1 mg lozenge
nicotine
WHAT NICOTINAL MINT SUCTION TABLETS ARE AND WHAT IT IS USED FOR
Nicotinell Mint belongs to a group of medicines that are used to make it easier for you to quit smoking. Nicotinell Mint lozenge contains the active substance nicotine, one of the substances found in tobacco. When you suck on the tablet, nicotine is slowly released and absorbed by the lining of the oral cavity. This medicine is used to help you quit smoking. The nicotine in Nicotinell Mint lozenges relieves symptoms of nicotine withdrawal and smoking cessation when you stop smoking completely or temporarily reduce smoking to facilitate smoking cessation. Nicotinell Mint relieves withdrawal symptoms and smoking cravings and prevents relapses to smoking in smokers who are motivated to quit smoking.
Advice and support usually improve the chances of success.
Nicotinell Mint lozenge is intended for smokers who are 18 years or older.
BEFORE YOU USE NICOTINAL MINT SUFFERING TABLETS
Do not use Nicotinell Mint lozenges
- If you are allergic to nicotine or any of the other ingredients of this medicine (see section 6.1).
- If you are a non-smoker.
Take special care with Nicotinell Mint lozenges
Talk to your doctor or pharmacist before using Nicotinell Mint lozenge 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 taking this medicine, the dose must be reduced or stopped.
- had a stroke (bleeding or blood clot in the brain)
- high blood pressure
- problems with blood circulation
- diabetes , you should check your blood sugar levels more often than usual when you start using nicotine lozenges. Your need for insulin or medicines may change.
- high production of thyroid hormone (hyperthyroidism)
- adrenal tumor ( pheochromocytoma )
- kidney or liver disease.
- esophagitis ( inflammation of the esophagus), gastritis ( inflammation of the stomach) or gastric ulcer
- had epilepsy (seizures)
Children and young people
Nicotinell Mint should not be used by young people aged 12-17 without a prescription from a healthcare professional. Nicotine doses tolerated by adults can cause severe poisoning in young children and can lead to death. That is why it is important to always keep Nicotinell Mint lozenges out of the reach and sight of children.
Nicotinell Mint must 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.
If you stop smoking while taking other medicines, your doctor may want to adjust your dose.
It is not known that Nicotinell Mint lozenges would affect or be affected by taking other medicines. In addition to nicotine, other substances in cigarettes can affect certain medications.
Quitting smoking can affect the way some medicines work, for example:
- theophylline (used to treat asthma )
- tacrine (used to treat Alzheimer’s disease )
- olanzapine and clozapine (used to treat schizophrenia)
- The dose of insulin ( used to treat diabetes ) may need to be adjusted.
Taking Nicotinell Mint lozenges with food and drink
Coffee, acidic beverages, and soft drinks can reduce nicotine uptake and should therefore be avoided 15 minutes before using Nicotinell Mint lozenges. Do not eat or drink while you have a lozenge 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 even 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 Mint only after consultation with your healthcare provider.
Breast-feeding
Nicotinell Mint should be avoided during breastfeeding as nicotine passes into breast milk and may affect your baby. If healthcare professionals recommend using Nicotinell Mint during breastfeeding, the lozenge should be taken immediately after or 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 Mint lozenge has no known effect on the ability to drive or use machines when using Nicotinell Mint according to the dosing instructions. Remember that smoking cessation can affect behavior.
Important information about some of the ingredients of Nicotinell Mint lozenges
Nicotinell Mint 1 mg lozenges contain aspartame, maltitol and sodium .
This medicine contains 10 mg of aspartame per lozenge. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
Nicotinell Mint 1 mg lozenges contain maltitol (E965), a fruit source
- If you have an intolerance to some sugars, contact your doctor before taking this medicine.
- The medicine may have a mild laxative effect.
The caloric value of maltitol is 2.3 kcal / g. The ingredients in the Nicotinell Mint lozenge are suitable for diabetics.
This medicine contains less than 1 mmol (23 mg) sodium per lozenge, ie essentially ‘sodium-free’.
HOW TO USE NICOTINAL MINT SUFFERING TABLETS
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.
Nicotinell Mint lozenge is available in two strengths: 1 and 2 mg
It is not recommended for smokers with strong or very strong nicotine addiction.
Nicotinell Mint 1 mg lozenges can be used alone (a) or in combination with Nicotinell transdermal patches ( b).
Adults over 18 years
(a) Treatment with Nicotinell Mint lozenge only
Nicotinell Mint 1 mg lozenge is recommended for smokers with mild to moderate nicotine dependence, it is not recommended for smokers with strong to very strong nicotine dependence.
| 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 | |
| Treatment with Nicotinell Mint lozenge only | 1 mg lozenge is preferred | Low (1 mg lozenge) or high (2 mg lozenge) dose depending on the user’s taste. | 2 mg lozenge is preferred |
If you experience side effects after starting a high dose (2 mg lozenge), you should use a lower dose (1 mg lozenge).
Dosage for adults over 18 years:
Suck on a lozenge when you feel the need to smoke. At the beginning of the treatment, 1 lozenge can be taken every two hours. In most cases, 8-12 lozenges per day are enough. If you still feel a craving for a smoke, you can take additional lozenges. The largest daily dose is 24 lozenges with 1 mg (applies to both smoking cessation and smoke reduction). Do not use more than 1 lozenge per hour.
Nicotinell Mint lozenges should mainly be used for smoking cessation.
Smoking cessation
To improve your chances of quitting smoking, you should completely refrain from smoking when you start using the lozenges and throughout the treatment period.
The treatment is individual but usually, it should last for at least 3 months. Thereafter, the number of lozenges per day is gradually reduced. Treatment should be discontinued when the dose is reduced to 1-2 lozenges per day. A treatment period longer than 6 months is not normally recommended, but some former smokers may need lozenge treatment for a longer time in order not to return to smoking.
If you are still using nicotine lozenges after more than nine months, consult your doctor or pharmacist.
Counseling increases the chances of succeeding in quitting smoking.
Smoke reduction
Nicotinell Mint lozenge is used between smoking periods to prolong the smoke-free intervals to reduce smoking as much as possible. The number of cigarettes will be gradually replaced by Nicotinell Mint lozenge. If you have not been able to reduce the daily number of cigarettes to at least half after 6 weeks, seek professional help. You should try to stop smoking as soon as you feel motivated, but not later than 4 months after you started using Nicotinell Mint lozenge. Thereafter, the number of lozenges used should be gradually reduced, for example by reducing with one lozenge every two to five days.
If you have not been able to make a serious attempt to quit smoking within 6 months, seek professional help. Regular use of Nicotinell Mint lozenge for longer than 6 months is usually not recommended. Some former smokers may need a longer treatment period with lozenges to avoid relapse. Counseling can increase the chances of successfully quitting smoking.
Instructions for use:
Do not swallow the lozenge.
- Suck on a lozenge until the taste feels strong.
- Then let the lozenge rest between the cheek and the gums.
- When the taste fades, you can start sucking again.
- Repeat this procedure until the lozenge has completely dissolved (approx. 30 minutes).
Avoid drinking coffee, sour drinks, or soft drinks for 15 minutes before you start sucking on the lozenge, as these can reduce the absorption of nicotine. Do not eat or drink while you have a lozenge in your mouth.
(b) Nicotinell Mint 1 mg lozenges in combination with Nicotinell transdermal patches
Smoking cessation
If you have failed treatment with Nicotinell Mint lozenges alone, you can use Nicotinell transdermal patches with Nicotinell Mint 1mg lozenges.
NOTE: Read the package leaflet for Nicotinell transdermal patch before use.
You should completely stop smoking when you start treatment with lozenges in combination with Nicotinell transdermal patches and do not smoke during the entire treatment period. This is to improve your chances of quitting smoking.
The use of Nicotinell patch together with Nicotinell 1 mg lozenge is recommended for smokers with a moderate to very strong dependence, ie. over 20 cigarettes per day. It is highly recommended that the combination treatment be used together with advice and support from healthcare professionals.
The combination treatment should only be used for smoking cessation.
Initial combination treatment:
Start treatment with a Nicotinell 21 mg / 24-hour transdermal patch in combination with Nicotinell Mint 1 mg lozenges. Use at least 4 lozenges (1 mg) per day. In most cases, 5-6 lozenges are a sufficient amount. Do not use more than 15 lozenges per day. The duration of treatment is usually 6-12 weeks. Then gradually reduce the nicotine dose.
Apply the transdermal patch to a clean, dry, hair-free, and undamaged skin area on the torso, arms or hips and press the patch against the skin for 10-20 seconds.
Vary the placement of the patch between different application sites to reduce skin irritation.
Wash your hands thoroughly after applying the transdermal patch to prevent the eyes from being irritated by the nicotine from your fingers.
Reduce nicotine dose after 6-12 weeks of treatment:
Dose one can be reduced in 2 ways.
Option 1: Use lower strength (14 mg / 24 hours patch ) of Nicotinell transdermal patch for 3-6 weeks and then strength 7 mg / 24 hours for 3-6 weeks with the starting dose of Nicotinell Mint 1 mg lozenges. Then gradually reduce the number of Nicotinell Mint lozenges. Treatment time with Nicotinell Mint lozenges longer than 6 months is not normally recommended. Some former smokers may need longer treatment with lozenges to avoid starting smoking again, but the total time for treatment should not exceed 9 months.
Option 2:
Stop using the prolonged-release patches and gradually reduce the number of 1 mg lozenges. Treatment with Nicotinell Mint lozenges longer than 6 months is not recommended. Some former smokers may need longer treatment with lozenges to avoid starting smoking again, but the total time for treatment should not exceed 9 months.
| Treatment period | Depot patches | Lozenge 1 mg |
|---|---|---|
| Initial treatment (then you switch to option 1 or option 2) | ||
| The first 6-12 weeks | 1 patch 21 mg / 24 hours | If necessary. Recommended amount: 5-6 lozenges per day |
| Reduce the nicotine dose – Option 1 | ||
| The following 3-6 weeks | 1 patch 14 mg / 24 hours | Continue to use lozenges if necessary |
| The following 3-6 weeks | 1 patch 7 mg / 24 hours | Continue to use lozenges if necessary |
| Up to a total of 9 months | – | Gradually reduce the number of lozenges |
| Reduce the nicotine dose – Option 2 | ||
| Up to a total of 9 months | – | Continue to gradually reduce the number of lozenges |
If you are still taking lozenges and transdermal patches after 9 months, consult your doctor or pharmacist.
If you use more Nicotinell Mint lozenges than you should
When you use too many lozenges, you can get the same symptoms as if you smoke too much. Symptoms of overdose include weakness, pale skin, sweating, increased salivation, burning sensation in the throat, nausea, vomiting, diarrhea, abdominal pain, visual and hearing disorders, headache, palpitations or other heart rhythm disturbances, shortness of breath, dizziness, tremors.
In case of large overdose, 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, for example, a child has accidentally ingested the medicine, 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 potentially life-threatening for children and can cause serious symptoms or death.
If you forget to use Nicotinell Mint
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 difficulty sleeping. These can be withdrawal symptoms associated with quitting smoking and can be caused by not adding enough nicotine. Other possible withdrawal symptoms during smoking cessation may be insomnia, cough, weakness, fatigue, general malaise, and flu-like symptoms.
Stop taking Nicotinell Mint and contact your doctor immediately if you experience any of the following symptoms of a severe allergic reaction ( angioedema or anaphylactic reaction ):
- swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing. These side effects are rare.
Very common (may affect more than 1 user in 10)
- nausea
Common (may affect up to 1 in 10 people)
- inflammation of the oral mucosa , unpleasant sensation in the mouth
- sore throat
- vomiting
- stomach upset, stomach pain
- diarrhea
- indigestion / heartburn. These symptoms can usually be avoided by sucking more slowly.
- weather voltage
- hiccup
- constipation
- dizziness and headache
- insomnia
- cough
- dry mouth
Uncommon (may affect up to 1 in 100 people)
- palpitation.
Rare (may affect 1 in 1000 users)
- heart rhythm disorders
- hypersensitivity reaction
No known frequency
- hives
- sore inflammation of the oral mucosa
- shaking
- respiratory distress
- difficulty swallowing
- burp
- increased salivation
- weakness
- fatigue
- general malaise and flu-like symptoms .
Cold sores can occur when trying to quit smoking, but the connection with nicotine treatment is unclear.
HOW TO STORE NICOTINELL MINT SUCTION TABLETS
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 (EXP). The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in the original package.
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
- The active substance is nicotine. A Nicotinell Mint 1 mg lozenge contains 1 mg of nicotine (as 3.072 mg of nicotine bitartrate dihydrate).
- The other ingredients are maltitol (E 965), anhydrous sodium carbonate, sodium bicarbonate, polyacrylate, xanthan gum, anhydrous colloidal silica, levomenthol, peppermint oil, aspartame (E 951), magnesium stearate.
What the medicine looks like and contents of the pack
Nicotinell Mint is a white, round, biconvex lozenge with mint flavor.
Nicotinell Mint lozenges are available in two strengths: 1 mg and 2 mg. This leaflet applies to Nicotinell Mint 1 mg lozenges.
The blister cards are packed in cartons containing 12, 36, 72, 96, 144, 192 resp. 204 lozenges.
Jars packed in cartons containing 24, 72, 96 resp. 144 lozenges. Each jar contains 24 lozenges. Packages contain 1, 3, 4, or 6 cans.
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
GlaxoSmithKline Consumer Healthcare ApS, Delta Park 37, 2665
Vallensbæk Strand, Denmark.
GlaxoSmithKline Consumer Healthcare SA, Apollo Site – Avenue Pascal 2-4-6
1300 Wavre, Belgium
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Barthstraße 4, 80339 Munich, Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
Tel: 020-100579
Email: scanda.consumer-relations@gsk.com