10 mg inhalation vapor, liquid
Nicotine
What Nicorette is and what it is used for
Nicorette belongs to a group of medicines that are used to help you quit smoking.
The nicotine in Nicorette relieves nicotine cravings and withdrawal symptoms when you quit smoking, thereby preventing relapse into smoking in smokers who are motivated to quit or facilitating a smoking reduction in smokers who can not or are unwilling to quit smoking.
When the body is suddenly no longer supplied with nicotine from tobacco, various discomforts called withdrawal symptoms occur. Using the Nicorette Inhaler can prevent or alleviate such discomfort and cravings by continuing to supply your body with a small amount of nicotine for a transitional period.
Nicorette Inhaler consists of a plug that contains nicotine and flavoring. The nicotine plug is inserted into a nozzle before use. Nicotine evaporates and is absorbed through the oral mucosa when air is drawn through the Nicorette Inhaler. Unlike cigarettes, the Nicorette Inhaler does not contain harmful tar or carbon monoxide.
Nicorette Inhaler should preferably be used in conjunction with a smoking cessation program.
Advice and support usually increase the chance of success with your smoking cessation.
What you need to know before using Nicorette
Do not use Nicorette
- if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).
- if you are under 12 years of age
- if you have never smoked
Warnings and cautions
Talk to your doctor, pharmacist, or nurse if you have any of the following conditions:
- recently (within 3 months) have had a heart attack or stroke
- chest pain ( unstable angina ) or angina at rest
- heart disease that affects the heart rate or heart rate
- high blood pressure that is not treated with drugs
- severe or moderate liver disease
- severe kidney disease
- diabetes
- overactive thyroid gland
- adrenal tumor ( pheochromocytoma ) _
- gastric ulcer or ulcer of the duodenum a
- chronic throat disease or disease that causes respiratory cramps
- inflammation of the esophagus
However, the risk of continued smoking always poses a greater danger than the use of Nicorette.
Children and young people
Young people between the ages of 12 and 17 should only use Nicorette on the advice of a healthcare professional.
Nicorette should not be used by children under 12 years of age.
The nicotine plug contains enough nicotine even after use to be able to poison a child and must therefore be kept out of the reach of children.
Other drugs and Nicorette
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, or might take other medicines. This is especially important if you are taking medicines that contain:
- theophylline to treat asthma
- tacrine for Alzheimer’s disease
- clozapine for schizophrenia
- ropinirole to treat Parkinson’s disease
Use of Nicorette with food and drink
You should not eat or drink while using the inhaler. Beverages that lower the pH in the oral cavity, e.g. coffee, juices, and soft drinks can reduce the uptake of nicotine into the oral cavity. These drinks should be avoided 15 minutes before using the inhaler.
Pregnancy, breastfeeding and fertility
It is very important to stop smoking during pregnancy because smoking can impair fetal growth. Smoking can also cause the baby to be born prematurely or lead to miscarriage. It is best if you can stop smoking without using nicotine-containing medicines. If you are unable to do this, use Nicorette only after consulting your healthcare provider, your doctor, or a doctor who specializes in smoking cessation.
Nicorette should be avoided during breastfeeding as nicotine passes into breast milk and may affect your baby. If your healthcare professional has recommended that you use Nicorette, use the inhaler immediately after breastfeeding.
Smoking increases the risk of infertility in women and men. The effects of nicotine on fertility are unknown.
Driving and using machines
No effects on the ability to drive or use machines have been observed.
How to use Nicorette
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Nicorette Inhaler can be used alone or in combination with Nicorette transdermal patches.
Treatment with Nicorette Inhaler only
You can puff on the Nicorette Inhaler in the same way you do with a cigarette. The amount of nicotine you get from a puff on the Nicorette Inhaler is much less than what you get from a cigarette. You should therefore use the Nicorette Inhaler more intensively than when smoking to control your desire to smoke. It is therefore recommended that you use the Nicorette Inhaler at each use (which can be about 10-20 minutes)with about 8-10 times more puffs than a cigarette. The user can always be terminated when the effect on the smoke extraction has been achieved. Each nicotine plug replaces about 3-4 cigarettes. You should use 6-12 nicotine plugs per day to achieve the best results. Fewer than 6 nicotine plugs can result in you not being able to control your desire to smoke. To maximize the chances of success, it is important not to underdose. An opened nicotine plug should be used within 48 hours.
A maximum of 12 nicotine plugs per day should be used.
The amount of nicotine you get from Nicorette Inhaler is temperature-dependent. In cold weather, you need to use the Nicorette Inhaler for longer periods to get the same effect.
Smoking cessation
The treatment time must be long enough, normally the treatment should last for three months. Thereafter, the nicotine dose is gradually reduced. Treatment should be stopped when dose one has been reduced to 1 nicotine plug per day. A treatment period longer than 12 months is not recommended.
In some cases, longer treatment times may be necessary to avoid a relapse into smoking.
Smoke reduction
Nicorette Inhaler is used between smoking periods to prolong smoke-free intervals and to reduce smoking as much as possible. If a reduction in the number of cigarettes per day has not been achieved after 6 weeks, professional help should be sought. Attempts to quit smoking should be made as soon as you feel ready, but no later than 6 months after starting treatment. If it is not possible to make a serious attempt to quit smoking within 9 months after starting treatment, seek professional help (eg “Stop-smoking line”
tel no. 020-84 00 00). A treatment period longer than 12 months is not recommended. In some cases, longer treatment times may be necessary to avoid a relapse into smoking.
Treatment with Nicorette Inhaler in combination with Nicorette transdermal patch
If you have a high nicotine dependence, the experience that nicotine cravings occur despite the use of nicotine drugs or if you have failed treatment with a nicotine drug alone, you can use Nicorette transdermal patches with the Nicorette Inhaler for quick relief of nicotine cravings.
NOTE! Read the package leaflet for Nicorette transdermal patches (included in that pack) before use.
Initial combination treatment
A 25 mg / 16-hour transdermal patch is applied in the morning and removed at bedtime for 8 weeks.
Use the Nicorette Inhaler with the patch as follows:
Use the inhaler when you feel a puff of smoke even though you are using Nicorette patches. The usual dose is 4-5 nicotine plugs per day, however, a maximum of 12 nicotine plugs per day.
After 8 weeks, gradually reduce the nicotine dose according to one of the following two options:
Weaning from nicotine replacement therapy – option 1
After the first 8 weeks, use patches with lower strength:
1 patch 15 mg / 16 hours daily for 2 weeks followed by 1 patch 10 mg / 16 hours daily for another 2 weeks.
Use as many nicotine plugs at the same time as during the initial treatment.
Then gradually reduce the number of nicotine plugs. Do not use the inhaler for more than 12 months from the start of treatment.
Weaning from Nicotine Drugs – Option 2
Discontinue the use of patches after the first 8 weeks. Then gradually reduce the number of nicotine plugs. Do not use the inhaler for more than 12 months from the start of treatment.
The course of the combination treatment in tabular form
| Initial treatment | ||
| Period | Band-Aid | Inhaler 10 mg |
| Week 1-8 | 1 patch 25 mg / 16 hours daily | If necessary. The usual dose is 4-5 nicotine plugs per day (max 12) |
| Weaning from nicotine replacement therapy – option 1 | ||
| Week 9-10 | 1 patch 15 mg / 16 hours daily | Continue to use the inhaler if necessary |
| Week 11-12 | 1 patch 10 mg / 16 hours daily | Continue to use the inhaler if necessary |
| Up to 12 months | — | Gradually reduce nicotine plugs |
| Weaning from Nicotine Drugs – Option 2 | ||
| Up to 12 months | — | Continue to reduce the number of nicotine plugs gradually |
Instructions for use
Remove the nozzle and blister pack from the carton.
Divide the nozzle into two parts by placing the markings opposite each other and pulling them apart (Fig. 1).
Picture 1
Detach the protective foil from the blister pack and remove a nicotine plug. Insert the nicotine plug into the nozzle (Fig. 2).
Picture 2
It does not matter in which direction you insert the nicotine plug into the nozzle. Assemble the nozzle by again putting the markings in the middle of each other.
The seal at both ends of the nicotine plug breaks when you press the nozzle together (Fig. 3).
Picture 3
Turn the two nozzle parts sideways in each direction so that the markings are not opposite each other.
Thus, the nozzle is sealed (Fig. 4).
Picture 4
Your Nicorette Inhaler is now ready to start using. The nicotine decreases in strength when the pipe seal has been broken. Therefore, use it relatively immediately. Opened nicotine plugs should be used within 48 hours.
Remove the nicotine plug from the mouthpiece after use and dispose of it according to the current instructions for the unused product (see section 5).
If you use more Nicorette inhaler than you should
You may ingest too much nicotine if you smoke while using the Nicorette Inhaler or if you take several doses in quick succession.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Nicotine doses tolerated by adult smokers during treatment can cause severe poisoning symptoms in children and can be fatal.
Symptoms of overdose include nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing loss and pronounced feeling of weakness. At high doses, these symptoms may be followed by low blood pressure, weak and irregular heartbeat, difficulty breathing, extreme fatigue, circulatory collapse, and generalized seizures.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Symptoms associated with quitting smoking (withdrawal symptoms)
Some of the side effects you experience when you quit smoking can be withdrawal symptoms, which occur due to reduced nicotine intake.
These symptoms include:
- Irritation, aggression, impatience or frustration
- Anxiety, restlessness or difficulty concentrating
- Waking up at night or sleep disturbances
- Increased appetite or weight gain
- Depression
- Smoke extraction
- Decreased heart rate
- Bleeding gums or sores in the mouth
- Dizziness or fainting
- Cough, sore throat, stuffy or runny nose
- Constipation
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nicorette can cause the same side effects as nicotine given in other ways. The side effects generally depend on the dose you take.
Irritation of the mouth and throat can be experienced, but most users adapt to this with continuous use.
If you notice that you have any of the following serious and rare side effects, stop taking Nicorette Inhaler and contact your doctor immediately. Symptoms of angioedema (may affect up to 1 in 1,000 people):
- swelling of the face, tongue or throat
- difficult to swallow
- hives, rash and difficulty breathing
Very common side effects ( may affect more than 1 user in 10):
- Headache
- Cough, throat irritation
- Hiccups, nausea
Common side effects ( may affect up to 1 in 10 people):
- Local effects such as burning sensation, inflammation in the mouth, altered taste experience
- Dry mouth or increased salivation
- Stomach upset or stomach pain
- Vomiting, flatulence or diarrhea
- Fatigue
- Hypersensitivity ( allergy )
- Stinging sensation
Uncommon side effects ( may affect up to 1 in 100 people):
- Nasal congestion, sneezing
- Breathing with wheezing ( bronchospasm ), difficulty breathing ( dyspnoea ), feeling of tightness in the throat
- Redness of the skin (swelling), increased sweating
- Tingling in the mouth, inflammation of the tongue, damage to the oral mucosa, voice changes, pain in the mouth and throat, belching
- Palpitations (a deviant experience of your heartbeat), increased heart rate, high blood pressure
- Skin rash (including hives ) and / or itching
- Abnormal dreams
- Discomfort and pain in the chest
- Feeling weak, feeling sick
Rare side effects ( may affect up to 1 in 1,000 people):
- Difficulty swallowing, decreased sensitivity in the mouth, ulcers
- Nausea
- Abnormal heart rhythm ( atrial fibrillation )
Adverse reactions with an unknown frequency (frequency can not be estimated from the available data):
- Blurred vision, increased tear production (tear flow)
- Dryness in the throat, discomfort in the stomach, pain in the lips
- Reddening of the skin
- Allergic reaction with swelling of the face and mouth ( angioedema or anaphylaxis )
How to store Nicorette
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is nicotine. A nicotine plug contains nicotine 10 mg (4 mg released)
- The other ingredients are levomentol and porous plug of polyethylene.
What the medicine looks like and contents of the pack
The nicotine plug is sealed with aluminum foil at both ends. The nicotine plug is inserted into a nozzle before use, breaking the seal.
18 nicotine plugs + nozzle
42 nicotine plugs + nozzle
Not all pack sizes may be marketed.
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