What Zonnic Mint is and what it is used for
The nicotine in Zonnic Mint relieves nicotine cravings and withdrawal symptoms when you stop smoking and thereby prevents relapse in smokers who are motivated to quit or to facilitate a smoking reduction in smokers who are unable or unwilling to quit.
When you suddenly stop supplying your body with nicotine via tobacco, you suffer from various forms of discomfort, so-called withdrawal symptoms. With the help of Zonnic Mint, you can prevent or at least reduce these discomforts by continuing to supply the body with a small amount of nicotine during a transition period.
Advice and support normally increase the chance of success.
What you need to know before using Zonnic Mint
Do not use Zonnic Mint
- if you are allergic to nicotine or any other ingredient in this medicine (listed in section 6),
- if you suffer from severe heart disease (e.g. unstable angina pectoris, severe arrhythmia),
- if you have recently (within 3 months) had a heart attack or stroke.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Zonnic Mint if you have:
- any heart or vascular disease,
- untreated high blood pressure,
- severe liver disease,
- severe kidney disease,
- diabetes and use insulin, see also “Other medicines and Zonnic Mint”,
- peptic ulcer,
- overactive thyroid,
- a tumor of the adrenal glands ( phaeochromocytoma ).
If you have any of these conditions, it may not be appropriate for you to use Zonnic Mint.
Children and young people
People under the age of 18 should only use Zonnic Mint after a doctor’s prescription. Zonnic Mint should not be used by non-smokers.
A regular dose for adults can seriously poison or even kill a small child. It is therefore important that you always store Zonnic Mint out of the sight and reach of children.
Other medicines and Zonnic Mint
Tell your doctor or pharmacist if you are using, have recently used, or might be using any other medicines, even those without a prescription. This is especially important if you are using medicines containing theophylline, tacrine, clozapine, ropinirole, flecainide, pentazocine, or insulin.
Zonnic Mint with food and drink
You should not eat or drink with the sachet in your mouth, as this may reduce the effect of Zonnic Mint.
Acidic drinks (e.g. juice) affect the absorption of nicotine in the oral cavity. To ensure the best effect, you should avoid these drinks for about 15 minutes before using Zonnic Mint.
Pregnancy and breastfeeding
It is very important to stop smoking during pregnancy as smoking can lead to poor fetal growth. It can also lead to premature labor or even miscarriage. It is best if you stop smoking without using drugs that contain nicotine. If you are unable to do this, Zonnic Mint should only be used after you have consulted the healthcare professional looking after your pregnancy, your doctor, or a doctor who specializes in smoking cessation.
Zonnic Mint should be avoided during breastfeeding as nicotine passes into breast milk and may affect your baby. If your doctor has advised you to use Zonnic Mint while breastfeeding, the sachet should be taken immediately after breastfeeding and not within two hours before breastfeeding.
Driving ability and use of machinery
Zonnic Mint does not affect the ability to drive or operate machinery.
Zonnic Mint contains aspartame
This medicine contains 0.06 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in the body.
How to use Zonnic Mint
Always use this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse. Consult a doctor, pharmacist, or nurse if you are unsure.
Place a portion bag under the upper lip and leave it there for about 30 minutes. Move around the bag from time to time with your tongue.
At the beginning of the treatment, 1 sachet can be taken every two hours. In most cases, 8-12 serving bags per day are sufficient. A maximum of 24 serving bags per day should be used.
Smoking cessation
The treatment time is individual but usually lasts at least 3 months. After that, the number of portion bags per day is gradually reduced. The treatment should end when the dose has been reduced to 1-2 sachets per day. However, you can take a portion bag on occasions when you are tempted to smoke.
Do not use Zonnic Mint for more than 6 months without consulting your doctor or pharmacist.
Smoke reduction
Zonnic Mint is used between smoking periods to extend smoke-free intervals to reduce smoking as much as possible. If after 6 weeks you have not been able to reduce the number of cigarettes per day, you should seek professional help. You should try to quit smoking as soon as you feel ready, but no later than 6 months after you start using Zonnic Mint. If you have not succeeded in making a serious attempt to quit smoking within 9 months, you should seek professional help.
Do not use Zonnic Mint for more than 6 months without consulting your doctor or pharmacist.
The nicotine effects only kick in after a few minutes. Therefore, you cannot expect the same quick satisfaction as smoking. The danger of poisoning is small if you accidentally swallow the portion bag because the nicotine is then released slowly and incompletely.
If you used too much Zonnic Mint
Nicotine overdose can occur if you smoke while using Zonnic Mint. Symptoms of overdose are nausea, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing loss, and a pronounced feeling of weakness. At high doses these symptoms may be followed by low blood pressure, weak irregular pulse, breathing difficulties, extreme fatigue, circulatory collapse, and convulsions.
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you have further questions about this medicine, contact your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Zonnic Mint can cause the same side effects as nicotine given in other ways. Side effects are usually dose-dependent. See also section 3 “If you use too much Zonnic Mint”.
The most common side effects ( occurring in more than 1 in 100 users) are irritation in the mouth and throat during the first weeks. Other common side effects are dizziness, headache, stomach discomfort, nausea, vomiting, and hiccups.
Less common side effects ( affecting less than 1 in 100 users) are heart palpitations and skin rash.
Rare side effects ( occurring in less than 1 in 1,000 users) are heart rhythm disturbances and allergic reactions, which can be serious.
If side effects are troublesome or persist, contact your doctor.
Certain symptoms such as dizziness, headaches, and sleep difficulties may be due to withdrawal symptoms when quitting smoking and are associated with reducing the nicotine supply.
Mouth ulcers can occur when you stop smoking, but the connection with nicotine treatment is unclear.
How to store Zonnic Mint
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25°C. Store in the original packaging.
Use before the expiry date which is stated on the can/aluminum bag after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is nicotine. Each sachet contains 2 mg of nicotine.
Other ingredients are microcrystalline cellulose, mint flavoring, ascorbyl palmitate (E 304), trisodium phosphate, acesulfame potassium (E 950), and aspartame (E 951).
Appearance and package sizes of the medicine
Zonnic Mint mouth pouch is a rectangular, powder-filled portion pouch.
Package sizes
Jar with a screw cap with a child-resistant closure in an aluminum bag:
20-portion bags.
Jar with screw cap with child-resistant closure:
20-portion bags.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Niconovum AB
Box 31008
200 49 Malmö
Telephone number: 042 – 19 94 30
Manufacturer
Viminco A/S
Lodshusvej 11
DK-4230 Skælskør
Denmark
Pharmacy Production & Laboratories (APL)
Celsiusgatan 43
SE-212 14 Malmö