1 mg/spray oral cavity spray
nicotine
What is Zonnic Peppermint and what it is used for
Zonnic Peppermint is intended to help you quit smoking when you want to quit smoking and to help you reduce your smoking when you don’t want to or can’t quit. Zonnic Peppermint is a nicotine medicine. Zonnic Peppermint relieves nicotine cravings and withdrawal symptoms when you quit or cut back on smoking.
When you suddenly stop supplying your body with nicotine from tobacco, you suffer from various discomforts known as withdrawal symptoms. Using Zonnic Peppermint can prevent or alleviate such discomfort and cravings by continuing to supply the body with a small amount of nicotine during a transition period. Zonnic Peppermint does not contain tar, carbon monoxide, or other toxins found in cigarette smoke.
Advice and support normally increase the chance of success.
What you need to know before using Zonnic Peppermint
Do not use Zonnic Peppermint
- if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6)
- if you have never used tobacco
- if you are under 12 years of age.
Warnings and precautions
Talk to your doctor before using Zonnic Peppermint if you have any of the following conditions:
- have recently (within 3 months) had a heart attack or stroke
- chest pain ( unstable angina ) or angina at rest
- heart disease that affects the heart rate or rhythm
- high blood pressure that is not treated with drugs
- have ever had allergic reactions in the form of swelling of the lips, face, and throat ( angioedema ) or itchy skin rash ( hives ). The use of nicotine medications can sometimes trigger this type of reaction
- severe or moderate liver disease
- severe kidney disease
- diabetes
- overactive thyroid
- tumor of the adrenal gland ( phaeochromocytoma )
- peptic ulcer or duodenal ulcer a
- inflammation of the esophagus
The benefits of quitting smoking outweigh any risks with the proper use of Zonnic Peppermint.
Children and young people
Young people between the ages of 12-17 should only use Zonnic Peppermint on the advice of healthcare professionals. Zonnic Peppermint should not be used by children under 12 years of age.
A normal dose for adults can seriously poison or even kill a small child. It is therefore important that you always store Zonnic Peppermint out of the sight and reach of children.
Other medicines and Zonnic Peppermint
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. This is especially important if you use medicines containing theophylline to treat asthma, tacrine for Alzheimer’s disease, clozapine for schizophrenia, or ropinirole to treat Parkinson’s disease.
Zonnic Peppermint with food and drink
You should not eat or drink while taking the oral spray.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
It is very important to stop smoking during pregnancy because smoking can impair the growth of the fetus. Smoking can also cause the baby to be born prematurely or lead to miscarriage. It is best if you can quit smoking without using drugs that contain nicotine. If you are unable to do this, Zonnic Peppermint 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 Peppermint should be avoided during breastfeeding as nicotine passes into breast milk and may affect your baby. If healthcare professionals have advised you to use Zonnic Peppermint, the oral cavity spray should be taken immediately after breastfeeding and not within two hours before breastfeeding.
Smoking increases the risk of infertility in women and men. The effects on the fertility of nicotine are unknown.
Driving ability and use of machinery
Zonnic Peppermint does not affect the ability to drive or operate machinery.
Zonnic Peppermint contains ethanol (alcohol)
Zonnic Peppermint mouth spray contains small amounts of ethanol (alcohol) less than 100 mg per spray (less than the alcohol found in 1 ml of wine).
How to use Zonnic Peppermint
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. Consult a doctor, pharmacist, or nurse if you are unsure.
The recommended dose is 1-2 sprays on each occasion when you would usually smoke a cigarette or get the urge to smoke. First, take a spray and if your cravings have not stopped within a few minutes, take a second spray. If 2 sprays are needed, continue to take 2 sprays each time. For most smokers, that means 1 or 2 sprays every 30 minutes to once an hour. Do not take more than 2 sprays at any one time or 4 sprays per hour for 16 hours. The maximum dose is 64 sprays over 16 hours per day.
Instructions for use
Spray 1-2 times between the cheek and teeth:
1. Turn the spray nozzle to the side
2. Aim the spray nozzle between the cheek and the teeth
3. Spray 1-2 times, alternating between left and right cheek
Smoking cessation
The treatment time is individual but usually lasts at least 3 months. After that, the nicotine dose is gradually reduced. The treatment should end when the dose has been reduced to 1-2 spray doses per day. However, you can take a spray dose on occasions when you are tempted to smoke.
Smoke reduction
Zonnic Peppermint 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 Peppermint. 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 Peppermint for more than 1 year without consulting your doctor or pharmacist.
The nicotine effects start 1 minute after a given spray dose.
If you have used too much Zonnic Peppermint
You may ingest too much nicotine if you smoke while using Zonnic Peppermint. If you have ingested too much medicine or if, for example, If a child has ingested the drug by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice. Nicotine doses during treatment tolerated by adult smokers can cause severe poisoning symptoms in children and can be fatal.
The symptoms of overdose are nausea, vomiting, increased salivation, stomachache, 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 and irregular pulse, breathing difficulties, extreme fatigue, circulatory collapse, and convulsions.
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 Peppermint can cause the same side effects as other forms of nicotine. Side effects are usually dose-dependent.
Symptoms associated with quitting smoking (withdrawal symptoms)
Some of the side effects you experience when you stop smoking can be withdrawal symptoms, which arise due to reduced nicotine intake.
These symptoms include :
- irritation, aggression, impatience, or frustration
- feelings of anxiety, restlessness, or difficulty concentrating
- waking up at night or having difficulty sleeping
- increased appetite or weight gain
- Depression
- craving for smoke
- decreased heart rate
- bleeding gums or mouth ulcers
- dizziness or feeling faint
- cough, sore throat, stuffy or runny nose
- constipation
If you notice that you have any of the following serious and rare side effects, stop taking Zonnic Peppermint and contact your doctor immediately (symptoms of angioedema ):
- swelling of the face, tongue, or throat
- difficult to swallow
- hives and difficulty breathing
Other side effects are
Very common: may affect more than 1 in 10 users:
- hiccups (especially common)
- headache, nausea
- throat irritation
Common: may affect up to 1 in 10 users:
- local effects such as burning sensation, inflammation in the mouth, altered taste experience
- dry mouth or increased salivation
- upset stomach or pain in the stomach
- vomiting, flatulence, or diarrhea
- fatigue
- hypersensitivity ( allergy )
- tingling sensation
Uncommon: may affect up to 1 in 100 users:
- stuffy nose, sneezing
- wheezing (bronchial spasm), difficulty breathing ( dyspnoea ), tightness in the throat
- redness of the skin (swelling of blood), increased sweating
- tingling in the mouth, inflammation of the tongue, mouth ulcers, damage to the lining of the mouth or voice changes, pain in the mouth and throat, belching
- palpitations (an abnormal experience of your heartbeat), increased heart rate, high blood pressure
- skin rash and/or itching ( pruritus, urticaria)
- abnormal dreams
- discomfort and pain in the chest
- the feeling of weakness, feeling of illness
- abnormal heart rhythm
- bleeding gums
- Runny nose
Rare: may affect up to 1 in 1,000 users:
- difficulty swallowing, reduced sensitivity in the mouth
- nausea
Has been reported: occurring in an unknown number of users:
- blurred vision, increased tear production (tear flow)
- dry throat, upset stomach, pain in the lips
- skin redness
- allergic reaction ( anaphylaxis )
How to store Zonnic Peppermint
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25°C. Store in the original packaging.
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. One spray contains 1 mg of nicotine.
- Other ingredients in Zonnic Peppermint mouth spray are Sucralose, mint flavoring, ethanol, glycerol, potassium dihydrogen phosphate, sodium hydroxide, and water.
Appearance and package sizes of the medicine
Clear solution with a faint scent of peppermint.
Package sizes:
Glass or plastic bottle with spray pump. One bottle contains 3 ml (40 sprays) or 15 ml (200 sprays)
40 sprays
200 sprays
400 (2 x 200) sprays
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Niconovum AB
Box 31008
200 49 Malmö
Manufacturer:
Pharmacy Production & Laboratories
Celciusgatan 43
212 14 Malmö