NICORETTE FRESHMINT GUM 4MG N30

ATC code: N07BA01 

Active substances: Nicotinum

Vendor, principal: Mcneil Consumer Healthcare,joh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

NICORETTE FRESHMINT 4MG N30

Package leaflet: Information for the user

Nicorette Freshmint, 2 mg medicated chewing gum Nicorette Freshmint, 4 mg medicated chewing gum

Nicotine

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

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What Nicorette Freshmint is and what it is used for
2.   What you need to know before you use Nicorette Freshmint
3.   How to use Nicorette Freshmint
4.   Possible side effects
5.   How to store Nicorette Freshmint
6.   Contents of the pack and other information

1. What Nicorette Freshmint is and what it is used for

Nicorette Freshmint is used to:
- treat tobacco addiction, including alleviation of withdrawal reactions and urge to smoke in patients motivated to stop smoking and reduction of smoking prior to final cessation of smoking in patients who cannot or are not ready to stop smoking suddenly.

2. What you need to know before you use Nicorette Freshmint Do not use Nicorette Freshmint:

-   If you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult with your doctor before using Nicorette Freshmint medicated chewing gum:
-   if you have recently experienced severe cardiovascular disease (e.g. stroke or myocardial infarction) or if you have been hospitalised due to cardiovascular complaints;
if you have chest pain;
-   if you have uncontrolled high blood pressure;
-   if you have acute duodenal or gastric ulcer;
-   if you have overactive thyroid gland;
-   if you have diabetes and you use insulin (careful monitoring of blood glucose is necessary when you stop smoking and start nicotine replacement therapy);
-   if you have a tumour of the adrenal gland (pheochromocytoma) - your doctor will tell you that;
-   if you have moderate/severe liver disease or severe kidney disease;
-   if you are under 18 years of age.
Smoking is a greater hazard to the health than using nicotine replacement therapy products.
Nicotine doses tolerated by smokers may cause serious poisoning and fatalities in children. Products containing nicotine must be stored in a place not accessible to children to prevent them from swallowing the product.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The best option to improve the health of mother and child is to stop smoking without nicotine replacement therapy. If pregnant women fail to stop smoking, they can use Nicorette Freshmint only after consulting healthcare professional.
Nicotine is excreted in breast milk in small quantities that may be harmful for the baby even in therapeutic doses. Thus, using Nicorette Freshmint should be avoided during breast-feeding. If breastfeeding women fail to stop smoking, they can use Nicorette Freshmint only after consulting with a healthcare professional. If nicotine replacement therapy is used while breast-feeding, Nicorette Freshmint should be used immediately after breast-feeding to reduce harmful effect of Nicorette Freshmint on the child.

Driving and using machines

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

Other medicines and Nicorette Freshmint

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Smoking may alter your response to certain medicines. Thus, when you stop smoking (either with or without using nicotine replacement therapy), the doses of medicines you use may need to be adjusted. Consult your doctor or pharmacist before using Nicorette Freshmint if you use medicines such as theophylline, tacrine, clozapine, insulin, flecainide, pentazocine, imipramine, olanzapine, ropinirole, clomipramine or fluvoxamine.
Doses may need to be adjusted when you stop smoking.
Nicorette Freshmint contains butylated hydroxytoluene (E321). Butylated hydroxytoluene might cause irritation of mucous membranes.

3. How to use Nicorette Freshmint

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
What is the recommended dose of medicated chewing gum?
2 mg Nicorette Freshmint medicated chewing gum is the right dose if you smoke less than 20 cigarettes a day or if you smoke your first cigarette later than 30 minutes after waking up.
4 mg Nicorette Freshmint medicated chewing gum is the right dose if you smoke more than 20 cigarettes a day or if you have failed to stop smoking when using 2 mg medicated chewing gum.
Do not exceed the recommended dose!
Chew medicated chewing gum if you feel the urge to smoke. Medicated chewing gum is chewed in order to release nicotine, then pause chewing so that released nicotine could be absorbed through buccal mucosa.
Nicorette Freshmint medicated chewing gum must be chewed slowly for approximately 30 minutes, with intermittent pauses. Chew the gum until you feel intense taste or a tingling sensation, then rest the gum between your cheek and gums until intense taste and/or tingling sensation are gone, then start chewing again and repeat the process.
Once the medicated chewing gum has completely lost its taste, throw it in a waste bin.

How much Nicorette Freshmint medicated chewing gum can I use and for how long?

Use only one pad at a time. At the same time, stop smoking entirely to improve your chances of success. The number of medicated chewing gum pads used in a day depends on your urge to smoke. Usual quantity is 8-12 pads a day. Do not use more than 24 medicated chewing gum pads a day. Use medicated chewing gum for up to three months, during which you must refrain from habits related to smoking. Then it is time to gradually reduce the number of medicated chewing gum pads, until you have fully stopped using medicated chewing gum.
It is usually recommended to limit regular use of Nicorette Freshmint to three months. Some former smokers may need prolonged therapy to prevent re-starting smoking.
Keep unused medicated chewing gum pads and use them if you suddenly have the urge to smoke again.

If you use more medicated chewing gum than you should or if a child has chewed it:

Excessive use of nicotine, both in the form of nicotine replacement preparations and smoking may cause symptoms of overdose. When using Nicorette Freshmint, symptoms of nicotine overdose may occur in smokers who have recently received less nicotine from cigarettes or who simultaneously receive nicotine from Nicorette Freshmint and other sources. If you develop symptoms of nicotine overdose, discontinue using the medicine temporarily. If the symptoms of nicotine overdose persist, reduce the frequency or dosage strength of this medicine.
The risk of poisoning as a result of swallowing a medicated chewing gum pad is very low, because the absorption of nicotine is slow and incomplete due to lack of chewing.
The symptoms of overdose are the same as the symptoms of acute nicotine poisoning, i.e.: nausea, vomiting, increased salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, loss of hearing and expressed weakness.
If you have used more medicated chewing gum than you should or if a child has chewed or swallowed a few pads, contact your doctor or the hospital emergency department immediately. Show this information leaflet and package to the doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nicorette Freshmint medicated chewing gum may cause side effects that are similar to side effects caused by nicotine when smoking or using other tobacco products. The side effects generally depend on the dose you take.
Majority of possible side effects develop within the first weeks after starting the therapy.
Very common side effects (may occur in more than one in 10 users):
-   headache;
-   hiccups, nausea;
-   pharyngo-laryngeal pain.
Common side effects (may occur in 1-10 in 100 users):
-   dizziness;
-   vomiting.
Very rare side effects (may occur in less than one in 10,000 users):
-   blurred vision, increased tear production;
-   abnormal dreams;
-   palpitation, rapid heartbeat, temporary atrial fibrillation;
-   muscle stiffness, pain of jaw;
-   flushing, high blood pressure;
-   bronchial muscle cramp, hoarseness, difficulty breathing, nasal congestion, oropharyngeal pain, sneezing, tightness in throat;
-   diarrhoea, dry throat, dysphagia, eructation, gastrointestinal discomfort, glossitis, numbness of the mouth, oral mucosal blistering and scaling, lip pain, paraesthesia of the mouth, retching;
-   swelling of the skin, redness of the skin, profuse sweating, itching, rash, urticaria;
-   anaphylactic reaction;
-   asthenia, chest pain and discomfort, feeling of illness.
Several symptoms may be common to cessation of smoking. They include effects related to emotions and receiving information such as feeling unwell or depressed, insomnia, irritability, disappointment or anger, anxiety, difficulty in concentrating and restlessness or impatience. There may also occur physical effects such as decreased heart rate, increased appetite or weight increase, dizziness or presyncope symptoms, cough, constipation, gingival bleeding or oral mucosal ulcers, nasopharyngitis. It is also clinically important that nicotine withdrawal may cause strong urge to smoke.
Increased frequency of oral mucosal ulcers with nicotine is unclear.
Medicated chewing gum may stick to dentures and in rare cases, damage them.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5.   How to store Nicorette Freshmint

Keep this out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the package.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

6.   Contents of the pack and other information What Nicorette Freshmint contains

-   The active substance is nicotine. 1 medicated chewing gum contains 10 mg nicotine resinate, which equals 2 mg nicotine.
-   The other ingredients are: medicated chewing gum base, xylitol, sodium bicarbonate, sodium carbonate anhydrous, magnesium oxide, acesulfame potassium, flavourings (peppermint oil, levomenthol).
Coating excipients are: xylitol, peppermint oil, acacia gum, titanium oxide, carnauba wax.
- The active substance is nicotine. 1 medicated chewing gum contains 20 mg nicotine resinate, which equals 4 mg nicotine.
The other ingredients are: medicated chewing gum base, xylitol, sodium carbonate anhydrous, magnesium oxide, acesulphame potassium, flavourings (peppermint oil, levomenthol), quinolone yellow (E 104).
Coating excipients are: xylitol, peppermint oil, acacia gum, titanium oxide, carnauba wax, quinolone yellow (E104).
Nicorette Freshmint medicated chewing gum (both doses) does not contain sugar (sucrose) or substances of animal origin.

What Nicorette Freshmint looks like and contents of the pack

Nicorette Freshmint 2 mg medicated chewing gum is white, coated, rectangular pad with approximate dimensions of 15 x 15 x 6 mm.
Nicorette Freshmint 4 mg medicated chewing gum is rectangular, creamy, coated pad with approximate dimensions of 15 x 15 x 6 mm
Blister pack contains 15 medicated chewing gums.
Blisters are packed in cardboard boxes, containing 15, 30 or 105 medicated chewing gums.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

McNeil AB Norrbroplatsen 2 SE-251 09 Helsingborg Sweden

Manufacturer:

McNeil AB Norrbroplatsen 2 SE-251 09 Helsingborg Sweden
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Cilag GmbH International Löötsa 2A, 11415 Tallinn Phone: 617 74 20

This leaflet was last revised in December 2016.