Document: leaflet MAH BRAND_PL 00079-0361 change

• leaflet MAH BRAND_PL 00079-0361
• leaflet MAH BRAND_PL 02855-0279

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PACKAGE LEAFLET

Package leaflet: Information for the user Nicabate Clear 7 mg, 14 mg, 21 mg/24 hrs transdermal patches

Nicotine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your healthcare professional has told you.

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

•    Ask a healthcare professional e.g. doctor, nurse, smoking cessation adviser or pharmacist if you need more information or advice.

•    If you get any side effects talk to your healthcare professional. This includes any possible side effects not listed in this leaflet.

•    Throughout this leaflet Nicabate Clear transdermal patches are referred to as Nicabate Clear. What is in this leaflet:

1.    What Nicabate Clear is and what it is used for

2.    What you need to know before you use Nicabate Clear

3.    How to use Nicabate Clear

4.    Possible side effects

5.    How to store Nicabate Clear

6.    Contents of the pack and other information

1. What Nicabate Clear is and what is it used for

Nicabate Clear is used to help people stop smoking. This type of treatment is called Nicotine Replacement Therapy or NRT.

Nicabate Clear comes in three strengths, each strength comes in its own pack.

•    Step 1: Nicabate Clear 21 mg/24 hrs transdermal patches; contain 114 mg nicotine and deliver 21 mg of nicotine over 24 hours.

•    Step 2: Nicabate Clear 14 mg/24 hrs transdermal patches; contain 78 mg nicotine and deliver 14 mg of nicotine over 24 hours.

•    Step 3: Nicabate Clear 7 mg/24 hrs transdermal patches; contain 36 mg nicotine and deliver 7 mg of nicotine over 24 hours.

It is the nicotine in cigarettes that can make you physically addicted to them.

•    Nicabate Clear helps you to give up smoking by replacing some of the nicotine you get from cigarettes.

•    When you put on Nicabate Clear, it slowly releases nicotine into the body.

•    The 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 Clear does not have the health dangers of tobacco. This is because it does not contain the tar, carbon monoxide or other toxins in cigarette smoke. Some people worry that after stopping smoking they may become dependent on the nicotine patches instead. This is very rare, and if it did happen, it is less harmful to you 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. For information on stop smoking programmes, please talk to a healthcare professional.

There are no health benefits to smoking. It is always better to give up smoking. Using NRT like Nicabate can help. In general any possible side effects associated with NRT are far outweighed by the well known dangers of continuing to smoke.

2. What you need to know before you use Nicabate Clear Do not use Nicabate Clear:

• if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).

•    if you are a non-smoker, an occasional smoker or under the age of 12 years.

Warnings and precautions

Talk to your healthcare professional before using Nicabate Clear

•    if you are in hospital because of a heart attack, severe heart rhythm problems or a stroke you should try to quit smoking without using any NRT products unless your doctor tells you to use them. 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 starting Nicabate Clear. 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 have allergic eczema or dermatitis you may get a reaction to the patch.

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 continue smoking. (See the section on pregnancy and breastfeeding below for more information.)

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.

•    uncontrolled, overactive thyroid gland or phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure) - your doctor will have told you this - because nicotine may make your symptoms worse.

Children (under 12 years)

The levels of nicotine in NRT are not suitable children under 12. The effects of nicotine affect children more than adults. It could cause severe poisoning in children which can cause death.

Other medicines and Nicabate Clear

Tell your healthcare professional if you are taking, have recently taken or might take any 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, breast-feeding

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 by a healthcare professional to help you stop smoking. This is because it is better for your developing baby than if you carry on smoking. The decision to use NRT should be made as early as possible in your pregnancy. You should aim to use it for only 2-3 months. Remember, the most important thing is to stop smoking. Products such as lozenges may be preferable to nicotine patches. This is because with lozenges, you do not get the nicotine all the time. However, patches may be preferred if you have nausea or sickness.

If you are breast feeding tobacco smoke causes breathing difficulties and other problems in babies and children. If you need NRT to help you quit, 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 at certain times of the day (such as gum or lozenge, rather than patches). It is also better to breast feed just before you take the product. This helps your baby to get the smallest amount of nicotine possible.

Driving and using machines

There are no known effects of Nicabate Clear on your ability to drive or use machines. However, you should be aware that giving up smoking can cause behavioural changes that could affect you in this way.

3. How to use Nicabate Clear

Always use this medicine exactly as described in this leaflet or as your healthcare professional has told you. Check with your healthcare professional if you are not sure.

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 gradually overcome your body’s need for nicotine.

Adults (18 years and over)

The patch should be used only once, for a maximum of 24 hours.

If you smoke 10 or more cigarettes a day, then start with:

Step 1, Nicabate Clear 21 mg/24 hrs for 6 weeks, then continue with:

Step 2, Nicabate Clear 14 mg/24 hrs for 2 weeks, then continue with:

Step 3, Nicabate Clear 7 mg/24 hrs for 2 weeks.

If you smoke less than 10 cigarettes a day, then start with:

Step 2, Nicabate Clear 14 mg/24 hrs for 6 weeks, then continue with:

Step 3, Nicabate Clear 7 mg/24 hrs for 2 weeks.

To increase your chances of success, it is important you complete the step down programme in full.

The patches can be used beyond 10 weeks if you feel you need to use them for longer to stay cigarette free. However if you are still using them after 9 months, talk to a healthcare professional for advice.

Do not exceed the stated dose.

Use in children and adolescents

Adolescents (12-17 years inclusive)

You should follow the instructions above but you should only use the patches for 12 weeks in total. If you feel the need to use Nicabate Clear for longer than 12 weeks, you should talk to a healthcare professional for advice.

Do not exceed the stated dose.

Children under 12 years

Children under 12 years of age should not use Nicabate Clear.

Talk to a healthcare professional if you are:

•    worried that you may start smoking again

•    finding it difficult to stop using the patches completely

If you do start to smoke again, they can advise you on how to get the best results from further courses of NRT.

How to apply your 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 that will be 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 off the other half of the protective liner.

•    Immediately apply the sticky side of the patch to your skin. Press the patch firmly on to 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.

•    When 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

A new patch should be applied once a day and at about the same time each day, preferably soon after waking. Leave each patch in place for 24 hours, and always choose a different area of skin on which to place the new patch. Do not reuse the same skin site for at least seven days.

Disposal of your patches

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 the reach of children or pets.

Nicabate Clear generally sticks 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 nonhairy 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 the patch after 16 hours will reduce its effectiveness in relieving the urge to smoke, felt by some smokers, upon waking.

If you use more patches than you should

If you use too many patches at once you may start to feel sick, dizzy and unwell. Remove all patches and wash and dry the skin with water only (no soap). Get advice straightaway from a doctor or hospital casualty department. If possible show them the packet or this leaflet.

The patches are not suitable for children under 12 or non-smokers. If the patches are used by children or non smokers, they may show signs of nicotine overdose. These include headache, sickness, stomach pains and diarrhoea. If a child has stuck a patch on themselves or eaten one, remove any patches from the skin and wash with water only (no soap) then dry. Contact your doctor or nearest hospital casualty department straightaway. If possible show them the packet or this leaflet.

If you forget to use Nicabate Clear

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 stop using Nicabate Clear

If you stop using this medicine before the recommended time you may feel the urge to smoke again.

If you have any further questions on the use of this medicine, ask your healthcare professional.

4. Possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them. At the recommended doses Nicabate Clear has not been found to cause any serious side effects.

Stopping smoking itself can cause some symptoms such as feeling weak, dizziness, headache, cough and flu-like symptoms. Symptoms such as changes in mood, insomnia, feeling depressed, irritable, anxious, drowsy, restless, nervous and unable to concentrate, sleep disturbance may also be related to withdrawal symptoms associated with giving up smoking.

Other side effects are listed below - they are grouped based on the likelihood with which they can occur.

Very common (may affect more than 1 in 10 people)

•    Skin reactions in the area where you apply the patch

•    Sleep disturbances including insomnia and abnormal dreams

•    Feeling /being sick

•    HeadacheDizziness

Common (may affect up to 1 in 10 people)

•    Nervousness

•    Trembling

•    Shortness of breath

•    Cough

•    Sore or swollen throat

•    Indigestion

•    Stomach pains

•    Diarrhoea

•    Constipation

Sweating

•    Dry mouth

•    Joint, muscle, chest and limb pains

•    Tiredness or weakness

•    Palpitations (feeling your heart beat).

Uncommon (may affect up to 1 in 100)

•    Allergic reaction

Very rare (may affect up to 1 in 10,000 people)

•    Skin reactions

•    Sensitivity of the skin to sunlight

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

You may get slight redness and itching, burning and tingling of the skin where a patch has been. This usually disappears quickly after removal of the patch. Rarely, a more severe reaction at the sticking site, may occur. If this happens stop using the patch and tell your doctor.

If you get any side effects talk to your healthcare professional. This includes any possible side effects not listed in this leaflet.

5. How to store Nicabate Clear

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

•    Store below 30°C.

•    Keep all patches in the carton, in their protective sachets, until you are ready to use one.

•    Do not use this medicine if you notice the sachets are damaged or open.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Nicabate Clear contains

•    The active substance is nicotine.

•    The other ingredients are ethylene vinyl acetate copolymer, polyethylene terephthalate layer, polyethylene film, polyisobutylene and printing ink.

What Nicabate Clear looks like and contents of the pack

Nicabate Clear is a clear, colourless, rectangular patch for sticking on your skin.

Each Step (strength) comes in its own pack and each pack contains 7, 14, 21, 28 or 42 patches. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

<To be completed nationally>

The manufacturer of Nicabate is FAMAR A.V.E. AVLON PLANT (48^th), 48^th km National Road Athens-Lamia, Avlona Attiki, 19011, Greece.

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