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NICOTINE (NICOTIN) AL 1 mg / spray for application in mouth 2 pc

ALIUD Pharma GmbH

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Nicotine AL 1 mg / spray spray for use in the oral cavity, solution
For use in adults.

Active ingredient: nicotine.

Nicotine AL is used to help you quit smoking when you want to quit smoking. This is a type of treatment known as nicotine replacement therapy. Nicotin AL alleviates nicotine withdrawal symptoms including the desire to smoke, ie the discomfort that occurs when smoking is stopped. If you suddenly stop adding nicotine to your body through smoking tobacco, you may experience unpleasant sensations called withdrawal symptoms. By using Nicotin AL, you can alleviate these unpleasant sensations and the desire to smoke or prevent them altogether. This is because you keep adding a small amount of nicotine to your body for a short period of time. Nicotin AL does not contain tar, Carbon monoxide or other toxins found in cigarette smoke. If possible, you should seek additional advice and support to increase your chances of quitting smoking.

Note: Contains ethanol (alcohol), propylene glycol, benzyl alcohol and levomenthol.

NICOTINE (NICOTIN) AL For information on risks and side effects, read the package insert and ask your doctor or pharmacist.
ALIUD PHARMA ® GmbH, Postfach 1380, 89146 Laichingen
Status: April 2021

Nicotin AL 1 mg / spray NICOTINE (NICOTIN) AL

To relieve the symptoms of nicotine withdrawal • Can help to quit smoking • Can reduce the desire to smoke • Should be accompanied by a consultation and supportive measures are used to help people quit smoking

NICOTINE (NICOTIN) AL can be used to treat tobacco addiction. The nicotine spray for use in the oral cavity acts as a nicotine receptor agonist in the peripheral and central nervous system. Suddenly stopping regular cigarette consumption is often associated with typical withdrawal symptoms and an intense desire to smoke. However, clinical studies have shown that nicotine substitutes can help smokers quit smoking by raising nicotine levels in the blood and relieving withdrawal symptoms.1 Nicotine does not contain tar, carbon monoxide, or any other toxins found in cigarette smoke.

NICOTINE (NICOTIN) AL Support for future non-smokers

Smoking causes considerable damage to almost all organs, especially the lungs and heart. Up to 90 percent of all lung cancer cases are caused by the consumption of tobacco products. Smokers are also at least twice as likely to develop cardiovascular disease and stroke as non-smokers. The risk of dementia and various mental illnesses is also significantly higher.

How does nicotine work? It binds to the tar particles in the smoke and gets into the lungs when you inhale. The nicotine is passed on into the blood via the mucous membranes of the respiratory tract and reaches the brain in a few seconds. There it influences the activity of certain nerve cells. As a result, certain messenger substances are released that have a stimulating effect, trigger a sense of well-being, increase blood pressure or accelerate the pulse.

Many smokers want to quit because of the serious consequences for their health, but cannot get rid of their addiction on their own. Because within a few hours after the last cigarette, the first withdrawal symptoms set in. Smokers who suffer from withdrawal symptoms are more likely to relapse. Nicotine replacement preparations can make it easier to quit by releasing nicotine and greatly reducing the symptoms of withdrawal. This helps smokers persevere.

Supplied nicotine in the form of nicotine replacement preparations such as Nicotin AL, can increase the success rate when trying to quit smoking. Significantly more smokers who used a nicotine spray managed to quit smoking than those who did not use nicotine substitutes

Compared to nicotine chewing gum and lozenges, the body also absorbs nicotine faster when using a spray.3, 4 A study on smoking cravings showed that administration as a spray reduced smoking cravings significantly more than 1-2 minutes after use Nicotine lozenge with four times the amount of nicotine. A maximum reduction in the desire to smoke occurred after about 10 minutes. 3, 4

NICOTINE (NICOTIN) AL RECOMMENDATION FOR USE:
Nicotin AL 1 mg / spray should be used according to a fixed schedule. Up to 4 sprays per hour are possible. Per application, 2 sprays should not be exceeded and no more than 64 sprays should be applied within 24 hours (4 sprays per hour over 16 hours).

Step 1: weeks 1 to 6
1 or 2 sprays if you have smoked habitually or if you have a desire to smoke. If the desire to smoke does not subside within a few minutes after a puff, a second puff should be used.

If 2 sprays are required, 2 consecutive sprays should be used for the following applications. Most smokers need 1 to 2 sprays every 30 to 60 minutes. Step 2: Weeks 7 through 9

Begin gradually reducing the number of puffs each day. At the end of week 9, only half of the average number of puffs used in step 1 should be used per day. Step 3: weeks 10 to 12

Reduce the number of sprays per day further so that by the 12th week no more than 4 sprays per day are required. As soon as the application has reduced to 2 to 4 sprays per day, the spray should be discontinued.

From week 13
In order to remain smoke-free, the spray can continue to be used in situations with a strong desire to smoke. The same applies here: First use 1 spray. A second spray only if the first spray does not help within a few minutes. From the 13th week onwards, no more than 4 sprays per day should be used.

Note: It is recommended not to use the spray regularly for more than 6 months.
Do not use more than 2 sprays in a row or 4 sprays per hour over 16 hours. The maximum dose over a 24-hour period is 64 puffs in a 16-hour period. Be careful with chronic illnesses Quitting smoking is always worthwhile. The doctor should carry out a risk-benefit assessment for the following diseases: • Cardiovascular diseases • Diabetes mellitus • Impaired kidney and liver functions • Allergies (susceptibility to angioedema and urticaria) • Hyperthyroidism and adrenal gland tumor (pheochromocytoma) • Diseases of the gastrointestinal tract

Caution: Nicotine doses that are tolerated by smokers can cause severe symptoms of poisoning in children, which can be fatal.

NICOTINE (NICOTIN) AL Fear of withdrawal symptoms Many smokers shy away from the possible unpleasant withdrawal symptoms during weaning. In fact, physical withdrawal only lasts four to six weeks. The worst withdrawal symptoms usually subside after a few days. Possible symptoms are: depressed mood, insomnia, irritability or restlessness. A decreased pulse, increased appetite, dizziness, cough or bleeding gums can also occur. Fertility, pregnancy and lactation

NICOTINE (NICOTIN) AL Women who want to have children should not smoke or take nicotine replacement therapy. This is because nicotine passes into the unborn child during pregnancy. Therefore, a pregnant smoker should always be advised to quit smoking completely without using nicotine replacement therapy. Pregnant smokers should therefore only use nicotine replacement therapy on the recommendation of a doctor.

The same goes for women who breastfeed. Nicotine passes quickly into breast milk and can thus harm the child. The newborns are often smaller and can have permanent physical and mental damage.

NICOTINE (NICOTIN) AL Frequently asked questions and answers

Are special warnings and precautionary measures to be observed when using NICOTINE (NICOTIN) AL 1 mg / spray spray?
Smoking should be stopped completely during treatment. The medicine must not be used by non-smokers, children and adolescents under 18 years of age. And care must be taken not to spray the spray in the eyes while using it.

Is it possible to overdose with NICOTINE (NICOTIN) AL 1 mg / spray spray?
Symptoms of overdose may occur in patients who have previously consumed little nicotine or who also smoke while using Nicotin AL. Symptoms include nausea, vomiting, diarrhea, sweating, headache.

What should be considered in the event of an overdose of Nicotin AL 1 mg / spray spray?
The nicotine supply must be stopped immediately in the event of an overdose. You must also contact your doctor immediately or go to the emergency department of the nearest hospital. Nicotine doses that are tolerated by adult smokers can cause severe symptoms of poisoning in children, which can be fatal.

Are there any known interactions with other drugs?
No interactions with other drugs have been observed. However, nicotine can increase the hemodynamic effects of adenosine and thereby e.g. B. increase blood pressure.

References:
1. Hartmann-Boyce J et al. Nicotine replacement therapy versus control for smoking cessation. Cochrane Database Syst Rev 2018; 5 (5): CD000146
2. Tønnesen P et al. Efficacy of a nicotine mouth spray in smoking cessation: a randomized, double-blind trial. Eur Respir J 2012; 40 (3): 548-554
3. Hansson A et al. Effects of nicotine mouth spray on urges to smoke, a randomized clinical trial. BMJ Open 2012; 2 (5): e001618
4. Kraiczi H et al. Single-dose pharmacokinetics of nicotine when given with a novel mouth spray for nicotine replacement therapy. Nicotine Tob Res 2011; 13 (12): 1176-1182