NICORAMA MINT 4 mg MEDICATED CHEWING GUMS

Introduction

Package Leaflet: Information for the User

Nicorama Mint 4mg medicated chewing gum EFG

Nicotine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• Consult your doctor if you continue to use this medicine after 6 months.

Contents of the Package Leaflet

1. What is Nicorama Mint and what is it used for
2. What you need to know before taking Nicorama Mint
3. How to take Nicorama Mint
4. Possible side effects
   1. Storage of Nicorama Mint

1. Package Contents and Additional Information

1. What is Nicorama Mint and what is it used for

Nicorama Mint belongs to a group of medicines used to help you quit smoking.

The nicotine in this medicine relieves nicotine cravings and problems caused by withdrawal from quitting smoking, thus avoiding relapse in motivated smokers. The goal of treatment is permanent tobacco cessation.

When the body suddenly stops receiving nicotine from tobacco, you may experience various discomforts, known as withdrawal symptoms. Using nicotine gum can prevent or alleviate these discomforts and the compulsive desire to smoke, as it provides the body with a small amount of nicotine during the transition period. As you chew the gum, nicotine is slowly released and absorbed in the mouth. Unlike cigarettes, nicotine gum does not contain tar or carbon monoxide, which are harmful.

Nicorama Mint should be used preferably along with a smoking cessation program. Counseling and support usually increase the chances of success in quitting smoking.

2. What you need to know before taking Nicorama Mint

Do not take Nicorama Mint:

• If you are allergic to nicotine or any of the other components of this medicine (listed in section 6).
• If you are under 12 years old.
• If you are a non-smoker.

Warnings and Precautions

Consult your doctor or pharmacist if you have any of the following conditions:

• Heart attackor strokein the last 3 months
• Chest pain(unstable angina) or rest angina
• Heart problemsthat affect heart rate or rhythm
• Uncontrolled high blood pressurewith medication
• Severe or moderate liver problems
• Severe or moderate kidney problems
• Diabetes
• Epilepsy
• Overactivity of the thyroid gland
• Adrenal gland tumor(pheochromocytoma)
• Stomach ulceror duodenal ulcer
• Esophageal inflammation

However, the risk of continuing to smoke is always greater than using nicotine gum.

The gum may stick to dentures and dental bridges and, in some cases, damage them.

Children and Adolescents

An appropriate dose for adults can cause severe poisoning or be fatal in children. Therefore, it is essential to always handle and store nicotine gum out of the sight and reach of children.

Adolescents between 12 and 17 years old should only use this medicine if prescribed by a doctor. This medicine should not be used in children under 12 years old.

Other Medicines and Nicorama Mint

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If you quit smoking and are taking other medicines, your doctor may decide to adjust the dose.

There is no information available on the interactions between nicotine and other medicines. However, apart from nicotine, other substances in cigarettes may have an effect on certain medicines.

Quitting smoking may affect the action of certain medicines, for example:

• Theophylline, used to treat asthma.
• Tacrine, used to treat Alzheimer's disease.
• Olanzapine and clozapine, used to treat schizophrenia.
• Insulin, used to treat diabetes. It may be necessary to adjust the insulin dose.

Using Nicorama Mint with Food and Drinks

You should avoid eating and drinking while you have the gum in your mouth. Drinking coffee, juices, or soft drinks with the gum can reduce the effect of the nicotine. These drinks should be avoided 15 minutes before using the gum.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

It is very important to quit smoking during pregnancy, as it can be harmful to the baby's development. It can also cause premature birth or fetal death. Ideally, you should quit smoking without using nicotine-containing medicines, but if you cannot, nicotine gum should only be used after consulting the doctor treating your pregnancy, your primary care physician, or another doctor specializing in smoking.

Breastfeeding

During breastfeeding, the use of nicotine gum should be avoided, as nicotine passes into breast milk and can affect your baby. If your doctor has recommended the use of nicotine gum, take the gum immediately after breastfeeding.

Fertility

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

Driving and Using Machines

No effects have been observed on the ability to drive and use machines.

Nicorama Mint contains xylitol, butylhydroxytoluene, and sodium.

This medicine may have a mild laxative effect because it contains xylitol.

Caloric value: 2.4 kcal/g of xylitol, corresponding to 0.8 kcal per piece (Nicorama Mint 2 mg and 4 mg).

This medicine may cause local skin reactions (such as contact dermatitis) or irritation to the eyes and mucous membranes because it contains butylhydroxytoluene.

Nicorama Mint contains less than 1 mmol of sodium (23 mg) per unit dose; i.e., it is essentially "sodium-free".

3. How to take Nicorama Mint

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Treatment with Nicorama Mint Gum

The dose of the gum should be chosen based on your nicotine dependence. If you smoke more than 20 cigarettes a day or if you have previously tried to quit smoking with 2 mg gum but were unsuccessful, you should choose the 4 mg gum. In any other case, the 2 mg gum should be used.

Nicotine gum should be taken at times when you would normally have smoked a cigarette, or if you feel a strong desire to smoke. At the start of treatment, you can take 1 piece every 1 to 2 hours. It is necessary to take a sufficient number of pieces every day. The dose is individual, based on your nicotine dependence. In most cases, 8 to 12 pieces are sufficient. To have the greatest chance of success, it is essential not to use a subtherapeutic dose.

Maximum daily dose:

Nicorama Mint 4 mg: 16 pieces per day, corresponding to 64 mg of nicotine per day.

The duration of treatment is individual. Normally, treatment should last at least 3 months, and then the nicotine dose should be gradually reduced. Treatment should end when the dose has been reduced to 1 or 2 pieces per day.

Normally, it is not recommended to use the gum habitually for more than 6 months. In some cases, longer treatments may be necessary to avoid smoking relapse. Leftover gum should be kept, as a strong desire to smoke can arise suddenly. Counseling and support can improve the chances of success.

Chewing Technique

It is essential to use the correct chewing technique. Chew the gum slowly and with pauses; otherwise, you may risk having heartburn and hiccups:

• Chew until the flavor intensifies or you notice a slight burning sensation, then stop chewing.
• Let the gum rest between your cheek and gums until the flavor and burning sensation cease.
• Then, chew slowly again until the flavor intensifies or you notice a slight burning sensation.
• Repeat this chewing procedure for about 30 minutes.

The effects of nicotine only occur after a few minutes, so you should not expect the same rapid satisfaction as smoking.

If you take more Nicorama Mint than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20) indicating the medicine and the amount ingested.

If you smoke while using nicotine gum, you may experience a nicotine overdose. The nicotine doses that adult smokers tolerate during treatment can cause severe poisoning symptoms in children and can have fatal consequences.

Among the symptoms of overdose are: nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disorders, and pronounced weakness. At high doses, these symptoms can be followed by low blood pressure, weak and irregular heart rate, difficulty breathing, extreme fatigue, circulatory collapse, and generalized convulsions.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Nicotine gum can cause the same side effects as nicotine administered by other routes. The side effects depend on the dose you take.

Irritation of the mouth and throat may occur, but most patients get used to it with continued use.

Stop taking this medicine and contact a doctor immediately if you experience any of the following symptoms of a severe allergic reaction(angioedema or anaphylactic reaction), which are rare:

• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Hives, rash, and difficulty breathing

Other side effects that may occur:

Very common side effects(may affect more than 1 in 10 patients):

• Headache
• Cough, throat irritation
• Hiccups, nausea

Common side effects(may affect up to 1 in 10 patients):

• Local effects, such as burning sensation, mouth inflammation, altered taste.
• Dry mouth or increased salivation
• Stomach problems or abdominal pain
• Vomiting, flatulence, or diarrhea
• Fatigue
• Hypersensitivity (allergy)
• Tingling sensation

Uncommon side effects(may affect up to 1 in 100 patients):

• Nasal congestion, sneezing
• Wheezing (bronchospasm), difficulty breathing (dyspnea), sensation of throat tightness
• Redness of the skin (flushing), increased sweating
• Tingling sensation in the mouth, tongue inflammation, oral mucosa lesions, voice changes, mouth and throat pain, belching
• Palpitations (awareness of heartbeats), increased heart rate, high blood pressure
• Rash (including hives) or itching
• Abnormal dreams
• Chest discomfort or pain
• Feeling of weakness, general malaise
• Jaw muscle pain

Rare side effects(may affect up to 1 in 1,000 patients):

• Difficulty swallowing, decreased sensitivity in the mouth
• Hiccups
• Abnormal heart rhythm (atrial fibrillation)

Frequency not known(occurs in an unknown number of patients):

• Blurred vision, increased tear production (lacrimation)
• Dry throat, stomach discomfort, lip pain
• Redness of the skin
• Jaw tension

Symptoms related to smoking cessation

Some of the side effects you experience when quitting smoking may be caused by the reduction of nicotine, known as withdrawal syndrome.

• Irritability, aggression, impatience, or frustration
• Feeling of anxiety, restlessness, or difficulty concentrating
• Waking up at night or sleep disturbance
• Increased appetite or weight gain
• Feeling of depression
• Strong desire to smoke
• Decreased heart rate
• Gum bleeding or mouth ulcers
• Dizziness or feeling of fainting
• Cough, sore throat, nasal congestion, or runny nose
• Constipation

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nicorama Mint

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date shown on the carton and blister after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Nicorama Mint

Nicorama Mint gum does not contain sugar and is available in two presentations: 2 mg and 4 mg.

Nicorama Mint 4mg medicated chewing gum EFG

• The active ingredient is nicotine. One piece contains 4 mg of nicotine in the form of nicotine resin.
• The other ingredients are: gum base (containing butylhydroxytoluene [E321]), xylitol (E967), silica (colloidal, hydrated), magnesium stearate, peppermint flavor, refreshing flavoring agent, sodium carbonate (anhydrous), hypromellose, sodium hydrogen carbonate, levomenthol, titanium dioxide (E171), macrogol, glycerol, potassium acesulfame, talc, sucralose, yellow iron oxide (E172), xanthan gum.

Appearance of the Product and Package Contents

Light yellow, rounded, biconvex, coated, and smooth gum on both sides. Diameter: 15 mm and thickness: 8 mm.

Available in blister packs containing 30, 96, 105, and 204 medicated gum pieces.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Enorama Pharma AB, Södra Förstadsgatan 1, 211 43 Malmö, Sweden

Manufacturer

ABF Pharmaceutical Services GmbH, Brunnerstraße 63/18-19, 1230 Vienna, Austria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Nicotin beta Mint 4 mg wirkstoffhaltiges Kaugummi

Spain Nicorama Mint 4 mg chicles medicamentosos EFG

France Nicotine Enorama Mint 4 mg gomme à mâcher médicamenteuse

Greece Nicobright Mint 4 mg Φαρμακευτικ? μασ?μενο κ?μμι

Poland Nicorama Mint 4 mg guma do zucia, lecznicza

United Kingdom Nicorama Mint 4 mg medicated chewing-gum

Sweden Nicorama Mint 4 mg medicinskt tuggummi

Date of the last revision of this leaflet March 2021