NIKOFRENON 14 mg/24 hours nicotine patches, patch smoking cessation transdermal

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active NIKOFRENON 14 mg nicotine patches, patch smoking cessation ingredients

• 35 mg nicotine

NIKOFRENON 14 mg nicotine patches, patch smoking cessation excipients

• Acrylate/vinyl acetate/methacrylate copolymer
• Triglycerides, medium chain
• Butyl methacrylate copolymer, basic
• paper
• Pegoterate, aluminum coated
• Printing ink brown

Indication/ NIKOFRENON 14 mg nicotine patches, patch smoking cessation Application

• The preparation is a nicotine-containing transdermal patch to support smoking cessation.
• It is used to relieve nicotine withdrawal symptoms and to help smoking cessation in nicotine dependence.
• Counseling and patient care usually increase success rates.

NIKOFRENON 14 mg nicotine patches, patch smoking cessation dosage

• Always use this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• When you start treatment with the medicine, you must stop smoking completely.
• The nicotine-containing patches are available in three strengths: 7 mg/24 hours, 14 mg/24 hours and 21 mg/24 hours.
• The starting dose depends on your previous smoking habits. For optimal treatment, please use the following dosing scheme:
  • More than 20 cigarettes a day
    • Starting phase 3 - 4 weeks: 21 mg/24 hours
    • Continuation phase 3 - 4 weeks: 14 mg/24 hours
    • End 3 - 4 weeks: 7 mg/24 hours
  • Up to and including 20 cigarettes per day
    • Starting phase 3 - 4 weeks: 14 mg/24 hours
    • Continuation phase 3 - 4 weeks: 14 mg/24 hours
    • End 3 - 4 weeks: 7 mg/24 hours
• In this way, gradually less and less nicotine is supplied over a period of 9-12 weeks. This weans the body of nicotine and at the same time physical withdrawal symptoms are significantly reduced.
• If your desire to smoke has already significantly reduced prematurely, you can switch to a lower patch strength after just one week. A 7 mg/24 hour patch is suitable for reducing nicotine replacement towards the end of treatment.
• Dose adjustment cannot be achieved by cutting a transdermal patch. Cutting can lead to a decrease in effectiveness that goes beyond the reduction of the adhesive surface.
• Unless otherwise prescribed by your doctor, apply a transdermal patch to your skin every day after you get up and leave it on your skin for 24 hours. By sticking it on immediately after getting up, you avoid any sleep disturbances that may occur at night and prevent the typical morning craving for a cigarette.
• Depending on the individual reaction, you can adjust the thickness of the plaster. For example, if you experience withdrawal symptoms such as a strong craving for a cigarette, nervousness, restlessness and mood swings, you should choose a higher patch strength.
• Withdrawal symptoms can be controlled by maintaining blood levels of nicotine, which are lower than when smoking. This effect is achieved with the help of the transdermal patch of the right strength.
• Furthermore, withdrawal symptoms should not be confused with undesirable effects (see side effects) that require appropriate countermeasures.
• combination therapy
  • Combination of this preparation with nicotine-containing medicines for smoking cessation with immediate smoking cessation.
    • If you have not had sufficient success with monotherapy, or if you experience acute or uncontrollable cravings for smoking during monotherapy, you can also use other medicines containing nicotine (e.g. nicotine chewing gum) in addition to this.
    • Even with combination therapy, the dosage is individual and based on your nicotine dependency. Please also note the information for use of the combination drug.
    • A maximum total daily dose of 64 mg must not be exceeded.
    • This drug can be used in conjunction with various smoking cessation programs, self-motivation, or behavioral therapy. In these cases, the dosage and application should also be adapted to the respective program.
• Notes for smokers of "light cigarettes", cigarillos, cigars or pipes:
  • There may be changes in the dosage for smokers of "light cigarettes", cigarillos, cigars or pipes. This also applies to smokers who do not inhale cigarettes deeply.
  • In these cases you should start the cessation with the lowest strength patch. In the event of an underdose with withdrawal symptoms occurring, the higher-dose patch can be used. You can then end the treatment with a weak patch.

• duration of use
  • Weaning is gradual (see dosing schedule).
  • The application period can be up to 3 months in total.
  • A notice:
    • There are no studies available on treatment periods totaling more than 3 months and on dosages of more than 1 transdermal patch per day.

• If you use more than you should
  • In higher doses than recommended, nicotine can cause symptoms of intoxication of varying severity. If signs of an overdose such as dizziness, nausea, vomiting, headache, hearing and vision problems, paleness, sweating, confusion, weakness and tremors, the patch must be removed from the skin immediately and a doctor must be contacted immediately. In severe overdose, these symptoms can be followed by a drop in blood pressure, a weak and irregular pulse, difficulty breathing, states of exhaustion (prostration), circulatory collapse and generalized seizures.
  • The adhesive area can be washed with water (no soap) and then dried. The skin will continue to release nicotine into the bloodstream for several hours, possibly due to an existing drug depot in the skin.
  • Contact a doctor immediately. If necessary, he will provide symptomatic therapy. When excessive amounts of nicotine are ingested, activated charcoal reduces the absorption of nicotine from the gastrointestinal tract.

• If you forgot the application
  • Apply the transdermal patch either immediately or wait until the usual time according to the prescribed dose. Do not apply two patches if you have forgotten the previous application.

• If you cancel the application
  • If you interrupt treatment with the drug or stop using it prematurely, you must expect that the desired effect will not occur or that the withdrawal symptoms will intensify again. Therefore, please consult your doctor if you want to stop or interrupt the treatment.

• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

NIKOFRENON 14 mg nicotine patches, patch smoking cessation way

• For transdermal use (sticking to the skin).
• Apply the transdermal patch to a healthy, hairless, dry and clean area of ​​skin (no lotion, alcohol or ointment residue, etc.), preferably on the upper arm (inside or outside). Other body parts to attach are the shoulder area or upper hip. The transdermal patch should be pressed in with the palm of the hand for 10-20 seconds.
• Apply the transdermal patch to a healthy, hairless, dry and clean area of ​​skin (no lotion, alcohol or ointment residue, etc.), preferably on the upper arm (inside or outside). Other body parts to attach are the shoulder area or upper hip. The transdermal patch should be pressed in with the palm of the hand for 10-20 seconds.
• Under no circumstances should the same area of ​​skin be used to apply the transdermal patch on consecutive days, ie the area of ​​skin should be changed daily.
• See instructions for use for more information!
• What should be considered when showering, bathing, visiting the sauna or solarium?
  • The preparation is not waterproof, but can be left on the skin with careful showering. From a medical point of view, it is not necessary to remove the transdermal patch in the solarium either.
    In order to protect the transdermal patch from moisture, it can be covered with an ordinary non-medicated patch. Alternatively, it is possible to remove a transdermal patch a maximum of 1-2 times without affecting its adhesive properties. After peeling it off the skin, it should be carefully placed on a smooth surface, e.g. B. a mirror, be glued to preserve the adhesiveness.
  • Under no circumstances should the plaster be left on the skin during a visit to the sauna or a dive. In these cases, an uncontrolled release of nicotine cannot be ruled out.
• What to do if the transdermal patch no longer sticks?
  • If the adhesive effect of the transdermal plaster has been impaired despite precautionary measures, it can be fixed with a conventional wound plaster that does not contain active ingredients.
• Instructions for the disposal of used transdermal patches
  • After removing the transdermal patch from your skin, hold the center of the patch together with the sticky side facing in so that the two halves stick together.

side NIKOFRENON 14 mg nicotine patches, patch smoking cessation effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• The frequency of side effects is based on the following categories:
  • Very common: may affect more than 1 in 10 people
  • Common: may affect up to 1 in 10 people
  • Uncommon: may affect up to 1 in 100 people
  • Rare: may affect up to 1 in 1,000 people
  • Very rare: may affect up to 1 in 10,000 people
  • Not known: frequency cannot be estimated from the available data
• Nicotine can cause headaches, dizziness and nausea, increased heart rate and temporary slight increases in blood pressure. However, when using this patch, the level of nicotine in the blood remains largely the same and does not reach the peak levels seen after smoking a cigarette. Therefore, such side effects are much less pronounced under treatment with the preparation.
• The symptoms described below under "Disorders of the nervous system" and "Disorders of the gastrointestinal tract" can also be attributed to the withdrawal symptoms associated with smoking cessation. When smoking, in addition to the nicotine effects, there are additional risks due to the known damaging effects of carbon monoxide and tar.
• diseases of the immune system
  • Very rare:
    • Generalized allergic reactions such as generalized hives, swelling of the skin and mucous membranes (angioneurotic edema), allergic reactions up to shock (anaphylactic reactions)
    • If these serious rare side effects (signs of angioedema) occur, stop using the medicine and see a doctor immediately:
      • Allergic reactions: Contact sensitization has occurred in some patients when using patches containing nicotine. These patients may experience allergic reactions if they continue to use nicotine-containing products or continue to smoke.
• Diseases of the nervous system
  • Very often:
    • headache
  • Often:
    • Insomnia, abnormal dreams, dizziness, agitation, feeling anxious, nervousness, difficulty concentrating, tiredness
  • Occasionally:
    • Drowsiness, emotional lability, irritability, depressed mood, confusion, memory problems, sensory disturbances (paresthesia), taste disturbances, swallowing problems (dysphagia), migraines
  • Rarely:
    • shaking (tremor), twitching
• eye diseases
  • Occasionally:
    • visual disturbances
• heart diseases
  • Occasionally:
    • palpitations (palpitations)
  • Rarely:
    • Chest pain, cardiac arrhythmias
• vascular diseases
  • Often:
    • blood pressure changes
• Respiratory, thoracic and mediastinal disorders
  • Often:
    • Cough
  • Occasionally:
    • upper respiratory infections
  • Rarely:
    • shortness of breath (dyspnea)
• Diseases of the gastrointestinal tract
  • Often:
    • Nausea, abdominal pain, indigestion (dyspepsia)
      Uncommon: vomiting, constipation, diarrhoea, flatulence, abnormal stools, dry mouth, gingivitis, stomach ulcer
• Skin and subcutaneous tissue disorders
  • Very often:
    • Application site reactions such as burning sensation, swelling, redness, itching, rash, hives, blistering, pinching
      Most of these reactions were mild and resolved within 48 hours. In severe cases, redness and swelling lasted 1-3 weeks. Significant skin reactions occurred 3-8 weeks after the start of treatment. In individual cases, the skin symptoms also extended beyond the adhesive site.
  • Occasionally:
    • Increased sweating, acne
  • Rarely:
    • Application site reactions such as skin discoloration, hyperpigmentation, vasculitis
    • If you know that you are sensitive to sticking plasters, you should carefully monitor the appearance of any skin symptoms during the first few days of treatment. If you notice significant redness or swelling of the skin where it was applied, you should apply the transdermal patch to a different part of your body. If skin irritation persists, treatment should be discontinued.
• Musculoskeletal, connective tissue and bone disorders
  • Often:
    • Muscle pain, movement disorders
  • Occasionally:
    • Joint pain, muscle cramps (e.g. calf cramps), back pain
• Diseases of the kidneys and urinary tract
  • Occasionally:
    • Bladder infection (cystitis)
• General disorders and administration site conditions
  • Very often:
    • Cold and flu-like symptoms of illness
  • Occasionally:
    • Weakness, pain, feeling unwell, weight gain, increased appetite, hot flashes, painful lymph nodes
• investigations
  • Occasionally:
    • thyroid disorder
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

NIKOFRENON 14 mg nicotine patches, patch smoking cessation interactions

• Use together with other medicines
  • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
  • Interactions between this and other medicines are not known.
  • When smoking, however, interactions can occur due to a variety of other substances contained in the smoke. Smoking can accelerate the breakdown of certain drugs, so after quitting smoking with the help of this preparation, an adjustment of the dosage of the corresponding drugs should be considered. Therefore, you should tell your doctor if you are taking any of the following medicines:
    • Caffeine, theophylline, acetaminophen, phenacetin, phenazone, phenylbutazone, pentazocine, lidocaine, benzodiazepines (eg, nordazepam, oxazepam), certain drugs used to treat depression (tricyclic antidepressants, eg, imipramine), warfarin, estrogen, and vitamin B ₁₂ .
  • Other effects of smoking include a reduction in the analgesic efficacy of propoxyphene, a reduction in the diuretic efficacy of furosemide, a change in the efficacy of propranolol, and altered response rates to H ₂ -antagonist treatment for gastric and intestinal ulcers.
  • Nicotine can increase blood levels of cortisol and catecholamines (adrenaline and noradrenaline). Dose adjustments of nifedipine and nerve receptor stimulating (adrenergic agonists) or nerve receptor blocking (adrenergic antagonists) substances may be required.
    • Dose reduction may be necessary after smoking cessation due to lack of induction of liver enzymes for:
      • tacrine, clomipramine
    • Dose reduction may be necessary after smoking cessation due to an increase in subcutaneous insulin absorption for:
      • insulin
    • Dose reduction may be necessary after smoking cessation due to a reduction in circulating catecholamines for:
      • Alpha and beta blockers such as prazosin, propranolol
    • Dose escalation may be necessary during smoking cessation due to a reduction in circulating catecholamines for:
      • Sympathomimetics such as isoprenaline, salbutamol.

Contraindications

• The drug must not be used
  • if you are allergic to the active substance nicotine or any of the other ingredients of this medicine
  • in general skin diseases
  • if you have unstable or worsening narrowing of the coronary arteries (angina pectoris)
  • immediately after heart attack
  • in severe cardiac arrhythmia
  • with a recent stroke
  • in vasospasm
  • if you have a tumor of the adrenal medulla (pheochromocytoma)
  • with children
  • among non-smokers and occasional smokers

pregnancy NIKOFRENON 14 mg nicotine patches, patch smoking cessation and breast feeding period

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
• pregnancy
  • Smoking can cause serious harm to the fetus and infant and should be stopped. Pregnant smokers are recommended to quit smoking without the support of nicotine-containing drugs. The use of this preparation should only be considered after consultation with the doctor if there is a risk of continued smoking. In this case, the risks of continuing to smoke (possibly higher nicotine plasma levels, harmful substances from tobacco smoke) must be weighed against the risk of nicotine substitution. The risks to the fetus when using the drug are not fully known. The benefit of smoking cessation assisted by nicotine-containing medicinal products in pregnant smokers who are unable to quit smoking without such therapy
• lactation
  • Nicotine passes into breast milk. When using the drug in therapeutic doses, nicotine levels in breast milk that have an effect on the child can be reached. If nicotine substitution with the preparation is necessary during breastfeeding, the infant should be switched to bottle feeding.
• fertility
  • Smoking can have adverse effects on female and male fertility (fertility). It is not known what specific contribution nicotine makes to these effects. If possible, women who want to have children should neither smoke nor use nicotine replacement therapy.

patient NIKOFRENON 14 mg nicotine patches, patch smoking cessation notes

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before using the preparation if:
    • Stable narrowing of the coronary arteries (angina pectoris)
    • older heart attack
    • cerebrovascular diseases
    • Circulatory problems in the arms or legs (e.g. "smoker's leg")
    • severely elevated blood pressure
    • myocardial insufficiency
    • Kidney and liver disorders
    • overactive thyroid
    • epilepsy
    • Muscle weakness (myasthenia gravis, pseudomyasthenic syndrome)
    • Diabetes (diabetes mellitus)
    • inflammation of the gastric mucosa and acute gastric and intestinal ulcers
  • In these cases you should talk to your doctor before using the medicine. In this case, the risks of continuing to smoke must be weighed against the risk of nicotine replacement therapy.
  • Patients with a history of seizures (ie epilepsy) may be at an increased risk of seizures while being treated with the medicine.
  • Patients with a known history of muscle weakness (myasthenia gravis, pseudomyasthenic syndrome) may experience worsening of their symptoms related to muscle weakness during treatment with the preparation.
• children and young people
  • Children must not be treated with this preparation.
    There is no experience with the use of this preparation in patients under 18 years of age.
• Elderly people
  • There is only limited experience with the use of this medicine in smokers over 65 years of age, but the efficacy and tolerability in this age group appear to be unproblematic.

• Ability to drive and use machines
  • There is no evidence of any risk from driving or using machines as long as the recommended dosage is followed. However, be aware that quitting smoking can induce behavioral changes.