2 mg and 4 mg compressed lozenges
nicotine
What Nicorette Fruit is and what it is used for
This medicine is used to relieve withdrawal symptoms and reduce the nicotine cravings you feel when you try to quit smoking or reduce smoking during smoking cessation. The treatment is intended for adult smokers over the age of 18.
Nicorette Fruit 2 mg lozenges are suitable for smokers with low nicotine dependence, e.g. those who either smoke the first cigarette of the day more than 30 minutes after waking up or smoke a maximum of 20 cigarettes a day.
Nicorette Fruit 4 mg lozenges are suitable for smokers with high nicotine dependence, e.g. those who smoke the first cigarette of the day within 30 minutes of waking up or smoke more than 20 cigarettes a day.
This medicine may help you to stop smoking abruptly or to stop smoking before quitting completely. If you think you can quit smoking abruptly, you should do so. However, if you feel that this is too big a step, you may want to try to reduce the number of cigarettes you smoke as a first step before quitting completely. See section 3 “How to use Nicorette Fruit” for more information.
Nicorette Fruit relieves withdrawal symptoms, including nicotine cravings, which occur when smoking is stopped. When the body suddenly no longer receives nicotine from tobacco, you suffer from various discomfort feelings called withdrawal symptoms, e.g. irritation, anger or depression, anxiety, restlessness, poor concentration, increased appetite or weight gain, cravings (cravings), nocturnal awakenings, or sleep disturbances. The nicotine in Nicorette Fruit can help prevent or alleviate such discomfort and cravings.
Also, seek advice and other forms of support to improve the chances of succeeding with smoking cessation.
What You Need to Know Before Taking Nicorette Fruit
Do not use Nicorette Fruit
- 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 if you have any of the following conditions. You may be able to use Nicorette Fruit lozenges, but first, need to discuss with your doctor if you have:
- recently had a heart attack or stroke
- chest pain ( unstable angina ) or angina at rest
- heart disease affecting heart rate or heart rate ( arrhythmia )
- high blood pressure that is not treated with drugs
- ever had allergic reactions in the form of swelling of the lips, face and throat ( angioedema ) or itchy skin rash ( hives ). The use of nicotine replacement therapy can sometimes trigger this type of reaction.
- severe or moderately severe liver disease
- severe kidney disease
- diabetes
- overactive thyroid gland
- adrenal tumor ( pheochromocytoma ) _
- ulcers in the stomach or duodenum a
- inflammation of the esophagus
This medicine should not be used by non-smokers.
Children
The correct dose for adults can seriously poison, or even be life-threatening for children. It is therefore important to always keep Nicorette Fruit lozenges out of the reach and sight of children.
Other Medicines and Nicorette Fruit
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any 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
Nicorette Fruit with food and drink
Do not drink or eat when you have the lozenge in your mouth.
Pregnancy and breastfeeding
It is very important to stop smoking during pregnancy because 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 Fruit only after consulting your healthcare professional, your family doctor, or a doctor who specializes in smoking cessation.
Nicorette Fruit should be avoided during breastfeeding as nicotine passes into breast milk and may affect your baby. If your doctor has recommended you to use Nicorette Fruit, the lozenge should be taken immediately after breastfeeding and not within 2 hours before breastfeeding.
Smoking increases the risk of infertility in women and men. The effects on fertility for nicotine are unknown.
Driving and using machines
No effects on the ability to drive or use machines have been observed.
Nicorette Fruit contains
Nicorette Fruit contains less than 1 mmol (23 mg) sodium per lozenge, ie is essential ‘sodium-free’. This medicine also contains small amounts of sulfites from the flavoring, which in rare cases can cause severe hypersensitivity reactions and convulsions in the trachea.
How to use Nicorette Fruit
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 instructions on how to take Nicorette Fruit depend on whether you:
- quit smoking abruptly
- quit smoking with tapering
Adults (over 18 years)
( a) Transverse smoking cessation
The idea is to stop smoking abruptly and to use the lozenge to reduce the urge to smoke.
- Start by using 8‑12 lozenges a day. Let a lozenge dissolve in your mouth as soon as you feel the urge to smoke.
- Use the lozenges in this way for up to 6 weeks, and then gradually reduce the number of lozenges you take per day.
- When you only use 1 or 2 lozenges a day, stop taking them completely. After you stop taking the tablets, you may sometimes feel a sudden urge to smoke. If this happens, you can use a lozenge again.
(b) Smoking cessation with tapering
The idea is to start by gradually replacing some of the cigarettes with the lozenge. Once you have succeeded, you stop smoking completely while using the lozenge. Eventually, you stop using the lozenge.
Quench your craving with a Nicorette Fruit lozenge instead of a cigarette when you feel a strong urge to smoke. Reduce the number of cigarettes you smoke per day as much as possible. Talk to your healthcare provider if you have not been able to reduce your daily cigarette consumption after 6 weeks.
As soon as you feel that you can handle it, you should stop smoking completely. Follow the instructions for abrupt smoking cessation above. Do this as soon as possible. Talk to your healthcare provider if your attempt to quit smoking has not been successful within 6 months of starting treatment with this medicine.
Do not take more than the indicated dose. Follow the instructions carefully and do not take more than 15 lozenges a day (24 hours).
If after 9 months of treatment you still feel the need to use this medicine, you should consult a doctor.
Children and young people
Young people 12 – 17 years
Nicorette Fruit should only be used after prescribing by healthcare professionals.
Children under 12 years
This medicine should not be used by children under 12 years of age.
Instructions for use
This medicine is used in the oral cavity. The lozenge should be placed in the mouth where it can be dissolved and release the nicotine that is absorbed through the oral mucosa to the body.
Put a lozenge in your mouth and periodically move it from one side of your mouth to the other until it has completely dissolved. This usually takes less than 20 minutes. Do not chew the lozenge or swallow it whole. You should not eat or drink while you have the lozenge in your mouth.
If you are tempted to start smoking again
Talk to your healthcare provider about you
- is worried that you might start smoking again
- find it difficult to completely stop using the lozenges
If you start smoking again, you can get advice on how to get the best results from your next treatment with nicotine replacement therapy.
If you take more Nicorette Fruit than you should
You can get too much nicotine if you smoke while using Nicorette Fruit.
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor or hospital immediately for risk assessment and advice.
Nicotine doses tolerated by adult smokers during treatment can cause severe poisoning symptoms in children and can be fatal.
The symptoms of overdose are nausea, vomiting, increased salivation, stomach 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 or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 difficulty sleeping
- Increased appetite or weight gain
- Depression
- Smoke extraction
- Decreased heart rate
- Bleeding gums or cold sores
- Dizziness or fainting
- Cough, sore throat, stuffy or runny nose
- Constipation
If you notice any of the following serious side effects, stop taking Nicorette Frukt and contact a doctor immediately, as they may be signs of a severe allergy ( reported: occurs in an unknown number of users):
- hives (a skin condition characterized by itchy raised or red spots)
- swollen face, tongue or throat
- breathing difficulties
- difficulty swallowing
Most side effects occur at the beginning of use. During the first days of treatment, irritation of the mouth and throat may occur, but most users get used to continued use.
Other side effects that may occur:
Very common: may affect more than 1 user in 10:
- Cough
- Headache
- Hiccup
- Nausea
- Irritation in throat, mouth or tongue
Common: may affect up to 1 in 10 users :
- Local effects such as burning sensation, inflammation in the mouth, altered taste experience
- Feeling of cold, heat or stinging sensation in the skin
- Dry mouth or increased salivation
- Stomach upset
- Pain or discomfort in the abdomen
- Vomiting, flatulence or diarrhea
- Heartburn
- Fatigue
- Hypersensitivity ( allergy )
Uncommon side effects: may affect up to 1 in 100 people:
- Nasal congestion, sneezing
- Breathing with wheezing (bronchial spasm), difficulty breathing ( dyspnoea ), feeling of tightness in the throat
- Redness of the skin (swelling) or increased sweating
- Stinging in the mouth, inflammation of the tongue, cold sores, damage to the oral mucosa or voice changes, pain in the mouth and throat, belching
- Palpitations, increased heart rate, hypertension
- A rapid and irregular heartbeat that can be treated with appropriate medication
- Skin rash and / or itching
- Abnormal dreams
- Discomfort and pain in the chest
- Feeling weak, feeling sick
Rare side effects: may affect up to 1 in 1000 people:
- Difficulty swallowing, decreased sensitivity in the mouth
- Nausea
Has been reported: occurs in an unknown number of users:
- Blurred vision, increased tear production
- Dryness in the throat, stomach upset, pain in the lips
- Reddening of the skin
How to store Nicorette Fruit
- 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 container and on the outer carton after “EXP. that ”. The expiration date is the last day of the specified month.
- Store in the original package. Moisture sensitive.
- Do not reuse the container for anything else as it may contain lozenge dust that can cover objects placed in the jar with a fine coating.
- 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
The active substance is nicotine. Each lozenge contains 2 mg or 4 mg of nicotine (in the form of nicotine resinate).
The other ingredients are
- lozenge core: mannitol (E421), xanthan gum, tutti frutti flavor (contains traces of sulphites), gum arabic (E414), anhydrous sodium carbonate (E500) (i), sucralose (E955), acesulfame potassium (E950), magnesium stearate (E470)
- coating: hypromellose (E464), tutti frutti taste, titanium dioxide (E171), sucralose (E955), microcrystalline cellulose (E460), potassium aluminum silicate (E555), acesulfame potassium (E950), polysorbate 80 (E433)
Nicorette Fruit lozenges are sugar free.
What the medicine looks like and contents of the pack
An oval, white to off-white lozenge embossed with an “n” on one side and “2” or “4” on the other side. The size of the lozenge is approximately 14 x 9 x 7 mm.
Pack sizes: Each plastic container contains 20 lozenges. Packages may contain 1, 4, or 8 containers.
Not all pack sizes may be marketed.