Nicotinell Gum 2mg fruit flavour without sugar per 96

In this manual :

1. What is NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum and what is it used for?

2. What you should know before taking NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum

3. How should I take NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum ?

4. What are the possible side effects?

5. How to keep NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum?

6. Additional information.

1. WHAT IS NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum AND WHAT IS IT USED FOR?

NICOTINELL FRUIT Gum contains nicotine, a tobacco ingredient.

NICOTINELL FRUIT 2 mg Gum is part of a family of medicines to help you quit smoking.

The nicotine is released slowly and then absorbed by mouth each time you chew the gum.

This medicine is indicated for the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in subjects wishing to stop smoking.

Appropriate treatment improves the chances of success in quitting smoking.

2. WHAT YOU SHOULD KNOW BEFORE TAKING NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum

Not applicable.

Never take NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum in the following cases:

- If you are not a smoker,

- If you are allergic to nicotine or to any of the excipients contained in NICOTINELL FRUIT 2 mg.

In case of doubt, it is essential to ask your doctor or pharmacist for advice.

Take care with NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum:

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

- cardiovascular disease, for example myocardial infarction, heart failure, angina pectoris, Prinzmetal's angina, heart rhythm disorder,

- history of stroke,

- high blood pressure,

- circulatory problems,

- liver or kidney failure,

- thyroid disease (hyperthyroidism)

- diabetes (monitor your blood sugar more often at the start of treatment as it may be altered),

- pheochromocytoma(adrenal gland disease leading to severe high blood pressure)

- inflammation of the mouth or throat, esophagitis, gastritis, ulcer of the stomach or duodenum

- fructose intolerance

Nicotine in small amounts is dangerous for children and can cause severe symptoms or death. Therefore, it is imperative that NICOTINELL FRUIT Gum be kept out of the reach and sight of children.

If denture wearers have difficulty chewing the gum, it is recommended to stop the treatment and use another pharmaceutical form. Ask your doctor or pharmacist for advice.

Taking or using other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicine, even if it is a medicine obtained without a prescription. If you quit smoking and are taking other medications, your doctor may want to adjust the dosage.

There are no data on possible interactions between NICOTINELL FRUIT Gum and other medicines. However, substances in cigarettes other than nicotine may affect some medicines.

Quitting smoking can change the way certain medications work, for example:

- theophylline (a drug used in the treatment of asthma),

- tacrine (a drug used to treat Alzheimer's disease)

- olanzapine and clozapine (drugs used to treat schizophrenia),

- insulin (a drug used to treat diabetes).

May require dosage adjustment.

Food and Beverage

Consumption of coffee, acidic and carbonated beverages (sodas) may decrease the absorption of nicotine and should be avoided for 15 minutes before chewing gum.

Not applicable.

Pregnancy

It is very important to stop smoking during your pregnancy as it may lead to stunted growth of your child or even prematurity or fetal death. Ideally, you should try to stop smoking without taking medication. If this fails, NICOTINELL FRUIT may be recommended to help you. This is because the risk to the fetus is probably lower than that of smoking. Nicotine in any form can harm your child. NICOTINELL FRUIT may be taken only after consulting your doctor who is monitoring your pregnancy or a doctor who specializes in smoking cessation.

Breastfeeding

NICOTINELL FRUIT Gum, like smoking, should be avoided while breast-feeding because nicotine passes into breast milk.

If your doctor recommends that you use NICOTINELL FRUIT Gum while you are breastfeeding, the gum should be chewed just after feeding and not during the two hours before feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Not applicable.

Driving and using machines

Smoking cessation may cause behavioural changes. At the recommended doses, there is no particular risk associated with NICOTINELL FRUIT 2 mg medicated chewing gum.

Important information about some of the ingredients of NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum

NICOTINELL FRUIT 2 mg chewing gum contains sorbitol, a source of fructose:

- if you know you are intolerant to certain sugars, consult your doctor before taking this medicine.

The gum contains butylated hydroxytoluene (E321) which may cause local irritation to the oral mucosa.

Each NICOTINELL FRUIT 2 mg gum contains sugars, including 0.2 g of sorbitol (E420), a source of fructose (0.04 g / gum). The caloric intake is 1.0 Kcal/gum.

Each chewing gum contains 11.50 mg of sodium, to be taken into account by people on a low-salt diet.

3. HOW DO I TAKE NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum?

Use NICOTINELL Chewing Gum as directed in the package insert. Ask your doctor or pharmacist for advice if you are not sure.

At initiation and throughout the course of treatment, complete cessation of smoking is necessary to increase your chances of success.

NICOTINELL FRUIT Gum is available in 2 strengths: 2 mg and 4 mg. The right dose will depend on your smoking habits.

NICOTINELL FRUIT 4 mg is recommended:

- for smokers who are strongly to very strongly addicted to nicotine,

- in case of failure after using the 2 mg dosage,

- if withdrawal symptoms remain strong with a risk of relapse.

In other cases, use 2 mg gums.

Choose the appropriate dosage using the table below

In case of adverse effects observed with the use of 4 mg gums, use the 2 mg gums.

Method of Administration

BY MOUTH.

- Chew gum until the taste becomes strong.

- Then place the gum between your gum and cheek.

- Start chewing the gum again when the taste has faded.

- Continue this process until the gum is completely dissolved (about 30 minutes).

DO NOT SWALLOW

Dosage in adults over 18 years of age

Frequency of administration

Chew one gum each time you feel the need to smoke. In general, the starting dose should be 1 gum every 1 to 2 hours. The usual dose is 8 to 12 pieces of gum per day. Otherwise, chew one gum every time you feel the need to smoke