Nicorette Novum 10 mg / 16 hours, 15 mg / 16 hours, 25 mg / 16 hours Transdermal Patch Nicotine
what Is Nicorette Novum, And What Nicorette Novum Used For?
Nicorette belongs to a group of medicines that are used to help you quit smoking. Nicorette Novum used for to relieves nicotine cravings and withdrawal symptoms when you quit smoking, thereby preventing relapse into smoking in smokers who are motivated to quit or facilitating smoking reduction in smokers who can not or are unwilling to quit smoking.
When the body is suddenly no longer supplied with nicotine from tobacco, various discomforts called withdrawal symptoms occur.
Nicorette Novum transdermal patches can prevent or alleviate such discomfort and cravings by continuing to supply your body with a small amount of nicotine for a transitional period.
When you use Nicorette Novum transdermal patch, nicotine is slowly released and absorbed through the skin, and transported via the body’s bloodstream. Unlike cigarettes, Nicorette Novum Nicotine does not contain harmful tar and carbon monoxide.
Nicorette transdermal patches should preferably be used in conjunction with a smoking cessation program. Advice and support usually increase the chance of succeeding with your smoking cessation.
What You Need To Know Before Using Nicorette Novum?
Do Not Use Nicorette Novum
- If you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).
- If you are under 12 years of age
- If you have never smoked
Warnings And Cautions:
Talk to your doctor, pharmacist, or nurse if you have any of the following conditions:
- Recently (within 3 months) have had a heart attack or stroke
- 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
- Severe or moderate liver disease
- Severe kidney disease
- Diabetes
- Overactive thyroid gland
- Adrenal medial tumor ( pheochromocytoma )
- Gastric ulcer or ulcer of the duodenum a
- Inflammation of the esophagus
However, the risk of continued smoking always poses a greater danger than the use of Nicorette Novum transdermal patches.
If you have skin problems before you start using Nicorette Novum transdermal patches, or suffer from problems during treatment, you should consult your doctor.
If you are having a magnetic resonance imaging (MRI) scan, the patch should be removed before the scan.
Children And Young People:
Young people between the ages of 12 and 17 should only use Nicorette Novum Nicotine on the advice of a healthcare professional. Children should not use Nicorette Novum transdermal patches under 12 years of age.
Other Drugs And Nicorette:
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 using medicines that contain
- Theophylline to treat asthma
- Tacrine for Alzheimer’s disease
- Clozapine for schizophrenia
- Ropinirole to treat Parkinson’s disease
Pregnancy, Breastfeeding And Fertility:
It is very important to stop smoking during pregnancy because smoking can impair fetal growth. Smoking can also cause the baby to be born prematurely or lead to miscarriage. It is best if you can stop smoking without using nicotine-containing medicines.
If you are unable to do this, use Nicorette Novum only after consulting your healthcare provider, your doctor, or a doctor who specializes in smoking cessation.
Nicorette Novum patches should be avoided during breastfeeding as nicotine passes into breast milk and may affect your baby. Consult a healthcare professional before using Nicorette patches while breast-feeding
Smoking increases the risk of infertility in women and men. The effects of nicotine on fertility are unknown.
Driving And Using Machines:
No effects on the ability to drive or use machines have been observed.
How To Use Nicorette Novum?
- Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
- Nicorette Novum transdermal patches can be used alone or in combination with either Nicorette 2 mg chewing gum/lozenge / travel tablet or Nicorette Inhaler 10 mg or Nicorette oral spray 1 mg/spray.
- To minimize the risk of local irritation, the placement of the patch should be alternated between different application sites.
- Advice and support can improve the chances of success.
Treatment with patches only for high nicotine dependence (if you smoke more than 20 cigarettes/day)
- A 25 mg / 16 hour transdermal patch is applied in the morning and removed at bedtime.
- The length of the treatment time is individual. After about 2 months, you should start getting rid of the nicotine addiction. This is done by gradually reducing the nicotine dose by using 15 mg / 16 hours transdermal patches for 2 weeks and then 10 mg / 16 hours transdermal patches for another 2 weeks.
Patch- only treatment for low nicotine dependence (if you smoke no more than 20 cigarettes/day)
- A 15 mg / 16 hour transdermal patch is applied in the morning and removed at bedtime.
- The length of the treatment time is individual. After about 2 months, you should start getting rid of the nicotine addiction. This is done by reducing the dose of nicotine by using 10 mg / 16 hours transdermal patches for 4 weeks.
Dosage instructions in tabular form:
| If you smoke more than 20 cigarettes/day | If you smoke a maximum of 20 cigarettes/day | ||
| Band-Aid | Period | Band-Aid | Period |
| 25 mg / 16 hours | Week 1-8 | ||
| 15 mg / 16 hours | Week 9-10 | 15 mg / 16 hours | Week 1-8 |
| 10 mg / 16 hours | Week 11-12 | 10 mg / 16 hours | Week 9-12 |
- A treatment period longer than 6 months is not recommended. In some cases, longer treatment times may be necessary to avoid a relapse into smoking.
- Treatment with patches in combination with Nicorette 2 mg chewing gum/lozenge / resorablett (Micro tab) or Nicorette Inhaler 10 mg or Nicorette oral spray 1 mg/spray
- If you have a high nicotine dependence, the experience that nicotine cravings occur despite the use of nicotine drugs or if you have failed treatment with a nicotine drug alone, you can use Nicorette Novum patches in combination with Nicorette 2 mg chewing gum/lozenge / resorablett or Nicorette Inhalator Nicorette oral spray 1 mg / spray for quick relief of nicotine cravings.
NOTE! Read the package leaflet for the Nicorette product you are using with the patch before use (included in each pack).
- Initial combination treatment
- A 25 mg / 16-hour transdermal patch is applied in the morning and removed at bedtime for 8 weeks.
- Use either Nicorette chewing gum 2 mg, Nicorette lozenge 2 mg, Nicorette resorablett 2 mg, Nicorette Inhaler 10 mg, or Nicorette oral spray 1 mg / spray together with the patch as follows:
- Chewing gum, lozenge, travel tablet: Take a pack of chewing gum or tablet when you feel the urge to smoke even though you are using Nicorette Novum patches. The usual dose is 5-6 chewing gums/tablets per day. Use a maximum of 24 chewing gums, 15 lozenges, or 24 resoriblets per day.
- Inhaler: Use the inhaler when you feel a puff of smoke even though you are using Nicorette Novum patches. The usual dose is 4-5 nicotine plugs per day, however, a maximum of 12 nicotine plugs per day.
- Mouthwash Spray: Use the mouthwash spray when you feel a puff of smoke even though you are using Nicorette Novum patches. The usual dose is 13 sprays per day, however, a maximum of 32 sprays per day.
- After 8 weeks, gradually reduce the nicotine dose according to one of the following two options:
- Weaning from nicotine replacement therapy – option 1
- After the first 8 weeks, use patches with lower strength:
- 1 patch 15 mg / 16 hours daily for 2 weeks followed by 1 patch 10 mg / 16 hours daily for another 2 weeks.
- At the same time, use as many chewing gums/lozenges / resoriblet tablets (2 mg) or nicotine plugs (10 mg) or sprays (1 mg/spray) as during the initial treatment.
- Then gradually reduce the number of chewing gums/lozenges / resoriblet tablets/nicotine plugs or sprays. Do not use chewing gum/lozenges / resoriblets / inhaler or oral spray for more than 12 months from the start of treatment.
- Weaning from Nicotine Drugs – Option 2
- Discontinue the use of patches after the first 8 weeks. Then gradually reduce the number of chewing gums/lozenges / resoriblet tablets/nicotine plugs or sprays. Do not use chewing gum/lozenges / resoriblets / inhaler or oral spray for more than 12 months from the start of treatment.
- The course of the combination treatment in tabular form
- Combine patches with only one of the options Nicorette chewing gum 2 mg / Nicorette lozenge 2 mg / Nicorette resorablett 2 mg / Nicorette Inhaler 10 mg or Nicorette oral spray 1 mg/spray.
| Initial treatment | |||
| Period | Band-Aid | Flexible dosage form (one of the following products can be used) | Dosage per day in combination with the patch |
| Week 1-8 | 1 patch 25 mg / 16 hours daily | 2 mg chewing gum | If necessary. The usual dose is 5-6 chewing gums (max 24) |
| 2 mg lozenge | If necessary. The usual dose is 5-6 lozenges (max 15) | ||
| 2 mg resoriblett (Micro tab) | If necessary. The usual dose is 5-6 resoriblets (max 24) | ||
| inhaler | If necessary. Usual dose 4-5 nicotine plugs (max 12) | ||
| oral spray | If necessary. The usual dose is 13 sprays per day (max. 32 sprays/day) |
| Weaning from Nicotine Drugs – Option 1 | ||
|---|---|---|
| Week 9-10 | 1 patch 15 mg / 16 hours daily | Continue to usechewing gum / lozenges / resoriblets / inhaler / oral spray if needed |
| Week 11-12 | 1 patch 10 mg / 16 hours daily | Continue to usechewing gum / lozenges / resoriblets / inhaler / oral spray if needed |
| Up to 12 months | — | Gradually reduce the number of chewing gums/lozenges / resoriblet tablets/nicotine plugs/sprays |
| Weaning from Nicotine Drugs – Option 2 | ||
| Up to 12 months | — | Continue to reduce the number of chewing gums / lozenges / resoriblets / nicotine plugs / sprays gradually |
Instructions for use
- Put on the patch when you wake up in the morning and take it off after about 16 hours before you go to bed in the evening.
- You can bathe and shower as usual.
- Do this:
- Fold the used patch with the sticky side inwards and throw it where children can not access it.
- Take a new patch the next day and repeat steps 1-6.
- If Nicorette Novum transdermal patches come off and fall off, immediately put on a new patch in another place and keep it on until you go to bed at night.
If You Use More Nicorette Novum Than You Should:
Nicotine overdose can occur if you smoke while using Nicorette Novum transdermal patches. 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.
Nicotine doses tolerated by adult smokers during treatment can cause severe poisoning symptoms in children and can be fatal.
Symptoms of overdose include:
- Nausea
- Vomiting
- 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
- Generalized seizures
Possible Nicorette Novum Side Effects:
Symptoms associated with quitting smoking (withdrawal symptoms)
Some of the side effects you experience when you quit smoking can be withdrawal symptoms due to reduced nicotine intake.
These symptoms include:
- Irritation, aggression, impatience, or frustration
- Anxiety, restlessness, or difficulty concentrating
- Waking up at night or sleep disturbances
- Increased appetite or weight gain
- Depression
- Smoke extraction
- Decreased heart rate
- Bleeding gums or sores in the mouth
- Dizziness or fainting
- Cough, sore throat, stuffy or runny nose
- Constipation
This medicine can cause side effects like all medicines, although not everybody gets them. Nicorette can cause the same side effects as nicotine, given in other ways. The side effects generally depend on the dose you take.
Local, mild skin reactions may occur during the first weeks of treatment. The best way to avoid the problems is to change the place of the patch daily, for example, between the right and left arm and the right and left hip.
If you notice serious and rare Nicorette Novum side effects, stop taking Nicorette and see a doctor immediately. Symptoms of angioedema (may affect up to 1 in 1,000 people) :
- Swelling of the face, tongue or throat
- Difficult to swallow
- Hives, rash and difficulty breathing
Very common side effect (may affect more than 1 user in 10):
- Itching
Common side effects ( may affect up to 1 in 10 people):
- Skin rash (including hives )
- Headache
- Nausea
- Vomiting
Uncommon side effects (may affect up to 1 in 100 people):
- Hypersensitivity ( allergy )
- Palpitations (a deviant experience of your heartbeat), increased heart rate
- Stinging sensation
- Redness of the skin (swelling), high blood pressure
- Breathing difficulties ( dyspnoea )
- Increased sweating
- Muscle pain near the patch
- Weakness
- Discomfort and pain in the chest, feeling sick
- Tiredness
- Reactions at the application site
Rare side effects ( may affect up to 1 in 1,000 people):
- Allergic reaction with swelling of the face and mouth ( angioedema or anaphylaxis )
- Reddening of the skin
- Pain in arm or leg
- Stomach upset
- Abnormal heart rhythm ( atrial fibrillation )
How To Store Nicorette Novum?
- Keep this medicine out of the sight and reach of children.
- Store below 25 ° C.
- Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
- Used patches should be folded with the sticky side inwards and discarded safely so that children do not have access to the patch. If your municipality burns household waste, it is a good idea to dispose of the patch together with the household rubbish. Otherwise, the used patch is returned to the pharmacy, preferably in the original packaging. Unused medicine 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
- Nicorette Novum transdermal patches are available in three strengths that release 10, 15, and 25 mg of nicotine during 16 hours of use.
- Nicorette Novum 10 mg / 16 h transdermal patch contains 15.8 mg of nicotine
- Nicorette Novum 15 mg / 16 h transdermal patch contains 23.6 mg of nicotine
- Nicorette Novum 25 mg / 16 h transdermal patch contains 39.4 mg of nicotine
- The other ingredients are: Triglycerides, medium-chain, basic butylated methacrylic copolymer, polyethylene terephthalate (PET) film
- Acrylate matrix: Acrylic adhesive (solution), potassium hydroxide, croscarmellose sodium, aluminum acetylacetonate
- Protective film: Polyethylene terephthalate (PET) film (aluminum coated on one side and siliconized on both sides)
What The Medicine Looks Like And Contents Of The Pack?
- Appearance:
- Nicorette Novum transdermal patch is a semi -transparent patch .
- The patch is marked with Nicorette in a light brown print.
- Patch size:
- 10 mg / 16h: area 9 cm 2 , dimensions: 27.7 x 33.2 mm
- 15 mg / 16h: area 13.5 cm 2 , dimensions: 33.2 x 41.3 mm
- 25mg / 16h: area 22.5 cm 2 , dimensions: 43 x 53 mm
- Pack sizes:
- 10 mg / 16 hours: 7 and 14 patches
- 15 mg / 16 hours: 7, 14, 21 and 28 patches
- 25 mg / 16 hours: 7, 14, 21 and 28 patches
- Not all pack sizes may be marketed.