NICORAMA FRUITMINT 4 mg MEDICATED CHEWING GUMS

Introduction

Package Leaflet: Information for the User

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

1. Contents of the pack and further information

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

Nicorama Fruitmint belongs to a group of medicines used to help you stop smoking.

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

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

2. What you need to know before you start taking Nicorama Fruitmint

Do not take Nicorama Fruitmint:

• 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 diseases:

• 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
• Tumor of the adrenal gland(pheochromocytoma)
• Stomach ulceror duodenal ulcer
• Esophageal inflammation

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

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

Children and adolescents

A suitable 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 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 Fruitmint

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 Fruitmint 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 development of the baby. 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 general practitioner, 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 Fruitmint contains xylitol, butylhydroxytoluene, butylhydroxyanisole, 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 Fruitmint 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 and butylhydroxyanisole.

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

3. How to take Nicorama Fruitmint

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 Fruitmint 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 of gum every 1 to 2 hours. It is necessary to take a sufficient number of pieces of gum every day. The dose is individual, based on your nicotine dependence. In most cases, 8 to 12 pieces of gum per day are sufficient. To have the greatest chance of success, it is essential not to use a subtherapeutic dose.

Maximum daily dose:

Nicorama Fruitmint 4 mg: 16 pieces of gum 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 be completed when the dose has been reduced to 1 or 2 pieces of gum per day.

Normally, it is not recommended to use gum habitually for more than 6 months. In some cases, longer treatment may be necessary to avoid relapse into smoking. Leftover gum should be kept, as a strong desire to smoke can suddenly arise. 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 Fruitmint 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 can experience a nicotine overdose. The nicotine doses that adult smokers tolerate during treatment can cause severe poisoning symptoms in children and can be fatal.

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 can 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 people):

• Headache
• Cough, throat irritation
• Hiccups, nausea

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

• Local effects, such as burning sensation, mouth inflammation, alteration of 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 people):

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

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

• 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(withdrawal symptoms)

Some of the side effects you experience when you stop smoking may be caused by the reduction of nicotine, which is 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 Agency's online platform: www.notificaRAM.es

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

5. Storage of Nicorama Fruitmint

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 expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Nicorama Fruitmint

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

Nicorama Fruitmint 4mg medicated chewing gum EFG

• The active substance is nicotine. One piece of gum contains 4 mg of nicotine in the form of nicotine resinate.
• The other ingredients are: gum base (containing butylhydroxytoluene [E321]), xylitol (E967), silica (colloidal, hydrated), magnesium stearate, sodium carbonate (anhydrous), hypromellose, refreshing flavoring agent, peppermint flavor, sodium hydrogen carbonate, citrus/fruit flavor (containing butylhydroxyanisole [E320]), levomenthol, macrogol, glycerol, titanium dioxide (E171), talc, potassium acesulfame, sucralose, yellow iron oxide (E172), xanthan gum.

Appearance of the product and contents of the pack

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 Fruitmint 4 mg wirkstoffhaltiges Kaugummi

Spain Nicorama Fruitmint 4 mg chicles medicamentosos EFG

France Nicotine Enorama Fruitmint 4 mg gomme à mâcher médicamenteuse

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

Poland Nicorama Fruitmint 4 mg guma do zucia, lecznicza

United Kingdom Nicorama Fruitmint 4 mg medicated chewing-gum

Sweden Nicorama Fruktmint 4 mg medicinskt tuggummi

Date of last revision of this leaflet: March 2021