2 mg and 4 mg medical chewing gum
WHAT NICOTINAL PEPPERMINT CHEWING RUBBER IS AND WHAT IT IS USED FOR
Nicotinell belongs to a group of medicines that are used to make it easier for you to quit smoking.
Nicotinell Peppermint chewing gum contains the active substance nicotine, one of the substances found in tobacco. When chewing, nicotine is released slowly and is absorbed by the mucous membrane in the mouth. This drug is used to reduce the nicotine cravings and withdrawal symptoms in nicotine addicts. It can thereby:
prevent relapse into smoking in smokers who are motivated to quit, or
facilitate a smoke reduction in smokers who can not or are unwilling to quit smoking.
Advice and support usually improve the chances of succeeding in quitting smoking.
Nicotinell Peppermint is for smokers over 18 years of age.
BEFORE YOU USE NICOTINAL PEPPERMINT CHEWING GUM
Do not use Nicotinell Peppermint chewing gum
• if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6)
• if you are a non-smoker.
Take special care with Nicotinell Peppermint chewing gum
Talk to your doctor or pharmacist before using Nicotinell Peppermint if you have any
• heart problems, such as a recent heart attack, irregular heartbeat, heart failure, or chest pain (angina, including Prinzmetal’s angina). If you experience increased heart problems while using this product, use should be reduced or discontinued.
• had a stroke
• high blood pressure
• problems with blood circulation
• diabetes, you should check your blood sugar levels more often than usual when you start using nicotine gums. Your need for insulin or medical treatment may change.
• overactive thyroid gland ( hyperthyroidism )
• adrenal tumor ( pheochromocytoma )
• impaired kidney and/or liver function
• inflammation of the esophagus ( esophagitis ), gastritis ( gastritis ), or gastric ulcer
• had epilepsy
If you have any of these conditions, it may not be appropriate for you to use Nicotinell Peppermint.
People who have problems with the joint in the jaw or using dentures can have difficulty chewing gum. In these cases, it is therefore recommended that you use other forms of nicotine replacement therapy than chewing gum. When chewing, Nicotinell Peppermint can loosen fillings or dental implants.
When using Nicotinell Peppermint, you should
Do not smoke as it may cause the nicotine concentration to be so high that you feel unwell.
Children and young people
Nicotinell should not be used by people between the ages of 12-17 without a prescription from a healthcare professional.
Nicotine doses tolerated by adult smokers during treatment can cause severe poisoning symptoms in young children and lead to death. Therefore, Nicotinell Peppermint must be always stored out of sight and reach of children. Nicotinell Peppermint should not be used by children under 12 years of age.
Use of other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, and are about to stop smoking.
It is not known that Nicotinell Peppermint chewing gum would affect or be affected by taking other medicines. However, the effect of other drugs can be affected by quitting smoking. This is especially important if you are using medicines that contain
• theophylline (used to treat asthma )
• tacrine (used to treat Alzheimer’s disease )
Olanzapine and clozapine (used to treat schizophrenia).
Intake of Nicotinell Peppermint chewing gum with food and drink
Coffee, sour drinks, and soft drinks can reduce nicotine uptake. You should therefore avoid these drinks 15 minutes before using Nicotinell Peppermint. Do not eat or drink while holding chewing gum in your mouth.
Pregnancy and breastfeeding
Pregnancy
It is very important to stop smoking during pregnancy as it can result in the poor growth of your baby. It can also lead to premature birth and stillbirth. It is best if you can stop smoking completely without the use of drugs that contain nicotine. If you are unable to do this, use Nicotinell Peppermint only after contact with your healthcare professional.
Breast-feeding
Nicotinell Peppermint should be avoided during breastfeeding as nicotine passes into breast milk and may affect your baby. If you have been advised by your healthcare professional to use Nicotinell Peppermint during breastfeeding, the chewing gum should be chewed shortly after breastfeeding and no later than two hours before breastfeeding.
Fertility
Smoking increases the risk of infertility in women and men. The effects of nicotine on fertility are not known.
Driving and using machines
Nicotinell Peppermint has no known effect on the ability to drive or use machines if used according to dosing instructions. Remember that smoking cessation can affect behavior.
Important information about some of the ingredients of Nicotinell Peppermint chewing gum
Nicotinell Peppermint contains sorbitol, which is a source of fructose. If you have been told by your doctor that you have an intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that prevents you from breaking down fructose, talk to your doctor before taking this medicine.
Chewing gum contains 0.1 g of sorbitol, which is converted to 0.02 g of fructose in the body. The caloric value of chewing gum is 1.2 kcal.
The chewing gum contains butylhydroxytoluene (E 321) which can irritate the oral mucosa. A Nicotinell Peppermint chewing gum contains 11 mg of sodium. This should be considered by people on a low-salt diet.
This medicine contains less than 1 mmol sodium (23 mg) per gum, ie essentially ‘sodium-free’.
HOW TO USE NICOTINELLAL PEPPERMINT CHEWING GUM
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. The chewing gum strength should be chosen based on your nicotine addiction. Use Nicotinell Peppermint 4 mg chewing gum again
• you are a smoker with a strong nicotine addiction
• you have previously failed to quit smoking after using chewing gum with a strength of 2 mg.
In other cases, Nicotinell Peppermint 2 mg chewing gum should be used.
See table for optimal strength:
| Weak to moderate nicotine dependence | Moderate to strong nicotine dependence | Strong to very strong nicotine addiction |
|---|---|---|
| Less than 20 cigarettes/day | Between 20-30 cigarettes / day | More than 30 cigarettes/day |
| A low dose (2 mg chewing gum ) is preferred | Low dose (2 mg chewing gum ) or high dose (4 mg chewing gum ) depending on the user’s taste | A high dose (4 mg chewing gum ) is preferred |
If you experience side effects after starting a high dose (4 mg), use a lower dose (2 mg).
To avoid discomfort (eg hiccups or heartburn), the chewing gum must be chewed properly.
Instructions for use:
Do not swallow the chewing gum.
Chew 1 chewing gum until a strong taste is felt.
Then let the chewing gum rest between the cheek and the gums.
3. Start chewing again when the taste fades.
4. Repeat this procedure for about 30 minutes.
Avoid drinking coffee, acidic beverages, or soft drinks 15 minutes before using the chewing gum as it may reduce the absorption of nicotine. Do not eat or drink when you have chewing gum in your mouth.
Dosage for adults over 18 years
Take a chewing gum when you feel a strong need to smoke.
At the beginning of the treatment, 1 chewing gum can usually be taken every two hours. In most cases, 8-12 chewing gums per day is enough, regardless of the strength of the chewing gum. The maximum daily dose when using 2 mg of medical chewing gum is 24 chewing gums and 4 mg of medical chewing gum 15 chewing gums. Do not use more than one chewing gum per hour.
Smoking cessation:
The treatment is individual but usually lasts for at least 3 months. Thereafter, the number of chewing gums per day is gradually reduced. Treatment should be discontinued when the dose is reduced to 1-2 chewing gums per day.
Nicotinell Peppermint chewing gum should not be used for more than 12 months without contacting a healthcare professional.
Counseling increases the chances of succeeding in quitting smoking.
Smoke reduction:
Nicotinell Peppermint is used between smoking periods to prolong the smoking-free periods and to reduce smoking as much as possible. If you have not been able to reduce the number of cigarettes per day after 6 weeks, you should seek professional help. Try to stop smoking as soon as you feel ready, but no later than 6 months after starting treatment. If you have not been able to make a serious attempt to quit smoking within 9 months of starting treatment, you should seek professional help.
Counseling increases the chances of succeeding in quitting smoking.
If you use too much Nicotinell Peppermint chewing gum
When you use too many chewing gums, you can get the same symptoms as if you smoke too much. Symptoms of overdose include weakness, paleness, sweating, increased salivation, heartburn, nausea, vomiting, diarrhea, abdominal pain, vision and hearing disorders, headache, palpitations or other heart rhythm disturbances, shortness of breath, dizziness, tremors, and confusion.
In case of large overdoses, these symptoms may be followed by fatigue, low blood pressure, circulatory collapse, coma, difficulty breathing, and seizures.
If you have ingested too much medicine, or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Contact a doctor immediately if a child is suspected of being poisoned. Even small amounts of nicotine are dangerous and possibly life-threatening for children and can lead to serious symptoms or death.
If you forget to take Nicotinell Peppermint Chewing Gum
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Symptoms that may appear during the first few days are dizziness, headache, and sleep disturbances. These can be withdrawal symptoms associated with smoking cessation and may be due to too low a supply of nicotine. Other possible withdrawal symptoms may be insomnia, cough, weakness, fatigue, general malaise, or flu-like symptoms.
Stop using Nicotinell Peppermint and contact a doctor immediately if you get any of the following symptoms of a severe allergic reaction ( angioedema or anaphylactic reaction)
- swelling of the face, tongue and / or throat and / or difficulty swallowing or hives . These side effects are rare.
Other side effects:
Very common (may affect more than 1 user in 10)
- nausea
Common side effects ( may affect up to 1 in 10 people)
- inflammation of the oral mucosa, discomfort in the mouth
- sore throat
- vomiting
- stomach discomfort, abdominal pain
- diarrhea
- indigestion / heartburn
- weather voltage
- hiccup
- constipation
- dizziness and headache
- insomnia
- cough
- dry mouth
- pain in the mouth, throat and jaw muscles
Uncommon side effects ( may affect up to 1 in 100 people)
- palpitation
- redness of the skin ( erythema )
- itchy skin rash ( hives ).
Rare side effects ( may affect up to 1 in 1,000 people)
• heart rhythm disorders
• hypersensitivity reactions.
No known frequency
- increased salivation
- difficulty swallowing
- belching
- shaking
- inflammation of the oral mucosa
- respiratory distress
- weakness
- fatigue
- general malaise
- flu-like symptoms
Cold sores can occur when trying to quit smoking, but the connection with nicotine treatment is unclear.
In very rare cases, the chewing gum can get stuck in dentures or dental bridges and damage them.
HOW TO STORE NICOTINELL PEPPERMINT CHEWING GUM
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
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.
FURTHER INFORMATION
Content declaration
Nicotinell Peppermint medical chewing gum is available in two strengths.
The active substance is nicotine.
A Nicotinell Peppermint chewing gum contains 2 mg or 4 mg of nicotine (equivalent to 10 mg or 20 mg of nicotine polarizing (1: 4)).
The other ingredients are
- chewing gum base (contains butylhydroxytoluene (E 321)), acesulfame potassium (E 950), polacrillin, calcium carbonate (E 170), glycerol (E 422), levomenthol, natural mint flavor, mint millicaps, sucralose, sodium carbonate (anhydrous carbonate), 420) 101.8 mg (2 mg) or 93.8 mg (4 mg), xylitol, mannitol (E 421), gelatin, titanium dioxide (E 171), carnauba wax and talc.
Nicotinell Peppermint medical chewing gum is sugar-free.
What the medicine looks like and contents of the pack
The coated chewing gum has an off-white color and is rectangular.
The chewing gums are packed in blister packs with 12 chewing gums in each. The blister cards are packed in cartons containing 12, 24, 84, 96, and 204 chewing gums, respectively.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline Consumer Healthcare ApS, PO Box 61,
2610 Rødovre, Denmark
Manufacturer
FAMAR SA, 48 th km National Road Athens-Lamia, 19011, Avlonas, Attiki, Greece
Novartis Sverige AB, Kemistvägen 1, 183 11 TÄBY
Fertin Pharma A / S, Dandyvej 19, DK-7100, Denmark