NICORETTE BERRYMINT 1mg/spray 13.2ml
Leaflet: user information
Nicoret Berimint 1 mg/injection , spray for oral mucosa, solution
Nicotine
Nicorette Berrymint 1 mg/spray oromucosal spray, solution
Nicotine
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you .
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- Contact your doctor if you have not been able to stop smoking after 6 months of treatment with Nicorette Berimint.
What this leaflet contains
1. What Nicoret Berimint is and what it is used for
2. What you need to know before you use Nicorette Berimint
3. How to use Nicorette Berimint
4. Possible side effects
5. How to store Nicorette Berimint
6. Contents of the package and additional information
1. What Nicoret Berimint is and what it is used for
Nicorette Berimint is used to help you stop smoking when you want to quit smoking. This is a type of treatment called nicotine replacement therapy (NRT).
Nicorette Berimint relieves nicotine withdrawal symptoms, including nicotine cravings, symptoms you get when you stop smoking. When you suddenly stop providing nicotine from tobacco to your body, you experience various unpleasant sensations called withdrawal symptoms. By using Nicorette Berimint, you can prevent or reduce these unpleasant sensations and the urge to smoke. This is because you keep putting a small amount of nicotine into your body for a short period of time. Nicorette Berimint does not contain tar, carbon monoxide or other toxins from cigarette smoke.
To improve your chances of quitting smoking, if you can, you should also seek support and advice.
- What you need to know before you use Nicorette Berimint
Do not use Nicorette Berimint
- if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).
- If you are under 18 years old .
- If you have never smoked .
Warnings and precautions
Talk to your doctor before taking this medicine if you suffer from any of the following conditions. You may be able to use Nicorette Berimint, but you should talk to your doctor first if you have:
- You have recently (within 3 months) had a heart attack or stroke
- Chest pain (unstable angina) or angina at rest
- Heart disease that affects the rate or rhythm of the heart's activity
- High blood pressure that is not controlled by medication
- You have ever had allergic reactions with swelling of the lips, face and throat (angioedema) or an itchy skin rash (urticaria). HRT use can sometimes trigger this type of reaction.
- Severe or moderate liver disease
- Severe kidney disease
- Diabetes
- Overactive thyroid gland
- Tumor of the adrenal gland (phaeochromocytoma)
- Stomach ulcer or duodenal ulcer
- Esophagitis
Nicorette Berimint should not be used by non-smokers .
Children and adolescents
Do not give this medicine to children and adolescents.
Other medicines and Nicorette Berimint
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is especially important if you are taking medicines containing:
theophylline to treat asthma
tacrine for Alzheimer's disease
clozapine for schizophrenia
ropinirole to treat Parkinson's disease
Nicorette Berimint with food and drink
Do not eat or drink when applying the oral mucosal spray.
Pregnancy, lactation and fertility
It is very important to stop smoking during pregnancy because it can damage your baby's growth. It can also lead to premature or stillbirth. It is best if you can quit smoking without the use of drugs containing nicotine. If you are unable to do this, Nicorette Berimint should only be used in consultation with the medical professional who is monitoring your pregnancy, your family doctor or a doctor from a center specializing in helping people who want to quit smoking.
Nicorette Berimint should be avoided during breastfeeding , as nicotine is found in breast milk and may affect your child. If your doctor has recommended that you use Nicoret Berimint, the spray should be applied immediately after breastfeeding and should not be used for at least 2 hours before breastfeeding.
Smoking increases the risk of infertility in both women and men. The effects of nicotine on fertility are not known.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
Nicorette Berimint contains 12 mg of propylene glycol per spray and small amounts of ethanol (alcohol), less than 100 mg per dose (1 or 2 sprays). This medicine contains less than 1 mmol sodium (23 mg) per injection, i.e. practically no sodium. Due to the presence of butylated hydroxytoluene, Nicorette Berimint may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
- How to use Nicorette Berimint
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
People under the age of 18 should not use Nicorette Berimint.
You must stop smoking completely during treatment with Nicorette Berimint.
The following table shows the recommended Nicorette Berimint step-by-step process.
Step 1: Weeks 1-6 Start by applying 1-2 puffs when you would normally smoke a cigarette or when you have the urge to smoke. Take one puff first, and if your urge to smoke doesn't go away within a few minutes, take a second puff. If 2 injections are required, future doses may be delivered as 2 consecutive injections. For most smokers, this means about 1-2 puffs every 30 minutes to 1 hour. For example, if you smoke an average of 15 cigarettes per day, you should apply 1 or 2 puffs at least 15 times during the day. Do not use more than 2 sprays at a time or 4 sprays per hour for 16 hours. The maximum dose is 64 injections within 16 hours in any 24-hour period. Step 2: Weeks 7-9 Start reducing the number of injections per day. By the end of week 9, you should be using HALF the average number of injections per day that you did in Step 1. Step 3: Weeks 10-12 You continue to reduce the number of sprays per day so that you do not use more than 4 sprays per day in week 12. When you have reduced to 2-4 sprays per day, you should stop using Nicorette Berimint. |
After stopping treatment, you may be tempted to smoke again. Save the remaining doses of the spray as the urge to smoke may come on suddenly. If you have the urge to smoke, take one or two puffs if one puff doesn't help within a few minutes.
You should usually take Nicorette Berimint for 3 months, but not longer than 6 months.
Consult your doctor if you need to use Nicoret Berimint for longer than 6 months.
Follow these directions carefully and use the pictures to guide you
Unlocking the tip
How to open the dispenser
- Use your thumb to slide down the button ( a ) while pressing it slightly inwards ( b ). Do not press too hard.
- While pushing in, slide up ( c ) to unlock the tip of the dispenser. Then release the button.
spray tip |
button |
How to charge the dispenser
When using the oral mucosal spray for the first time, you must first prime the pump of the spray. Point the spray nozzle safely away from you, other adults, children or pets. Press the tip of the dispenser with your index finger 3 times until a fine spray appears. If you do not use the spray for 2 days, this charging procedure will need to be repeated.
How to use the probe
- Aim the spray nozzle at your open mouth and hold it as close to the mouth as possible
. - Press firmly on the tip of the dispenser to release one spray into the mouth, avoiding the lips. To avoid getting spray in the throat, do not inhale while inhaling. For best results, you should not swallow for a few seconds after the injection.
Retracting the tip
How to make the dosing device
- Slide the button down ( d ) until it can be pushed in ( e ).
- While pressing, slide the tip of the dispenser down ( f ). Release the button. The dispenser is now closed.
To take another dose, repeat the above steps.
Close the container with the dispenser each time after use to prevent children from using the spray and accidental spraying.
Care should be taken not to splash the eyes while applying the oral mucosal spray. If spray gets in your eyes, rinse thoroughly with water.
If you have taken more than the required dose of Nicoret Berimint
Nicotine overdose may occur if you smoke while taking Nicorette Berimint.
If a child takes Nicoret Berimint or if you have taken more Nicoret Berimint than you should, you should contact your doctor or go to the nearest hospital immediately . Doses of nicotine that are tolerated by adult smokers during treatment can cause severe symptoms of poisoning in children , which can be fatal .
Overdose symptoms are retching (nausea), vomiting, excessive salivation, stomach pain, diarrhea, sweating, headache, dizziness, hearing changes, and feeling very weak. At high doses, these symptoms may be followed by lowering of blood pressure, weak and irregular pulse, difficulty in breathing, extreme fatigue, circulatory collapse and generalized convulsions.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nicorette Berimint can cause the same side effects as other forms of nicotine. Side effects usually depend on the dose you take.
Effects related to smoking cessation ( withdrawal symptoms )
Some of the side effects you experience when you quit smoking may be withdrawal symptoms due to a reduction in nicotine intake.
These reactions include:
- Irritability, aggression, impatience or feeling powerless
- Feeling anxious, restless, or having trouble concentrating
- Nighttime awakening or sleep disturbance
- Increased appetite or weight gain
- Feeling depressed
- Desire to smoke ( nicotine craving )
- Slowing of the pulse
- Bleeding gums or mouth ulcers
- Dizziness or vertigo
- Cough, sore throat, stuffy or runny nose
- Constipation
If you notice any of the following serious rare side effects, stop taking Nicoret Berimint and contact a doctor immediately (signs of angioedema):
- Swelling of the face, tongue or pharynx
- Difficulty swallowing
- Prominent rash and difficulty breathing
Very common: may affect more than 1 in 10 people:
- Hiccups (this is especially common)
- Headache, nausea (urges to vomit)
- Throat irritation
Common: may affect up to 1 in 10 people:
- Local effects such as burning sensation, inflammation in the mouth, changes in taste
- Dry mouth or increased amounts of saliva
- Feeling of dyspepsia
- Abdominal pain or discomfort
- Vomiting, flatulence (passing gas) or diarrhoea
- Feeling tired
- Hypersensitivity (allergy)
- Numbness
Uncommon: may affect up to 1 in 100 people:
- Effects in the nose, e.g. runny, stuffy nose, sneezing
- Running nose
- Wheezing (bronchospasm) or feeling like breathing takes more effort than usual (dyspnoea), throat tightness
- Redness of the skin (flushing) or increased sweating
- Effects in the mouth, such as numbness, inflammation of the tongue, mouth ulcers, damage to the lining of the mouth or changes in the sound of the voice, pain in the mouth and throat, belching, bleeding gums.
- Palpitations (abnormal feeling of heartbeats), fast heart rate, hypertension
- Skin rash and/or itching (pruritus, urticaria).
- Unusual dreams
- Chest discomfort and pain
- Weakness, malaise
Rare: may affect up to 1 in 1,000 people
- Difficulty swallowing, reduced sensations in the mouth
- Nausea
Frequency not known: cannot be estimated from the available data:
- Blurred vision, increased tearing (lacrimation)
- Dry throat, stomach discomfort, sore lips
- Irregular heart rhythm
- Redness of the skin
- Allergic reactions including swelling of the face and mouth (angioedema or anaphylaxis)
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet.
You can also report side effects directly through the national reporting system at
Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
Tel.: +359 2 8903417
website: www.bda.bg
.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Nicorette Berimint
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the dosing device and on the blister card after EXP. The expiration date corresponds to the last day of the specified month.
To be stored below 30°C.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment, especially the aquatic environment in the case of nicotine.
6. Contents of the package and additional information
What Nicorette Berimint contains
- The active substance is nicotine. One puff delivers 1mg of nicotine.
- The other ingredients are: propylene glycol (E1520), anhydrous ethanol, trometamol, poloxamer 407, glycerol (E422), sodium hydrogen carbonate, levomenthol, red berry flavor, cooling flavor, sucralose, acesulfame potassium, butylated hydroxytoluene (E 321), hydrochloric acid (for pH adjustment) and purified water.
What Nicoret Berimint looks like and contents of the pack
Nicoret Berimint consists of a plastic bottle with a solution in a package with a dosing device with a mechanical spray pump. The packaging with the dosing device is child-resistant.
Each bottle contains 13.2 ml of solution, which provides 150 sprays.
Nicoret Berimint is supplied in packs with 1 or 2 dosing devices.
Not all types of packaging can be marketed.
Marketing Authorization Holder and Manufacturer
McNeil AB, Norrbroplatsen 2, SE-251 09 Helsingborg, Sweden
This medicinal product is authorized for use in the EEA member states under the following names :
Sweden | Nicorette Fruktmint |
Austria | Nicorette Fruit & Mint Spray |
Belgium / Netherlands | Nicorette Fruit & Mint Mondspray |
Bulgaria | Nicorette Berrymint |
Croatia | Nicorette taste fruit |
Cyprus | Nicorette Quickspray Berry |
Czech Republic | Nicorette Spray s příchutí lesního ovoce |
Denmark | Nicorette QuickMist Cool Berry |
Estonia | nicorette cool berry |
Finland | Nicorette Berrymint |
France | NICORETTESPRAY® FRUITS ROUGES |
Germany | Nicorette Fruit & Mint Spray |
Greece | Nicorette Quickspray Berry |
Hungary | Nicorette Cool Berry |
Iceland | Nicorette Quickmist Cool Berry |
Ireland | Nicorette QuickMist Cool Berry |
Italy | Nicorettequick |
Latvia | Nicorette Coolberry |
Luxembourg | Nicorette Fruit & Mint Spray Buccal |
Norway | Nicorette |
Poland | Nicorette Cool Berry |
Portugal | Nicorette Bucomist sabor Fruta Menta |
Romania | Nicorette Berrymint |
Slovak Republic | Nicorette Spray s príchuťou lesného ovocia |
Slovenia | Nicorette z okusom gozdnih sadežev |
Spain | Nicorette Bucomist sabor Fruta Menta |
Date of last revision of the leaflet 03/2020.
