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Zonnic Mint

Information för alternativet: Zonnic Mint 2,5 Mg Sugtablett, visar 5 alternativ

Package leaflet: Information for the user


Zonnic Mint 1.25 mg lozenge

Zonnic Mint 2.5 mg lozenge


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 or nurse has told you.


What is in this leaflet:

What Zonnic Mint is and what it is used for

What you need to know before you use Zonnic Mint

How to use Zonnic Mint

Possible side effects

How to store Zonnic Mint

Contents of the pack and other information


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


The nicotine in Zonnic Mint relieves craving for nicotine and withdrawal symptoms when you stop smoking and counteracts thereby relapse into smoking in smokers who are motivated to stop or to facilitate reduction of smoking for smokers who cannot or are unwilling to stop smoking completely.


When you suddenly stop providing nicotine in the form of tobacco to your body, you get hit by different kinds of discomfort, called withdrawal symptoms. By means of Zonnic Mint you can prevent or at least reduce this discomfort, by continuing to provide a small amount of nicotine to your body during a short period of time.


Advice and support normally improve the success rate.


2. What you need to know before you use Zonnic Mint


Do not use Zonnic Mint:

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Zonnic Mint.

Contact your doctor if you suffer from:


If you have any of these conditions it may not be safe for you to use Zonnic Mint.


Children and adolescents

People under 18 years of age should not use Zonnic Mint lozenge unless prescribed by a doctor. Zonnic Mint should not be used by non-smokers


The correct dose for adults could seriously poison or even kill small children. It is therefore essential that you keep Zonnic Mint lozenge out of reach and sight of children at all times.


Other medicines and Zonnic Mint

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is specially important if you use other medicines which contain theophylline, tacrine, clozapine, ropinirole, flecainide, pentazocine or insulin.


Zonnic Mint with food and drink

You should not eat or drink while you use the lozenge since this may decrese the effect of Zonnic Mint.

Acidic drinks (e.g. fruit juice) influence the absorption of nicotine in the mouth cavity.

To make sure that the best effect will be achieved, you should avoid these drinks approximately 15 minutes prior to using the Zonnic Mint lozenge.


Pregnancy and breast-feeding

It is very important to stop smoking during pregnancy because it can result in poor growth of your baby. It can also lead to premature births and even stillbirths. Ideally you should try to give up smoking without the use of medicines containing nicotine. If you cannot manage this, Zonnic Mint should only be used after consulting the healthcare professional who is managing your pregnancy, your family doctor, or a doctor in a centre that is specialised in helping people quit smoking.


Zonnic Mint should be avoided during breast-feeding as nicotine is found in breast milk and may effect your child. If your doctor has recommended you to use Zonnic Mint during breast-feeding, the tablet should be taken just after breast-feeding and not during the two hours before breast-feeding.


Driving and using machines

There is no known risks associated with driving or using machinery when the Zonnic Mint lozenge is used accordning the recommended dose.


Zonnic Mint contains phenylalanin source (aspartam) and isomalt

Zonnic Mint lozenge contains phenylalanin source (aspartam). It can be harmful for people with phenylketonuria.


If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


3. How to use Zonnic Mint


Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure.


At the beginning of treatment 1 lozenge may be taken every to every second hour. In most cases, 8 -12 lozenges per day is normally sufficient. Not more than 24 lozenges per day should be used.


The strength of lozenge should be chosen considering your nicotine dependence. If you smoke more than 20 cigarettes per day or if you have previously failed to quit smoking using 1.25 mg lozenge, the 2.5 mg lozenge should be chosen. Otherwise the 1.25 mg should be chosen.


Smoking cessation

Duration of treatment is individual, but it usually takes at least 3 months. Thereafter the nicotine dosage should be reduced gradually. The therapy should be stopped when the dose is at a level of 1-2 lozenges per day. You may however take a lozenge when you are tempted to smoke.

Do not use Zonnic Mint lozenge for more than 6 months unless you have asked you doctor or pharmacist for advice.


Smoking reduction

Zonnic Mint lozenge can be used in between periods of smoking, in order to prolong smoking –free intervals with intention to reduce smoking as much as possible. If you, after 6 weeks, have not succeeded to cut down the number of cigarettes per day you should seek professional help. You should try to stop smoking as soon as you feel motivated, however no later than 6 months after you started to use Zonnic Mint. If you do not succeed to make a serious attempt to stop smoking within 9 months you should seek professional help.


Do not use Zonnic Mint lozenge for more than 6 months without asking your doctor och pharmacist for advice.


Directions for use.

1. Place the lozenge in the mouth and let is dissolve.

2. Occasionally move the lozenge from one side of the mouth to the other until it completely dissolves (approx. 10 minutes).

Do not chew or swallow the lozenge.


Nicotine effects will appear first after a few minutes.

Therefore you cannot expect the same fast satisfaction as if you smoked. The risk of poisoning is low if the lozenge is accidentally swallowed, as the nicotine will then be released slowly and inefficiently.


If you use more Zonnic Mint than you should

Overdose with nicotine could occur if you smoke simultaneously with using Zonnic Mint lozenge. The symptoms of overdose include nausea, increased saliva, abdominal pain, diarhhoea, sweating, headache, dizziness, hearing disturbances and pronounced weakness (feeling of weakness). At high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, difficulty breathing, extreme tiredness, circulatory collapse and general convulsions.


If a child takes Zonnic Mint lozenge or if you take too much nicotine, contact your doctor or the emergency department at the hospital immediately for a risk of judgement.


If you have any further questions regarding this medicine , please contact you doctor or pharmacist or nurse.


4. Possible side effects


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


Zonnic Mint lozenge may cause side effects similar to those associated with nicotine administered in other forms. Side effects are generally dose dependent.


The most common side effects (occur in more than 1 of 100 users) are irritated mouth or throat, during first weeks. Other commonly occuring side effects are dizziness, headache, gastrointestinal discomfort, nausea, vomiting, and hiccups.


Less common side effects (ocurring in less than 1 of 100 users) are palpitation (feeling fast or irregular heartbeat) and skin redness or rash.


Rare side effects (occurring in less than 1 in 1000 users) are disturbances in heartbeat (irregular heartbeat) and allergic reactions, which can be serious.


Some symptoms such as dizziness, headache and sleeping disturbances may be caused by withdrawal symptoms during smoking cessation and can depend on too low supply of nicotine.


Mouth ulcers can appear when you stop smoking but the connection to the nicotine tratment is unclear.


Reporting of side effects

If you getany side effects, talk to your doctor or pharmacist or nurse.This includes any possible side effectsnot listed in this leaflet. You can also report side effects directly(see details below). By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]


5. How to store Zonnic Mint


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


Do not use Zonnic Mint after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.


Do not throw away any medicines via wastewater or household waste. Ask you pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.


6. Contents of the pack and other information


What Zonnic Mint contains


The active substance is nicotine. Zonnic Mint lozenge is available in two strengths 1.25 and 2.5 mg.


The other ingredients in Zonnic Mint are:Isomalt (E953), cellulose microcrystalline, peppermint flavour, eucalyptus flavour, sodium carbonate, carbomer, magnesium stearate, aspartame (E951), methacrylic acid-methyl methacrylate-copolymer


Zonnic Mint lozenge are sugarfree.


What Zonnic Mint looks like and the contents of the pack


Zonnic Mint is a white, round, convex lozenge.

Package size:

20, 100, 200 pieces aluminium bag

20, 100, 200 pieces blister pack


Blister pack is composed of aluminium/PVC/PVDC.

Aluminium bag of polyester is composed of aluminium and polyethylene.


Marketing Authorisation Holder and Manufacturer


Niconovum AB

Järnvägsgatan 13

252 24 Helsingborg


Manufacturer:

Viminco A/S

Lodshusvej 11

DK-4230 Skaelskor

Denmark


This medicinal product is authorised in the Member States of the EEA under the following names:


This leaflet was last revised in 2013-12-20



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