What is Nicorette Microtab and when is it used?

Nicorette Microtab is recommended as a support when trying to quit smoking.

Nicorette Microtab with original flavor is a nicotine-containing sublingual tablet, i. a tablet that is placed under the tongue, where it slowly releases its active ingredient, nicotine. With this dosage form, the nicotine is mainly absorbed through the oral mucosa, while a smaller part is swallowed. Nicotine is the addictive component in tobacco smoke and is responsible for the various withdrawal symptoms associated with smoking cessation. Administering nicotine with Nicorette Microtab reduces withdrawal symptoms and makes it 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) over a period of time, experience has shown that you will find it easier to gradually reduce the number of sublingual tablets and later give them 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 are taking Nicorette Microtab as part of a cessation cure, you should stop smoking completely, as if you continue smoking unabated, there is a risk of side effects, including for the heart and circulatory system, due to higher nicotine levels than with normal smoking.

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

Nicorette Microtab with original flavor is not a luxury food. It may take a few days to get used to the taste of Nicorette Microtab with Original Flavor.

When must Nicorette Microtab not be used?

Nicorette Microtab 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 Microtab should not be used if there is a known hypersensitivity to nicotine or other ingredients in the Microtab.

When should you be careful when using Nicorette Microtab?

If you have any medical condition, chronic throat disease, or any of the following conditions, 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.

Smoking addicts immediately (less than four weeks) after a heart attack, with unstable or worsening angina, severe cardiac arrhythmia, uncontrolled high blood pressure or recent stroke should only use Nicorette Microtab under medical supervision. In these cases, the use of the drug should only be considered if smoking cessation is not possible without medical support. 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!).

One Smoking cessation, with or without Nicorette Microtab, may alter 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.

This medicinal product contains 84.5 mg of cyclodextrin per sublingual tablet.

Can Nicorette Microtab be used during pregnancy or breastfeeding?

Smoking cessation is the single most effective 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 Microtab after consulting a doctor, pharmacist or druggist.

No form of nicotine should be taken/used while breastfeeding. If smoking cessation is not achieved, Nicorette Microtab should only be used in breast-feeding smokers after consulting a doctor, pharmacist or druggist. Should the use of Nicorette Microtab become necessary, Nicorette Microtab 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 Microtab?

Nicorette Microtab is intended for adults aged 18 and over. For young people under the age of 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.

Dosage

The nicotine sublingual tablets are placed under the tongue, where they slowly dissolve over about 30 minutes. They must not be swallowed or chewed. Mouth and throat irritation may occur during the first few days of treatment. Almost all patients get used to these sensations after the first few days.

In the beginning, one tablet should be taken every hour to two hours; 8-12 tablets is the appropriate daily dose for most smokers to achieve effective control of withdrawal symptoms.

If you are heavily dependent on nicotine and cannot stop smoking with one 2 mg tablet every hour, you should increase the dose to 2 sublingual tablets of 2 mg per intake and thus achieve a daily dose of 16-24 2 mg sublingual tablets . Do not take more than 30 sublingual tablets a day. After 8 weeks, it's time to start gradually cutting back on nicotine. For the next two weeks, reduce the number of tablets per day by half. Stop treatment after the next two weeks if you managed to get the dose down to zero on the last day. The maximum duration of treatment is three months.

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 Microtab have?

In principle, Nicorette Microtab can cause the same side effects as other dosage 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.

Very common (affects more than 1 in 10 people)

Headache, hiccups, cough, throat irritation, nausea, mouth and throat sores.

Common (affects 1 to 10 users in 100)

Increased hypersensitivity reactions, taste disturbances, sensory disturbances, vomiting, indigestion, intestinal gas, abdominal pain, diarrhea, burning or dryness in the mouth salivation, inflammation of the oral mucosa, tiredness.

Uncommon (affects 1 to 10 users in 1000)

Abnormal dream, palpitations, strong/rapid heartbeat, flushing, high blood pressure, difficulty breathing, sneezing, stuffy nose, pain in the mouth, tightness in the throat, inflammation of the tongue, belching, numbness in the mouth, increased sweating, itching, rash, hives, weakness, feeling unwell, scaling of the oral mucosa. Voice changes, chest pain and discomfort.

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

Difficulty swallowing, nausea, decreased sensitivity in the mouth.

Clear vision, increased tear production, allergic reactions, dry throat, gastrointestinal problems, lip pain, swelling of the face/neck and reddening of the skin have also been reported.

Persistent nicotine addiction can occur.

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.

Overdose

Overdose can occur if you use other forms of nicotine at the same time as Nicorette Microtab treatment (e.g. if you continue to smoke cigarettes).

In the event of an overdose, the signs are the same as those of acute nicotine poisoning. The following occur: nausea, vomiting, salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disorders and pronounced weakness. 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 Microtab, or if you have used more Nicorette Microtab 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.

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 Microtab, nicotine can lead to life-threatening symptoms of poisoning in children. Therefore, Nicorette Microtab must be kept and disposed of out of the reach of children at all times.

Shelf life

The drug may only be used up to the date marked "EXP" (= expiry: month/year) on the container.

Storage Instructions

Nicorette Microtab should be stored in the closed original packaging at room temperature (15 - 25 °C) and out of the reach of children.

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

What does Nicorette Microtab contain?

Nicorette Microtab with original flavor are sublingual tablets containing nicotine.

Active ingredients

Nicotine as nicotine-β-cyclodextrin

1 Nicorette 2 mg Microtab Original-Aroma sublingual tablet contains 17.1 mg nicotine beta-cyclodextrin equivalent to 2 mg nicotine.

Excipients

Betadex (E 459) (β-cyclodextrin), magnesium stearate, crospovidone, colloidal

Silicon dioxide.

Approval number

55372 (Swissmedic).

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

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

Pack sizes

Nicorette Microtab with Original Flavor: Packages with 100 sublingual tablets of 2 mg.

Authorization holder

Janssen-Cilag AG, Zug, ZG.

This leaflet was last checked by the Medicines Agency (Swissmedic) in November 2022.