2 mg and 4 mg oral powder in a sachet
nicotine
What Nicovel Mint is and what it is used for
Nicovel Mint contains the active substance nicotine. It relieves nicotine cravings and withdrawal symptoms when you quit smoking, thereby preventing relapse into smoking in smokers who are motivated to quit. Nicovel Mint facilitates smoke reduction in smokers who can not or are unwilling to quit smoking. It is intended for adults aged 18 and over.
When you suddenly stop supplying the body with nicotine in the form of tobacco, you suffer from various forms of discomfort, so-called withdrawal symptoms. When you use Nicovel Mint, you can prevent or reduce this discomfort by continuing to supply your body with a small amount of nicotine for a transitional period.
Advice and support can help you increase your chances of success.
You must talk to your doctor or pharmacist if you have been using Nicovel Mint for more than 6 months.
What you need to know before using Nicovel Mint
Do not use Nicovel Mint
- if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from severe heart disease (eg unstable angina pectoris, severe arrhythmia ),
- if you have recently had a heart attack (within 3 months) or stroke .
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Nicovel Mint if you have any of the following. You may still be able to use Nicovel Mint, but you need to talk to your doctor first if you have:
- chest pain ( unstable angina ) or angina at rest
- heart disease that affects the heart rate or heart rate
- 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 replacement therapy can sometimes trigger this type of reaction.
- moderate to severe liver disease
- severe kidney disease
- gastric ulcer or ulcer of the duodenum a
- overactive thyroid gland
- an adrenal tumor ( pheochromocytoma ) _
- diabetes and use insulin because you may need a lower dose of insulin
- inflammation of the esophagus.
Children and young people
Children and adolescents under 18 years of age should not use Nicovel Mint unless prescribed by a doctor.
A normal dose for adults can seriously poison or even kill a small child. It is therefore important that you always keep Nicovel Mint out of the reach and sight of children.
Other medicines and Nicovel Mint
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially important if you are taking other medicines that contain
- theophylline (to treat asthma )
- tacrine (for Alzheimer’s disease)
- clozapine (for schizophrenia)
- ropinirole (to treat Parkinson’s disease).
Nicovel Mint with food and drink
You should not eat or drink with the oral powder in your mouth, as this may reduce the effect of Nicovel Mint.
Acidic beverages (eg coffee, fruit juice, or soft drinks) can reduce the absorption of nicotine in the oral cavity. To ensure the best effect, you should avoid these drinks for about 15 minutes before using Nicovel Mint.
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 taking this medicine.
It is very important to stop smoking during pregnancy because smoking can lead to poor growth of the fetus. It can also lead to premature birth or stillbirth. It is best if you stop smoking without using nicotine-containing medicines. If you are unable to do this, use Nicovel Mint only after consulting your healthcare professional, your doctor, or a doctor who specializes in smoking cessation.
Nicovel Mint should be avoided during breastfeeding as nicotine passes into breast milk and this may affect your baby. If your doctor has recommended that you use Nicovel Mint during breastfeeding, you should take the oral powder immediately after breastfeeding and not within two hours before breastfeeding.
Smoking increases the risk of infertility in women and men. The effects on fertility for nicotine are unknown.
Driving and using machines
Nicovel Mint has no or negligible influence on the ability to drive and use machines.
How to use Nicovel Mint
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose at the beginning of treatment is 1 serving bag taken every two hours.
8-12 serving bags per day is usually enough. Do not use more than 24 serving bags per day.
Opening instructions:
- Press the sides of the package below the lid.
- Lift the lid.
Place the portion bag under the upper lip and leave it there for about 30 minutes. Occasionally move around the bag with your tongue.
Activation of power when Nicovel Mint is used is not as fast as when smoking and you can therefore not expect to feel the same rapid satisfaction as when smoking.
Do not use Nicovel Mint for more than 6 months without consulting your doctor or pharmacist. Regular use of Nicovel Mint for more than 1 year is usually not recommended.
Smoking cessation
The treatment period is individual but usually lasts for at least 3 months. Thereafter, the number of portion bags per day is gradually reduced. Treatment should be discontinued when the dose is reduced to 1-2 sachets per day. However, you can take a portion bag at times when you are tempted to smoke.
Smoke reduction
Nicovel Mint can be used between smoking periods to prolong smoke-free intervals and to reduce smoking as much as possible. If, after 6 weeks, you have not managed to reduce the number of cigarettes per day, you should seek professional help. You should try to quit smoking as soon as you feel motivated, but not later than 6 months after you start using Nicovel Mint. If you have not been able to make a serious attempt to quit smoking within 9 months, you should seek professional help.
Children and young people
Adolescents under the age of 18 should only use Nicovel Mint on a doctor’s prescription.
If you use more Nicovel Mint than you should
Nicotine overdose may occur if you are only used to low doses of nicotine or if you smoke while using Nicovel Mint.
Symptoms of overdose include nausea, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing loss and pronounced feeling of weakness. At high doses, these symptoms may be followed by low blood pressure, weak and irregular heartbeat, difficulty breathing, extreme fatigue, circulatory collapse, and seizures.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nicovel Mint can cause the same side effects as nicotine administered in other forms. The side effects are usually dose-dependent. See also section “If you have used too much Nicovel Mint”.
Stop using Nicovel Mint and consult a doctor, or go to the nearest emergency room immediately if you experience any of the following symptoms of allergic reactions that can be serious such as angioedema. These are uncommon side effects (may affect up to 1 in 1,000 people):
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing.
Other side effects that may occur:
Common (may affect up to 1 in 10 people):
- dizziness
- headache
- feeling of discomfort in the stomach
- hiccups, nausea, vomiting
- irritated mouth or throat.
Uncommon (may affect up to 1 in 100 people):
- palpitation
- redness and hives.
Rare (may affect up to 1 in 1,000 people):
- disturbance of heart rhythm.
Some symptoms such as dizziness, headache, and difficulty sleeping may be due to withdrawal symptoms during smoking cessation and are associated with lowering your nicotine intake.
Cold sores can occur when you stop smoking, but the connection with smoking cessation is unclear.
How to store Nicovel Mint
Keep out of sight and reach of children.
Close the package tightly. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the bag and the container after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is nicotine. One sachet contains 2 or 4 mg of nicotine.
- The other ingredients are alginic acid, anhydrous sodium carbonate, copovidone, cellulose powder, peppermint flavor and neohesperidine dihydric chalcone.
What the medicine looks like and contents of the pack
Nicovel Mint is a rectangular portion bag filled with powder.
Pack size:
20 serving bags in a polypropylene container with closure in a laminated aluminum bag.
The portion bag is made of a viscose fabric material with an acrylic binder.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB,
Box 56048
102 17 Stockholm
info@orifarm.com