Niquitin Clear Patch 21mg, Patch 21

When to apply?

WHAT IS NiQUITIN® CLEAR AND WHAT IS IT USED FOR?

NiQuitin® CLEAR is used to help people quit smoking. This type of therapy is called nicotine replacement therapy. NiQuitin® CLEAR is offered in 3 strengths, each in separate packaging:

Stage 1: NiQuitin® CLEAR 21 mg/24 hours transdermal patch; contain 114 mg nicotine and deliver 21 mg nicotine over 24 hours.

Stage 2: NiQuitin® CLEAR 14 mg/24 hours transdermal patch; contain 78 mg nicotine and deliver 14 mg nicotine over 24 hours.

Stage 3: NiQuitin® CLEAR 7 mg /24 hours transdermal patch; contain 36 mg nicotine and release 7 mg nicotine over 24 hours.

The nicotine contained in cigarettes can lead to physical dependence.

· NiQuitin® CLEAR helps you quit smoking by partially replacing the nicotine you absorb from smoking.

· When you use NiQuitin® CLEAR, it slowly releases the nicotine in the body.

· The nicotine alleviates some of the uncomfortable symptoms that smokers may experience when attempting to quit. These symptoms include feeling ill or irritable. The nicotine can also reduce your craving for a cigarette and help you resist the urge to smoke. NiQuitin® CLEAR does not harm your health in the way tobacco does because it does not contain tar, carbon monoxide or other toxins , which are components of cigarette smoke. Some people worry that they might become dependent on nicotine patches after quitting smoking. This happens very rarely, and when it does, it's less harmful than continuing to smoke. It's also easier to break the habit. Your chances of quitting smoking increase by participating in a supportive program. These “quit smoking programs” are known as behavioral support. Please consult your doctor or pharmacist for more information on quit smoking programs.

How to apply

How to use NiQuitin Clear

Always use this medicine exactly as described in this leaflet or asyour doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It is important thatyou stop smoking completely when you stop smoking with the aid of NiQuitinClear patches. No other nicotine products, e.g. nicotine chewing gum, must beused at the same time as the patches.

Dosage

For smokers whosmoke more than 10 cigarettes a day it is recommended that the following dosingschedule be observed:

Dose Duration

Step 1 NiQuitinClear 21 mg/24 hours 1 patch everyday for the first 6 weeks, then

Step 2 NiQuitinClear 14 mg/24 hours 1 patch everyday for the next 2 weeks, then

Step 3 NiQuitinClear 7 mg/24 hours 1 patch every day for the last 2 weeks.

Light smokers(those smoking fewer than 10 cigarettes a day) are advised to observe thefollowing dosing schedule:

Dose Duration

Step 2 NiQuitinClear 14 mg/24 hours 1 patch everyday for the first 6 weeks, then

Step 3 NiQuitinClear 7 mg/24 hours 1 patch every day for the last 2 weeks.

Patients using NiQuitin Clear 21 mg whoexperience excessive side effects that do not resolve within a few days shouldtransfer to the following dosing schedule:

Dose Duration

Step 2 NiQuitinClear 14 mg/24 hours 1 patch everyday for the rest of the first 6 weeks, then

Step 3 NiQuitinClear 7 mg/24 hours 1 patch every day for the last 2 weeks.

Consult a doctor if the symptoms persist.

Instructions for use

· NiQuitinClear patches should be affixed once a day.

· AffixNiQuitin Clear patches at the same time each day, preferably soon after waking,to a clean, dry, hairless area of skin. Avoid areas with skinfolds (such asover a joint) or when he skin creases when you move.

· Do notaffix NiQuitin Clear patches to areas of skin that are red, irritated ordamaged.

· NiQuitinClear patches should be worn continuously, for 24 hours. If desired, patchescan be removed before going to sleep. However, 24-hour use is recommended foroptimum effect against the urge to smoke in the morning.

· Apatch should not be worn for longer than 24 hours.

· After24 hours the used patch should be removed and a new patch affixed to adifferent area of skin.

· Whenyou have removed a patch, fold it in half with the adhesive side inwards andplace it in the empty sachet of the patch that is to be newly applied. Disposeof the sachet with the used patch inside with care, keep out of the reach ofchildren.

· Anarea of skin used for a patch should not be used again for a new patch for atleast seven days.

· Do notuse several patches at the same time.

How do you affix NiQuitin Clear?

· TheNiQuitin Clear patch should be affixed immediately after opening the sachet.

· Cutthe sachet open along the dotted line or fold the sachet over this line andtear it open, being careful not to damage the patch.

· Carefullyremove the patch from the sachet. A transparent protective layer covers the adhesiveside of the patch – the side that will be put on your

· Remove one half of the protective layer from the middle, with the adhesive layerfacing you. Hold the patch by the outermost edge (touching the adhesive layeras little as possible) and remove the other half of the protective layer.

· Applythe adhesive layer of the NiQuitin Clear patch straightaway to your skin. Pressthe patch firmly to your skin with the palm of your hand for at least 10seconds. Ensure that the patch sticks to the skin well, particularly along theedges.

· Alwayswash your hands just with water after you have affixed the NiQuitin Clearpatch. (Soap can increase the absorption of nicotine).

If used correctly,water is not harmful to NiQuitin Clear patches. You can bathe, swim or showerfor short periods whilst using NiQuitin Clear patches.

For how long may you useNiQuitin Clear?

· Foroptimum results the full 10-week course of treatment (8 weeks for light smokersor patients using a lower strength, as described above) should be completed.

· Thetreatment should not last for longer than 10 consecutive weeks.

· NiQuitinClear users who do not succeed in quitting or who resume smoking can howeverstart a new course of treatment at a later date.

side effects

WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, NiQuitin® CLEAR can have side effects, although not everyone gets them. The evaluation of side effects is based on the following frequency information:

Very common: affects more than 1 in 10 people

Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1000

Rare: affects 1 to 10 users in 10,000

Very rare: affects less than 1 in 10,000 people

At the recommended dosage, NiQuitin® CLEAR has no serious side effects. Quitting smoking itself can cause some symptoms such as weakness, dizziness, headache, cough and flu-like symptoms. Symptoms such as mood swings, insomnia, depression, irritability, anxiety, drowsiness , Restlessness, nervousness, concentration problems and sleep disorders can be related to the withdrawal symptoms when smoking cessation. Further side effects are listed below, which are grouped according to the probability of their occurrence.

Very often

· Skin reactions at the application site

· Sleep disorders, including insomnia and unusual dreams

· Nausea

· Headache

· Dizziness

Frequently

· nervousness

· Tremble

· Shortness of breath

· Cough

· Sore throat or swelling in the throat area

· Indigestion

· Stomach pain

· Diarrhea

· Sweat

· Dry mouth

· Muscle, chest and joint pains

· Fatigue or weakness

· palpitations

Occasionally

· Allergic reaction

Very rare

· Skin reactions

· Photosensitivity of the skin

· Symptoms of severe allergic reactions such as sudden difficulty in breathing and chest tightness, skin rash and feeling faint.

You may experience slight reddening and itching, burning and tingling of the skin at the application site of the patch. These reactions usually subside quickly after the patch is removed. Rarely, a more severe application site reaction may occur. In this case, the use of the patch should be stopped and the doctor should be informed.

composition

What does NiQuitin® CLEAR contain?

The active ingredient is nicotine. One NiQuitin® CLEAR21 mg patch contains 114 mg of nicotine and delivers 21 mg of nicotine over 24 hours.

The other ingredients are: poly(ethylene-co-vinyl acetate) poly(ethylene terephthalate)/poly(ethylene-co-vinyl acetate), polyethylene film; polyisobutylene B100 and B12 SFN, polyester film, siliconized and printing ink white ink 3015Z.

What NiQuitin® CLEAR 21 mg looks like and contents of the pack

NiQuitin® CLEAR is a clear, colorless, rectangular patch that is applied to the skin. Each level (strength) is available in a separate pack. Original pack containing 7 transdermal patches

warnings

WHAT DO YOU NEED TO CONSIDER BEFORE USING NiQuitin® CLEAR?

NiQuitin® CLEAR must not be used:

if you have an allergy (hypersensitivity) to nicotine or any of the other ingredients of this patch (see Section 6: Further information)

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

Smoking has no health benefits. It is always better to quit smoking. Nicotine replacement therapy with NiQuitin® CLEAR can help. In general, any potential side effects that may occur with nicotine replacement therapy are significantly less than the known dangers of continuing to smoke.

Particular care is required when using NiQuitin® CLEAR:

· If you are being treated in hospital for a heart attack, serious heart rhythm problems, or stroke: You should try to quit smoking without using nicotine replacement therapy products unless your doctor tells you to use those products. After you are discharged from the hospital, you can use nicotine replacement therapy products as usual.

· If you are diabetic: You should check your blood sugar levels more often than usual when you start using NiQuitin® CLEAR. Your insulin or medication needs may change.

· If you have had allergic reactions: These reactions include swelling of the lips, face and throat (angioedema) or an itchy rash (urticaria). In some cases, the use of nicotine replacement products can trigger such reactions.

· If you have allergic eczema or dermatitis: The patch may cause unwanted reactions.

· If you are pregnant or breastfeeding, it is best to stop smoking without using nicotine replacement therapy. However, quitting smoking with the help of NiQuitin® CLEAR is better than continuing to smoke (see the Pregnancy and Lactation section below for more information).

Ask your doctor for advice and help if you

· have severe liver or kidney problems because the chance of side effects is increased.

· have an overactive thyroid gland or pheochromocytoma (a tumor of the adrenal gland affecting blood pressure) - your doctor will have told you about this - as nicotine can make your symptoms worse.

When using NiQuitin® CLEAR with other medicines Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, even if they are non-prescription medicines. If you stop smoking, it can affect the effects of others medicines you use. Talk to your doctor or pharmacist if you have any questions or concerns.

pregnancy and breast feeding period

Smoking during pregnancy is dangerous for the unborn child. These include slow growth before birth, prematurity or stillbirth. Quitting smoking is the best measure to improve both your health and that of your unborn child. The sooner you stop smoking, the better. Ideally, if you are pregnant, you should quit smoking without nicotine replacement therapy. However, if you have tried unsuccessfully, nicotine replacement therapy may be recommended by your doctor to support your cessation attempt, as it is better for the development of your unborn child than continuing to smoke would. The decision to use nicotine replacement therapy should be made as early as possible in the pregnancy. You should only plan on using it for 2-3 months. Don't forget: the most important thing is to stop smoking. products such as B. Lozenges may be preferred to patches as lozenges do not consistently deliver nicotine. However, in cases of nausea or illness, the patches might be preferred.

If you are breastfeeding, cigarette smoke can cause breathing difficulties and other problems in babies and children. If you need nicotine replacement therapy to help you quit smoking, the amount of nicotine your baby will receive will be small. This therapy is significantly less harmful than inhalation from secondhand smoke. Nicotine replacement products to be used at specific times of the day (such as gum or lozenges) are preferable to patches. In addition, it is better to breastfeed before using the product. This will help ensure that your infant receives the least possible amount of nicotine.

Children (under 12 years)

The nicotine levels in nicotine replacement therapy are not appropriate for children under 12 years of age. Nicotine has a stronger effect on children than on adults. In children, it can cause severe poisoning that can be fatal.

Driving and using machines

There are no known effects of NiQuitin® Clear on the ability to drive and use machines. However, you should be aware that quitting smoking can cause behavioral changes that affect you in this way.