Nicorette - Nicotine uses, dose and side effects

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 suddenly no longer supplies nicotine from tobacco, various discomforts called withdrawal symptoms to occur. Using Nicorette chewing gum can prevent or alleviate such discomfort and cravings by continuing to supply your body with a small amount of nicotine for a transitional period.

When you chew Nicorette, the nicotine is slowly released and absorbed into the oral cavity. Unlike cigarettes, Nicorette does not contain harmful tar and carbon monoxide.

Nicorette chewing gum should preferably be used in conjunction with a smoking cessation program.

Advice and support usually increase the chance of succeeding with your smoking cessation.

What you need to know before you take Nicorette

Do not take 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 medial tumor ( pheochromocytoma )
gastric ulcer or ulcers of the duodenum
inflammation of the esophagus

However, the risk of continued smoking always poses a greater danger than the use of Nicorette.

The chewing gum can get stuck in dentures and dental bridges and in some cases cause damage to them.

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 chewing gum should not be used by children under 12 years of age.

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 medical chewing gum with food and drink

You should not eat or drink with chewing gum in your mouth. Concomitant use of coffee, juices, or soft drinks can reduce nicotine uptake. These drinks should be avoided 15 minutes before using the chewing gum.

Pregnancy, breastfeeding and fertility

It is very important to stop smoking during pregnancy as 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 your doctor who specializes in smoking cessation.

Nicorette chewing gum 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, the chewing gum should be taken 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.

Nicorette contains 2 mg and 4 mg

sorbitol (2 mg: 190 mg / chewing gum, 4 mg: 179 mg / chewing gum) which is a source of fructose. If you have been told by your doctor that you have an intolerance to some sugars, or have been diagnosed with hereditary fructose intolerance , a rare, inherited disease that prevents you from breaking down fructose, talk to your doctor before using this medicine.
less than 0.7 mg butylhydroxytoluene (E321) per chewing gum from the chewing gum base, which may cause local skin reactions (eg contact dermatitis) or be irritating to eyes and mucous membranes.
less than 1 mmol (23 mg) sodium per chewing gum , ie essentially ‘sodium-free’.
0.616 mg alcohol ( ethanol ) per chewing gum . This low amount of alcohol comes from a flavoring and gives no noticeable effects.

Nicorette Peppermint contains 2 mg and 4 mg

Xylitol (2 mg: 608 mg / chewing gum, 4 mg: 596 mg / chewing gum) , which may have a laxative effect. Caloric value: 2.4 kcal / g xylitol, which corresponds to 1.5 kcal and 1.4 kcal per chewing gum (Nicorette Peppermint 2 mg and 4 mg, respectively).
less than 0.6 mg butylhydroxytoluene (E321) per chewing gum base, which may cause local skin reactions (eg contact dermatitis) or be irritating to eyes and mucous membranes.
less than 1 mmol (23 mg) sodium per chewing gum , ie essentially ‘sodium-free’.

Nicorette Fruit Mint contains 2 mg and 4 mg

xylitol (2 mg: 592 mg / chewing gum, 4 mg: 580 mg / chewing gum) , which may have a laxative effect. Caloric value: 2.4 kcal / g xylitol, which corresponds to 1.4 kcal per chewing gum (Nicorette Fruktmint 2 mg and 4 mg).
less than 0.6 mg butylhydroxytoluene (E321) per chewing gum base, which may cause local skin reactions (eg contact dermatitis) or be irritating to eyes and mucous membranes.
less than 1 mmol (23 mg) sodium per chewing gum , ie essentially ‘sodium-free’.
0.014 mg alcohol ( ethanol ) per chewing gum . This low amount of alcohol comes from a flavoring and gives no noticeable effects.

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.

Medical chewing gum 2 mg: can be used alone or in combination with Nicorette transdermal patch.

Medical chewing gum 4 mg: used alone.

The proper chewing technique is important. Nicorette should be chewed slowly and with breaks during which you let the chewing gum rest in your mouth before continuing to chew. Otherwise, you risk heartburn and hiccups.

The nicotine effects only appear after a few minutes. Therefore, one can not expect the same rapid satisfaction as smoking. The risk of poisoning is small if you happen to swallow the chewing gum because the nicotine is then released slowly and incompletely.

Treatment with only Nicorette chewing gum

Chewing gum strength should be chosen based on your nicotine addiction. If you smoke more than 20 cigarettes a day or if you have previously failed Nicorette 2 mg, 4 mg should be chosen. In other cases, 2 mg should be used.

Nicorette chewing gum should be taken when cigarettes would normally have been smoked or if the urge to smoke arises. At the beginning of the treatment, 1 chewing gum can be taken every two hours. Enough chewing gum should be taken every day. Dosage one is individually based on your nicotine addiction. In most cases, 8-12 chewing gums per day is enough. To maximize the chances of success, it is important not to underdose. A maximum of 24 chewing gums per day should be used.

Smoking cessation

The treatment time is individual. Normally, the treatment should last for at least 3 months. Thereafter, the nicotine dose is gradually reduced. Treatment should be stopped when the dose is reduced to 1-2 chewing gums per day.

Regular use of Nicorette chewing gum for longer than 1 year is not normally recommended.

In some cases, longer treatment times may be necessary to avoid a relapse into smoking.

Leftover chewing gum should be saved, as the urge to smoke may suddenly arise.

Smoke reduction

Nicorette chewing gum 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).

Regular use of Nicorette chewing gum for longer than 1 year is not normally recommended.

In some cases, longer treatment times may be necessary to avoid a relapse into smoking.

Leftover chewing gum should be saved, as the urge to smoke may suddenly arise.

Treatment with Nicorette 2 mg chewing gum 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 together with Nicorette 2 mg chewing gum 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 Nicorette 2 mg chewing gum with the patch as follows:

Take chewing gum when you feel the urge to smoke even though you are using Nicorette patches. The usual dose is 5-6 chewing gums per day. Use a maximum of 24 chewing gums per day.

After 8 weeks, gradually reduce the nicotine dose according to one of the following two options:

Weaning from Nicotine Drugs – 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 2 weeks.

At the same time, use as many chewing gums (2 mg) as during the initial treatment.

Then gradually reduce the number of chewing gums. Do not use chewing gum 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 amount of chewing gum. Do not use chewing gum for more than 12 months from the start of treatment.

The course of the combination treatment in tabular form

Period	Band-Aid	Chewing gum 2 mg
Week 1-8	1 patch 25 mg / 16 hours daily	If necessary. The usual dose is 5-6 chewing gums per day (max 24)
Weaning from nicotine replacement therapy – option 1
Week 9-10	1 patch 15 mg / 16 hours daily	Continue to use chewing gum if necessary
Week 11-12	1 patch 10 mg / 16 hours daily	Continue to use chewing gum if necessary
Up to 12 months	—	Gradually reduce the number of chewing gums
Weaning from Nicotine Drugs – Option 2
Up to 12 months	—	Continue to reduce the number of chewing gums gradually

If you take more Nicorette than you should

Nicotine overdose can occur if you smoke while using Nicorette chewing gum.

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 any of the following serious and rare side effects, stop taking Nicorette and see a 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
Pain in the jaw muscle

Rare side effects ( may affect up to 1 in 1,000 people):

Difficulty swallowing, decreased sensitivity in the mouth
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 )
Tight jaw

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

Nicorette chewing gums are sugar-free, available in several different flavors, and two strengths, 2 mg, and 4 mg.

Nicorette 2 mg

The active substance is nicotine. A chewing gum contains 2 mg of nicotine in the form of nicotine resinate.
The other ingredients are: 190 mg sorbitol, chewing gum base (contains butylhydroxytoluene E 321), sodium bicarbonate, sodium carbonate (anhydrous), flavors (contains traces of ethanol ), glycerol and talc.

Nicorette 4 mg

The active substance is nicotine. A chewing gum contains 4 mg of nicotine in the form of nicotine resinate.
The other ingredients are: 179.3 mg sorbitol, chewing gum base (contains butylhydroxytoluene E 321), sodium carbonate (anhydrous), flavors (contains traces of ethanol ), glycerol , quinoline yellow (E104) and talc.

Nicorette Fruit Mint 2 mg

The active substance is nicotine. A chewing gum contains 2 mg of nicotine in the form of nicotine resinate.
The other ingredients are: 591.5 mg xylitol, chewing gum base (contains butylhydroxytoluene E 321), sodium bicarbonate, sodium carbonate (anhydrous), magnesium oxide (light), acesulfame potassium, flavors (peppermint oil, levomentol, tuttifrutti ), contains traces of hyprom , polysorbate 80, acacia rubber, titanium dioxide (E 171), carnauba wax and talc.

Nicorette Fruit Mint 4 mg

The active substance is nicotine. A chewing gum contains 4 mg of nicotine in the form of nicotine resinate.
The other ingredients are: 579.5 mg xylitol, chewing gum base (contains butylhydroxytoluene E 321), sodium carbonate (anhydrous), magnesium oxide (light), acesulfame potassium, flavors (peppermint oil, levomentol, tutti frutti (contains traces of ethanol ), sukralose, hypromellose 80, acacia gum, titanium dioxide (E 171), quinoline yellow (E 104), carnauba wax and talc.

Nicorette Peppermint 2 mg

The active substance is nicotine. A chewing gum contains 2 mg of nicotine in the form of nicotine resinate.
The other ingredients are: 608 mg xylitol, chewing gum base (contains butylhydroxytoluene E 321), sodium bicarbonate, sodium carbonate (anhydrous), magnesium oxide (light), acesulfame potassium, flavoring agents (peppermint oil, levomenthol), acacia gum, titanium dioxide (E2), titanium dioxide (carbon dioxide).

Nicorette Peppermint 4 mg

The active substance is nicotine. A chewing gum contains 4 mg of nicotine in the form of nicotine resinate.
The other ingredients are: 596 mg xylitol, chewing gum base (contains butylhydroxytoluene E 321), sodium carbonate (anhydrous), magnesium oxide (light), acesulfame potassium, flavoring agents (peppermint oil, levomenthol), acacia gum, titanium dioxide (E 171), quinolax and talc.

What the medicine looks like and contents of the pack

Nicorette

2 mg: light beige square

4 mg: light yellow square

Nicorette Peppermint, Nicorette Fruit Mint

2 mg: whitish, coated chewing gum, approximately 15 x 15 x 6 mm

4 mg: cream-colored, coated chewing gum , approximately 15 x 15 x 6 mm

2 mg

Nicorette Peppermint: 10, 12, 15, 24, 30, 48, 90, 96, 105, 204, 210 pcs in blister pack

Nicorette Fruit Mint: 12, 15, 24, 30, 48, 90, 96, 105, 204, 210 pcs in blister pack

Nicorette: 30, 105, 210 pcs in blister pack

4 mg

Nicorette Peppermint, Nicorette Fruit Mint: 12, 15, 24, 30, 48, 90, 96, 105, 204, 210 pcs in blister pack