What is Nicorette Spray and when is it used?

Nicorette Spray is recommended as a support when trying to quit smoking. This medicinal product is an oromucosal spray containing nicotine, from which nicotine is released and absorbed through the mucous membranes. Nicotine is the addictive component in tobacco and is responsible for the various withdrawal symptoms that occur when smoking cessation. The controlled administration of nicotine with Nicorette Spray reduces these withdrawal symptoms and makes it easier for smokers to give up cigarette nicotine. Treatment beyond 3 months is not recommended.

If you have acquired new habits (substitute actions for smoking) after a while, experience has shown that you may find it easier to gradually reduce the amount of nicotine in the Nicorette Spray and later to give up entirely. Damage to health caused by the tar and carbon monoxide content in tobacco smoke is avoided.

What should be considered?

Your motivation and willpower are decisive for the success of the treatment.

If you use Nicorette Spray as part of a cessation cure, you should stop smoking completely, as continuing to smoke unabated carries the risk of side effects, including for the heart and circulatory system, due to higher nicotine levels than with normal smoking.

It is therefore important that you are strongly motivated to quit smoking before starting Nicorette treatment. Professional smoking advice increases the chances of quitting successfully.

This medicine contains a small amount of alcohol, less than 100 mg per actuation.

The spray must not be inhaled.

When must Nicorette Spray not be used?

Nicorette Spray must not be used by non-smokers and children under the age of 12. Adolescents under the age of 18 and over 12 years of age may only use the drug if they are heavily dependent on nicotine and only if prescribed by a doctor. Nicorette Spray must not be used if there is a known hypersensitivity to nicotine or other ingredients in the spray.

When should you be careful when using Nicorette Spray?

If you suffer from any medical condition, have chronic throat conditions or have any of the following conditions, you should you carefully discuss the benefits and risks with your doctor before starting the treatment program with Nicorette Spray:

Kidney and liver disease, inflammation of the esophagus, stomach and intestinal ulcers, hyperthyroidism, pheochromocytoma (adrenaline-producing tumor of the adrenal gland), diabetes.

Smoking addicts immediately (less than four weeks) after a heart attack, with unstable or worsening angina pectoris, severe cardiac arrhythmia, uncontrolled high blood pressure or recent stroke should only use Nicorette Spray under medical supervision. In these cases, the use of the preparation should only be considered if smoking cessation is not possible without the support of medication. If new cardiovascular symptoms develop or existing symptoms worsen (chest pain, irregular pulse, shortness of breath), a doctor should be consulted.

This medicine can impair your ability to react, the ability to drive and the ability to use tools or machines!

Tell your doctor, pharmacist or druggist if you have

• suffer from other illnesses,
• have allergies or
• take other medicines (including those you bought yourself!)!

Stop smoking with or without Nicorette Spray may change the response to concomitant medicines for asthma, cardiac arrhythmia, severe pain, mood disorders, Alzheimer's disease, Parkinson's disease, restless leg syndrome or diabetes (insulin). If necessary, your doctor will prescribe a dose adjustment of the medicines concerned.

Can Nicorette Spray be used during pregnancy or breastfeeding?

Smoking cessation is the single most effective measure to improve the health of the pregnant smoker and the baby. The sooner you give up nicotine, the better.

No form of nicotine should be used during pregnancy, either through cigarettes or as part of a cessation therapy. Nicotine, and especially smoking, can seriously endanger the health of the fetus and child and should be discontinued during pregnancy. Pregnant women who smoke should only use Nicorette Spray after consulting a doctor, pharmacist or druggist.

Since nicotine gets into breast milk and can affect your child, you should not use Nicorette Spray while breastfeeding. You should not ingest/use any form of nicotine while breastfeeding. If smoking cessation is not achieved, Nicorette Spray should only be used in breast-feeding smokers after consulting a doctor, pharmacist or druggist. Should nicotine substitution be necessary during breastfeeding, Nicorette Spray should be used immediately after breastfeeding and as much time as possible should be allowed before the next breastfeeding (at least 2 hours).

How do you use Nicorette Spray?

Young people under the age of 18 may only use Nicorette Spray if prescribed by a doctor. Children under the age of 12 should not use the spray.

You should stop smoking completely while you are being treated with Nicorette Spray.

Nicorette Spray should be used according to the following schedule:

Step I (Weeks 1 to 6)

Apply 1 or 2 sprays orally if you would normally smoke a cigarette or have a craving. Do not inhale during the spraying process to avoid spray mist getting into the respiratory tract. You should use one spray at first; if your craving to smoke has not subsided within a few minutes, a second puff should be used. If 2 sprays are required, subsequent applications should be administered 2 consecutive sprays. Most smokers need 1 or 2 puffs every 30 to 60 minutes.

For example, if you smoke an average of 15 cigarettes per day, you should use 1 or 2 sprays at least 15 times throughout the day.

The maximum dose is 2 sprays per application, 4 sprays per hour and 64 sprays per day.

Step II (weeks 7 to 9)

In week 7, start reducing the number of sprays per day. By the end of week 9 you should only be using HALF as many sprays as you used on average in Step I.

Step III (Weeks 10 to 12)

Reduce the number of sprays per day further so that by week 12 you are using no more than 4 sprays per day. As soon as you have reduced the number to 2 to 4 sprays per day, you should stop using Nicorette Spray.

After stopping treatment, you may be tempted to smoke again. You should therefore save the rest of the spray as the craving to smoke can come on suddenly. Use one puff when you feel like smoking. If you do not feel any relief within a few minutes with one spray, you can use a second spray. In this phase you should not use more than 4 sprays per day.

Treatment with Nicorette Spray should not last longer than 3 months. Contact your doctor or pharmacist if you need Nicorette Spray for longer than 3 months.

The spray is applied as follows:

Open the dispenser

• Use your thumb to move the slider down (a) until you can easily push it in (b). Do not press too hard.
• Hold the slider in and move it up (c) to release the spray head. Then release the slider.

Activating the dispenser

When using the spray for the first time, you must first activate the spray pump. Hold the dispenser so the spray nozzle is pointing away from you, other adults, children, or nearby pets. Press the spray head 3 times with your index finger until a fine mist comes out. If you do not use the spray for more than 2 days, this activation process must be repeated.

Application of the dispenser

• Aim the spray nozzle at your open mouth and hold it as close to your mouth as possible.
• Squeeze the spray head to deliver a puff into your mouth without pinching to spray the lips. Do not inhale during the spraying process to prevent the spray from entering the respiratory tract. For best results, do not swallow for a few seconds after spraying.

Closing the dispenser

• Move the slider down (d) until it can be pushed in slightly (e).
• Hold the slider and move the spray head down (f) . Release the slider. The dispenser is now sealed.

If you need a second spray, repeat the above steps.

Close the dispenser after each use to prevent children from using the spray or accidentally releasing puffs.

When using the spray, be careful not to spray into the eyes. If the spray mist does get into your eyes, rinse them thoroughly with water. Do not breathe spray mist.

Stick to the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Nicorette Spray have?

Nicorette Spray can cause the same side effects as other forms of nicotine. These are generally dose dependent.

Some of the undesirable effects of quitting smoking can be withdrawal symptoms due to reduced nicotine intake. These include irritability, aggression, impatience, frustration, anxiety, restlessness, difficulty concentrating, trouble sleeping, increased appetite, weight gain, constipation, depression, craving to smoke, slow heart rate, bleeding gums, dizziness, lightheadedness, cough, sore throat, mouth ulcers, stuffy or runny nose. If you stop smoking, canker sores can also develop. The reason for this is not known.

Very common (affects more than 1 in 10 people)

Headache, taste disturbances, hiccups, cough, irritation in the throat, nausea, indigestion, pain or abnormal sensations in the mouth, Inflammation of the lining of the mouth, increased salivation, burning sensation on the lips and dry mouth and/or throat.

Common (affects 1 to 10 users in 100)

Hypersensitivity reactions, numbness, vomiting, intestinal gas, abdominal pain, diarrhea, tightness in the throat, tiredness, pain and chest discomfort .

Uncommon (affects 1 to 10 users in 1000)

abnormal dreaming, increased tearing, heavy/rapid heartbeat, flushing, high blood pressure, difficulty breathing, runny nose, sneezing, congestion nose, pain in the mouth, inflammation of the tongue, belching, increased sweating, itching, rash, hives, weakness, feeling unwell, peeling of the lining of the mouth and voice changes.

Rare (affects 1 to 10 users in 10,000)

Difficulty swallowing, nausea, reduced sensitivity in the mouth.

Individual cases

blurred vision, allergic reactions, blurred vision, dry throat, gastrointestinal discomfort, lip pain, swelling of the face/throat and skin redness.

Persistent nicotine addiction can occur.

If you get any side effects, talk to your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

Overdose

An overdose can occur if you take other forms of nicotine at the same time as Nicorette Spray (e.g. if you continue to smoke cigarettes). In the event of an overdose, the signs correspond to those of acute nicotine poisoning. The following occur: nausea, vomiting, salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disorders and pronounced weakness. In this case, the nicotine supply must be stopped immediately.

If you suspect nicotine poisoning in a child, or if a child has taken Nicorette Spray, or if you have used more Nicorette Spray than recommended, contact your doctor or go to the nearest hospital straight away. Doses that are well tolerated by adult smokers can cause severe and possibly life-threatening symptoms of intoxication in children.

What else needs to be considered?

Special warning for children: Nicotine is a highly effective substance. Even in a dosage that is tolerable for adults during treatment with Nicorette Spray, nicotine can lead to life-threatening symptoms of poisoning in children. Nicorette Spray must therefore be kept out of the reach of children and disposed of at all times.

The medicinal product may only be used up to the date marked «EXP» on the container.

Store Nicorette Spray at room temperature (15-25°C) and out of the reach of children.

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What does Nicorette Spray contain?

Nicorette Mint Spray

1 spray contains 1 mg nicotine and the following additives : Propylene Glycol (E 1520), Anhydrous Ethanol, Trometamol, Poloxamer 407, Glycerol, Sodium Bicarbonate, Levomenthol, Mint Flavor, Fresh Flavor, Sucralose, Acesulfame Potassium, Hydrochloric Acid (for pH adjustment), Purified Water.

Nicorette Fruit & Mint Spray

1 spray contains 1 mg nicotine and the following excipients: propylene glycol (E 1520), anhydrous ethanol, trometamol, poloxamer 407, glycerol, sodium bicarbonate, Levomenthol, Red Fruit Flavor, Fresh Flavor, Sucralose, Acesulfame Potassium, Hydrochloric Acid (to adjust pH), Purified Water.

Approval number

62566 (Swissmedic).

Where can you get Nicorette Spray? What packs are available?

Nicorette Mint Spray and Nicorette Fruit & Mint Spray are available in pharmacies and drugstores without a doctor's prescription.

Packs of 1 dispenser of 150 aerosols and packs of
2 dispensers of 150 aerosols are available.

Authorization holder

Janssen-Cilag AG, Zug, ZG.

This leaflet was last checked by the medicines authority (Swissmedic) in October 2019.