Nicabate A 2 Mg Mint Lozenges
165 mm
13mm
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Please read right through this leaflet before you start using this medicine.
[This medicine is available without prescription, but you itill need to use Nicabate A Mint Lozenges carefully to eftheFest resultsTrom 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).
In this leaflet:
1. What Nicabate A Mint Lozenges do ;:: 2. Check before you use Nicabate A Mint Lozenges How to use Nicabate A Mint Lozenges Possible side effects
5. How to store Nicabate A Mint Lozenges Further information
8mm
Nicabate A Mint Lozenges are used to help people stop smoking. This type of treatment is called Nicotine Replacement Therapy or NRT.
Nicabate A Mint Lozenges come in two strengths, each strength comes in its own pack.
• Nicabate A 4 mg Mint Lozenges are for smokers who smoke within 30 minutes of waking up.
• Nicabate A 2 mg Mint Lozenges are for smokers who smoke after 30 minutes of waking up.
Nicabate A Mint Lozenges can help you give up smoking straightaway. They can also help you cut down smoking before stopping completely or to stop smoking for short periods of time. If you think you can stop smoking straightaway then you should because it is best for your health. See Section 3 "How to use Nicabate A Mint Lozenges" for further details.
It is the nicotine in cigarettes that can make you physically addicted to them.
• Nicabate A Mint Lozenges help you to give up smoking by replacing some of the nicotine you get from cigarettes.
• When you suck Nicabate A Mint Lozenges, they release nicotine into the mouth where it is absorbed into the body.
• This nicotine relieves some of the unpleasant symptoms that smokers may have when they try to give up. These include feeling ill or irritable.
• The nicotine can also relieve your cravings for a cigarette and help you to resist the urge to smoke.
Nicabate A Mint Lozenges do not have the health dangers of tobacco. This is because they do not contain the tar, carbon monoxide or other toxins in cigarette smoke. Some people worry that after stopping smoking, they may become dependent on nicotine lozenges instead. This is very rare and if it did happen, it is less harmful than continuing to smoke. It is also an easier habit to break.
Your chances of stopping smoking will be improved if you take part in a support programme. These "stop smoking programmes" are known as behavioural support. Please see the insert in this pack for more details.
2. Check before you use Nicabate A Mint Lozenges
□ Do not use Nicabate A 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 Nicabate A contains soya protein
• if you are a non-smoker
• if you are under 12 years. The levels of nicotine in NRT are suitable for people who are giving up smoking but not for children under 12. Children are more susceptible to the effects of nicotine and it could cause severe toxicity which can be fatal.
There are no health benefits to smoking. It is always better to give up smoking. Using NRT like Nicabate A Mint Lozenges can help. In general, any possible side effects associated with NRT are far outweighed by the well established dangers of continuing to smoke.
Take special care with Nicabate A Mint Lozenges
• If you are in hospital because you have had a heart ITftacR.'severe'fiearrrfiytKrn dSturbaTicesFr'ersfrdker “ Try to quit smoking without NRT unless your doctor tells you to use it. Once you are discharged from hospital, you can use NRT as normal.
• If you have diabetes you should monitor your blood sugar levels more often than usual when you start using Nicabate A Mint Lozenges. Your insulin or medicine requirements may change.
• 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 this type 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 Hallydose may"Ee RlrrrmirTFyou are on a low sodium diet.
• If you have phenylketonuria. Nicabate A Mint Lozenges contain aspartame, a source of phenylalanine which may be harmful to you if you suffer from phenylketonuria.
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.
Get help and advice from a healthcare professional:
• 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 been told by your doctor that you have an intolerance to some sugars; contact your doctor before taking this medicinal product.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding it is best if you can give up smoking without the use of NRT. However, it is better to stop smoking using NRT than to continue smoking.
Smoking during pregnancy has risks for the baby.
These include poor growth before birth, premature birth or stillbirth. Stopping smoking is the best way to improve both your health and that of your baby. The earlier you stop smoking the better.
Ideally, if you are pregnant you should stop smoking without using NRT. However, if you have tried and this has not worked, NRT may be recommended to help you stop: it is better for your developing baby than if you carry on smoking. The decision to use NRT should be made as early on in your pregnancy as possible.
• Aim to use NRT for only 2 to 3 months. Remember, the most important thing is to stop smoking.
• NRT gum or lozenges may be preferable to nicotine patches as you do not get nicotine all the time.
However, patches may be preferred if you have nausea or sickness.
If you are breastfeeding tobacco smoke causes breathing difficulties and other problems in babies and children. If you need to use NRT, the amount of nicotine your baby may get is small. It is much less harmful than breathing in second hand smoke.
• It is best to use NRT products that are taken intermittently such as gum or lozenges, rather than patches.
• It is better to breastfeed just before you take the product - this helps your baby to get the smallest amount of nicotine possible.
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3. How to use Nicabate A Mint Lozenges
01 The instructions for using Nicabate A J Mint Lozenges depend on your age and whether you are:
(a) stopping smoking straightaway
(b) cutting down before stopping
(c) stopping smoking for a short period of time.
In all cases 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 shnulH talrp 70 tn 30 minutes________
(a) Stopping smoking straightaway
Adults and young people aged 12 years and over:
It is important that you make every effort to stop smoking completely. If you do smoke a cigarette while you are using NRT, continue your quit attempt but talking to a healthcare professional may help.
• Use at least 9 lozenges a day (maximum 15) for the first 6 weeks.
• Gradually reduce the number of lozenges you use a day.
• Once you are using only 1-2 lozenges a day, try to stop using them altogether.
“After you Tiave"giveh"up youlfiayTornefirhe'sTeera sudden craving for a cigarette. You can use a lozenge again if this happens.
To increase your chances of success, complete the step down programme in full and follow a stop smoking behavioural support programme - see the insert in this pack for more details.
If you are under 18 years old and not ready to stop smoking straightaway, you should talk to a healthcare professional for advice.
(b) Cutting down before stopping smoking
Adults aged 18 years and over:
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. 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 able, you should give up cigarettes completely. Follow the instructions for stopping smoking straightaway given above. Do this as soon as possible. If you have not been able to make a quit attempt within 6 months of starting to use the lozenges, speak to a healthcare professional.
(c) Stopping smoking for short periods of time
Adults aged 18 years and over:
Nicabate A Mint Lozenges can help you manage your cravings so you can refrain from smoking in situations where it should be avoided:
• Where your secondhand smoke may damage others e.g. around children.
• Where smoking is not allowed e.g. on a flight or hospital stay.
• When smoking should be avoided e.g. before surgery.
If you feel an urge to smoke, have a lozenge instead of a cigarette. This will help you manage your cravings. Continue to use one lozenge every 1 to 2 hours (maximum 15a day) during the period when you are avoiding smoking.
As soon as you feel able, you should give up cigarettes completely. If you have not been able to make a quit attempt 6 months after starting to use the lozenges, you should get advice from a healthcare professional.
• Do not use more than the recommended dose.
• Do not use more than 15 lozenges a day.
• Do not chew the lozenge or swallow it whole.
• Do not eat or drink while a lozenge is in your mouth as this may reduce the absorption of the nicotine.
If you use too many lozenges
If you take too many lozenges, you may start to feel sick, dizzy and unwell. Stop using the lozenges and contact your doctor or casualty department immediately. If possible, show them the packet or this leaflet.
The lozenges are not suitable for children under 12 or non-smokers. They may develop signs of nicotine overdose including headache, sickness, stomach pains and diarrhoea. If a child has used or eaten any of the i 13mm
lozenges, contact your doctor or casualty department |--—
_immediately.____________ri_m_m_rTT.
If possible, show them the packet or this leaflet.
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 E:::====:=:
the more nicotine you take, but not everybody gets
them.
Stopping smoking itself can cause some symptoms such as dizziness, headache, sleep disturbance, cough and cold-like symptoms, depression, irritability, anxiety and E:::====:=: insomnia.
Other side effects may include:
• Very rare: Severe allergic reaction symptoms which include sudden wheeziness or tightness of the chest, rash & feeling faint. Stop taking the lozenge and tell a healthcare professional if you get these.
• Feeling/being sick, hiccups, burping, wind, feeling bloated, diarrhoea, constipation.
• Difficulty swallowing, dry mouth/throat/lips, sore throat, mouth irritation, ulcers in/around mouth.
• Indigestion, heartburn, bad breath, increase in saliva, shortness of breath.
• Bad dreams, restlessness, lethargy, alertness, migraine.
• Tight chest, chest pain, stomach pains, changes in appetite, taste changes.
• Rash, itchy skin, hot flushes, feeling unwell.
If you do get any side effects, even those not mentioned in this leaflet, tell a healthcare professional.
5. How to store Nicabate A Mint Lozenges
Keep out of the reach and sight of children.
Do not use this medicine after the 'EXP' date shown on the pack.
Keep all lozenges in the carton, in their blister pack, until you are ready to use one.
Do not store above 25°C.
6. Further information
Active ingredient
Nicabate A 4 mg Mint Lozenges contain 4 mg Nicotine in the form of a resin complex (nicotine polacrilex 22.2 mg). Nicabate A 2 mg Mint Lozenges contain 2 mg Nicotine in the form of a resin complex (nicotine polacrilex 11.1 mg).
Other ingredients
Mannitol (E421), sodium alginate, xanthan gum, potassium bicarbonate, calcium polycarbophil, sodium carbonate, aspartame (E951), magnesium stearate and spearmint flavour (contains lactose and soya protein).
Packs of Nicabate A Mint Lozenges contain 36 or 72 lozenges.
The Marketing Authorisation holder is Omega Pharma Ltd, 32 Vauxhall Bridge Road, London, SW1V 2SA, UK and all enquiries should be sent to this address.
The manufacturer is Cardinal Health, Sedge Close, Great Oakley, Corby, Northamptonshire NN18 8HS
This leaflet was last revised in October 2015
Nicabate A is a registered trade mark of ELAN PHARMA INTERNATIONAL LTD.
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• If you feel you need to use the lozenges for longer than 9 months (3 months for 12-17 year olds), you should talk to a healthcare professional.
• If you are worried that you may start smoking again or are finding it difficult to stop using NRT completely, talk to a healthcare professional. If you do start to smoke again, they can advise you on how to get the best results from further courses of NRT.
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