21 mg / 24 hours, 14 mg / 24 hours, 7 mg / 24 hours Nicotine transdermal
patch
What NiQuitin Clear is and what it is used for
NiQuitin Clear is used for smoking cessation. The active substance in NiQuitin Clear is nicotine.
It acts as a temporary aid so that you can quit smoking. It alleviates the nicotine-induced discomfort symptoms that occur in connection with smoking cessation, and thereby counteracts relapse to smoking. If possible, NiQuitin Clear should be used as part of a smoking cessation program.
NiQuitin Clear are transparent, square transdermal patches that release an even amount of nicotine through the skin to the body for 24 hours.
NiQuitin Clear is less harmful than smoking because NiQuitin Clear does not contain cigarette smoke tar or carbon monoxide.
What you need to know before using NiQuitin Clear
Do not use NiQuitin 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, if you only smoke occasionally or are a child under 12 years of age.
Adolescents 12 – 17 years old should only use NiQuitin Clear if they have been prescribed it by a healthcare professional.
Adolescents should not use NiQuitin Clear patches in combination with oral forms of NiQuitin such as lozenges, compressed lozenges, or chewing gums.
Warnings and cautions
Talk to your doctor or pharmacist before using NiQuitin Clear:
- if you have high blood pressure that is not treated with drugs.
- if you have any cardiovascular disease, such as angina or heart failure .
- if you have cerebrovascular disease (condition of impaired blood supply to the brain).
- if you are hospitalized due to a heart attack, irregular heartbeat or stroke . Tell your doctor that you are using NiQuitin Clear.
- if you have dermatitis ( eczema ), as you may get a reaction from the patch.
- if you have diabetes , as your blood sugar level may change when you stop smoking. Your doctor may ask you to check your blood sugar more often than usual when you start using NiQuitin Clear.
- if you have liver or kidney disease then it is more common that you get side effects .
- if you have an uncontrolled and overactive thyroid gland or have been diagnosed with a tumor in the adrenal glands.
- if you have ever experienced seizures.
- if you have an inflammation of the mouth, pharynx or esophagus, or if you have gastritis or ulcers . Nicotine replacement therapy can worsen these symptoms.
If you get redness, swelling or rash, stop using the patch and contact your doctor or pharmacist.
Some worry that once they have stopped smoking, they will instead become addicted to nicotine replacement therapy. Such an addiction is very unusual and if it were to occur, it is both less harmful and easier to break than an addiction to smoking.
Children
The amounts of nicotine that are tolerated by adult smokers can cause poisoning symptoms and be life-threatening if NiQuitin Clear transdermal patches are used or swallowed by children. Consumed NiQuitin Clear transdermal patches also contain sufficient nicotine residues to be harmful to children.
Keep the patches out of the reach of children and dispose of used patches so that they are not accessible.
Other medicines and NiQuitin Clear
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It may be necessary for your doctor to change the dosage if you are taking any of the following medicines:
Asthma medicines (theophylline), medicines for mental disorders (imipramine, clomipramine), medicines for pain relief (pentazocine, phenacetin), anti-inflammatory medicines (phenylbutazone), medicines for dementia (Alzheimer) (tacrine), medicines for diabetes ( insulin ), and medicines for irregular or rapid heartbeat ( adenosine ).
When you stop smoking, with or without NiQuitin Clear, the effect of other medicines taken at the same time may be affected.
Pregnancy, breastfeeding and fertility
Pregnancy
It is very important to stop smoking during pregnancy because smoking can impair fetal growth. Smoking can also lead to premature birth or miscarriage. It is best if you can quit smoking without taking nicotine replacement therapy. If you are unable to do this, use NiQuitin Clear only after consulting your healthcare professional.
Breast-feeding
NiQuitin Clear should be avoided during breastfeeding as nicotine passes into breast milk and may affect the baby. Talk to your healthcare provider before using NiQuitin Clear while breastfeeding.
The use of NiQuitin Clears patches in combination with oral nicotine replacement therapy such as lozenges, compressed lozenges, or chewing gums is not recommended during pregnancy or breastfeeding unless advised by a healthcare professional.
Driving and using machines
There is no known effect of nicotine patches on the ability to drive or use machines.
How to use NiQuitin Clear
Always use this medicine exactly as your doctor or pharmacist has told you.
Ask your doctor or pharmacist if you are unsure.
You must stop smoking completely when you stop using NiQuitin Clear patches. In some cases, it may be easier to use other nicotine replacement products (such as lozenges or chewing gum ) in combination with NiQuitin Clear transdermal patches to more easily resist a sudden puff of smoke.
Dosage
If you smoke more than 10 cigarettes a day, it is recommended that you follow the following dosing schedule:
| Dose: | Time: | |
|---|---|---|
| Step 1 | NiQuitin Clear 21 mg / 24 hours | 1 patch every day for the first 6 weeks, then |
| step 2 | NiQuitin Clear 14 mg / 24 hours | 1 patch every day for the next 2 weeks, next |
| Step 3 | NiQuitin Clear 7 mg / 24 hours | 1 patch every day for the last 2 weeks |
Moderate smokers (smoking less than 10 cigarettes per day) are recommended to follow the following dosing schedule:
| Dose: | Time: | |
|---|---|---|
| step 2 | NiQuitin Clear 14 mg / 24 hours | 1 patch every day for the first 6 weeks, then |
| Step 3 | NiQuitin Clear 7 mg / 24 hours | 1 patch every day for the last 2 weeks |
Patients using NiQuitin Clear 21 mg and experiencing severe side effects, which do not resolve within a few days, should switch to the following dosing schedule:
| Dose: | Time: | |
|---|---|---|
| step 2 | NiQuitin Clear 14 mg / 24 hours | 1 patch every day for the first 6 weeks, then |
| Step 3 | NiQuitin Clear 7 mg / 24 hours | 1 patch every day for the last 2 weeks |
Combination therapy
If you feel a strong urge to smoke, combination therapy with transdermal patches and other forms of nicotine may give you a greater chance of quitting smoking than transdermal patches alone.
Read the package leaflet for NiQuitin 1.5 mg compressed lozenge / NiQuitin 2 mg lozenge / NiQuitin 2 mg chewing gum before use.
The recommended dose of NiQuitin Clear transdermal patch follows the same step-by-step process as described above. In addition to the patches, you can take either NiQuitin 1.5 mg compressed lozenge, NiQuitin 2 mg lozenge, or NiQuitin 2 mg chewing gum as soon as you get an acute smoke suction – an average of 5-6 pieces per day. Do not take more than 15 pieces per day (24 hours) and use only one NiQuitin product in combination with NiQuitin Clear transdermal patch.
Continue to use NiQuitin 1.5 mg compressed lozenge / NiQuitin 2 mg lozenge / NiQuitin 2 mg chewing gum for 2-3 months and then start to gradually reduce the amount of smoke. When you have reduced your dose to 1-2 daily, you should end the treatment.
| Smokers who smoke more than 10 cigarettes a day | ||
| Period | Depot patches | NiQuitin 1.5 mg compressed lozenge /NiQuitin 2 mg lozenge / NiQuitin 2 mg chewing gum |
| Step 1: 6 weeks | NiQuitin Clear 21 mg / 24 hours | 5 to 6 pieces per day |
| Step 2: 2 weeks | NiQuitin Clear 14 mg / 24 hours | Continue to use lozenges / chewing gums if necessary |
| Step 3: 2 weeks | NiQuitin Clear 7 mg / 24 hours | |
| After 10 weeks | Stop using NiQuitin Clear transdermal patches | Gradually reduce the number of chewing gums/lozenges. When the daily use is down to 1-2 pieces, the treatment should be stopped. |
| Moderate smoker (smokes less than 10 cigarettes a day) | ||
| Period | Depot patches | NiQuitin 1.5 mg compressed lozenge /NiQuitin 2 mg lozenge / NiQuitin 2 mg chewing gum |
| Step 2: 6 weeks | NiQuitin Clear 14 mg / 24 hours | 5 to 6 pieces per day |
| Step 3: 2 weeks | NiQuitin Clear 7 mg / 24 hours | Continue to use lozenges / chewing gums if necessary |
| After 8 weeks | Stop using NiQuitin Clear transdermal patches | Gradually reduce the number of lozenges / chewing gums. When the daily use is down to 1-2 pieces, the treatment should be stopped. |
Information on how long NiQuitin 1.5 mg compressed lozenge / NiQuitin 2 mg lozenge / NiQuitin 2 mg chewing gum can be used can be found in the package leaflet for each product.
Contact a doctor if symptoms persist. If you feel that you need to use NiQuitin 1.5 mg compressed lozenge / NiQuitin 2 mg lozenge / NiQuitin 2 mg chewing gum for more than a total of 9 months, consult your doctor for advice.
Instructions for use
- NiQuitin Clear patches are applied once a day.
- A new patch should be applied at about the same time each day, preferably shortly after waking up, on a skin area that is clean, dry and free of hair. Avoid areas with skin folds (such as over a joint), or where the skin folds as you move.
- Do not place NiQuitin Clear patches on areas of skin that are red, irritated or have cuts.
- NiQuitin Clear patches should remain in place for 24 hours. If you wish, the patch can be removed before going to bed. Use for 24 hours is recommended, however, to optimize the effect against the smoke in the morning.
- The patch should not remain on the skin for more than 24 hours.
- The applied patch is removed after 24 hours and a new patch is applied to another area of skin.
- When removing a patch , fold it in half with the sticky side inwards and then place it in the empty package from the new patch to be applied. Dispose of the packaging with the used patch with care, out of the reach of children.
- The used skin area should not be reused until after at least seven days.
- Never use more than one patch at a time.
How are the patches applied?
- NiQuitin Clear patches should be applied immediately after opening the package.
- The patch should be stored tightly in its protective packaging until it is to be used.
- Cut the packaging around the dashed line, or fold along the line and tear from the corner. Be careful not to damage the patch.
- Carefully remove the patch from the package. A transparent protective layer covers the sticky side of the patch – the side that should sit against the skin.
- Hold the sticky side up and peel off the protective layer from the patch, starting in the middle. Hold the patch at the outer edge (touch the sticky side as little as possible) and pull off the other half of the protective layer.
- Immediately apply the sticky side of the NiQuitin Clear patch to the skin. Squeeze the patch with the palm of your hand for at least 10 seconds. Make sure it adheres firmly to the skin, especially around the edges.
- Avoid contact with eyes and nose when handling the patch.
- Always wash your hands with water only after handling NiQuitin Clear. (Soap can increase the absorption of nicotine through the skin).
When handled properly, water is not harmful to the NiQuitin Clear patch. You can swim, swim or shower for short periods while using the NiQuitin Clear patch.
How long can you use NiQuitin Clear?
- For optimal results, the entire ten-week treatment should be completed (8 weeks for moderate smokers or patients who have used the lower dose as above).
- The treatment should not last longer than 10 consecutive weeks.
- However, the treatment can be repeated at a later time if the person who has used NiQuitin Clear continues or resumes smoking.
- Information on how long you can use NiQuitin 1.5 mg compressed lozenge / NiQuitin 2 mg lozenge / NiQuitin 2 mg chewing gum can be found in the package leaflet that comes with each product.
If you leave the NiQuitin Clear patch on for too long
- Remove the patch immediately. Contact a doctor if symptoms of overdose occur, show this package or package leaflet to the doctor if possible. Symptoms of overdose include; pallor, cold sweats, nausea, increased salivation, vomiting, abdominal pain, diarrhea, headache, dizziness, impaired hearing and vision, tremors, mental confusion and weakness.
- The skin surface can be rinsed with water and dried. Soap should not be used, as nicotine absorption can then be accelerated.
- The nicotine supply to the blood continues for several hours after the patch has been removed, as there is a nicotine depot in the skin.
- If possible, show your doctor the package leaflet or this leaflet.
If you forget to use NiQuitin Clear or if a patch comes off:
- Forgetting a dose does not have to have negative consequences. However, the level of nicotine in the blood drops, which can contribute to a temporary increased risk of nicotine withdrawal. You should continue with the indicated dose as soon as possible.
- NiQuitin Clear patches usually adhere well to the skin. If the patch falls off, put on a new patch and make sure you choose a new place that has no hair and is clean and dry. Then continue as before.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects of NiQuitin Clear are application site reactions such as transient rash, itching, burning and tingling sensation, numbness, swelling, and rash. The majority of these local reactions are mild and resolve quickly once the patch has been removed. If severe or prolonged local reactions occur, either at the application site or elsewhere, consult your physician and discontinue treatment with NiQuitin Clear.
Stop using NiQuitin Clear and contact your doctor immediately if you experience any of the following side effects:
Common (may affect up to 1 in 10 people)
- palpitation; abnormal or rapid heartbeat
Very rare (may affect up to 1 in 10,000 people)
- severe allergic reactions with symptoms that include sudden wheezing or pressure in the chest, rash and fainting
Has been reported (occurs in an unknown number of users)
- cramps
Other side effects that may occur:
Very common (may affect more than 1 user in 10)
- sleep disorders incl. abnormal dreams and insomnia
- nausea
- vomiting
- headache
- dizziness
Common (may affect up to 1 in 10 people)
- nervousness
- chest pain
- pain in arms and legs
- pains
- impotence
- muscle pain
- joint pain
- increased sweating
- indigestion
- dry mouth
- constipation
- respiratory distress
- inflammation of the pharynx
- cough
- Shaking
- diarrhea
- fatigue
Uncommon (may affect up to 1 in 100 people)
- palpitation
- feeling uncomfortable
- flu-like symptoms
allergy
Very rare (may affect up to 1 in 10,000 people)
- contact dermatitis
- photosensitivity (skin reaction)
However, these side effects may also be due to you quitting smoking. Some people experience sleep disorders, which also include vivid dreams. As these may be because you have stopped smoking, rather than on the patch, you should continue to wear the patch for a day or two. If the problem persists, try to remove the patch before going to bed (after about 16 hours) and put on a new one when you wake up. If the patch is removed after 16 hours, however, the patch will be less effective at reducing the smoke craving that many smokers experience when waking up.
How to store NiQuitin Clear
- Store below 30 ° C.
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
- Leave all the patches in the box, in their protective packaging, until they are to be used.
- Do not use NiQuitin Clear patches where the package is damaged or opened.
Used patches should be folded with the sticky side inwards and placed in the empty packaging or a piece of aluminum foil and discarded safely so that children do not have access to the patch.
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.
Contents of the package and other information
Content declaration
- The active substance is nicotine.
- The other ingredients are ethylene / vinyl acetate copolymer, polyethylene terephthalate / ethylene vinyl acetate, polyethylene film, polyisobutylene, white ink (titanium dioxide E171).
NiQuitin Clear is available in three strengths:
Step 1: NiQuitin Clear 21 mg / 24 hours; contains 114 mg of nicotine and releases 21 mg of nicotine for 24 hours.
Step 2: NiQuitin Clear 14 mg / 24 hours; contains 78 mg of nicotine and releases 14 mg of nicotine over 24 hours.
Step 3: NiQuitin Clear 7 mg / 24 hours; contains 36 mg of nicotine and releases 7 mg of nicotine for 24 hours.
What the medicine looks like and contents of the pack
Each transdermal patch is rectangular and consists of a transparent backing and a protective layer. Each patch is in a laminated protective package. One pack contains 7, 14, 21, 28, or 42 patches.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Perrigo Sverige AB
Box 7009
164 07 Kista
Manufacturer
FAMAR AVE, Avlon Plant, 48th km National Road Athens – Lamia, Avlona Attiki, 19011 Greece
or
LTS Lohmann Therapie-Systeme AG, Lohmannstrasse 2, 56626 Andernach, Germany
This medicinal product is authorized under the European Partnership under the name:
Netherlands: NiQuitin Clear 7 mg / 24 hours, 14 mg / 24 hours, 21 mg / 24 hours