    rash, itching, difficulty breathing.

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include;

•    dysphoria/depressed mood

•    irritability/aggression

•    anxiety

•    restlessness

•    poor concentration

•    increased appetite/weight gain

•    urges to smoke (cravings)

•    mouth ulcers

•    sleep disturbance

•    decreased heart rate.

Patients prone to indigestion may suffer initial heartburn if the 4mg gum is used. Slower chewing and use of the 2mg gum (more frequently if necessary) will normally stop this problem.

Patients with dentures should be cautious as the gum can stick to and damage false teeth.

Very Common (Occurs in more than 1 in 10 patients)

•    headache

•    hiccups

•    sore mouth and throat

•    stomach upsets

•    nausea

•    jaw-muscle ache

Common (Occurs in more than 1 in 100 patients)

•    dizziness

•    vomiting

Uncommon (Occurs in less than 1 in 100 patients)

•    skin reddening

•    palpitations (an increased awareness of the beating of your heart)

•    itchy rash

Rare (Occurs in less than 1 in 1000 patients)

•    allergic reactions

Very Rare (Occurs in less than 1 in 10,000 patients)

•    abnormal heart rhythm

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: 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 Nicotine Fruit Medicated Chewing Gum

•    Keep out of sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the outer packing. The expiry date refers to the last day of that month.

•    Do not store above 25°C. Store in the original blister in order to protect from moisture. Keep the blister in the outer carton in order to protect from light. Do not transfer the gums to another container.

•    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.

•    Used gum should be disposed of with care as they can be toxic in small children.

6. Further information

What Nicotine Mint Medicated Chewing Gum contains

The active ingredient in this medicine is Nicotine (as resinate). There are two different strengths of gum available: a gum containing 2 mg of nicotine and a gum containing 4 mg of nicotine.

Other ingredients are:

•    Gum base (containing Butylhydroxytoluene(E321))

•    Xylitol(E967)

•    Sodium carbonate, anhydrous

•    Sodium hydrogen carbonate(E500)

•    Magnesium oxide (light)

•    Entrapped menthol flavour

•    Levomenthol

•    Toothpaste flavour

•    Talc(E553b)

•    Hydroxypropylcellulose

•    Acacia, spray-dried

•    Acesulfame potassium(E950)

•    Titanium dioxide (E171)

•    Carnauba wax (E903)

•    Sunset yellow FCF (E110) (4mg gum)

What Nicotine Mint Medicated Chewing Gum looks like and the contents of the pack

Nicotine Mint Medicated Chewing Gum is supplied in blister packs containing ten pieces of gums. Cartons may contain 40 or 100 pieces of gum.

Marketing Authorisation Holder and Manufacturer:

Nicobrand Limited 189 Castleroe Road Coleraine

BT51 3RPNorthern Ireland

For any information about this medicine, please contact the Marketing Authorisation Holder, details provided above.

Nicotine Mint Medicated Chewing Gum 2mg PL 10866/0007

Nicotine Mint Medicated Chewing Gum 4mg PL 10866/0008

This leaflet was last revised in October 2014.