Nicabate Opaque 21 Mg Transdermal Patch
Nicabate Opaque 21 mg Transdermal Patch
Nicotine
Please read right through this leaflet before you start using this medicine. This medicine is available without prescription, but you still need to use Nicabate Opaque 21 mg Patch 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).
In this leaflet:
1. What Nicabate Opaque 21 mg Patch does
2. Check before you use Nicabate Opaque 21 mg Patch
3. How to use Nicabate Opaque 21 mg Patch
4. Possible side-effects
5. How to store Nicabate Opaque 21 mg Patch
6. Further information
1. What Nicabate Opaque 21 mg Patch does
Nicabate Opaque 21 mg Patch is used to help people stop smoking. It works 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 toxins, are more harmful to your health. NRT products like Nicabate Opaque 21 mg Patch 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. The patches provide a steady amount nicotine to your body, generally at a lower level than from cigarettes.
Nicabate Opaque 21 mg Patch 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, Nicabate Opaque 21 mg Patch may 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.
Nicabate Opaque 21 mg Patch can be used during pregnancy and breast-feeding (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 Nicabate Opaque 21 mg Patch 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 Nicabate Opaque 21 mg Patch Do not use Nicabate Opaque 21 mg Patch:
• 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 have never been a regular 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, and it could cause severe toxicity, which can be fatal.
Take special care with Nicabate Opaque 21 mg Patch 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 had allergic reactions that involve swelling of the lips, face and throat (angiodema) or itchy skin rash (urticaria), using NRT can sometimes trigger this type of reaction.
• If you have allergic eczema or dermatitis you may get a reaction to the patch.
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 have to 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 do need to use NRT patches, remove the patch before you go to bed.
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 whilst 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.
• Try to breast-feed just before you take 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 Nicabate Oqaue 21 mg Patch Adults and young people aged 12 years and over:
Instructions for use of Nicabate Opaque 21 mg Patch 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 professional for advice.
In all cases:
• Apply the patches as described in the instructions below.
• Do not use more than the recommended dose.
Nicabate Opaque 21 mg Patch is not suitable for children under 12 years of age or for nonsmokers. They may develop signs of nicotine overdose, including headache, sickness, stomach pain and diarrhoea.
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.
If you smoke 10 or more cigarettes a day,
Start with Step 1 and use the following step down programme:
Step 1, Nicotine 21 mg for 6 weeks
Step 2, Nicotine 14 mg for 2 weeks
Step 3, Nicotine 7 mg for 2 weeks
If you smoke fewer than 10 cigarettes a day,
Start with Step 2 and use the following step down programme:
Step 2, Nicotine 14 mg for 6 weeks Step 3, Nicotine 7 mg for 2 weeks
As your body adjusts to not smoking, you are able to reduce the strength of patches used until you no longer need to use them. This step-down programme allows you to overcome your body’s need for nicotine.
To increase your chances of success, complete the step down programme in full and follow a stop smoking behavioural support 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 Nicabate Opaque 21 mg Patch to help you cut down on smoking first.
If you smoke 10 or more cigarettes a day you can use Nicabate Opaque 21 mg Patch to help you prepare to stop smoking. You can continue to smoke for the first two to four weeks of using patches, then stop smoking completely. You should use the following step down programme: Pre-Step, Nicabate Opaque 21 mg Patch + smoking for 2-4 weeks.
STOP SMOKING COMPLETELY Step 1, Nicotine 21 mg for 6 weeks Step 2, Nicotine 14 mg for 2 weeks Step 3, Nicotine 7 mg for 2 weeks
If you have not felt able to make a quit attempt 6 weeks after 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 future.
If you feel an urge to smoke, apply a patch as directed in this leaflet to help you manage the cravings. Cut down the number of cigarettes you smoke per day by as many as possible.
It is best to stop 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:
Nicabate Opaque 21 mg Patch can help you manage your cravings so that you can resist cigarettes in situations where smoking is inappropriate, for example:
• 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, apply a patch as directed in this leaflet. Continue to use patches during the period when you are avoiding smoking. Remove the patch when you start smoking again.
It is best to stop smoking completely as soon as you feel able to. Follow the instructions above, under ‘Stopping smoking straightaway’.
Once you have stopped smoking...
After you have stopped smoking, you may still sometimes feel a craving for a cigarette. You can use Nicabate Opaque 21 mg Patch again to help you relieve these cravings- using NRT is always better than smoking again.
If you are worried 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.
If you are finding it difficult to stop using NRT completely, talk to a healthcare professional.
How to apply the patches
It is important to choose a clean, dry and hairless area of skin on which to position the patch, to make sure that it sticks properly. Avoid areas where the skin creases (such as over a joint) or where the skin folds when you move. Also avoid skin which is red, broken or irritated.
• Do not remove the patch from its sealed protective sachet until you are ready to use it.
• Cut open the sachet along the dotted line, taking care not to damage the patch inside.
• Take out the patch carefully. A clear protective liner covers the sticky side of the patch - the side to put on your skin.
• With the sticky side facing you, pull half the liner away from the patch starting at the middle. Hold the patch at the outside edge (touch the sticky side as little as possible), and pull of the other half of the protective liner.
• Immediately apply the sticky side of the patch to your skin. Press the patch firmly onto your skin with the palm of your hand for at least 10 seconds. Make sure it sticks well to the skin, especially round the edges.
• After applying the patch avoid touching the eyes and nose. When you have finished, always wash your hands with water only. Do not use soap which may increase nicotine absorption.
• Water will not harm the patch if it has been applied properly. You can bathe, swim or shower for short periods while you are wearing the patch.
How to change your patches
• Apply a new patch once a day and at about the same time each day, preferably soon after waking.
• Leave each patch in place for 24 hours (remove at bedtime if you are pregnant).
• Always choose a different area of skin on which to place the new patch.
• Do not reuse the same skin site for at least 7 days.
• When you take off a patch, fold it in half with the sticky side inwards and place it in the sachet from which you have just taken your new patch.
• Throw the sachet containing the used patch away carefully, making sure it is out of reach of children or pets.
Nicabate Opaque 21 mg Patch generally stick well to most people’s skin. However, a patch may occasionally come off. If your patch falls off during the day, put on a new patch, making sure you choose a different non-hairy skin site that is clean and dry. Then go on as before.
If you wish, the patch can be removed before you go to bed (after about 16 hours) and a new one put on when you wake up. However, removing a patch after 16 hours will reduce its effectiveness in relieving the urge to smoke felt by some smokers on waking.
If you forget to change your patch at the usual time, change it as soon as you remember then go on as before.
If you use more Nicabate Opaque 21 mg Patch than you should
If a child has stuck a patch on themselves or eaten one, contact your doctor or hospital emergency department immediately.
If possible, show them the Nicabate Opaque 21 mg Patch packet or this leaflet. Symptoms of nicotine overdose in children include headache, sickness, stomach pain and diarrhoea.
If you apply too many patches, you may start to feel sick, dizzy and unwell. Remove all patches 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 dose Nicabate Opaque 21 mg Patch has not been found to cause any serious side-effects.
Stopping smoking itself can cause some symptoms such as feeling weak, tired, depressed, irritable, nervous, restless, anxious, drowsy, dizzy, unable to concentrate, headache, sleep disturbance/night-time awakening, cough, flu-like symptoms and changes in mood.
Other side-effects may include:
• Severe reactions at the sticking site.
• Very rare: Severe allergic reaction symptoms which include sudden wheeziness or tightness of the chest, rash & feeling faint.
Stop using the patch and tell a healthcare professional if you get these.
• Increased heart rate.
Remove the patch and reduce the dose if you get this.
• Abnormal dreams, trembling, palpitations (feeling your heart beat).
• Shortness of breath.
• Feeling or being sick, indigestion, stomach pains, diarrhoea or constipation.
• Sweating.
• Dry mouth.
• Joint, muscle, chest and limb pains.
• Tiredness and feeling unwell.
• Slight redness and itching, burning and tingling of the skin where a patch has been. This usually disappears within a day.
• Sensitivity of the skin to sunlight.
Tell a healthcare professional if you get any of these.
If you do get any side-effects, even those not mentioned in this leaflet, tell a healthcare professional.
If you smoke too much while using the patches
If you are following the programme for preparing to stop smoking, or cutting down with no immediate plans to stop, and you smoke too many cigarettes while you are wearing a patch, you may feel sick, dizzy and unwell. Stop smoking and remove the patch. Wash your hands with water only (no soap) and contact your doctor.
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.
5. How to store Nicabate Opaque 21 mg Patch
• Keep out of the reach and sight of children.
• Do not store above 25°C.
• Do not use this medicine after the ‘EXP’ date shown on the sachet and outer packaging. The expiry date refers to the last day of the month.
• Keep all patches in the original carton, in their protective sachet, until you are ready to use one.
• Do not use patches that are in sachets which are damaged or open.
• 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 Nicabate Opaque 21 mg Patch contains
The active substance is nicotine. The 21 mg patches contain 114 mg of nicotine and deliver 21 mg over 24 hours. The other ingredients are ethylene/vinyl acetate copolymer, polyethylene/aluminium/polyethylene terephthalate, polyethylene film, polyisobutylene and printing ink.
What Nicabate Opaque 21 mg Patch looks like and the contents of the pack
Each step (strength) comes in its own pack and each pack contains 7 patches (1 week kit) in individual sachets. A 14 patch pack (2 week kit) is available for Step 1 (21 mg).
Marketing Authorisation Holder and Manufacturer
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 of Nicabate Opaque 21 mg Patch is Catalent UK Packaging Limited, Sedge Close, Great Oakley, Corby, Northamptonshire NN18 8HS.
This leaflet was last revised in October 2015
Page 9 of 9