Nicorette Coolmint Lozenges 4 mg tablets 20 pcs.

Nicorette Coolmint Lozenges 4 mg tablets 20 pcs.

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Description

Nicorette Coolmint Lozenges 4 mg tablets 20 pcs.

The main features of the product
For people who smoke no more than 20 cigarettes per day, mint flavor
Description
4 mg nicotinum
lozenges

Alleviation of nicotine craving and withdrawal symptoms occurring after immediate or gradual cessation of smoking.

OTC - Medication dispensed without a prescription.
Storage and use
Application to the oral mucosa.

To dissolve in the mouth. Do not bite or swallow the tablet.

Read the leaflet before using the drug.
Storage: Store at ambient temperature.
Packaging: blister pack.
Composition
Each lozenge tablet contains 4 mg nicotine, in the form of nicotine with cationite, E421, xanthan gum, Winterfresh RDE4-149 spray-dried, E414, E500(i), E950, E470b, E464, E171, E460, E555, E433
Manufacturer
Johnson & Johnson Ltd.
Manufacturer's address
Responsible party
McNeil AB,
251 09 Helsingborg,
Sweden

Manufacturer
McNeil AB,
Norrbroplatsen 2,
251 09 Helsingborg,
Sweden
Safety warning
Keep the drug out of sight and reach of children.

Do not use more than 15 lozenges per day.

Persons aged 12 - 17 years should use Nicorette Coolmint only on the recommendation of a doctor.
Number of units
Number of units: 20
General information
Carefully read the leaflet before taking the drug, as it contains important information for the patient.
Always take this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If, after 9 months, you continue to have difficulty stopping smoking without the help of Nicorette Coolmint, you should contact your doctor.
Table of contents of the leaflet
Table of contents of the leaflet
1 What is Nicorette Coolmint and what is it used for?
2. important information before using Nicorette Coolmint
3 How to use the drug Nicorette Coolmint
4 Possible side effects
5 How to store the drug Nicorette Coolmint
6. package contents and other information
Description and use
1 What is the drug Nicorette Coolmint and for what purpose it is used.

The drug is used to relieve withdrawal symptoms and reduce nicotine cravings that occur when trying to stop smoking or reduce the number of cigarettes smoked when trying to quit. This treatment is for adult smokers aged 18 and older.

Nicorette Coolmint, 2 mg, lozenges are suitable for smokers with low nicotine dependence, i.e., who smoke their first cigarette during the day more than 30 minutes after waking up or who smoke 20 or fewer cigarettes per day.

The drug Nicorette Coolmint, 4 mg, lozenges is suitable for smokers with a high degree of nicotine dependence, i.e. who smoke their first cigarette during the day within 30 minutes of waking up or who smoke more than 20 cigarettes per day.

The drug can help you stop smoking immediately or reduce the number of cigarettes you smoke before finally quitting. If the patient thinks he can stop smoking immediately, he should do so. However, if he or she feels that this will be too difficult, he or she may want to reduce the number of cigarettes smoked as a first step before achieving complete abstinence. More detailed information is presented in section 3 "How to use Nicorette Coolmint".

Nicorette Coolmint relieves withdrawal symptoms that occur after smoking cessation, including nicotine craving. When the body's supply of nicotine from tobacco is abruptly discontinued, various types of unpleasant sensations, known as withdrawal symptoms, develop, such as irritability, feelings of anger or depression, anxiety, restlessness, decreased attention, increased appetite or weight gain, a strong desire to smoke a cigarette (hunger), awakenings at night or sleep disturbances. The nicotine in Nicorette Coolmint can prevent or reduce the severity of these unpleasant sensations and reduce the desire to smoke a cigarette.

To increase the chance of a successful outcome of a smoking cessation attempt, you should also seek psychotherapeutic advice and support.
How to use the drug
3 How to use the drug Nicorette Coolmint

Always take this medication as described in the leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist. How you take Nicorette Coolmint depends on whether you:
(a) quits smoking immediately
(b) quits smoking gradually

Adults (18 years and older)

(a) Immediate smoking cessation
Refers to immediate smoking cessation and the use of lozenges to reduce cigarette cravings.
- Begin treatment with 8 to 12 lozenges per day. As soon as the craving for a cigarette arises, place one lozenge tablet in the mouth and wait for it to dissolve.
- Use suction tablets in this way for up to 6 weeks, and then gradually reduce the number of tablets used per day.
- When the patient uses only 1 or 2 lozenges per day, he or she should discontinue them completely. After completely stopping smoking, the patient may sometimes feel a sudden urge to smoke a cigarette. In this case, the lozenge tablet can be used again.

(b) Gradual smoking cessation
Refers to starting to gradually replace some cigarettes with a lozenge tablet. Once this is achieved, smoking cigarettes are completely discontinued with the use of a lozenge tablet. Finally, the use of lozenges is also discontinued.
If you feel a strong desire to smoke a cigarette, use a Nicorette Coolmint lozenge tablet instead of a cigarette to control nicotine craving. Reduce the number of cigarettes smoked per day to as few as possible. If the patient is unable to reduce the number of cigarettes smoked per day after 6 weeks, he should seek advice from the relevant medical professional.
As soon as the patient feels able to do so, he should stop smoking cigarettes completely. He should then follow the instructions for immediate smoking cessation outlined above. The patient should do this as soon as possible. If the attempt to completely stop smoking is unsuccessful within 6 months of starting the drug, consult an appropriate health care professional.

Do not exceed the specified dose. Follow instructions strictly and do not use more than 15 lozenges per day (24 hours).

If you feel the need to use the drug for more than 9 months in total, you should consult your doctor.

Children and adolescents

Adolescents aged 12-17 years
Nicorette Coolmint should be used only on the recommendation of a doctor.

Children under 12 years of age
The drug should not be administered to children under 12 years of age.

The drug is intended to be administered on the mucous membrane of the mouth. Place it in the mouth and wait for it to dissolve and release nicotine so that it can be absorbed into the body through the membrane lining the mouth.
Place one tablet in the mouth and move it occasionally from one side of the mouth to the other until it is completely dissolved. This should take less than 20 minutes. The lozenge tablet should not be chewed or swallowed whole. Do not eat or drink while the lozenge tablet is in the mouth.

How to deal with the temptation to relapse
If the patient:
- is worried that he or she may start smoking again,
- finds it difficult to stop taking the lozenges completely, he or she should seek advice from an appropriate health care professional. If the patient nevertheless starts smoking again, the relevant medical staff representative can advise him on how to get the best results from the use of subsequent courses of nicotine replacement therapy (NTZ).

Taking more than the recommended dose of Nicorette Coolmint
If you smoke cigarettes while taking Nicorette Coolmint, you may experience a nicotine overdose. If the drug is taken by a child or if you take a higher dose of Nicorette Coolmint than recommended, contact your doctor immediately or go to the nearest hospital. The doses of nicotine tolerated during treatment by adult smokers can lead to severe symptoms of intoxication and can prove fatal in children.
Symptoms of overdose include nausea (nausea), vomiting, increased saliva, abdominal pain, diarrhea, excessive sweating, headache, dizziness, hearing impairment and significant weakness. In high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, difficulty breathing, exhaustion, vascular collapse and generalized convulsions.

If you have any further concerns about the use of this drug, ask your doctor or pharmacist.
How to store the drug
5 How to store the drug Nicorette Coolmint

- Store the drug out of sight and reach of children.
- Do not use this drug after the expiration date on the container and on the outer packaging. The expiration date means the last day of the given month.
- Polypropylene container: Store in original container to protect from moisture.
- Blister: No special recommendations for storage conditions.
- Do not use the drug container for storing anything else, as tablet dust may remain in the container, which may coat other items put into the container.
- Medicines should not be disposed of down the drain or in household waste containers. Ask your pharmacist how to dispose of medicines you no longer use. Doing so will help protect the environment.
Possible side effects
4 Possible side effects
Like any drug, this medication may cause side effects, although they will not occur in everyone.

Actions related to smoking cessation (nicotine withdrawal).
Some of the side effects that occur when quitting smoking may be withdrawal symptoms caused by a reduction in the administered dose of nicotine.

Possible actions include:
- irritability, aggression, impatience or frustration,
- feelings of restlessness, motor restlessness or difficulty concentrating,
- waking up during the night or sleep disturbances,
- increased appetite or weight gain,
- malaise,
- desire to smoke a cigarette (nicotine craving),
- decreased heart rate,
- bleeding gums or ulceration of the mouth,
- dizziness or a feeling of emptiness in the head,
- cough, sore throat, blocked nose or nasal leakage,
- constipation.

If you notice any of the following severe side effects, you should stop taking Nicorette Coolmint and contact your doctor immediately, as they may be signs of severe sensitization (frequency is unknown: frequency cannot be determined from available data):
- urticaria (a skin disorder characterized by the presence of itchy, raised or red patches)
- swelling of the face, tongue or throat
- difficulty breathing
- difficulty swallowing

Most side effects occur in the early phase of drug use. There may be irritation in the mouth and throat during the first few days of treatment, but most patients adapt to treatment with the disappearance of this symptom as therapy continues.

Other side effects that may occur:

Very common: may occur in more than 1 in 10 patients:
- Cough,
- headache,
- hiccups,
- nausea (nausea),
- irritation of the throat, mouth and tongue.

Frequent: may occur in no more than 1 in 10 patients:
- local reactions such as burning sensation, stomatitis, changes in taste sensation,
- cold, warm and tingling sensations on the skin,
- dry mouth or increased saliva production,
- a feeling of indigestion,
- pain or discomfort in the abdominal cavity,
- vomiting, bloating or diarrhea,
- heartburn,
- feeling of fatigue,
- hypersensitivity (allergy)

Uncommon: may occur in no more than 1 in 100 patients:
- nasal complaints such as obstruction, sneezing,
- wheezing (bronchospasm) or feeling more labored breathing than normal (shortness of breath), tightness in the throat,
- redness of the skin or increased sweating,
- oral reactions such as a tingling sensation in the mouth, inflammation of the tongue, ulceration of the mouth, damage to the oral mucosa or a change in the sound of the voice, pain in the mouth and throat, belching,
- palpitations, accelerated heart rate, hypertension,
- rapid and irregular heartbeat, which can be treated with appropriate therapy,
- skin rash and/or itching,
- unusual dreams,
- discomfort and pain in the chest,
- weakness, malaise.

Rare: may occur in no more than 1 in 1,000 patients:
- difficulty swallowing, decreased sensation in the mouth,
- vomiting reflex.

Unknown: frequency cannot be determined from available data:
- blurred vision, increased tear production,
- Dryness in the throat, discomfort in the stomach, pain in the lips,
- redness of the skin.

Reporting of side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist

Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl. Adverse reactions can also be reported to the responsible party. By reporting side effects, more information on the safety of the drug can be gathered.
Package contents and other information
6 Contents of the package and other information

What the drug Nicorette Coolmint contains
The active substance is nicotine. One lozenge tablet contains 2 mg or 4 mg of nicotine (in the form of nicotine with cationite).
The other ingredients are: tablet core - mannitol (E 421), xanthan gum, Winterfresh RDE4-149 spray-dried (contains gumarabic (E 414) and menthol, peppermint and eucalyptus flavors), sodium carbonate anhydrous (E 500)(i), sucralose (E 955), acesulfame potassium (E 950), magnesium stearate(E 470b); Envelope - hypromellose (E 464), Winterfresh RDE4-149 (contains menthol, peppermint and eucalyptus flavors), titanium dioxide (E 171), sucralose (E 955), Sepifilm Gloss (contains hypromellose (E 464), microcrystalline cellulose (E 460), potassium aluminum silicate (E 555) and titanium dioxide (E 171), acesulfame potassium (E 950), polysorbate 80 (E 433).

Nicorette Coolmint lozenges do not contain sugar.

What Nicorette Coolmint looks like and what the packaging contains.
An oval-shaped, white to almost white-colored lozenge tablet, marked with "n" on one side and "2" or "4" on the other side.

Package sizes:
Each PP container contains 20 sucking tablets. Packages may contain 1, 4 or 8 containers.
Each cardboard box contains 2 blister packs (12 tablets each) of sucking tablets. With or without a case. Not all package sizes must be on the market.

This medicinal product is authorized in the member countries of the European Economic Area under the following names:
Austria, Finland Nicorette Icemint
Belgium, Luxembourg, Germany Nicorete Freshmint
Czech Republic Nicorette Mint
Denmark, Iceland Nicorette Cooldrops
Ireland Nicorette Cools
Norway Nicorette
Poland Nicorette Coolmint
Sweden Nicorette Pepparmint
Important before use
2 Important information before using Nicorette Coolmint

When not to use Nicorette Coolmint:
- if the patient is allergic to nicotine or any of the other ingredients of this drug (listed in section 6).
- if the patient is less than 12 years old.
- if the patient has never smoked.

Warnings and precautions
Contact your doctor if you have any of the conditions listed below. It is possible that the patient may be able to use Nicorette Coolmint, but must first consult a doctor if:
- a recent history of heart attack or stroke
- chest pain (unstable angina) or symptoms of angina at rest
- heart disease that affects the rate or regularity of your heart rhythm (arrhythmia)
- high blood pressure that is not balanced by medication
- the ever occurrence of allergic reactions such as swelling of the lips, face and throat (angioedema) or an itchy rash (urticaria). NTZ use can sometimes provoke this type of reaction
- severe or moderately severe liver disease
- severe kidney disease
- diabetes
- hyperthyroidism
- adrenal tumor (pheochromocytoma of the adrenal glands)
- peptic ulcer disease of the stomach or duodenum
- esophagitis

The drug should not be used by non-smokers.

Children
The correct adult dose, given to children, can cause serious poisoning and even lead to death. It is therefore important to keep the drug Nicorette Coolmint out of sight and reach of children at all times.

Other medications and Nicorette Coolmint
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take. This is especially important if you are using medications containing:
- theophylline in the treatment of asthma
- tacrine in Alzheimer's disease
- clozapine in schizophrenia
- ropinirole in the treatment of Parkinson's disease.

Nicorette Coolmint with food and drink
Do not eat or drink while taking the lozenges.

Pregnancy, breastfeeding and effects on fertility
It is very important to stop smoking during pregnancy, as it can lead to fetal stunting. It can also cause miscarriage or stillbirth. Ideally, a pregnant woman should stop smoking without using nicotine-containing drugs. However, if she fails to do so, she can use the drug Nicorette Coolmint, but only after consulting her pregnancy doctor, general practitioner or a doctor from a center specializing in treating tobacco addiction.

Nicorette Coolmint should not be taken while breastfeeding, as nicotine enters breast milk and can affect the baby. If your doctor prescribes the use of Nicorette Coolmint, the lozenge tablet should be taken immediately after breastfeeding and no later than 2 hours before nursing.

Smoking increases the risk of infertility in men and women. The effect of nicotine on fertility is unknown.

Driving and operating machinery
The effects of the drug on the ability to drive and operate machinery have not been observed.

Nicorette Coolmint contains less than 1 mmol sodium (23 mg) per tablet, that is, the drug is considered "sodium free."
Product identification
Nicorette Coolmint, 2 mg, lozenge tablets
Nicorette Coolmint, 4 mg, lozenge tablets

Nicotinum

Product Details

MCNEIL AB
1 Item

Specific References

EAN13
5909990956333

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