NICOTIN AL 1 mg/spray Spray Z.i.d.Mundhö.,pcs

Instructions for use for NICOTIN AL 1 mg/spray Spray Z.i.d.Mundhö.,pcs

Detailed instructions for NICOTIN AL 1 mg/spray Spray Z.i.d.Mundhö.,pcs

Field of use

Nicotin al 1 mg/spray spray for use in the oral cavity, solution (pack size: 2 pc) is used to support you when you give up smoking if you want to quit smoking. This is a type of treatment called nicotine replacement therapy.



Help with the smoke stop
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. The sudden cigarette consumption suddenly stopped is often associated with typical withdrawal symptoms and a violent request for smoke. However, clinical studies have shown:
Nicotine substitute preparations can help smokers give up smoking by lifting the nicotine levels in the blood and relieving the withdrawal symptoms. 1
Nicotin al contains neither tar, carbon monoxide nor other toxins in cigarette.

Beware of chronic diseases
Starting smoking is worthwhile at all times. In the case of the following diseases, a risk assessment should be carried out by the doctor:
• Cardiovascular diseases
• Diabetes mellitus
• Restricted kidney and liver functions
• Allergies (disposition to angioedema and urticaria)
• Overactive thyroid and tumor of the adrenal gland (Phäochromocythoma)
• Diseases of the gastrointestinal tract

Caution: Nicotand boxes that are tolerated by smokers can cause severe symptoms in children that can be fatal.

Fear of withdrawal symptoms
Many smokers shy away from the possible unpleasant withdrawal symptoms during weaning. In fact, physical withdrawal only takes four to six weeks. The worst withdrawal symptoms usually decrease after a few days.
Possible symptoms are: depressed mood, insomnia, irritability or restlessness. A reduced pulse, an increased appetite, dizziness, cough or bleeding gums can also occur.

Fertility, pregnancy and breastfeeding
Women with a desire to have children should basically neither smoke nor do nicotine replacement therapy. Because during pregnancy nicotine passes into the unborn child. Therefore, a pregnant smoker should always be advised to completely set smoking without the use of nicotine replacement therapy. Pregnant smokers should therefore only use nicotine substitute therapy on the recommendation of a doctor.
The same applies to women who breastfeed. Because nicotine quickly turns into breast milk and can damage the child. The newborns are often smaller and can permanently have physical and mental damage.

Source information:
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

Mode of action

Nicotin al relieve the symptoms of nicotine, including the request for smoke, i.e. H. die symptoms that occur when smoking. If you suddenly no longer give your body nicotine about smoking tobacco, you can occur unpleasant sensations that are referred to as withdrawal symptoms. By using Nicotin AL you can alleviate or prevent these unpleasant sensations and the request for smoke. This is because you continue to supply your body a small amount of nicotine over a short period of time. Nicotin AL does not contain a tar, carbon monoxide or other toxins in cigarette smoke.

In order to increase your chances of smoking cessation, you should get additional advice and support if possible.

Active ingredients / ingredients / ingredients

Nicotin al 1 mg/spray spray for application in the oral cavity, solution (pack size: 2 pcs) contains:

The active ingredient is nicotine. A spray kick releases 1 mg of nicotine in 0.07 ml solution. 1 ml solution contains 13.6 mg nicotine.

The other components are: propylene glycol, glycerol, ethanol, poloxamer 407, glycin, sodium hydrogen carbonate, levomenthol, mint aroma, liquid (contains benzyl alcohol, propylen glycol, pulegon), fresh aroma, fluid (contains menthol carboxamide, etheric oil) , Sucralose, acesulfam potassium, sodium hydroxide and cleaned water. Nicotin AL contains ethanol, sodium, propylene glycol and benzyl alcohol.

Contradictions

Nicotin al 1 mg/spray spray for use in the oral cavity, solution (pack size: 2 pcs) should not be used in the case of hypersensitivity in one of the ingredients it contains.

Nicotin al must not be used
•If you are allergic to nicotine, benzyl alcohol or one of the other components of this medicine mentioned in the section "active ingredients" section,
•If you are under 18,
•If you have never smoked.

dosage

Nicotin al 1 mg/spray spray should be used according to a fixed scheme. Up to 4 sprays per hour are possible. 2 sprays should not be exceeded per application and should not be applied within 24 hours more than 64 sprays (4 sprays per hour over 16 hours).

Step 1: weeks 1 to 6
1 or 2 sprays when usually smoking or you have a smoking request. If the desire to smoke after a spray, a second spray should be used within a few minutes.
If 2 sprays are required, successive sprays should be used in the following applications. Most smokers need 1 to 2 sprays every 30 to 60 minutes.

Step 2: weeks 7 to 9
Start with the gradual reduction in sprays per day. At the end of week 9, only half of the number of sprays per day used in step 1 should be used.

Step 3: weeks 10 to 12
The number of sprays a day further reduce, so that no more than 4 sprays per day are required in the 12th week. As soon as the application has reduced to 2 to 4 sprays per day, the spray should be stopped.

From week 13
In order to remain smoke -free, the spray can be used in situations with heavy request for smoke. The following also 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 no more than 4 sprays per day should be used.

Note: It is recommended not to apply the spray regularly for more than 6 months. Do not apply more than 2 sprays directly in a row or 4 sprays per hour over 16 hours. Over a period of 24 hours, the maximum dose is 64 sprays within 16 hours.

Taking

• The overview in the package insert shows the recommended step by step when using this preparation.
• Application of the donor
  • Place the spray nozzle on your open mouth and hold You her on your mouth as densely as possible.
  • Press firmly on the top of the donor to release a spray in your mouth. Avoid wetting your lips. So that no spray gets into your throat, you should not breathe in during the spray. You will achieve the best results if you don't swallow for a few seconds after spraying.
• Close the donor after each application to prevent the use of the donor by children and accidental sprays.
• Make sure not to spray anything in the eyes while using the spray. If Spray gets in the eye, you have to flush your eyes thoroughly with water.
• For more information, see package insert.

Patient information

Warnings and Precautions

Please speak to your doctor before using this medicine if you suffer from one of the following diseases. You may be able to use Nicotin AL, but must first consult with your doctor,

If you have recently suffered a heart attack or a stroke (within the last 3 months),
If you have pain in the chest (unstable angina pectoris) or angina pectoris at rest,
If you have a heart disease that affects the speed of your heartbeat or heart rhythm,
If you suffer from high blood pressure that is not sufficiently set by medicines,
If you ever had allergic reactions with swelling of lips, face and throat (angioedema) or itchy rash (urticaria). The use of nicotine substitutes can sometimes trigger such reactions.
If you have a severe or moderate liver disease,
If you suffer from severe kidney disease,
If you have diabetes (diabetes),
If you have a thyroid overactive,
If you have a tumor of the adrenal glands (Phäochromocytoma),
If you have a stomach or duodenum ulcer,
if you suffer from inflammation of the esophagus (esophagitis).

Nicotin al must not be used by non -smokers.
Do not give this medicine to children or adolescents.

Wateriness and ability to operate machines

No effects on the traffic and operating machines have been observed.

Pregnancy

It is very important to stop smoking during pregnancy, as smoking can lead to poor growth of your baby and also to a premature birth or stillbirth. It is best if you can give up smoking without using nicotine-containing medicines. If you do not succeed, Nicotin Al should only be used after consulting the medical staff who accompanies your pregnancy, with your family doctor or with a doctor in a center that specializes in helping people to give up smoking.

Breastfeeding
The use of Nicotin AL should be avoided during breastfeeding because nicotine is found in breast milk and can affect your child. If your doctor has recommended the application of Nicotin Al, you should apply the spray immediately after breastfeeding and not in the last 2 hours before breastfeeding.

Fertility
Smoking increases the risk of infertility in women and men. It is not known what effects nicotine has on fertility.

Hints

Keep this drug for children inaccessible.

Nicotin al 1 mg/spray spray for application in the oral cavity, solution. For use in adults. Active ingredient: Nicotin. Nicotin Al is used to support them when they quit smoking if they want to stop smoking. This is a type of treatment that is referred to as a nicotine replacement therapy. Nicotin al relieve the symptoms of nicotine, including the request for smoke, i.e. the symptoms that occur when smoking. If you suddenly no longer give your body about smoking tobacco, you can occur unpleasant emptying that as a withdrawal symptomen are called. By using nicotine al, you can alleviate or prevent these unpleasant emptying and the request for smoke. This is because you will continue to supply your body a small amount of Nicotin over a short period of time. Nicotin AL does not contain a tar, carbon monoxide or others in cigarette smoke. In order to increase your chances of smoking cessation, you should get additional advice and support if possible. Note: Contains ethanol (alcohol), propylene glycol, benzyl alcohol and levomenthol. Read the package supplement and ask your doctor or pharmacist for risks and side effects. ALIUD PHARMA® GmbH, Postfach 1380, 89146 Laichingen. As of April 2020.