2 mg or 4 mg medical chewing gum
nicotine
What NiQuitin Mint is and what it is used for
NiQuitin Mint is used to help people who want to quit smoking. This type of drug is called a nicotine replacement drug.
It is the nicotine in the cigarettes that can make you physically addicted to smoking.
- NiQuitin Mint helps you quit smoking by replacing some of the nicotine you get from cigarettes.
- This nicotine reduces some of the discomfort that smokers may feel when trying to quit. This includes feelings of illness and irritability.
- Nicotine can also relieve the urge to smoke and make it easier to resist the urge to smoke.
NiQuitin Mint is not harmful to health in the same way as tobacco. This is because they do not contain tar, carbon monoxide, or other toxic substances found in tobacco smoke. Some worry that, once they have stopped smoking, they will instead become addicted to nicotine chewing gum. Such an addiction is very unusual and if it were to occur, it would be both less harmful and easier to quit than smoking.
Your chances of quitting smoking increase if you participate in a smoking cessation program. Such “quit-smoking” programs will help you change your behavior. Talk to your doctor or pharmacist for information on smoking cessation programs.
There are no health benefits to smoking, it is always better to quit. Nicotine replacement therapy such as NiQuitin Mint may be helpful. In general, the risks of smoking outweigh the possible side effects of using nicotine replacement therapy.
What you need to know before using NiQuitin Mint
Do not use NiQuitin Mint
- 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 are a non-smoker or occasional smoker.
Warnings and cautions
Talk to your doctor or pharmacist before using NiQuitin Mint:
- if you have recently had a heart attack or stroke , or if you have severe problems with your heart rhythm, unstable or worsening angina (angina), untreated high blood pressure , or angina at rest. In these cases, try smoking cessation without the use of nicotine replacement therapy, unless your doctor prescribes it.
- if you have diabetes . Check your blood sugar more often than usual when you start using NiQuitin Mint. Your insulin or drug needs may change.
- if you have ever had allergic reactions that caused swelling of the lips, face and throat ( angioedema ), or itchy skin rash ( hives ). Nicotine replacement therapy can sometimes trigger such reactions.
- if you have or have had epilepsy (seizures)
- if you have a denture, as you may have difficulty chewing. Fillings or dental implants can come loose when chewing nicotine gum.
Do not switch between NiQuitin Mint and nicotine lozenges when trying to quit smoking.
Consult a doctor if you have:
- severe or moderate liver or kidney problems, as the risk of side effects may then be higher.
- untreated overactive thyroid gland or pheochromocytoma (a tumor in the adrenal glands that can affect blood pressure ) – in which case your doctor has told you – because nicotine can worsen the symptoms.
- gastric ulcer or duodenal ulcer , or inflammation of the esophagus , as symptoms may worsen when you swallow nicotine. It can also cause sores in the mouth. Talk to your doctor if your symptoms get worse. It may be better for you to use another form of nicotine replacement therapy, e.g. nicotine patches.
Children and young people
Children (under 12 years)
A normal dose for adults can seriously poison or even kill a small child. NiQuitin Mint must therefore always be kept out of the reach and sight of children.
Other drugs and NiQuitin Mint
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Quitting smoking can change the effect of other medicines that you take. If you have any further questions or concerns about this, talk to your doctor or pharmacist.
This is especially important if you are taking other medicines that contain:
- theophylline (used in asthma )
- tacrine (in Alzheimer’s disease )
- clozapine (for schizophrenia)
- ropinirole (in Parkinson’s disease ).
NiQuitin Mint with food, drink and alcohol
You should not eat or drink anything while NiQuitin Mint chewing gum is in your mouth.
Acidic beverages (eg fruit juice, coffee, or soft drinks) affect the uptake of nicotine into the oral cavity. For best results, avoid such drinks for about 15 minutes before using NiQuitin Mint.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Smoking during pregnancy carries risks for the fetus. Such risks are poor growth before birth, premature birth, or stillbirth. Quitting smoking is the best way to improve both your own and your child’s health. The earlier you quit smoking the better.
If you are pregnant, it is best if you can stop smoking without using nicotine replacement therapy. If you have tried and failed, your doctor may recommend nicotine replacement therapy to help you quit. It is better for the child you are carrying than if you continue to smoke. The decision to use nicotine replacement therapy should be made as early as possible during pregnancy. The goal is for it to only be used for 2-3 months. Remember that the most important thing is that you stop smoking. Chewing gum can be better than nicotine patches because chewing gum does not add nicotine all the time. However, if you feel unwell or vomit, it may be better to use patches.
If you are breastfeeding your baby, tobacco smoke may cause your baby to have difficulty breathing or other problems. You should stop smoking without using nicotine replacement therapy. If you have tried and failed, your doctor may recommend nicotine replacement therapy to help you quit. If you have to use nicotine replacement therapy to be able to quit, the amount of nicotine the child ingests is small. It is best to use nicotine replacements that are only taken at certain times of the day (eg chewing gum or lozenges rather than patches ). It is also best to breastfeed just before taking the chewing gum. Then the child gets as little nicotine as possible.
Driving and using machines
NiQuitin Mint has no known effects on the ability to drive or use machines. However, you must be aware that you may experience behavioral changes when you stop smoking, which could affect your ability to drive and use machines.
NiQuitin Mint contains:
- Sodium – This medicine contains less than 1 mmol sodium (23 mg) per gum , ie. is next to “sodium-free”.
- Sorbitol (E420) – Each 2 mg chewing gum contains 148.65 mg sorbitol. Each 4 mg of chewing gum contains 137.55 mg of sorbitol. Sorbitol 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 (HFI), a rare inherited disease that prevents you from breaking down fructose, talk to your doctor before taking this medicine.
- Butylhydroxytoluene (E321) – May cause local skin reactions (eg contact dermatitis) or be irritating to eyes and mucous membranes.
How to use NiQuitin Mint
Always use this medicine exactly as described in this leaflet or as your doctor/healthcare professional has told you. If you are not sure, talk to your doctor or healthcare professional.
While trying to quit smoking with the help of NiQuitin Mint, you must try to quit smoking completely. If you were to smoke a cigarette while using nicotine replacement therapy, you should continue with your attempt to quit smoking. If it is difficult for you to quit, it may help to talk to a doctor, nurse, smoking cessation counselor, or pharmacist.
NiQuitin Mint 2 mg is suitable for people who smoke less than 20 cigarettes a day.
NiQuitin Mint 4 mg is suitable for people who smoke 20 cigarettes or more per day.
Do not use NiQuitin Mint as a pack of regular chewing gum. If you chew NiQuitin Mint too quickly and without interruption, the nicotine will be released too quickly. It can cause discomfort (eg heartburn or hiccups).
To use NiQuitin Mint, proceed as follows: Peel off the protective paper and squeeze out a pack of chewing gum. Put the chewing gum in your mouth and chew slowly until the taste is strong (about 1 minute), then stop chewing and let the chewing gum rest against your cheek. When the taste diminishes, chew a few times until the taste is strong, then let the chewing gum rest again. After about 30 minutes, the chewing gum is finished. Do not eat or drink anything with chewing gum in your mouth. It can reduce nicotine uptake. Do not use more than 15 chewing gums per day. Talk to your doctor/healthcare professional if you need to use NiQuitin Mint for more than a total of 9 months.
NiQuitin Mint can be used according to the following schedule with a gradual reduction in the number of chewing gums per day.
Adults (from 18 years of age)
- Start with 8 to 12 chewing gums per day. Take a chewing gum when you feel the urge to smoke.
- Use the chewing gum in this way for up to 3 months, then gradually reduce the number of chewing gums you use each day (see table below).
- When you are down to 1 or 2 chewing gums per day, stop using them completely.
If you get a craving for a smoke at some point after you stop, you can take a chewing gum again.
| STEP 1: | ||
|---|---|---|
| STEP 2: | ||
| STEP 3: | ||
| Initiation of treatment takes chewing gum when you feel the urge to smoke. Use 8-12 pcs / day for up to 3 months | DownsizingDecrease gradually until you take 1-2 chewing gums per day. Then stop completely. | Supportive treatment take chewing gum if you become addicted to smoking. |
Use for children and adolescents
Young people (from 12 years to 17 years)
Adolescents should not use NiQuitin Mint unless recommended by a doctor.
Do not take more chewing gum than the indicated dose. Do not smoke or take any other nicotine-containing products at the same time. Follow the instructions carefully and use a maximum of 15 chewing gums per day (24 hours).
Children under 12 years
Children under the age of 12 are not allowed to use NiQuitin Mint.
If you feel tempted to start smoking again
If you are worried about starting to smoke again or find it difficult to stop chewing gum completely, consult your doctor or pharmacist. If you have started smoking again, they can help you get the best results from nicotine replacement therapy in a new attempt.
If you use more NiQuitin Mint than you should
If you have used too many NiQuitin Mint, you may start to feel nauseous, dizzy, and sick. Stop using the chewing gum and contact a doctor or hospital immediately for risk assessment and advice. If possible, show the package or this leaflet.
Chewing gum is not suitable for children under 12 years. If children chew on the chewing gum, they may experience symptoms of nicotine overdose. Symptoms include headache, nausea/vomiting, stomach pain, and diarrhea. If a child has accidentally ingested the medicine, contact a doctor or hospital immediately for risk assessment and advice, as it can be very dangerous and even fatal. If possible, show the package or this leaflet.
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. At the recommended dosages, no serious side effects have been reported with NiQuitin Mint.
Quitting smoking can in itself cause symptoms such as dizziness, headaches, sleep problems, coughing, and cold-like symptoms. Symptoms such as depression, irritability, anxiety, and difficulty sleeping can also be due to withdrawal symptoms when you stop smoking.
Stop taking NiQuitin Mint and see a doctor immediately if you get any of the following symptoms of an allergic reaction, which can be serious:
Very rare side effects (may affect up to 1 in 10,000 people)
- swelling of the face, tongue or throat
- difficult to swallow
- hives and difficulty breathing
- irregular heartbeats
- severe allergic symptoms such as sudden wheezing / wheezing or tightness in the chest, rash and fainting.
Other side effects are listed below according to the probability that they occur.
Very common (may affect more than 1 user in 10)
- nausea
Common (may affect up to 1 in 10 people)
- discomfort from the gastrointestinal tract
- sore throat, sore / dry mucous membranes, irritation and sores in the mouth, inflammation of the throat, cough
- difficulty sleeping, headache, irritability, dizziness
- vomiting, hiccups, indigestion, flatulence, diarrhea, constipation
- pain from the jaws
None of these side effects are serious and they often go away after a few days of treatment.
Uncommon (may affect up to 1 in 100 people)
- faster heartbeat or increased heart rate awareness
- difficulty breathing, chest pain
- taste disturbances / taste distortion
- redness of the skin, hives , increased sweating
- pain or swelling in muscles and joints
- inflammation of the oral mucosa
- tremors
- feeling sick.
Has been reported (occurs in an unknown number of users)
- seizures, difficulty swallowing, belching, increased salivation, weakness, fatigue, flu-like symptoms , hypersensitivity, abnormal dreams, itching or rash, numbness or tingling in the mouth.
How to store NiQuitin Mint
- 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 blister and the carton after “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.
Contents of the package and other information
Content declaration
- The active substance is nicotine. A chewing gum contains 2 mg or 4 mg (in the form of nicotine resinate).
- The other ingredients are
- The chewing gum contains butylhydroxytulouen (E321), sorbitol (E420), xylitol (E967), calcium carbonate (E170), sodium carbonate, anhydrous (E500), glycerol (E422), acesulfame potassium (E950), mannitol (E421), acral4 (E955), titanium dioxide (E171) and flavoring agents: Flavorings with cooling effect, eucalyptus menthol and levomenthol.
What the medicine looks like and contents of the pack
White to off-white rectangular chewing gum
A blister card contains 4 or 10 chewing gums.
Available in packs of 4, 10, 30, 100, or 200 chewing gums.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Perrigo Sverige AB
Box 7009
164 07 Kista
Manufacturer:
Fertin Pharma A / S, Dandyvej 19, 7100 Vejle, Denmark