NICOTINE AL 1 mg/spray spray for oral use
Nicotin AL 1 mg/spray Oromucosal spray, solution
For use in adults.
Active ingredient:
nicotine.
For the treatment of tobacco dependence in adults by relieving nicotine withdrawal symptoms, including the craving to smoke, when trying to quit smoking. Complete cessation of smoking should be the ultimate goal.
Note:
Contains ethanol (alcohol), propylene glycol, benzyl alcohol and levomenthol.
For risks and side effects, read the package insert and ask your doctor or pharmacist.
ALIUD PHARMA GmbH, PO Box 1380, 89146 Laichingen.
Status: May 2020
For relieving the symptoms of nicotine withdrawal
• Can help you quit smoking
• Can reduce the craving to smoke
• Should be used together with advice and supportive measures
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 also have at least twice the risk of 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 smoke and enters the lungs when inhaled. The nicotine is passed on to 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 feeling 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 break their addiction on their own. The first withdrawal symptoms set in within a few hours of the last cigarette. Smokers who suffer from withdrawal symptoms are at an increased risk of relapse. Nicotine replacement products can make quitting easier by releasing nicotine and greatly reducing withdrawal symptoms. This helps smokers to stick with it.
Nicotine administered in the form of nicotine replacement products such as Nicotin AL can increase the success rate of attempts to quit smoking. Significantly more smokers who used a nicotine spray managed to quit smoking than those who did not use a nicotine replacement product. 2
In comparison to nicotine gum and lozenges, the body also absorbs the nicotine more quickly via the spray. 3-4A study on the urge to smoke showed that the spray reduced the urge to smoke significantly more 1-2 minutes after use than a nicotine lozenge with four times the amount of nicotine. A maximum reduction in the urge to smoke occurred after about 10 minutes. 3-4
Help with quitting smoking
Nicotin AL can be used to treat tobacco addiction. The nicotine spray for use in the mouth acts as a nicotine receptor agonist in the peripheral and central nervous system. The sudden cessation of regular cigarette consumption is often associated with typical withdrawal symptoms and a strong desire to smoke. However, clinical studies have shown that
nicotine replacement products can help smokers to give up smoking by increasing the nicotine level in the blood and alleviating withdrawal symptoms. 1
Nicotin AL contains neither tar, carbon monoxide nor other toxins found in cigarette smoke.
RECOMMENDED USE:
Nicotin AL 1 mg/spray should be used according to a fixed schedule. Up to 4 sprays per hour are possible. Do not exceed 2 sprays per application and do not apply more than 64 sprays 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 craving to smoke. If the craving to smoke does not subside within a few minutes after one spray, a second spray should be
used. If 2 sprays are required, 2 consecutive sprays should be used on subsequent applications. Most smokers require 1 to 2 sprays every 30 to 60 minutes.
Step 2: Weeks 7 to 9
Begin to gradually reduce the number of sprays per day. By the end of week 9, only half the average number of sprays per day used in step 1 should be used.
Step 3: Weeks 10 to 12
Continue to reduce the number of sprays per day so that by week 12 no more than 4 sprays per day are needed. Once use has been reduced to 2 to 4 sprays per day, the spray should be reduced
from week 13
to remain smoke-free. The spray can be continued to be used in situations where there is a strong craving for smoking. Again, use 1 spray initially. Only use a second spray if the first spray does not help within a few minutes. From week 13 onwards, no more than 4 sprays per day should be used.
Note: It is recommended that the spray is not used regularly for longer than 6 months.
Do not use more than 2 sprays in quick succession or 4 sprays per hour for 16 hours. Over a 24-hour period, the maximum dose is 64 sprays within 16 hours.
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 also have at least twice the risk of 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 smoke and enters the lungs when inhaled. The nicotine is passed on to 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 feeling 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 break their addiction on their own. The first withdrawal symptoms set in within a few hours of the last cigarette. Smokers who suffer from withdrawal symptoms are at an increased risk of relapse. Nicotine replacement products can make quitting easier by releasing nicotine and greatly reducing withdrawal symptoms. This helps smokers to stick with it.
Nicotine administered in the form of nicotine replacement products such as Nicotin AL can increase the success rate of attempts to quit smoking. Significantly more smokers who used a nicotine spray managed to quit smoking than those who did not use a nicotine replacement product. 2
In comparison to nicotine gum and lozenges, the body also absorbs the nicotine more quickly via the spray. 3-4A study on the urge to smoke showed that the spray reduced the urge to smoke significantly more 1-2 minutes after use than a nicotine lozenge with four times the amount of nicotine. A maximum reduction in the urge to smoke occurred after about 10 minutes. 3-4
Help with quitting smoking
Nicotin AL can be used to treat tobacco addiction. The nicotine spray for use in the mouth acts as a nicotine receptor agonist in the peripheral and central nervous system. The sudden cessation of regular cigarette consumption is often associated with typical withdrawal symptoms and a strong desire to smoke. However, clinical studies have shown that
nicotine replacement products can help smokers to give up smoking by increasing the nicotine level in the blood and alleviating withdrawal symptoms. 1
Nicotin AL contains neither tar, carbon monoxide nor other toxins found in cigarette smoke.
RECOMMENDED USE:
Nicotin AL 1 mg/spray should be used according to a fixed schedule. Up to 4 sprays per hour are possible. Do not exceed 2 sprays per application and do not apply more than 64 sprays 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 craving to smoke. If the craving to smoke does not subside within a few minutes after one spray, a second spray should be
used. If 2 sprays are required, 2 consecutive sprays should be used on subsequent applications. Most smokers require 1 to 2 sprays every 30 to 60 minutes.
Step 2: Weeks 7 to 9
Begin to gradually reduce the number of sprays per day. By the end of week 9, only half the average number of sprays per day used in step 1 should be used.
Step 3: Weeks 10 to 12
Continue to reduce the number of sprays per day so that by week 12 no more than 4 sprays per day are needed. Once use has been reduced to 2 to 4 sprays per day, the spray should be reduced
from week 13
to remain smoke-free. The spray can be continued to be used in situations where there is a strong craving for smoking. Again, use 1 spray initially. Only use a second spray if the first spray does not help within a few minutes. From week 13 onwards, no more than 4 sprays per day should be used.
Note: It is recommended that the spray is not used regularly for longer than 6 months.
Do not use more than 2 sprays in quick succession or 4 sprays per hour for 16 hours. Over a 24-hour period, the maximum dose is 64 sprays within 16 hours.
Caution with chronic illnesses
Fear of withdrawal symptoms
Many smokers shy away from the possible unpleasant withdrawal symptoms during the weaning process. In fact, physical withdrawal only lasts four to six weeks. The worst withdrawal symptoms usually subside after just a few days.
Possible symptoms are: depressed mood, insomnia, irritability or restlessness. A reduced pulse, increased appetite, dizziness, coughing or bleeding gums can also occur.
Fertility, pregnancy and breastfeeding
Women who want to have children should generally neither smoke nor use nicotine replacement therapy. During pregnancy, nicotine passes to the unborn child. Therefore, a pregnant smoker should always be advised to stop smoking completely without using nicotine replacement therapy. Pregnant smokers should therefore only use nicotine replacement therapy on the recommendation of a doctor. The same applies to women who are breastfeeding. Nicotine passes quickly into breast milk and can therefore harm the child. Newborns are often smaller and can suffer permanent physical and mental damage.
Frequently asked questions
Are there any special warnings and precautions to be observed when using 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 should be taken not to spray the spray into the eyes during use.
Is an overdose with Nicotin AL 1 mg/spray possible?
Symptoms of an 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, headaches.
What should you watch out for in the event of an overdose of Nicotin AL 1 mg/spray?
In the event of an overdose, nicotine intake must be stopped immediately. 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 medicines?
Interactions with other medicines have not been identified. However, nicotine can increase the haemodynamic effects of adenosine and thereby, for example, increase blood pressure.
Sources:
1. Hartmann-Boyce Jetal. Nicotine placement therapy versus control for smoking cessation. Cochrane Database SystRev2018;5(5):CD000146
2 .Tønnesen Petal. Efficacy of an icotine mouth spray in smoking cessation: a randomized, double-blind trial. Eur RespirJ2012;40(3):548–554
3 .Hansson Aetal. Effects of nicotine mouth spray on urges to smoke, a randomized clinical trial. BMJ Open2012;2(5):e001618
4 .KraicziHetal.Single-dose pharmacokinetics of nicotine when given with an ovel mouth spray for nicotine replacement therapy. Nicotine TobRes2011;13(12):1176–1182