Niquitin Minis Orange 1.5 Mg Lozenges
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 Minis carefully to get the 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)._ _
• Throughout this leaflet NiQuitin Minis Orange 1.5 mg Lozenges
are referred to as NiQuitin Minis.
In this leaflet:
1. What NiQuitin Minis do
2. Check before you use NiQuitin Minis
3. How to use NiQuitin Minis
4. Possible side-effects
5. How to store NiQuitin Minis
6. Further information
■ 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
NiQuitin Minis 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).
The nicotine in cigarettes makes them addictive, but other substances in cigarette smoke, such as tar, carbon dioxide and other toxirs, are more harmful to your health. NRT products like N Quitin Minis do not have the health dangers of tobacco.
The nicotine from NRT reduces your cravings for cigarettes and helps you resist the urge to smoke It also relieves some of the unpleasant symptoms (like feeling ill or irritable) that smokers have when they try to give up
NiQuitin Minis can be used to help you:
• stop smoking straightaway (a quit attempt).
• cut down on smoking, perhaps before you go on to stop completely (reducing to quit or just reducing).
In addition, NiQuitin Minis can be used when you:
• do not wish to smoke or are unable to smoke, for example in confined spaces (in the car, in the house), where others (such as children) could be harmed by tobacco smoke or in places where smoking is prohibited (temporary abstinence).
• develop cravings once you have stopped smoking.
Reducing the number of cigarettes smoked can increase the chances that you will go on to quit completely.
NiQuitin Minis can be used during pregnancy and breastfeeding (see Pregnancy and breast-feeding below).
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 Minis 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 Quit ine on 1850 201 203]
Do not use NiQuitin Minis:
• if you have ever had an allergic reaction to nicotine, or any of the other ingredients (listed in Section 6).
• if you are a non-smoker.
• if you are aged under 12. The level of nicotine in NRT is not suitable for children under 12. Children are more susceptible to the effects of nicotine, severe toxicity, which can be fatal.
Take special care with NiQuitin Minis
and it could cause
professional: e had a heart attack,
Get help and advice from a healthcare
• if you are in hospital because you hav> 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.
(urticaria). Using reaction. before us
NRT can sometimes trigger this type of
>u 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 pregnart 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 co 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.
-feed
Try to breast when the nicotir That way, your
just before you take e levels in your body ar baby gets as little nicotin
th
e gum or lozenge, e at their lowest. e as possible.
Adults and yourg people aged 12 years and over
Instructions for use of NiQuitin Minis depend on whether you are:
• stopping smoking straightaway.
• cutting down on smoking before you stop.
• cutting down with no immediate plans to stop.
• going without cigarettes for a short time.
or if you have cravings after you have stopped smoking.
If you are under 18 years old and not ready to stop smoking straightaway, talk to a healthcare profess onal for advice.
In all cases:
• NiQuitin Minis Orange 1.5 mg Lozenges
who smoke fewer than 20 cigarettes a day.
• You should 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 around
10 minutes.
• Do not chew the lozenge or swallow it whole.
• Do not use more than 15 lozenges a day.
NiQuitin Minis are not suitable for children under 12 years of
age or for non-smokers. They may develop signs of nicotine overdose, including headache, sickness, stomach pain and diarrhoea.
are for smokers
Stopping smoking straightaway
Adults and young people aged 12 years and over:
It is important to make every effort to stop smoking completely. But if you do sometimes smoke a cigarette while using NRT, don't be discouraged — just keep going with your quit attempt. It may help to talk to a healthcare professional if you are finding your quit attempt difficult.
• Start by using 8 - 12 lozenges a day. Suck a lozenge when ever you have an urge to smoke.
• Use the lozenges like this for up to 6 weeks, then gradually cut down the number of lozenges you use a day.
Very common (affects more than 1 in 10 people)
• The lozenges may cause your mouth cr tongue to be slightly sore or irritated. You may also feel sick.
Common (affects between 1 in 10 and 1 in 100 people)
• Sore throat
• Being sick
• Stomach discomfort
• Diarrhoea
• Indigestion/heartburn
• Flatulence
• Once you are using only 1 - 2 lozenges a day, try to stop using them altogether.
To increase your chances of success follow a stop smoking behavioural suoport programme - see the end of Section 1 for more details.
Cutting down on smoking before you stop
Adults aged 18 years and over:
You may find it easier to quit completely later if you use NiQuitin Minis to help you cut down on smoking first.
When you feel a strong urge to smoke, have a lozenge instead of a cigarette to help you manage your cravings.
Cut down the rumber of cigarettes you smoke per day by as many as possib e. If you have not been able to cut down the number of cigarettes you smoke each day after 6 weeks, talk to a healthcare professional.
As soon as you feel ready to stop smok ng completely, follow the instructions above, under 'Stopping smoking straightaway'. If you have not felt able to make a quit attempt within 6 months of starting to use NRT, you may find it helpful to talk to a healthcare professional.
Cutting down with no immediate plans to stop
Adults aged 18 years and over:
It is always best to stop smoking completely, but using NRT to cut down is less harmful than continuing to smoke heavily. Cutting down the number of cigarettes you smoke each day will make it easier to quit completely in the future.
When you feel an urge to smoke, have a lozenge instead of a cigarette to help you manage your cravings. Cut down the number of cigarettes you smoke per day by as many as possible.
It is best to stoo smoking completely as soon as you feel able to. Follow the instructions above, under 'Stopping smoking straightaway'.
Going without cigarettes for a short time
Adults aged 18 years and over:
NiQuitin Minis :an help you manage your cravings so that you can resist c garettes in situations where smoking is inappropriate, for example:
• Hiccups
Less common side-effects (affects between 1 in 100 and 1 in 1000 people)
• Nervousness
• Depression
• Palpitations (feeling your heartbeat)
• Increased heartbeat
• Chest pain
• Rash
• Tiredness and generally feeling unwell Very rare (affects less than 1 in 10,000 people)
_• Severe allergic reaction, symptoms of which include
sudden wheeziness or tightness of the chest, rash and feeling faint.
If you experience seizures (fits), stop taking this medicine.
If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, tell a healthcare professional.
Reporting of side-effects
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
I I
• where your second-hand smoke may damage other people, such as children.
• where smoking is not allowed, such as on a flight or in a hospital.
• when smoking should be avoided, such as before surgery. When you feel an urge to smoke, have a lozenge instead of a cigarette to help you manage your cravings. Continue to use one lozenge every 1 - 2 hours (maximum 15 a day) during the period when you are avoiding smoking.
It is best to stoo smoking completely as soon as you feel able to. Follow the instructions above, under 'Stopping smoking straightaway'.
Once
Keep out of the reach and sight of children.
Do not use this medicine after the 'EXP' date shown on the container and outer packaging. The exp ry date refers to the last day of the month.
Keep all lozenges in the original container in order to protect from moisture.
Do not store above 30°C.
Do not use the container for anything e se due to possible fine coating of tablet dust inside.
Dispose of the container responsibly. 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.
After you have stopped smoking, you may still sometimes feel a craving for a cigarette. You can ise NiQuitin Minis again to help you relieve these cravings - using NRT is always better than smoking again.
If you are worr ed that you may start smoking again, talk to a healthcare professional. They can advise you on how to get the best results from further courses of NRT.
What NiQuitin Minis contain
The active substance is nicotine. Each lozenge contains 1.5 mg (in the form of a resin complex cal ed nicotine resinate). The other ingredients are mannitol (E 421), sodium alginate (E 401), xanthan gum (E 415), potassium bicarbonate (E 501), calcium polycarbophil, sodium carbonate anhydrous (E 500), acesulfame potassium (E 950), orange flavour, peppermint flavour and magnesium stearate (E 970b).
What NiQuitin Minis look like and the contents of the pack White to off-white oval lozenges with convex surfaces.
The 1.5 mg orange lozenge has a "J" on one side. Each container contains 20 lozenges. Packs may contain one or three containers.
ng NRT completely,
If you are finding it difficult to stop usi talk to a healthcare professional.
If you use more NiQuitin Minis than you should
If a child has used or eaten any of the ozenges, contact your
doctor or hospital emergency department immediately. If
possible, show them the NiQuitin Minis packet or this leaflet. Symptoms of n cotine 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.
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 Minis Orange Lozenges is GlaxoSmithKline Dungarvan Ltd, Knockbrack, Co. Waterford, Ireland.
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
Minis have not been found to cause any
serious side-effects.
Stopping smok ng itself can cause some symptoms such as dizziness, headache, sleep disturbance, cough and cold-like symptoms. Symptoms such as depression, irritability, anxiety, restlessness, increased appetite and insomnia may also be related to withdrawal symptoms associated with giving up smoking.
If you have any questions or comments about NiQuitin Minis, please FREEPHONE our Information Line on 0500 100 222 or e-mail customer.relations@gsk.com.
NIQUITIN and the MINIS device are trade marks of the GlaxoSmithKline croup of companies.
GlaxoSmithKline
Other side-effects are listed below - they are grouped based
This leaflet was prepared in February 2014.
