NICORETTE INVISIPATCH 10mg/16h x 7
NICORET transdermal patches 10 mg. / 16 hours * 7
LEAFLET: PATIENT INFORMATION
NICORET INVIZIPECH 10 mg/16 hours transdermal patch
NICORET INVIZIPECH 15 mg/16 hours transdermal patch
NICORET INVIZIPEC 25 mg/16 hours transdermal patch
NICORETTE INVISIPATCH 25 mg/16h, 15 mg/16 h and 10 mg/16 h, transdermal patch
Nicotine
Read the entire leaflet carefully as it contains important information for you.
NICORET INVIZIPEC is available without a prescription. However, in order to get the best results from the treatment, you must carefully follow the instructions for use of NICORET INVISIPECH.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
You should seek medical help if you cannot refrain from smoking after 6 months of treatment with NICORET INVIZIPEC.
If any of the side effects become serious, or you notice other side effects not described in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What NICORET INVIZIPECH is and what it is used for
2. Before starting treatment with NICORET INVISIPECH
3. How to take NICORET INVISIPECH
4. Possible side effects
5. How to store NICORET INVISIPECH
6. Additional information
1. WHAT NICORET INVISIPECH IS AND WHAT IT IS USED FOR
NICORET INVIZIPEC belongs to the group of medicines used to stop smoking such as nicotine replacement therapy (NRT).
NICORET INVIZIPEC is used to treat tobacco dependence in smokers who are motivated to quit by minimizing the need to light a cigarette and reducing the difficulties smokers experience when trying to quit (eg headache, insomnia, anxiety).
When you stop smoking, your body does not get nicotine from the tobacco and therefore you may experience unpleasant sensations called withdrawal syndrome. With the help of pure (therapeutic) nicotine from NICORET INVISIPECH you can avoid these unpleasant syndromes.
NICORET INVIZIPEC transdermal patch does not contain life-threatening substances such as tar and carbon monoxide, which are found in cigarette smoke. NICORET INVIZIPECH contains nicotine in pure form, resorbed by the skin for 16 hours, and replaces the nicotine that the smoker would ingest from cigarette smoke.
Advice and support usually increase success.
If possible, use NICORET INVISIPECH as part of a smoking cessation program.
2. BEFORE STARTING TREATMENT WITH NICORET INVISIPECH
Do not use NICORET INVISIPECH
if you are allergic (hypersensitive) to nicotine or to any of the other ingredients of NICORET INVISIPECH.
Take special precautions when using NICORET INVISIPECH:
if you have had a serious cardiovascular event or been admitted to hospital with cardiovascular complaints in the previous 4 weeks (occlusion of peripheral arteries, cerebrovascular disease, unstable angina or heart failure, bypass);
if you have severe liver or kidney disease;
if you have an acute stomach or duodenal ulcer;
if you have diabetes, because in patients with diabetes, stopping smoking may lead to the need for lower insulin levels;
if you have untreated hyperthyroidism (overactive thyroid gland or pheochromocytoma);
if you have psoriasis, chronic dermatitis or urticaria, do not apply NICORET INVISIPECH to the affected areas.
Pure nicotine in the form of transdermal patches is less harmful than smoking.
Young people under the age of 18 should use NICORET INVISIPECH only on a doctor's recommendation.
NICORET INVISIPECH should not be used by non-smokers.
Use of other drugs
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not prescribed for you.
This is especially important when you are using theophylline, tacrine, clozapine, ropinirole, flecainide or pentazocine.
Pregnancy and breastfeeding
Ask your doctor or pharmacist before using any medicine.
Nicotine passes into the fetus and affects its breathing and blood circulation. The effect on circulation is dose dependent.
Pregnant smokers should always be advised to stop smoking without the use of nicotine replacement therapy. In case of failure in highly dependent pregnant women, NICORET INVIZIPEC should be used only after consultation with medical specialists.
Nicotine passes into breast milk in small amounts that may affect the infant even in therapeutic doses. NICORET INVISIPECH should not be used by breastfeeding women who smoke. If you need NRT to help you quit smoking, the amount your baby can get is significantly less and the harm is less. It's best to use immediate-release HRT products (ie, not patches, a Nicorette Gums, or Microtabs), trying to take them right after breastfeeding, not in the two hours before.
Driving and using machines
No effects on the ability to drive or use machines were observed.
3. HOW TO TAKE NICORET INVISIPECH
Children and adolescents
NICORET INVIZIPEC should not be administered to persons under the age of 18 without the recommendation of a medical professional. Experience with the treatment of this age group with NICORET INVIZIPEC is limited.
Adults and elderly patients
Treatment with NICORET INVIZIPEC usually lasts 12 weeks.
On the day of starting treatment, you must have completely stopped smoking, so the last cigarette is the day before the patch is applied to the skin. Do not smoke during treatment.
Treatment is started with the higher dose patches and then gradually switched to patches with lower amounts of nicotine.
Treatment with the patch mimics the fluctuations of nicotine in smokers during the day, with no nicotine input during sleep. Daily treatment with the nicotine patch does not lead to the sleep disturbances seen with nicotine administration during sleep.
Highly dependent smokers (Fagerstrom Nicotine Dependence Test > 6 or smoking > 20 cigarettes per day) should start treatment at Step 1 with the 25 mg/16 hourly patch, applying one patch for 8 weeks.
Gradual withdrawal of the patches should then be initiated - Step 2. One 15 mg/16 hour patch should be applied daily for 2 weeks, followed by one 10 mg/16 hour patch daily for 2 weeks.
Smokers with low dependence start at Step 2 (15 mg/16 hours) for 8 weeks and taper to Step 3 (10 mg/16 hours) over the last 4 weeks.
Smokers with high dependence Smokers with low dependence
Dosing schedule Cont-
Dosing schedule Continued
residency
Step 1 Nicorette Invisipech 25 mg The first 8 weeks Step 1 -
Step 2 Nicoret Invisipech 15 mg The next 2 weeks Step 2 Nicoret Invisipech 15 mg The first 8 weeks
Step 3 Nicoret Invisipech 10 mg Last 2 weeks Step 3 Nicoret Invisipech 10 mg Last 4 weeks
In general, the use of NICORET INVIZIPEC for more than 6 months is not recommended, but some people may need longer treatment to avoid resuming the smoking habit.
How to apply NICORET INVISIPECH?
The patch should be applied once daily to a clean, dry, undamaged area of skin on the thigh, armpit or chest. To avoid skin irritation, these areas should be changed daily, and one area should not be used on consecutive days.
NICORET INVISIPECH should be pressed against the skin in the morning and removed before going to bed. The resorption period is 16 hours, so the need to smoke is covered and sleep is not disturbed.
You do not need to remove the patch when you take a bath or shower.
1. Wash your hands before applying the patch.
2. Open the side of the bag with scissors as shown. Choose a clean, dry, undamaged area of skin without hair, such as the thigh, armpit, or chest.
3. Remove one part of the silver aluminum backing as much as possible. Avoid touching the sticky surface of the patch with your fingers as much as possible.
4. Carefully apply the adhesive part of the patch to the skin and remove the rest of the silver aluminum backing.
5. Press the patch firmly onto your skin with your palm or fingertips.
6. Rub the edges vigorously with your fingers so that the patch adheres firmly.
The use of skin oils or talc may prevent the patch from adhering well.
After their removal, used patches should be disposed of carefully. The patch should not remain on the skin during nighttime sleep.
If you forget to remove the patch at night, you can continue the treatment in the morning by removing the old patch and applying the new one - without any interruption.
If you apply more than the required dose of nicotine
An overdose can occur if you are a smoker with a low degree of dependence, it can be caused by using one NICORET INVIZIPEC patch and smoking at the same time or by applying additional means to stop smoking.
Overdose symptoms are those of acute nicotine poisoning and include nausea, drooling, abdominal pain, diarrhea, sweating, headache, dizziness, impaired hearing, and marked weakness. At high doses, these symptoms may be followed by hypotension (low blood pressure), sudden weakness, arrhythmias, difficulty breathing, depression, circulatory collapse, and generalized convulsions.
Doses of nicotine that are normally tolerated by adult smokers during treatment can cause severe symptoms of poisoning in young children, and may even lead to their death.
Please note that used patches may still contain residual amounts of nicotine which may be harmful to children. Therefore, keep used patches out of the reach of children.
What to do in case of overdose:
If you have applied more than the recommended dose of NICORET INVIZIPEC, left the patch on too long or smoked while using NICORET INVIZIPEC, or if a child has been in contact with the patch, nausea, salivation, abdominal pain, diarrhea, sweating may occur , headache, dizziness, impaired hearing or weakness. Tell your doctor immediately or contact the emergency department of the nearest hospital.
If you have any further questions about the use of this product, please ask your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, NICORET INVIZIPEC can cause side effects, although not everybody gets them.
NICORET INVIZIPEC can cause side effects similar to those associated with nicotine administered by other routes, and these are dose-dependent.
Mild skin reactions occur mostly during the first weeks of treatment.
Other side effects are described below.
Frequent cases
Headache, dizziness, nausea and vomiting, erythema, itching, edema.
Uncommon cases
Palpitations, urticaria.
Very rare cases
Reversible atrial fibrillation.
Some symptoms (dizziness, headache and insomnia) may be related to withdrawal symptoms.
An increased incidence of aphthous ulcers may be observed after smoking cessation, but the relationship to nicotine treatment is unclear.
If any of the side effects become serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE NICORET INVISIPECH
Keep the medicine out of the reach and sight of children.
Store below 25 ºС.
Do not use NICORET INVISIPECH after the expiry date which is stated on the patch bag and carton. The expiration date corresponds to the last day of the specified month.
6. ADDITIONAL INFORMATION
What NICORET INVISIPECH contains
The active substance is: nicotine.
NICORET INVISIPECH 25 mg/16 hours
One patch contains 39.37 mg of nicotine, which releases 25 mg of nicotine in 16 hours.
NICORET INVISIPECH 15 mg/16 hours
One patch contains 23.62 mg of nicotine, which releases 15 mg of nicotine in 16 hours.
NICORET INVISIPECH 10 mg/16 hours
One patch contains 15.75 mg of nicotine, which releases 10 mg of nicotine in 16 hours.
The other ingredients are: medium chain triglycerides, butylated methacrylate copolymer base, polyethylene terephthalate (PET) film, acrylic adhesive solution, potassium hydroxide, croscarmellose sodium, aluminum acetylacetonate, siliconized PET release pad, aluminized on one side, printing ink.
NICORET INVIZIPECH (all amounts of the active substance) does not contain any product of animal origin.
What NICORET INVIZIPECH looks like and what it contains
NICORET INVIZIPECH is a beige, translucent rectangular transdermal patch with a light beige ink label. It consists of a top layer, a middle layer containing the nicotine, and an adhesive layer that comes into contact with the skin, this layer also containing an aluminized backing.
Each patch is packaged in a laminated film consisting of paper, PET film and aluminum acrylonitrile copolymer.
The foil patches are packed in a cardboard box together with a patient leaflet.
Cardboard boxes with 7, 14 or 28 transdermal patches.
Not all packages may be on the market.
Marketing Authorization Holder:
McNeil AB, Sweden.
Manufacturer:
LTS Lohman Therapie-Systeme AG, Germany;
