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Zonnic Pepparmint

Document: Zonnic Pepparmint oromucosal spray ENG PL change

Package leaflet: Information for the user


Zonnic Pepparmint 1 mg/spraying oromucosal spray

Nicotine


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

This medicine is available without prescription. However, you still need to use Zonnic Pepparmint carefully to get the best results from it.


What is in this leaflet:

What Zonnic Pepparmint is and what it is used for

What you need to know before you use Zonnic Pepparmint

How to use Zonnic Pepparmint

Possible side effects

How to store Zonnic Pepparmint

Contents of the pack and other information


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


The nicotine in Zonnic Pepparmint 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 Pepparmint 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 Pepparmint


Do not use Zonnic Pepparmint:


Warnings and precautions

Talk to your doctor or pharmacist before using Zonnic Pepparmint

Contact your doctor if you suffer from:


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


Children and adolescents

People under 18 years of age should not use Zonnic Pepparmint oromucosal spray unless prescribed by a doctor. Zonnic Pepparmint 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 Pepparmint oromucosal spray out of reach and sight of children at all times.


Other medicines and Zonnic Pepparmint

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 Pepparmint with food and drink

You should not eat or drink while you use the oromucosal spray since this may decrese the effect of Zonnic Pepparmint.

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 Pepparmint oromucosal spray.


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 Pepparmint 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 Pepparmint 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 Pepparmint during breast-feeding, the spray should be taken just after breast-feeding and not during the two hours before breast-feeding.


Driving and using machines

There are no known risks associated with driving or using machinery when the Zonnic Pepparmint oromucosal spray is used accordning the recommended dose.


Zonnic Pepparmint contains ethanol (alcohol)

Zonnic Pepparmint contains small amounts of ethanol (alcohol), the amount is less than 100 mg per dose.


3. How to use Zonnic Pepparmint


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.


The recommended dosage is 1-2 sprayings at one occasion. Initially the oromucosal spray can be taken every 1-2 hours. The usual dosage is 1-2 sprayings, 8 to 12 times a day. The maximum dose per day is a total of 30 sprayings (eg, spraying twice, 15 times a day).


Directions of use:

Spray 1-2 times between the cheek and teeth:

Turn the spray nozzle to the side.

Direct the spray nozzle between the cheek and the teeth.

Spray 1-2 times, alter between the leaft and right cheek.


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 doses per day. You may however take a dose when you are tempted to smoke.

Do not use Zonnic Pepparmint for more than 6 months without asking your doctor or pharmacist for advice.


Smoking reduction

Zonnic Pepparmint can be used in between periods of smoking, in order to prolong smoking –free intervals with the 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 Pepparmint. 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 Pepparmint for more than 6 months without asking your doctor och pharmacist for advice.


The effects of the nicotine will appear in 1 minute after using a dose of the spray.

If you use more Zonnic Pepparmint than you should

Overdose with nicotine could occur if you smoke simultaneously with using Zonnic Pepparmint oromucosal spray. 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 Pepparmint oromucosal spray 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.


4. Possible side effects


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


Zonnic Pepparmint oromucosal spray 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.


If side effects are troublesome or do not go away contact your doctor.


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.This includes any possible side effectsnot listed in this leaflet. You can also report side effects directly via (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 Pepparmint


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


Do not use Zonnic Pepparmint 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 Pepparmint contains


The active substance is nicotine. Each dose contains 1 mg nicotine.


The other ingredients in Zonnic Pepparmint oromucosal spray are: sucralose, mint flavour, ethanol, glycerol, potassium dihydrogen phosphate, sodium dihydrogen, purfied water.


What Zonnic Pepparmint looks like and the contents of the pack


Clear solution with a faint scent of peppermint.


Package size:

Glass or plastic vial with accuator. Each vial contains 3 ml (40 sprayings) or 15 ml (200 sprayings).

40 sprayings

200 sprayings

400 (2 x 200) sprayings


Marketing Authorisation Holder and Manufacturer

To be completed nationally.

For Sweden:

Niconovum AB

Järnvägsgatan 13

252 24 Helsingborg


Manufacturer:

Apoteket Produktion & Laboratorier

Box 26

401 20 Göteborg


or

Viminco A/S

Lodhusvej 11, DK-4230 Skælskør

Denmark


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


This leaflet was last revised in 2015-11-13


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