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Natural Product Number (NPN):

80064786

Market status:

Not Marketed

Licence Status:

Active

Brand name(s):

Zonnic Mint Lozenges (4 mg nicotine lozenges)

Licence holder:

Niconovum AB

Dosage Form:

Lozenge

Recommended route of administration:

Buccal

Recommended use or purpose:

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 acts as a temporary aid to those who want to stop smoking cigarettes or break the cigarette habit, when used as part of a smoking cessation program. By means of Zonnic Mint you can reduce the discomfort of withdrawal symptoms, by continuing to provide a small amount of nicotine to your body during a short period of time. The effectiveness of this product is directly related to your motivation to stop smoking. Consult your pharmacist or doctor regarding the availability of smoking cessation programs in your area.

Risk Information:

Cautions and Warnings 

Do not use Zonnic Mint: Do not use if you are an occasional smoker. Do not smoke, use nicotine patches or any other form of nicotine while using nicotine lozenges. If you are allergic (hypersensitive) to nicotine or any of the other ingredients in the lozenge. 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. Keep out of reach of pets. Consult your doctor before using this product if you have or have had thyroid, stomach or throat or mouth problems, high blood pressure. Consult your dentist or doctor if injury or irritation to the mouth, teeth or gum around dentures occurs. Discontinue using nicotine lozenges and consult your doctor if irregular heartbeat, chest pain or leg pain occurs or if severe persistent stomach upset (indigestion, heartburn) develops. Consult your doctor if you have difficulty in reducing the quantity of nicotine lozenges. In case of overdose or if a child chews or swallows one or more nicotine lozenges, contact your doctor or local poison control centre at once. Young children are especially sensitive to the effects of even small doses of nicotine. Symptoms of an overdose include nausea, abdominal pain, vomiting, diarrhea, cold sweat, dizziness, disturbed hearing and vision, mental confusion, rapid heartbeat, difficulty breathing and marked weakness. Children and adolescents: People under 18 years of age should not use Zonnic Mint lozenge unless prescribed by a doctor. Do not use Zonnic Mint if you are a non-smoker. 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. See your doctor before using if you have or have ever had allergies to drugs and if you are taking any prescription medications. Zonnic Mint with food and drink: You should not eat or drink while you use the lozenge since this may decrease the effect of Zonnic Mint. Acidic drinks (e.g. fruit juice, coffee, tea, alcohol) 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 are pregnant or breastfeeding, consult the health care professional who is managing your pregnancy, your family doctor, or a doctor in a centre that is specialised in helping people quit smoking before using Zonnic Mint. Smoking can seriously harm your child. Try to stop smoking without the use of any nicotine replacement medicine. Nicotine in any form can cause harm to your unborn baby. Avoid becoming pregnant while using Zonnic Mint. Zonnic Mint should be avoided during breastfeeding as nicotine is found in breast milk and may affect your child. If your doctor has recommended you to use Zonnic Mint during breastfeeding, the tablet should be taken just after breast-feeding and not during the two hours before breastfeeding. 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 isomalt and maltitol: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Side effects, which may be a sign of improper use, include light-headedness, nausea, hiccups. Carry the lozenges with you at all times in the first few months in case you feel a sudden urge to smoke. One cigarette may be enough to start the smoking habit again.

Contra-Indications 

Talk to your doctor or pharmacist or nurse before using Zonnic Mint. Contact your doctor if you suffer from: severe heart disease (e.g. unstable angina pectoris, severe arrhythmia); a recent (within 3 months) heart attack or stroke; any heart or blood circulation disorders of the brain; untreated high blood pressure; severe liver disease; severe kidney disease; diabetes and use insulin, see section "Using other medicines"; stomach ulcer; hyperactive thyroid gland; tumor of the adrenal gland (phaeochromocytoma). If you have any of these conditions it may not be safe for you to use Zonnic Mint.

Known Adverse Reactions 

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 occurring side effects are dizziness, headache, gastrointestinal discomfort, nausea, vomiting, and hiccups. Less common side effects (occurring 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 treatment is unclear. If you get any side effects, talk to your doctor or pharmacist or nurse. Overdose with nicotine could occur if you smoke simultaneously with using Zonnic Mint lozenge. The symptoms of overdose include nausea, increased saliva, abdominal pain, diarrhoea, 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.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
Pyridine, 3-(1-methyl-2-pyrrolidinyl)-, (S)-, (R-(R*,R*))-2,3-dihydroxybutanedioate (1:2)	12.29 milligrams		4.0   milligrams Nicotine

List of non-medicinal ingredients:

• Acesulfame-K
• Blue 1
• Isomalt
• Maltitol solution
• Mint flavour
• Purified water
• Sodium carbonate anhydrous

Date of licensing:

2015-10-26

Revised date of licence:

2023-06-15