1.5 mg compressed lozenge (lozenge)
Nicotine
WHAT NIQUITIN IS AND WHAT IT IS USED FOR
NiQuitin is used to help people who want to quit smoking. This type of treatment is called nicotine replacement therapy. NiQuitin 1.5 mg lozenges are suitable for smokers who smoke 20 cigarettes or less per day.
It is the nicotine in the cigarettes that makes you physically addicted to them.
- NiQuitin helps you quit smoking by replacing some of the nicotine you get from cigarettes.
- NiQuitin reduces some of the discomfort that smokers may feel when trying to quit. This includes irritability or a feeling of being ill.
- NiQuitin can also relieve the urge to smoke and make it easier to resist the urge to smoke.
NiQuitin lozenges are not as harmful to health as tobacco. They do not contain tar, carbon monoxide, or other toxins found in tobacco smoke. You can become addicted to nicotine replacement therapy, but it is uncommon. It is also less harmful and easier to break than tobacco addiction.
Your chances of quitting smoking increase if you participate in a smoking cessation program. Contact a doctor or pharmacist for information on smoking cessation programs.
There are no health benefits associated with smoking. It is always better to quit smoking than to continue. Nicotine replacement products such as NiQuitin may be helpful. In general, the risks of smoking outweigh the possible side effects of using nicotine replacement therapy.
2. What you need to know before taking NiQuitin
Do not take NiQuitin if:
- you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6)
- you are a non-smoker, or are under 12 years of age.
There are no health benefits associated with smoking. It is always better to quit smoking than to continue. Nicotine replacement products such as NiQuitin may be helpful.
In general, the risks of smoking outweigh the possible side effects of using nicotine replacement therapy.
Warnings and cautions
Talk to your doctor, pharmacist,t or nurse before using NiQuitin:
- If you have recently had a heart attack or stroke or if you suffer from severe heart rhythm problems, unstable or worsening angina (chest pain) or angina at rest, you should try to stop smoking without using nicotine replacement therapy, unless your doctor tells you to.
- If you have diabetes , you should check your blood sugar more often when you start taking NiQuitin. Your need for insulin or antidiabetic medicines may change.
- if you have or have had epilepsy (seizures)
- if you have ever had allergic reactions that caused swelling of the lips, face and neck ( angioedema ) or itchy rash on the skin ( urticaria ). Sometimes nicotine substitutes can trigger such reactions.
Do not switch between NiQuitin lozenges and nicotine gum while trying to quit smoking.
Ask your doctor or pharmacist for advice if you have:
- severe or moderate liver problems or severe kidney problems , as the risk of side effects is then greater.
- untreated overactive thyroid gland or pheochromocytoma (a tumor on the adrenal glands that can affect blood pressure ) – in which case your doctor has told you so – as nicotine may worsen the symptoms.
- gastric or duodenal ulcers, or esophagitis , as your symptoms may worsen when you swallow nicotine. Sores in the mouth can also occur. If your symptoms worsen, you should talk to your doctor. You may need to switch to a form of nicotine replacement therapy that is not administered orally, such as patches .
- any questions about becoming addicted or think you have become addicted to this product.
Children and young people
This medicine must not be used by children under 12 years of age. A normal dose for adults can seriously poison or even kill a small child. NiQuitin must therefore always be kept out of the reach and sight of children.
Other medicines and NiQuitin
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Quitting smoking can change the effect of other medicines that you take. If you have any questions or concerns about this, talk to your doctor, pharmacist,t or nurse.
Pregnancy and breastfeeding
If you are pregnant orbreastfeedingg, think you may be pregnant,t 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,h or stillbirth. Quitting smoking is the best way to improve both your health and that of your child. The earlier you quit smoking the better.
Ideally, you should stop smoking without taking nicotine medication if you are pregnant. However, if you have tried and failed, nicotine replacement therapy may be recommended by your doctor to help you quit.
It is better for the child you are carrying than for you to continue smoking. The decision to take nicotine medication should be made as early as possible during pregnancy. You should try to use the nicotine medicine only for 2-3 months. Remember that the most important thing is that you stop smoking. Products such as lozenges may be better than nicotine patches. This is because when you use lozenges, you do not add nicotine to the body all the time. However, if you get nausea or vomiting, it may be better to use patche .
If you arebreastfeedingg your baby, smoking tobacco may cause your baby to have difficulty breathing or other problems. Ideally, you should stop smoking without using nicotine replacement therapy. However, if you have tried and failed, nicotine replacement therapy may be recommended by your doctor to help you quit. If you use nicotine medication to be able to quit, the amount of nicotine that the child is exposed to will be too small. It is much less harmful than secondhand smoke. It is best to use nicotine medicines that are taken at certain times of the day (eg in the form of chewing gum or lozenges rather than patches ). It is also better to breastfeed immediately before taking the nicotine medicine. Then the child gets as little nicotine as possible.
Driving and using machines
NiQuitin 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 contains:
Sodium: This medicine contains less than 1 mmol (23 mg) per compressed lozenge, ie essentially ‘sodium-free’
How to take NiQuitin
Always use NiQuitin exactly as the instructions in this leaflet indicate. Ask your doctor or pharmacist if you are unsure.
Use NiQuitin lozenges by placing a lozenge in your mouth and then moving it at regular intervals from one side of your mouth to the other, until it has completely dissolved. This should take about 10 minutes. The lozenge should not be chewed or swallowed whole. Do not take more than 15 lozenges per day. If you have the impression that you need to use NiQuitin for more than 9 months in total, you should consult your doctor or pharmacist.
Avoid eating or drinking with a lozenge in your mouth.
Adults (from 18 years of age)
- Start with 8 to 12 lozenges per day. Suck on a tablet when you feel a urge to smoke.
- Use the lozenges in this way for up to 6 weeks, and then gradually reduce the number of lozenges per day.
- When you are on 1 or 2 lozenges per day, you should stop completely.
When you stop, you can sometimes feel a sudden urge to smoke. In that case, you can take a lozenge again.
Use for children and adolescents
Young people (from 12 years to 17 years)
You should only use NiQuitin on the recommendation of your doctor.
Do not exceed the stated dosage one. Follow the instructions carefully and do not take more than 15 tablets per day.
Children under the age of 12 are not allowed to use NiQuitin
The product is intended for use in the mouth. The nicotine in the lozenge is slowly released in the mouth and then absorbed into the body.
If you feel tempted to start smoking again
If you are worried that you may start smoking again or find it difficult to stop taking the lozenges completely, consult your doctor or pharmacist.
If you have started smoking again, they can give you advice on how to get the best results from nicotine replacement therapy in a new attempt.
If you take more NiQuitin than you should
If you take too much NiQuitin, you may start to feel nauseous, dizzy,y and sick.
The tablets should not be used by children under 12 years of age or by non-smokers. If the lozenges are taken by children or non-smokers, they may show signs of nicotine poisoning. Such signs are headache, nausea, abdominal pain, n, and diarrhea.
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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, NiQuitin can cause side effects, although not everybody gets them. At the recommended dosage, no serious side effects have been reported with NiQuitin.
Quitting smoking can in itself cause dizziness, headaches, sleep problems, coughing,g, and cold-like symptoms. Symptoms such as depression, irritability, anxiety, restlessness, increased appetite,e and difficulty sleeping can also be due to withdrawal symptoms associated with smoking cessation.
Other side effects are listed below. They have been grouped according to the probability that they occur:
Very common (may affect more than 1 user in 10)
- The lozenges can easily make your mouth or tongue sore or irritated. They can also cause nausea.
Common (may affect up to 1 in 10 people)
- sore throat
- nausea
- stomach upset
- diarrhea
- heartburn
- gas formation
- hiccup
- pharyngitis ( inflammation is in the throat)
Uncommon (may affect up to 1 in 100 people)
- nervousness
- Depression
- palpitation
- heart rate increase
- chest pain
- rash
- fatigue and general malaise
Very rare (may affect up to 1 in 10,000 people)
- severe allergic reaction (anaphylactic shock ) with sudden difficulty breathing, pressure over the chest, difficulty swallowing, rash and fainting
Has been reported (occurs in an unknown number of users):
- seizures
- dysphagia (difficulty swallowing)
- belching
- increased salivation
- flu-like illness / symptoms
- hypersensitivity
- tremor , taste changes, paresthesia in the mouth (numbness or tingling in the mouth)
- dyspnoea (shortness of breath)
- itching or rash, swelling of the skin or mucous membranes, reddening of the skin, increased sweating
HOW TO STORE NIQUITIN
- Keep this medicine out of the sight and reach of children.
- Do not use lozenges after the expiry date which is stated on the tube and the outer carton. Expiration date is the last day of the specified month.
- Do not store above 30 ° C.
- Store in the original package. Moisture sensitive.
- Do not use the pack for anything else, as there may be fine dust from the lozenges in the pack.
- Take care of empty packaging responsibly. 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. Each lozenge contains 1.5 mg (in the form of a resin complex, called nicotine resinate). The other ingredients are mannitol (E421), sodium alginate (E401), xanthan gum (E415), potassium bicarbonate (E501), calcium polycarbonate, anhydrous sodium carbonate (E500), acesulfame potassium (E950), flavor masking agent, peppermint, magnesium,
NiQuitin’s appearance and pack sizes
White or almost white oval compressed lozenges with the convex exterior.
The 1.5 mg lozenge has an L embossed on one side.
Each tube contains 20 tablets. One package contains one, there,e or five tubes.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Perrigo Sverige AB
Box 7009
164 07 Kista
Manufacturer
NiQuitin is manufactured by Wrafton Laboratories Limited, Exeter Road, Wrafton, Braunton, EX33 2DL, U, K, and Omega Pharma International NV, Venecoweg 26, Nazareth, 9810, Belgium.