Document: leaflet MAH BRAND 2_PL 00079-0370 change

• leaflet MAH BRAND 2_PL 00079-0370
• leaflet MAH BRAND_PL 00079-0370

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Please read right through this leaflet before you start using this medicine. This medicine is available without prescription, but you still need to use ^NiQuitin Pre-Quit Mint Lozenges carefully to get Jthe best results from them.

Keep this leaflet. You may need to read it again.__

• If you have any further questions, ask a healthcare professional (doctor, nurse, smoking cessation advisor or pharmacist).

|n this leaflet:

: 1. What NiQuitin Pre-Quit Mint Lozenges do

2.    Check before you use NiQuitin Pre-Quit Mint Lozenges

3.    How to use NiQuitin Pre-Quit Mint Lozenges i|4. Possible side-effects

5.    How to store NiQuitin Pre-Quit Mint Lozenges

6.    Further information

1. What NiQuitin Pre-Quit Mint Lozenges do

NiQuitin Pre-Quit Mint Lozenges are used to help people stop smoking. They work by replacing some of the nicotine you get from cigarettes. This type of treatment is called Nicotine Replacement Therapy (NRT). They are for smokers who smoke within 30 minutes of waking up.

The nicotine in cigarettes makes them addictive, but other substances in cigarette smoke, such as tar, carbon dioxide and other toxins, are more harmful to your health. NRT products like NiQuitin Pre-Quit Mint Lozenges do not have the health dangers of tobacco.

It is always better to stop smoking straightaway. However if you are not able to, you can use NiQuitin Pre-Quit Mint Lozenges to help you cut down the number of cigarettes you smoke as a first step towards stopping completely. The nicotine from NRT reduces your cravings for cigarettes and helps you resist the urge to smoke. It also relieves some of the unpleasant withdrawal symptoms (like feeling ill or irritable).

Some people worry that, when they have stopped smoking, they may become dependent on NRT instead. This is very rare, and if it were to happen it is still safer than continuing to smoke. It is also an easier habit to break.

It is always better to stop smoking completely.

Smoking is harmful and has no health benefits. NRT products like NiQuitin Pre-Quit Mint Lozenges can help you stop. Any risks or possible side-effects of nicotine from NRT are much less than the proven dangers of continuing to smoke.

Your chance of stopping smoking will be improved if you also take part in a support programme. These 'Stop Smoking' programmes are known as behavioural support. For more information:

•    call the NHS Free Smoking Helpline on 0800 022 4332, or visit http://www.smokefree.nhs.uk [or the Irish National Smokers Quitline on 1850 201 203],

•    or visit http://www.niquitin.co.uk for information about a free online support plan.

2. Check before you use NiQuitin Pre-Quit Mint Lozenges

Do not use NiQuitin Pre-Quit Mint Lozenges:

•    if you have ever had an allergic reaction to nicotine or any of the other ingredients (listed in Section 6).

•    if you are allergic to peanut or soya. The flavouring in NiQuitin Pre-Quit Mint Lozenges contains soya protein.

•    if you are a non-smoker.

•    if you are under 18 years.

Take special care with NiQuitin Pre-Quit Mint Lozenges

Get help and advice from a healthcare professional:

•    if you are in hospital because you have had a heart attack, severe heart rhythm disturbances or a stroke.

Try to stop smoking without NRT unless your doctor has told you to use it. Once you are discharged from hospital, you can use NRT as normal.

•    if you have diabetes. When you start using NRT, you need to monitor your blood sugar levels more often than usual, because your dose of medication for diabetes may need to be adjusted.

•    if you have serious liver or kidney problems, because

_ you may be more likely to get side-effects._____

•    if you have uncontrolled overactive thyroid gland or an adrenal gland tumour (phaeochromocytoma), because nicotine may make your symptoms worse.

•    if you have stomach or duodenal ulcers or inflammation of the oesophagus or gullet (the passage between the mouth and stomach) because swallowing nicotine can make your symptoms worse.

It may also cause mouth ulcers. If your symptoms do get worse you should talk to your doctor. You might want to use a non-oral form of NRT instead, such as patches.

•    if you have had allergic reactions that involve swelling of the lips, face and throat (angioedema) or itchy skin rash (urticaria). Using NRT can sometimes

- trigger 4his4ype-of reaction-------

•    if you are on a low sodium diet. Each lozenge contains about 15 mg sodium and the maximum daily dose (15 lozenges) contains 225 mg sodium. The maximum daily dose may be harmful if you are on a low sodium diet.

•    if you have phenylketonuria. The lozenges contain aspartame, a source of phenylalanine which may be harmful to you if you suffer from phenylketonuria.

•    if you have been told by your doctor that you have an intolerance to some sugars. The flavouring in NiQuitin Pre-Quit Mint Lozenges contains lactose.

•    NiQuitin Pre-Quit Mint Lozenges contain mannitol which may cause a mild laxative effect.

•    before using if you have ever experienced seizures (fits).

If you are taking other medicines

Stopping smoking may alter the effect of other medicines you may be taking. If you have any questions or concerns about this, talk to a healthcare professional.

Pregnancy and breast-feeding

If you are pregnant or planning to become pregnant

Smoking when you are pregnant is harmful to the baby. The risks include poor growth before birth, damage to the baby's lungs, premature birth and stillbirth. Stopping smoking is the best way to improve your health and the health of your baby, and the earlier you stop smoking the better.

It is best to give up smoking without using NRT. If

that's too difficult, using NRT is safer for you and your baby than continuing to smoke. The nicotine in NRT is less dangerous than the more harmful substances in cigarette smoke, such as tar and other toxins.

If you have tried to stop smoking without using NRT, and haven't been able to, your healthcare advisor may recommend NRT to help you stop. If you do use NRT during pregnancy:

•    Start as early in your pregnancy as possible.

•    Aim if possible to use NRT for only 2 to 3 months. But remember — the most important thing is not to smoke. It is safer to carry on using NRT than to start smoking again.

•    If you can use them, NRT gum or lozenges are better than patches. That's because you will not be absorbing nicotine into your body all the time. But if you feel sick, you may need to use NRT patches instead.

If you are breast-feeding

Tobacco smoke is harmful to babies and children,

causing breathing difficulties and other problems.

If you are breast-feeding, it is best if you stop smoking without using NRT. But if you do need to use NRT, the nicotine that gets into breast milk is less dangerous to your baby than breathing in second-hand smoke. If you do use NRT while breast-feeding:

•    It is better to use NRT gum or lozenges to control your cravings as they happen, rather than patches.

With gum or lozenges, you will not be absorbing nicotine into your body all the time.

continued overleaf

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• Try to breast-feed just before you take the gum or lozenge, when the nicotine levels in your body are at their lowest. That way, your baby gets as little nicotine as possible.

3. How to use NiQuitin Pre-Quit Mint Lozenges

Pre-Quit Programme

Adults aged 18 years and over

Decide on_your quit date - up to 6 weeks from now. “The number oTTozenges useJwiTTclepenB’onflow many cigarettes you smoke. Do not use more than 15 lozenges a day.

Pre-Quit:

NiQuitin Pre-Quit 4 mg Mint lozenge. Use for up to 6 weeks. Gradually cut out your easiest cigarettes followed by the harder cigarettes. When you get a craving have a lozenge.

STOP SMOKING COMPLETELY and follow the NiQuitin 4 mg Lozenge Step Down Programme as outlined below:

Step 1, weeks 1-6:1 lozenge every 1 to 2 hours

Step 7, weeks 7-4: 1 lozenge every 7-4 hours__

Step 3, weeks 10-12:1 lozenge every 4-8 hours

Put one lozenge in your mouth and periodically move it from one side of your mouth to the other, until it has completely dissolved. This should take 20 to 30 minutes.

The lozenges help manage your cravings and withdrawal symptoms. The Pre-Quit Programme helps you reduce the number of cigarettes smoked each day so you are ready to quit completely with the help of NiQuitin 4 mg Mint Lozenges.

•    Do not use more than the recommended dose.

•    Do not use more than one lozenge at a time.

•    Do not use more than 15 lozenges a day.

•    Do not chew the lozenge or swallow it whole.

•    You should not eat or drink while a lozenge is in your mouth as this may reduce the absorption of the nicotine.

Talk to a healthcare professional if:

•    you have not been able to cut down the number of cigarettes you smoke each day after 6 weeks of using the lozenges.

•    you have not been able to make a quit attempt within 6 months of starting to use the lozenges.

If you use more NiQuitin Pre-Quit Mint Lozenges than you should

If a child has used or eaten any of the lozenges, contact your doctor or hospital emergency department immediately. If possible, show them the NiQuitin Pre-Quit Mint Lozenges packet or this leaflet. Symptoms of nicotine overdose in children include headache, sickness, stomach pain and diarrhoea.

If you take too many lozenges, you may start to feel sick, dizzy and unwell. Stop using the lozenges and contact your doctor or hospital emergency department immediately.

4. Possible side-effects

Like all medicines, the nicotine in NRT products can have side-effects. They are similar to those you might get from the nicotine in cigarettes, and are more likely the more nicotine you take, but not everybody gets them. At the recommended doses NiQuitin Pre-Quit Mint Lozenges have not been found to cause any serious side-effects.

Stopping smoking itself can cause some symptoms such as dizziness, headache, sleep disturbance, cough and cold-like symptoms, depression, irritability, anxiety and night-time awakening.

Side-effects may include

Side-effects may occur with certain frequencies, which are defined as follows:

Very common: affects more than 1 user in 10

Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000

Rare: affects 1 to 10 users in 10,000

Very rare: affects less than 1 user in 10,000

Not known: frequency cannot be estimated from the

available data.

If you notice the following very rare but serious side-effect, stop taking the lozenges and tell a healthcare professional:

•    Severe allergic reaction symptoms which include sudden wheeziness or tightness of the chest, rash and feeling faint

Very common side-effects

•    Feeling sick, hiccups, wind

Common side-effects

•    Being sick, burping, feeling bloated,diarrhoea, constipation, indigestion, heartburn, difficulty

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in/around mouth

•    Headache, dizziness

•    Cough or sore throat

•    Difficulty in sleeping

Uncommon side-effects

•    Tight chest, chest pain, hot flushes, bad breath, swollen throat, feeling unwell

•    Shortness of breath, severe cough, excessive sneezing, chest infection, respiratory problems

•    Rash, itchy skin

•    Taste changes

•    Sore lips, lip ulcers, dry throat, stomach pain, acid

^— ref I mr(attcrregnrgimian)rtTicreased sativar retching^-(dry heaving), gagging, excessive phlegm

•    Anxiety, bad dreams, restlessness, decreased or loss of appetite, lack of energy

•    Migraine, increased alertness, burning, tingling or numbness of the mouth, disturbance to your senses

•    Bleeding gums

•    Feeling thirsty

If you experience seizures (fits), stop taking this medicine.

5. How to store NiQuitin Pre-Quit Mint Lozenges

>    Keep out of the reach and sight of children.

>    Do not use this medicine after the 'EXP' date shown on the blister pack and outer packaging. The expiry date refers to the last day of the month.

>    Keep all lozenges in the carton, in their blister pack, until you are ready to use one.

>    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 NiQuitin Pre-Quit Mint Lozenges contain

The active substance is nicotine. Each lozenge contains 4 mg (in the form of a resin complex called nicotine resinate). The other ingredients are mannitol (E 421), sodium alginate, xanthan gum, potassium bicarbonate, calcium polycarbophil, sodium carbonate, aspartame (E 951), magnesium stearate and spearmint flavour.

What NiQuitin Pre-Quit Mint Lozenges look like and the contents of the pack

White, round lozenges with convex surfaces and "NL4S" on one side. Packs contain 36 lozenges.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder is GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.

The manufacturer of NiQuitin Pre-Quit Mint Lozenges is Catalent UK Swindon Zydis Limited, Frankland Road, Blagrove, Swindon, Wiltshire, SN5 8RU, U.K. or FAMAR A.V.E. ANTHOUSSA PLANT, Anthoussa Avenue 7, Anthoussa Attiki, 15344, Greece.

If you have any questions or comments about NiQuitin Pre-Quit Mint Lozenges, please FREEPHONE our Information Line on 0500 100 222 or e-mail customer.relations@gsk.com.

NIQUITIN is a registered trade mark of the GlaxoSmithKline group of companies.

GlaxoSmithKline

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