Sunday 1 April 2012

Boots NicAssist 5mg Patch





Boots NicAssist Patch



(Nicotine)



Boots NicAssist 15 mg Patch



Boots NicAssist 10 mg Patch



Boots NicAssist 5 mg Patch




Read all of this leaflet carefully because it contains important information for you.



This medicine is available without prescription to help you to stop smoking.



However, you still need to use it 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





What this medicine is for



This medicine contains nicotine which belongs to a group of medicines called nicotine replacement therapy (NRT). It acts to substitute the nicotine that you normally get from cigarettes and can help you stop smoking.



It can be used to relieve the symptoms of nicotine withdrawal and reduce the cravings for nicotine that you get when you try to stop smoking.



To help you quit smoking you should also try to use a behavioural support programme to increase your chances of success.



When you stop smoking, your body misses the nicotine that you have been absorbing from the smoke. You may experience unpleasant feelings and a strong desire to smoke (“craving”).



This shows that you were dependent on nicotine. When you use the patch, nicotine is released and passes into your body through your skin. The nicotine is sufficient to relieve the unpleasant withdrawal symptoms. It will also help to stop your craving to smoke but will not give you the “buzz” you get from a cigarette.



The benefits of stopping smoking far outweigh any potential risk from using nicotine from NRT. It is the toxins in cigarette smoke such as tar, lead, cyanide and ammonia that cause smoking related disease and death, not the nicotine.





Before you use this medicine



This medicine can be used by adults and children of 12 years and over. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.




Do not use:



  • If you are allergic to any of the ingredients in this medicine




Talk to your pharmacist, nurse or doctor:



  • If you are in hospital because of heart disease (e.g. heart attack, problems with your heart rate or rhythm, stroke) – try to give up smoking first without using NRT. You can use this medicine to help you stop smoking once you are out of hospital. For other heart conditions that do not require you to be in hospital, using NRT is better than continuing to smoke

  • If you have diabetes – monitor your blood sugar levels more often when you start using this medicine. You may find that you need to adjust the amount of insulin you use, or the amount of tablets you take (ask your doctor or diabetes nurse about this)

  • If your liver or kidneys do not work properly

  • If you have an overactive thyroid gland

  • If you have high blood pressure due to a tumour near your kidney (your doctor may have told you that you have a condition called phaeochromocytoma)

  • If you have skin problems such as psoriasis, dermatitis, or raised red itchy skin – you should not use the patches (ask your pharmacist about other products that will be more suitable for you such as gums, lozenges, microtabs, inhalator)

  • If you are taking other medicines regularly prescribed by your doctor (see “If you take other medicines”)

  • If you are pregnant or breastfeeding (see “Other important information”)




Other important information



If you are pregnant: You should try to stop smoking without using medicines. If you still need help you can use this product. The risk to your baby whilst using this product is far less than if you continue to smoke. Talk to your pharmacist or doctor for more advice.



Products that are used intermittently may be preferable to nicotine patches. However if you feel sick or are sick (morning sickness) the patches may be better for you. If you do use nicotine patches they should be taken off before bedtime.



If you are breastfeeding: You should try to stop smoking without using medicines. If you can’t manage this you are best to use an NRT product that is used intermittently (not patches). You should talk to your doctor, nurse or pharmacist for advice.



Breastfeed your baby just before you use the patch to make sure that your baby gets the smallest amount of nicotine possible.



If you need to use this product, the amount of nicotine that your baby may receive 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. If your husband, partner or other family members smoke too, try to get them to give up with you.



Nicotine products and children: Nicotine can be very dangerous to children. The amount of nicotine tolerated by adults and adolescents can make children very ill, and can sometimes be fatal. Do not leave your patches where children may get hold of them.





If you take other medicines



Before you use this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:



  • Theophylline, clozapine, ropinirole – your doctor may want to monitor the amount of medicine that you take

When you stop smoking your metabolism slows down. This can mean that some medicines may stay in your body longer than usual. If you take any medicine on a regular basis, tell your doctor that you intend to stop smoking and follow his or her advice about these medicines.






How to use this medicine



Check that the foil pouch is not broken before use. If it is do not use that patch.



Follow the directions which tell you how to use the patches.




Choosing where to apply the patch



1. Before you apply the patch, choose a completely clean, dry area of hairless skin on the front or side of the chest, upper arm or hip

2. Do not place the patch onto any area of skin that is red, cut or irritated

3. Do not apply oil or talcum powder to the skin before putting on the patch as this may prevent it from sticking properly

4. It is important that you do not use the same area on two consecutive days to help avoid irritating that site





How to apply the patch



1. Each patch comes in a child resistant sachet which can be opened by cutting along the edge with a pair of scissors

2. Remove the patch from its sachet and then remove the clear plastic backing

3. Apply the patch firmly by pressing the sticky side of the patch to the chosen area of skin

4. Run your finger around the edge of the patch to ensure it sticks properly





Removing and disposing of the patch



1. The patch should be removed before you go to bed as it is not designed to be worn when you go to sleep at night or for more than 16 hours each day

2. After removal, the patch should be folded in half, sticky side inwards and placed inside the opened sachet or a piece of aluminium foil

3. The patch should then be disposed of carefully in the household rubbish, out of reach of children and animals





When to use the patch



Look at the following information below, which shows the number of patches you should be using, when you should use them and maximum amount of time you should be using Nicotine Replacement Therapy (NRT) for.



Please read this information carefully and then go to the “How to stop smoking “ section which shows you how to give up.



  • Depending on where you are in your treatment programme, the strength of the patch that you are using may differ. See the “How to stop smoking “ section for more information

  • However all patches are used and applied in the same way

Adults and children of 12 years and over: Apply one new patch (of appropriate strength) to the skin when you wake up (usually in the morning).



Remove the patch 16 hours later, which is usually at bed time.



  • Do not use more than one patch at a time

  • If you lose a patch whilst swimming, bathing or showering you can replace it with another patch

  • Dispose of the patches carefully after you have removed them, make sure they are out of the reach of children and pets

  • Adults aged 18 years and over should not use for longer than 9 months in total without asking for help and advice from a doctor, nurse or pharmacist

  • Children aged 12 to 17 years should not use for longer than 12 weeks in total without asking for help and advice from a doctor, nurse or pharmacist

Children under 12 years



Do not give this product to children under 12 years.





How to stop smoking



Because smoking is an addiction you may find it difficult to give up. From time to time you may still have strong urges to smoke but if you follow these recommendations, you have a good chance of quitting.



If you find it hard to stop smoking using nicotine patches, you are worried that you will start smoking again without it or you find it difficult to reduce the number of patches you are using, talk to your doctor, nurse or pharmacist.



Remember nicotine patches are not intended as a substitute for smoking, they are an aid to give up.



The idea is to stop smoking immediately and use the patch to relieve the cravings to smoke. After achieving this you then slowly reduce the amount of nicotine that you are getting by switching to lower strength patches. You then stop using the patches. You should aim to do this within 12 weeks (3 months).



Adults aged 18 years and over



The following information shows the basic step by step process. Make sure that you read the instructions for each step in the information which follows.



Step 1:

(15 mg - 8 weeks)



Begin treatment with the highest strength 15 mg patch the day after you stop smoking completely. Use a new 15 mg patch each day for eight weeks.



Step 2:

(10 mg - 2 weeks)



If you are successful and avoid smoking during this eight week period, you should then begin to reduce the amount of nicotine you are getting by switching to a lower strength patch.



You should switch from using the 15 mg patch each day to using the 10 mg patch each day for two weeks.



Step 3:

(5 mg - 2 weeks)



If you are successful and avoid smoking over this two week period, then switch from the 10 mg patch to the 5 mg patch each day for a further two weeks.



You might feel a sudden craving to smoke long after you have given up smoking and stopped using the patch. Remember you can use nicotine replacement therapy again if this should happen.



If you need to use this product for more than 9 months, ask your doctor, nurse or pharmacist for advice.



Children 12 to 17 years



Children can follow the same method as Adults, however they should not use NRT for longer than 12 weeks without asking for help and advice from a doctor, nurse or pharmacist.




If you have used too many patches: If you have used more than the recommended number of patches, left the patch on for too long or have smoked whilst using the patch, you may experience nausea, salivation, pain in your abdomen, diarrhoea, sweating, headache, dizziness, hearing disturbance or weakness.



If this happens contact a doctor or hospital casualty department straight away. Take the medicine and this leaflet with you.



If a child under 12 accidentally uses, sucks or chews a patch take them to casualty immediately. Take the medicine and this leaflet with you. Nicotine absorption or ingestion by a child may result in severe poisoning.





Possible side effects



Most people can use this medicine without any problems but sometimes you may notice some side effects. Many of these effects are due to nicotine, they may also happen when you smoke.



If you notice any of the following serious side effects, stop using the medicine, do not smoke and see your doctor as soon as possible.



  • You develop a fast, slow or irregular heart beat

  • You have an allergic reaction to the patch such as rash, itching or swelling of the tongue, mouth or throat (go straight to casualty if severe)

Effects related to stopping smoking (nicotine withdrawal)



You may experience unwanted effects because by stopping smoking you have reduced the amount of nicotine you are taking. You may also experience these effects if you reduce the size of your patch that you use before you are ready to reduce your nicotine intake.



These effects include:



  • Irritability or aggression

  • Feeling low

  • Anxiety

  • Restlessness

  • Poor concentration

  • Increased appetite or weight gain

  • Urges to smoke (craving)

  • Night time awakening or sleep disturbance

  • Lowering of heart rate

Effects of too much nicotine



You may also get these effects if you are not used to inhaling tobacco as you smoke. You may be able to relieve these effects by reducing the strength of the patch you are using.



These effects include:



  • Feeling faint

  • Feeling sick (nausea)

  • Headache

Side effects of the patch



When you use Boots NicAssist patches for the first time they may cause a mild skin reaction. This is usually redness or itching of the skin where the patch has been applied. This will usually disappear after a few days.



Rarely, this reaction may continue for longer, or the reaction may be more severe. If this happens, stop using the patches and talk to your doctor, nurse or pharmacist.



Very common side effects:



(more than 1 in every 10 people are affected)



  • Itching – this usually disappears within a few days

Common side effects:



(less than 1 in every 10 people are affected)



  • Headache

  • Dizziness

  • Stomach discomfort

  • Feeling sick (nausea)

  • Sickness (vomiting)

  • Redness of the skin – this usually disappears within a few days

Uncommon side effects:



(less than 1 in every 100 people are affected)



  • Raised, red or itchy skin

  • Chest palpitations

Very rare side-effects:



(less than 1 in 10,000 people are affected)



  • Abnormal beating of the heart

If any of the side effects get serious, or you notice any side effect not listed here, please tell your pharmacist or doctor.



When you stop smoking you may also develop mouth ulcers. The reason why this happens is unknown.





How to store and dispose of this medicine



Keep this medicine in a safe place out of the sight and reach of children and animals, preferably in a locked cupboard. Nicotine in high doses can be very dangerous and sometimes fatal if used or swallowed by small children.



Use the medicine by the date on the carton and keep it in the original pack.



Do not store above 30°C.



Store in the original package.



Dispose of the patch as directed by folding it in half and placing inside the empty sachet (or wrapping in a piece of aluminium foil) before throwing away. Always dispose of used patches sensibly, away from the reach of children and animals.





What is in this medicine



This pack contains 7 patches packed into individual sachets.



Each patch contains nicotine, which is the active ingredient.



As well as the active ingredient, these patches also contain medium molecular weight polyisobutylene, low molecular weight polyisobutylene, polybutylene, polyester non-woven backing film and siliconised polyester release liner.





Who makes this medicine



This product is manufactured for




The Boots Company PLC

Nottingham

NG2 3AA



by




McNeil AB

Helsingborg

Sweden



The Marketing Authorisation holder is




McNeil Products Ltd

Maidenhead

Berkshire

SL6 3UG




Leaflet prepared February 2010



If you would like any further information about this product, please contact




The Boots Company PLC

Nottingham

NG2 3AA



Other formats



To request a copy of this leaflet in Braille, large print or audio please call, free of charge:



0800 198 5000 (UK only)



Please be ready to give the following information:



Product name Reference Number



Boots NicAssist 15 mg Patch 15513/0177



Boots NicAssist 10 mg Patch 15513/0176



Boots NicAssist 5 mg Patch 15513/0175



This is a service provided by the Royal National Institute of Blind People.



Helpful tips about giving up smoking



You may have tried to stop smoking before and you know from bitter experience that it’s not easy to give up cigarettes. However, you have now taken the first constructive step towards becoming a non-smoker. In overcoming your tobacco dependence you will have to tackle two problems:



1 Your smoking habit

2 Your addiction to nicotine



Willpower



The overriding success factor in quitting is how determined you are. The first few weeks of quitting will probably be the most difficult because your smoking ritual is still fresh in your mind. However, you will find that as time goes by, your willpower becomes stronger.



Telling friends, family and work colleagues that you are stopping smoking and that you envisage a tough time ahead will encourage them to support you.



1 Pick the right day



There is never a perfect time to give up smoking, but you should plan ahead by choosing a date in the not too distant future on which you are going to give up cigarettes completely. Try to pick a day when you will not be too stressed.



2 Break your routine



For a number of years you will have become accustomed to smoking at certain times, with particular people or circumstances. Think about the times you will miss smoking the most and plan how you will cope on these occasions. Changing your routine will help you break the habit of smoking.



3 Quit with a friend



Quitting with a fellow smoker is a good idea. It will strengthen your resolve and build on your determination. Encourage a friend or family member to quit with you. It will give your morale a boost since there will be another person knowing exactly what you’re feeling and with whom you can share your determination to quit smoking.



4 Remove any temptation



To help yourself succeed, be sure to remove all cigarettes, matches, lighters etc. from the home, the car, and at work. Ask your friends and colleagues not to offer you cigarettes or smoke close by you – but be careful not to offend them. Explain that you have given up. This type of support from friends is of greatest benefit for the first couple of weeks of quitting, as this is your most vulnerable time. The last thing you want is a cigarette close at hand in a moment of weakness.



5 Take one day at a time



When you reach your Quit Day, don’t allow yourself to think that you’re quitting for good. That will make it seem like a superhuman task. Just promise yourself “I won’t have a cigarette today”, and take it one day at a time. You’ll be surprised how much that little thought helps.



6 Keep active



Whenever you feel the urge to smoke coming on, distract yourself by keeping active. Don’t feel sorry for yourself. Get up and DO something. Do that job around the house or garden that you’ve been putting off, or take up a hobby. Remember that the craving only lasts a few minutes.



7 Learn to relax



Once you have stopped smoking, taking exercise regularly will not only help you get fitter but will encourage you to relax. Exercise has the ability to relieve stress and tension. Taken regularly it will benefit you physically and psychologically. If you haven’t exercised for some time, take it slowly to begin with and increase the amount of time spent exercising over the course of a few weeks. Not only will exercising help you relax but also helps to keep your weight under control, which some people find a problem when quitting.



8 Think cash not ash



One of the really noticeable benefits of “stopping” is the extra cash that’s suddenly available. To emphasise the point put the money into a pot marked “cash not ash” and watch it accumulate. But be sure to use the money to treat yourself. You deserve a REWARD for NOT smoking.



9 Dealing with relapses



After you have stopped smoking you might find that in times of stress, reaching for a cigarette is the only thing that will help you through. There may also be certain situations – particularly social situations such as a party – where temptation just gets the better of you, so you smoke one or two cigarettes. You might feel that your only option is to go back to smoking. Don’t think of it as having failed, just think through the reasons why you wanted to quit in the first place and don’t let those couple of cigarettes get the better of you. Refer back to your plan and start again. You can beat it!



10 If you don’t succeed



Giving up is more difficult for some people than others. If you fail to stop first time, don’t be disheartened. Try again at a later date – you can do it! Remember the most successful long term ex-smokers have usually had to try several times to stop smoking… if you don’t succeed – quit again.






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