NIKOFRENON 21 mg- 24 hours, nicotine patches 7 pc

HEUMANN PHARMA GmbH & Co. Generica KG

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Nicotine patches nikofrenon 21 mg / 24 hours patch, transdermal patch

For use in adults.
Active ingredient: nicotine.
Application:
Relief of nicotine withdrawal symptoms, support of smoking cessation in case of nicotine dependence. Counseling and care for the patient generally increases the success rates.

For Nicotine patches information on risks and side effects, read the package insert and ask your doctor or pharmacist.

As of: 03/2018

Active ingredients

  • 52.50 mg nicotine

Auxiliary materials

  • Acrylate / vinyl acetate / methacrylate copolymer
  • Triglycerides, medium chain
  • Butyl methacrylate copolymer, basic
  • paper
  • Pegoterate, aluminum-coated
  • Brown printing ink

Nicotine patches Indication / application

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

Nicotine patches dosage

  • Always use this medicine exactly as described or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
  • When starting 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 dosage scheme:
    • More than 20 cigarettes a day
      • Start phase 3 - 4 weeks: 21 mg / 24 hours
      • Continuation phase 3 - 4 weeks: 14 mg / 24 hours
      • Finish 3 - 4 weeks: 7 mg / 24 hours
    • Up to and including 20 cigarettes per day
      • Start phase 3 - 4 weeks: 14 mg / 24 hours
      • Continuation phase 3 - 4 weeks: 14 mg / 24 hours
      • Finish 3 - 4 weeks: 7 mg / 24 hours
  • So gradually less and less nicotine is supplied over 9-12 weeks. This weans the body from nicotine and at the same time significantly reduces physical withdrawal symptoms.
  • If your desire to smoke has already significantly reduced ahead of time, you can switch to a lower plaster thickness after just one week. A plaster with 7 mg / 24 hours is suitable for reducing the nicotine replacement towards the end of the treatment.
  • Dosage adjustment cannot be achieved by cutting a transdermal patch. When cutting, there may be a decrease in effectiveness that goes beyond the reduction of the adhesive surface.
  • Unless your doctor tells you otherwise, stick a transdermal patch on every day after getting up and leave it on 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 your individual reaction, you can adjust the thickness of the plaster. For example, if you experience withdrawal symptoms such as craving for a cigarette, nervousness, restlessness, and mood swings, you should choose a thicker patch.
  • Withdrawal symptoms can be controlled by constant nicotine concentrations in the blood, which are lower than when smoking. This effect is achieved with the help of the transdermal patch in the correct strength.
  • Furthermore, withdrawal symptoms are not to be confused with undesirable effects (see side effects), which make appropriate countermeasures necessary.
  • Combination therapy
    • Combination of this preparation with nicotine-containing drugs for smoking cessation with immediate smoking cessation.
      • If you have not had sufficient success with monotherapy or if you develop acute or uncontrollable smoking craving during monotherapy, you can also use other nicotine-containing medicinal products (e.g. nicotine chewing gum) in addition to this.
      • Even with combination therapy, the dosage is individual and based on your nicotine dependence. Please also note the instructions for use of the combination drug.
      • A maximum daily dose of 64 mg in total must not be exceeded.
      • This medicine can be used in conjunction with various smoking cessation programs, self-motivation, or behavior 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 begin weaning with the lowest strength patch. In the event of underdosing with withdrawal symptoms, the higher-dose patch can be used. You can then end the treatment with a weak plaster.

 

  • Duration of application
    • Weaning proceeds gradually (see dose schedule).
    • The duration of use can be up to 3 months in total.
    • A notice:
      • No studies are available on treatment times of more than 3 months in total and on doses of more than 1 transdermal patch per day.

 

  • If you use more than you should
    • Nicotine in doses higher than the recommended can cause symptoms of intoxication to varying degrees. If there are signs of an overdose such as dizziness, nausea, vomiting, headache, hearing and vision disorders, paleness, sweating, confusion, weakness and tremors, the patch must be removed from the skin immediately and a doctor informed immediately. In the case of severe overdose, these symptoms can be followed by a drop in blood pressure, weak and irregular pulse, breathing difficulties, states of exhaustion (prostration), circulatory collapse and generalized seizures.
    • The attachment point can be washed off with water (not soap) and then dried. The skin may continue to release nicotine into the bloodstream for several hours due to the presence of an active ingredient depot in the skin.
    • Call a doctor immediately. If necessary, he will treat symptomatically. If excessive amounts of nicotine are swallowed, activated charcoal will reduce the absorption of nicotine from the gastrointestinal tract.

 

  • If you forget to use it
    • Either use the transdermal patch immediately or wait until the usual time, according to the prescribed dose. Do not use two patches to make up for a forgotten 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 be achieved 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.

Nicotine patches way

  • For transdermal use (to stick to the skin).
  • Apply the transdermal patch to a healthy, hairless, dry and clean area of ​​skin (no lotion, alcohol or ointment residues, etc.), preferably on the upper arm (inside or outside). Other parts of the body to attach are the shoulder area or the upper hip. The transdermal patch should be pressed on 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 residues, etc.), preferably on the upper arm (inside or outside). Other parts of the body to attach are the shoulder area or the upper hip. The transdermal patch should be pressed on with the palm of the hand for 10-20 seconds.
  • Under no circumstances should the same area of ​​skin be used for applying the transdermal patch on consecutive days, ie it is essential to keep the skin area changed every day.
  • For more information, see the instructions for use!
  • What should you watch out for when showering, bathing, visiting the sauna or solarium?
    • The preparation is not waterproof, but can be left on the skin if you shower carefully. From a medical point of view, it is also not necessary to remove the transdermal patch in the solarium.
      In order to protect the transdermal patch from moisture, it can be covered with an ordinary active ingredient-free patch. Alternatively, it is possible to remove a transdermal patch a maximum of 1-2 times without affecting its adhesive properties. After removing it from the skin, use the outermost edge of the adhesive to carefully apply it to a smooth surface, e.g. B. a mirror to be glued to preserve the adhesiveness.
    • Under no circumstances should the patch 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 should I do if the transdermal patch no longer sticks?
    • If the adhesive effect of the transdermal patch has been impaired in spite of the precautionary measures, it can be fixed with an active substance-free conventional wound patch.
  • Instructions for the disposal of used transdermal patches
    • After removing the transdermal patch from the skin, hold it in the middle with the adhesive layer facing inwards so that the two halves stick together.

Nicotine patches Side effects

  • Like all medicines, this medicine can have 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, an increase in heart rate and temporary slight increases in blood pressure. When using this patch, however, the nicotine level in the blood remains largely the same and no peak values ​​such as those after smoking a cigarette are reached. Therefore, such side effects are significantly less pronounced during treatment with the preparation.
  • The symptoms described below under "Disorders of the nervous system" and "Diseases of the gastrointestinal tract" can also be attributed to the withdrawal symptoms in connection with smoking cessation. When smoking, in addition to the nicotine effects, there are additional risks due to the known harmful effects of carbon monoxide and tar.
  • Immune system disorders
    • 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 straight away:
        • 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 if they continue to smoke.
  • Nervous system disorders
    • Very often:
      • headache
    • Often:
      • Insomnia, abnormal dreams, dizziness, agitation, anxiety, nervousness, difficulty concentrating, tiredness
    • Occasionally:
      • Drowsiness, emotional lability, irritability, depressed mood, confusion, memory disorders, sensory disorders (paraesthesia), taste disorders, swallowing disorders (dysphagia), migraines
    • Rarely:
      • Tremors (tremor), twitching
  • Eye diseases
    • Occasionally:
      • Visual disturbances
  • Heart disease
    • Occasionally:
      • Palpitations
    • Rarely:
      • Chest pain, irregular heartbeat
  • Vascular disease
    • Often:
      • Changes in blood pressure
  • Respiratory, thoracic and mediastinal disorders
    • Often:
      • to cough
    • Occasionally:
      • Upper respiratory tract infections
    • Rarely:
      • Shortness of breath (dyspnoea)
  • Gastrointestinal disorders
    • Often:
      • Nausea, abdominal pain, indigestion (dyspepsia)
        Uncommon: vomiting, constipation, diarrhea, flatulence, abnormal stool, dry mouth, inflammation of the gums, stomach ulcer
  • Skin and subcutaneous tissue disorders
    • Very often:
      • Reactions at the application site such as burning sensation, swelling, reddening of the skin, itching, rash, hives, blistering, pinching.
        Most of these reactions were mild in nature and resolved within 48 hours. In severe cases, redness and swelling lasted for 1 to 3 weeks. Significant skin reactions occurred 3 to 8 weeks after the start of treatment. In individual cases, the skin symptoms also extended beyond the point of attachment.
    • Occasionally:
      • Increased sweating, acne
    • Rarely:
      • Reactions at the application site such as skin discoloration, hyperpigmentation, vasculitis
      • If you know that you are hypersensitive to adhesive patches, you should watch out for skin symptoms during the first few days of treatment. If you notice significant reddening or swelling of the skin where it was attached, you should apply the transdermal patch to a different part of the body. If the skin irritation persists, the treatment should be discontinued.
  • Musculoskeletal, connective tissue and bone diseases
    • Often:
      • Muscle pain, movement disorders
    • Occasionally:
      • Joint pain, muscle cramps (e.g. calf cramps), back pain
  • Kidney and urinary tract disorders
    • Occasionally:
      • Inflammation of the bladder (cystitis)
  • General disorders and administration site conditions
    • Very often:
      • Cold and flu-like signs of illness
    • Occasionally:
      • Loss of strength, pain, malaise, 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.

Nicotine patches Interactions

  • Use with other medicines
    • Tell your doctor or pharmacist if you are taking, have recently used, or may use any other medicines.
    • There are no known interactions between this and other medicinal products.
    • When smoking, however, there can be interactions due to a large number of other substances contained in the smoke. Smoking can accelerate the breakdown of certain drugs, so that after giving up 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, paracetamol, phenacetin, phenazone, phenylbutazone, pentazocine, lidocaine, benzodiazepines (e.g. nordazepam, oxazepam), certain drugs used to treat depression (tricyclic antidepressants, e.g. imipramine), warfarin, estrogen and vitamin B 12 .
    • Other effects of smoking are a reduction in the analgesic effectiveness of propoxyphene, a reduction in the diuretic effect of furosemide, a change in the effectiveness of propranolol and an altered response rate in the treatment of gastric and intestinal ulcers with H 2 antagonists.
    • Nicotine can increase the blood levels of cortisol and catecholamines (adrenaline and noradrenaline). It may be necessary to adjust the dose of nifedipine and substances that stimulate nerve receptors (adrenergic agonists) or block nerve receptors (adrenergic antagonists).
      • Dose reduction may be necessary after quitting smoking due to a lack of induction of liver enzymes for:
        • Tacrine, clomipramine
      • Dose reduction may be necessary after quitting smoking due to an increase in subcutaneous insulin absorption for:
        • insulin
      • Dose reductions after quitting smoking due to a decrease in circulating catecholamines may be necessary for:
        • Alpha and beta blockers such as prazosin, propranolol
      • Increasing the dose in smoking cessation due to a decrease in circulating catecholamines may be necessary for:
        • Sympathomimetics such as isoprenaline, salbutamol.

Nicotine patches 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
    • for general skin diseases
    • with unstable or worsening narrowing of the coronary arteries (angina pectoris)
    • immediately after a heart attack
    • with severe cardiac arrhythmias
    • if you have had a recent stroke
    • with vasospasm
    • if you have a tumor of the adrenal medulla (pheochromocytoma)
    • with children
    • for non-smokers and occasional smokers

Nicotine patches pregnancy and breast feeding period

  • Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant.
  • pregnancy
    • Smoking can cause serious harm to the fetus and infant and should be stopped. Pregnant smokers are advised to give up smoking without the support of drugs containing nicotine. The use of this preparation should only be considered after consulting a doctor if there is a risk of continued smoking. In this case, the risks of continued smoking (possibly higher nicotine plasma levels, harmful substances from tobacco smoke) must be weighed against the risk of nicotine substitution. The risks to the fetus from using the drug are not fully known. The benefit of smoking cessation supported by nicotine-containing drugs in pregnant smokers who cannot give up smoking without such therapy,
  • Breastfeeding
    • Nicotine passes into breast milk. When using the drug in therapeutic doses, nicotine levels in breast milk can be achieved, which have an effect on the child. 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 both female and male fertility. It is not known what specific contribution nicotine has to these effects. However, if possible, women who want to have children should neither smoke nor undergo nicotine replacement therapy.

Nicotine patches Patient information

  • Warnings and Precautions
    • Please talk to your doctor or pharmacist before using the product if:
      • stable narrowing of the coronary arteries (angina pectoris)
      • elderly heart attack
      • Cerebral vascular disease
      • Circulatory disorders in the arms or legs (e.g. "smoker's leg")
      • severely increased blood pressure
      • Heart failure
      • 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 speak 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 known seizures (ie epilepsy) may be at an increased risk of having seizures while taking the medicine.
    • Patients with a history of muscle weakness (myasthenia gravis, pseudomyasthenic syndrome) may develop their symptoms caused by the muscle weakness worsening during treatment with the preparation.
  • Children and adolescents
    • 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 drug in smokers over 65 years of age, but the effectiveness and tolerability in this age group do not seem to be problematic.

 

  • Driving and using machines
    • There are no indications of risks when driving or using machines as long as the recommended dosage is observed. Be aware, however, that giving up smoking can cause behavior changes.