What is Nicorette Kaudepot and when is it used?

Nicorette Kaudepot is a nicotine-containing chewing depot. It is recommended as a support when trying to quit smoking or to reduce cigarette consumption as a first step.

By chewing, nicotine is released for about 30 minutes. Nicotine is the addictive component in tobacco smoke and is responsible for the various withdrawal symptoms associated with smoking cessation. By administering nicotine with Nicorette Kaudepot, these withdrawal symptoms are reduced and it is easier for smokers to give up cigarettes. This roughly doubles the chances of successfully quitting smoking.

Once you have acquired new habits (substitute actions for smoking) after a while, experience has shown that you will find it easier to gradually get by with less Nicorette Chewing Depot and later to give up entirely. Health damage caused by the tar and carbon monoxide content in tobacco smoke is avoided.

What should be considered?

Your motivation and willpower are decisive for the success of the treatment.

If you use Nicorette chewing depot to reduce cigarette consumption, there is probably no risk of higher nicotine levels than with regular smoking if Nicorette chewing depot is only used during the smoke-free intervals.

If you use Nicorette Kaudepot 2 mg as part of a cessation cure or in combination with the Nicorette Invisi depot plaster, you should stop smoking completely, as continuing to smoke without reducing the risk of side effects, including for cardiovascular system and the risk of maintaining nicotine dependence due to higher nicotine levels than with regular smoking.

It is therefore important that you are strongly motivated to quit smoking before starting Nicorette treatment. Professional smoking advice increases the chances of quitting successfully.

Nicorette with original aroma, Nicorette Freshfruit and Nicorette Polar Mint Kaudepots are not stimulants. It may take a few days to get used to the taste of Nicorette Original Flavor. Nicorette Freshfruit contains peppermint oil, levomenthol and fruit flavors, Nicorette Polar Mint contains peppermint oil and levomenthol.

Nicorette with Original-Aroma chewing depots are sweetened with sorbitol, Nicorette Freshfruit and Nicorette Polar Mint chewing depots with xylitol. This is why diabetics can also chew Nicorette with original flavor, Nicorette Freshfruit and Nicorette Polar Mint (see « What does Nicorette Kaudepot contain?»).

When must Nicorette Kaudepot not be used?

Nicorette Kaudepot must not be used by non-smokers and children under the age of 12! For young people under 18 and over 12 years of age, the drug should only be used if they are heavily dependent on nicotine and only after consultation with a doctor, pharmacist or druggist. Nicorette Kaudepot should not be used if there is a known hypersensitivity to nicotine or other ingredients in the Kaudepot.

When is caution required when using Nicorette Kaudepot?

If you suffer from health disorders, chronic throat diseases or you have one of the following diseases, you should you carefully discuss the benefits and risks with your doctor before starting the treatment program with Nicorette:

Kidney and liver disease, inflammation of the esophagus or stomach and intestinal ulcers, hyperthyroidism, pheochromocytoma (adrenaline-producing tumor of the adrenal gland), diabetes.

Heart disease: Dependent smokers immediately (less than 4 weeks) after a heart attack, with unstable or worsening angina pectoris, severe cardiac arrhythmia, uncontrolled high blood pressure or recent stroke should only use Nicorette Kaudepot under medical supervision use. In these cases, the use of the preparation should only be considered if smoking cessation is not possible without the support of medication. If new cardiovascular symptoms develop or existing symptoms worsen (chest pain, irregular heart rate, shortness of breath), a doctor should be consulted.

This medicine can impair your ability to react, the ability to drive and the ability to use tools or machines!

Tell your doctor, pharmacist or druggist if you:

• suffer from other diseases,
• have allergies or
• take other medicines (including those you bought yourself!).

The warnings and precautionary measures that apply to the individual preparations also apply to the combined treatment of depot plaster and chewing depot.

Smoking cessation with or without Nicorette Kaudepot may change the response to concomitant medicines for asthma, cardiac arrhythmia, severe pain, mood disorders, Alzheimer's disease, Parkinson's disease, restless leg syndrome or diabetes (insulin). If necessary, your doctor will prescribe a dose adjustment of the medicines concerned.

Can Nicorette Kaudepot be used during pregnancy or breastfeeding?

Smoking cessation is the most effective single measure to improve the health of the pregnant smoker and the baby. The sooner you give up nicotine, the better.

No forms of nicotine should be used during pregnancy. Nicotine, and especially smoking, can seriously endanger the health of the fetus and child and should be discontinued during pregnancy. Pregnant women who smoke should only use Nicorette after consulting a doctor, pharmacist or druggist.

No form of nicotine should be taken/used while breastfeeding. If smoking cessation is not achieved, Nicorette Kaudepot should only be used in breast-feeding smokers after consulting a doctor, pharmacist or druggist. Should the use of Nicorette Kaudepot be necessary, Nicorette Kaudepot should be used immediately after breastfeeding and as much time as possible should be allowed before the next breastfeeding (at least 2 hours).

How do you use Nicorette Kaudepot?

Nicorette Kaudepot is intended for adults aged 18 and over. For young people under the age of 18 and over 12, the preparation should only be used if they are heavily dependent on nicotine and only after consultation with a doctor, pharmacist or druggist.

The starting dose should be individualized based on nicotine dependency. 8 - 12 Nicorette chewing depots of the appropriate dosage strength per day should usually be sufficient.

If you are heavily addicted to nicotine, i. smoke the first cigarette within 20 minutes of getting up and smoke more than 20 cigarettes a day, start treatment with Nicorette Kaudepot 4 mg. In the case of weak to moderate nicotine dependence, Nicorette Kaudepot 2 mg is usually sufficient. No more than 15 chewing depots should be chewed per day.

If you feel like smoking, chew a Nicorette Kaudepot very slowly for about 30 minutes. Take regular breaks from chewing and let the chewed nicotine soak into your oral mucosa. The chew depot should be chewed until a strong taste or a slight burning sensation is experienced. The chewing depot should then be pushed into the cheek and left there until the taste and/or burning sensation has subsided. Then continue chewing slowly and repeatedly. Avoid chewing too quickly and too intensively so that too much nicotine is not released too quickly. You should not have any drinks immediately before or during chewing, as this will greatly reduce the effect of the nicotine released.

Weaning

Most smokers require 8-12 chews of the appropriate dosage per day. Up to 15 pieces of Nicorette Kaudepot can be chewed as required. After 8 weeks, it's time to start gradually cutting back on nicotine. In the following 2 weeks, reduce the number of chewing depots per day by half. Stop treatment after the next 2 weeks if you managed to get the dose down to 0 on the last day. The duration of treatment is individual, but is a maximum of 3 months.

Combination with Nicorette Invisi Depot Patch (15 mg or 10 mg)

In the case of strong or uncontrollable cravings to smoke or in people who have relapsed under therapy with a single nicotine preparation it makes sense to use Nicorette 2 mg Kaudepot in addition to Nicorette Invisi depot plaster.

Nicorette Kaudepot 4 mg must not be combined with the depot plasters. Persons with severe cardiovascular disease or a history of stroke, heart attack, angina pectoris, cardiac arrhythmia, coronary artery surgery (e.g. bypass) or uncontrolled high blood pressure not more than 4 weeks ago may only use the combination therapy after consulting a doctor .

The depot patch is worn daily for 16 hours according to the package insert. If there is a craving for cigarettes or if withdrawal symptoms are felt, Nicorette Kaudepot 2 mg can also be chewed (maximum 15 per day). The Nicorette Invisi depot patch at 15 mg/16 hours is used for the first 8 weeks, then the depot patch at 10 mg/16 hours for 4 weeks. The combination of depot patch and chewing depot at 2 mg may be used for a maximum of 3 months. The chewing depots of 2 mg can then be used alone for up to a total of 12 months (reduce the number of chewing depots per day slowly to 0).

Reduction of cigarette consumption

The chewing depots are used during the smoke-free intervals in order to extend them as long as possible and thus reduce cigarette consumption as much as possible. Never chew chewing depots and smoke at the same time or chew chewing depots and smoke in direct succession without a break. If you have not achieved a significant reduction in your daily cigarette consumption after 6 weeks, you should seek advice from your doctor.

You should try to quit smoking as soon as you feel ready, but no later than 6 months after starting treatment. If you still cannot stop smoking 9 months after starting treatment, you should see your doctor.

The recommended duration of treatment with Nicorette Kaudepot is a maximum of 12 months.

Unused chewing depots should be saved as the urge to smoke may suddenly reappear.

Follow the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Nicorette Kaudepot have?

Nicorette Kaudepot can cause the same undesirable effects as other forms of nicotine. These are generally dose dependent.

Some of the undesirable effects of quitting smoking can be withdrawal symptoms due to reduced nicotine intake. These include irritability, aggression, impatience, frustration, anxiety, restlessness, difficulty concentrating, waking up late at night, trouble sleeping, increased appetite, weight gain, constipation, feeling depressed, craving to smoke, slow heart rate, bleeding gums, dizziness, light-headed, cough, sore throat, mouth ulcers, stuffy or runny nose. If you stop smoking, canker sores can also develop. The reason for this is not known.

Most side effects occur during the first few weeks after starting Nicorette treatment. In many cases, incorrect chewing technique is the reason.

The undesirable reactions in a combination treatment of depot plaster and chewing depot do not differ significantly from those of monotherapy with one of the two preparations. The frequency of occurrence corresponds to that reported for each of the individual preparations.

At the beginning of Nicorette treatment, the oral mucosa may become somewhat irritated, or hiccups and nausea caused by chewing too quickly may occur. In these cases, stop chewing immediately and leave the chewing depot in a cheek pouch for 1 to 2 minutes. The release of nicotine is thus interrupted and the irritation subsides quickly. Then chew again very slowly with more breaks.

Very common (affects more than 1 user in 10)

Headache, gastrointestinal problems, hiccups, nausea, sores in the mouth and throat, pain in the chewing muscles, Cough, irritation in the throat.

Common (affects 1 to 10 users in 100)

Hypersensitivity reactions, sensory disturbances, taste disturbances, vomiting, indigestion, intestinal gas, abdominal pain, dry mouth, increased salivation, inflammation of the oral mucosa and diarrhoea, burning sensation in the mouth/lips, tiredness.

Uncommon (affects 1 to 10 users in 1000)

Abnormal dreams, palpitations, racing heart, flushing, high blood pressure, difficulty breathing, voice changes, sneezing, stuffy/runny nose, Pain in the mouth, tightness in the throat, belching, inflammation of the tongue, peeling of the oral mucosa, increased sweating and itching, skin rash, reddening of the skin, hives, abnormal sensations in the mouth, weakness, discomfort, pain and discomfort in the chest.

Rare (affects 1 to 10 users in 10,000)

Decreased sensitivity in the mouth, difficulty swallowing, nausea.

Allergic reactions, blurred vision, increased lacrimation, dry throat, lip pain and swelling of the face/neck have also been reported.

Persistent nicotine addiction can occur.

The chew deposit can stick to dentures and in rare cases damage them.

Overdosing can occur when nicotine replacement products are not used as recommended, for example when multiple chews are mistakenly chewed at the same time or in rapid succession, or when smoking occurs at the same time. In the event of an overdose, the symptoms correspond to those of acute nicotine poisoning. The following occur: nausea, vomiting, salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disorders and pronounced weakness. In extreme cases, the following can follow: drop in blood pressure, weak, irregular pulse, shortness of breath, fainting, circulatory collapse and generalized seizures. In this case, the nicotine supply must be stopped immediately.

If you suspect nicotine poisoning in a child, or if a child has taken Nicorette Kaudepot, or if you have used more Nicorette Kaudepot than recommended, contact your doctor or go to the nearest hospital straight away. Doses that are well tolerated by adult smokers can cause severe and possibly life-threatening symptoms of intoxication in children.

If you get any side effects, talk to your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be considered?

Nicotine is a highly effective substance. Even at a dosage that is tolerable for adults during treatment with Nicorette Kaudepot, nicotine can lead to life-threatening symptoms of poisoning in children. Nicorette Kaudepot must therefore be kept out of the reach of children at all times and disposed of.

The medicinal product may only be used up to the date marked «EXP» on the container.

Storage instructions

The chewing depots should be stored at room temperature (15 - 25 °C) and out of the reach of children.

The chewing depots with the flavor variant Polar Mint should be stored in the original packaging, protected from light, at room temperature (15 - 25 °C) and out of the reach of children.

Further information

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What does Nicorette Kaudepot contain?

Nicorette Kaudepot is chewing gum containing nicotine.

Active ingredients

Nicotine (in the form of a resinate)

Nicorette with original flavor 2 mg / Nicorette Freshfruit 2 mg / Nicorette Polar Mint 2 mg

1 chewing depot contains: 2 mg nicotine ( in the form of a resinate).

Nicorette with original flavor 4 mg / Nicorette Freshfruit 4 mg / Nicorette Polar Mint 4 mg

1 chewing depot contains: 4 mg nicotine ( in the form of a resinate).

Excipients

Nicorette with original flavor 2 mg

Chewing gum mass, 190 mg (0.46 kcal) sorbitol , flavourings, antioxidant butylated hydroxytoluene (E 321) and other excipients.

Nicorette with original flavor 4 mg

Chewing gum mass, 179 mg (0.43 kcal) sorbitol, flavorings, coloring agent quinoline yellow (E 104), antioxidant butylated hydroxytoluene (E 321 ) and other excipients.

Nicorette Freshfruit 2 mg

Gum mass, 591.5 mg (1.42 kcal) xylitol, flavorings (peppermint oil, levomenthol), antioxidant butylated hydroxytoluene (E 321) and others excipients.

Nicorette Freshfruit 4 mg

Gum mass, 579.5 mg (1.39 kcal) xylitol, flavorings (peppermint oil, levomenthol), coloring agent quinoline yellow (E 104), antioxidant Butylated hydroxytoluene (E 321) and other excipients.

Nicorette Polar Mint 2 mg

Gum mass, 591.5 mg (1.42 kcal) xylitol, flavorings (peppermint oil, levomenthol), antioxidant butylhydroxytoluene (E 321) and other excipients.

Nicorette Polar Mint 4 mg

chewing gum mass, 579.5 mg (1.39 kcal) xylitol, flavorings (peppermint oil, levomenthol), coloring quinoline yellow (E 104), Antioxidant butylated hydroxytoluene (E 321) and other excipients.

Approval number

40580 (Swissmedic).

Where can you get Nicorette Kaudepot? What packs are available?

In pharmacies and drugstores, without a doctor's prescription.

Nicorette with original aroma / Nicorette Freshfruit / Nicorette Polar Mint

Packages with 30 and 105 chewing depots of 2 mg and 4 mg

Nicorette Freshfruit / Nicorette Polar Mint

Packs with 210 chewing depots of 2 mg

Authorization holder

Janssen-Cilag AG, Zug, ZG.

This leaflet was last checked by the medicines authority (Swissmedic) in October 2019.