7 mg / 24 hours, 14 mg / 24 hours, 21 mg / 24 hours
nicotine
WHAT NICOTINAL DEPOSIT PATTERNS ARE AND WHAT IT IS USED FOR
Nicotinell transdermal patch reduces withdrawal symptoms in connection with you quitting smoking and thereby counteracts relapse to smoking.
Nicotinell transdermal patch is a patch that adds nicotine to the body. When you smoke, your body gets used to nicotine and when you stop smoking, you, therefore, suffer from so-called withdrawal symptoms. Nicotinell transdermal patches reduce withdrawal symptoms and thus reduce the risk of relapse. Supply of nicotine when using Nicotinell transdermal patches is less risky than when smoking, as it avoids the other harmful constituents found in tobacco smoke. The nicotine is stored in the patch and is slowly absorbed into the body through the skin. The concentration of nicotine in the blood usually reaches a maximum value after 8-10 hours.
BEFORE YOU USE NICOTINELL DEPOSIT PATCHES
Do not use Nicotinell transdermal patches
- if you are allergic to nicotine or any of the other ingredients of Nicotinell transdermal patches .
- in case of skin hypersensitivity
- in severe skin disease
- in acute myocardial infarction
- in unstable angina in the heart
- in case of severe heart rhythm disturbance
- in a recent disorder of the blood circulation of the brain
- if you are a non-smoker
Take special care with Nicotinell transdermal patches
Talk to your pharmacist or doctor before using Nicotinell transdermal patches if you have cardiovascular disease; high blood pressure not treated with drugs; inflammation of the esophagus, mouth, or pharynx; gastric catarrh; gastric ulcer; hyperthyroidism (high production of thyroid hormone); diabetes; epilepsy; take medicines for seizures or have impaired kidney or liver function.
Never smoke while using Nicotinell transdermal patches as you may then ingest nicotine levels so high that you feel unwell.
Nicotinell transdermal patches contain aluminum. The patch must therefore be removed before the magnetic resonance imaging.
If you have skin problems ( dermatitis ) even before you start using this medicine, or suffer from skin problems during treatment, you should consult a doctor.
Warnings and precautions for combination therapy with Nicotinell transdermal patch and Nicotinell medical chewing gum or lozenge are the same as for each treatment alone (see package leaflet for Nicotinell 2 mg medical chewing gum and Nicotinell 1 mg lozenge, respectively).
Children and young people
People under the age of 18 should only use Nicotinell transdermal patches as prescribed by a doctor.
Use of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Smoking cessation may require the adjustment of certain drug treatments.
For combination therapy: Read the package leaflet for Nicotinell 2 mg medical chewing gum and Nicotinell 1 mg lozenge respectively.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
It is very important to stop smoking during pregnancy because smoking can impair fetal growth. It is best if you who are pregnant can stop smoking without using drugs that contain nicotine. If you are pregnant and unable to do this, Nicotinell patches should only be used after consulting your healthcare professional.
Breast-feeding
Nicotinell patches should be avoided during breastfeeding as nicotine passes into breast milk and may affect your baby. Consult a healthcare professional before using Nicotinell patches during breastfeeding.
Fertility
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 NICOTINAL DEPOSIT Patches
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.
Ask your doctor or pharmacist if you are unsure.
Nicotinell transdermal patch can be used alone or in combination with Nicotinell 2 mg medical chewing gum or Nicotinell 1 mg lozenge.
Children and young people
People under the age of 18 should not use Nicotinell transdermal patches without a doctor’s prescription. Even small amounts of nicotine are dangerous for children and can lead to severe cases of poisoning that can be fatal.
Dosage for adults over 18 years and older
You must stop smoking completely during treatment with Nicotinell transdermal patches.
Treatment with Nicotinell transdermal patches only
A patch once a day is applied in the morning in connection with waking up. The patch should remain in place throughout the day or during the time you are awake. Use of the patch around the clock is necessary if you feel “tobacco cravings” already in the morning. Do not divide the patch as it may not give you the correct dose. Strength is chosen based on how many cigarettes you smoke daily. Nicotinell transdermal patch 7 mg / 24 hours is used for dose reduction at the end of treatment.
Those who smoke more than 20 cigarettes per day are recommended to start treatment with a patch Nicotinell transdermal patch 21 mg / 24 hours. If the effect is satisfactory after 3-4 weeks of treatment, switch to the nearest lower strength. Then lower the dose one more step to the lowest strength for 3-4 weeks (treatment ends when you feel ready). See the dosing table below for more information.
For those who smoke less than 20 cigarettes a day, it is advisable to start treatment with Nicotinell transdermal patch 14 mg / 24 hours. If the effect is satisfactory after 3-4 weeks of treatment, switch to the nearest lower strength. Then continue with the lowest strength for another 3-4 weeks or end the treatment (if you feel ready). See the dosing table below for more information.
Dosage tables:
For more than 20 cigarettes a day – start with step 1
| Step 1 | step 2 | Step 3 | |
| Strength | 21 mg / 24 hours | 14 mg / 24 hours | 7 mg / 24 hours |
| Treatment time for more than 20 cigarettes per day | 3-4 weeks | 3-4 weeks | 3-4 weeks * |
* when you feel ready, you can end the treatment
With less than 20 cigarettes a day – start with step 2
| Step 1 | step 2 | Step 3 | |
| Strength | – | 14 mg / 24 hours | 7 mg / 24 hours |
| Treatment time for less than 20 cigarettes per day | – | 3-4 weeks | 3-8 weeks * |
* when you feel ready, you can end the treatment
The strength of the patch should be adjusted according to individual response, increase the strength of the effect is not satisfactory or if withdrawal symptoms are observed.
The treatment time is about 3 months but can vary depending on individual response. However, treatment should not last for more than three months.
Instructions for use
1. Open the package at the marking and take out the patch.
2. Remove the narrow part of the aluminum foil.
Then pull off the rest of the foil. Avoid touching the adhesive.
After opening, the patch should be applied to a clean, dry, hair-free, and undamaged skin surface on e.g. chest, back, upper arm, or hip. The patch must not be applied to red, damaged, or irritated skin. The skin surface where the patch is applied should not be lubricated with skin lotion or cream.
5. To minimize the risk of local irritation, it should take a week before using the same skin surface again.
6. Hold your hand over the entire patch surface and press the patch against the skin for 10-20 seconds. Make sure that the patch adheres properly around the edges. Do not loosen or move the patch, as it will adhere worse.
7. Wash your hands thoroughly after applying the transdermal patch to avoid eye irritation with nicotine from your fingers.
After removal, used patches should be folded (with the sticky side inwards) and returned to the pharmacy (see section 5) and stored out of sight and reach of children.
The patch is firmly attached to the skin and can be kept on during bathing and showering. If the patch should come off, take a new one and attach it to a new skin surface.
Treatment with Nicotinell transdermal patch in combination with Nicotinell medical chewing gums
People who have a craving for smoke or withdrawal symptoms despite the use of nicotine medicines, or who have failed treatment with Nicotinell transdermal patches / chewing gums alone or who wish to reduce the use of chewing gums due to local side effects can use Nicotinell transdermal patches together with Nicotinell 2 mg chewing gum. The use of Nicotinell patches together with Nicotinell 2 mg chewing gum is recommended for smokers with a moderate to very strong dependence, ie. over 20 cigarettes a day, or smokers who take their first cigarette within 30 minutes of waking up.
You should completely stop smoking when you start treatment with transdermal patches in combination with Nicotinell 2 mg chewing gum and do not smoke during the entire treatment period.
NOTE! Read the package leaflet for Nicotinell 2 mg medical chewing gum before use.
Initial combination treatment:
Treatment should start with a 21 mg / 24-hour patch in combination with Nicotinell 2 mg chewing gum. At least 4 chewing gums (2 mg) per day should be used. In most cases, 5-6 chewing gums are enough. A maximum of 24 chewing gums per day should be used. Normally, treatment should last for 6-12 weeks. Thereafter, the nicotine dose is gradually reduced.
Reduction of nicotine dose:
This can be done in two ways. Either by using lower strength patches, ie patches 14 mg / 24 hours for 3-6 weeks followed by 7 mg / 24 hours for a further 3-6 weeks together with the initial dose of a Nicotinell 2 mg. Thereafter, the number of 2 mg chewing gums is gradually reduced for up to 12 months. Alternatively, the use of patches can be discontinued and the number of 2 mg chewing gums gradually reduced for up to 12 months.
| Period | Band-Aid | Chewing gum 2 mg |
|---|---|---|
| Initial treatment | ||
| First 6-12 weeks | 1 patch 21 mg / 24 hours | If necessary, 5-6 chewing gums per day is recommended |
| Nicotine dose reduction – option 1 | ||
| Next 3-6 weeks | 1 patch 14 mg / 24 hours | Continue to use chewing gum if necessary |
| Subsequent 3-6 weeks | 1 patch 7 mg / 24 hours | Continue to use chewing gum if necessary |
| Up to 12 months | — | Gradually reduce the number of chewing gums |
| Reduction of nicotine dose – alternative 2 | ||
| Up to 12 months | — | Continue to reduce the number of chewing gums gradually |
Treatment with Nicotinell transdermal patch in combination with Nicotinell Mint 1 mg lozenges
People who feel smoke or withdrawal symptoms despite the use of nicotine replacement therapy, or who have failed treatment with Nicotinell prolonged-release patches/lozenges alone or who wish to reduce the use of lozenges due to local side effects can use Nicotinell transdermal patches with Nicotinell 1 mg lozenges.
The use of Nicotinell patch together with Nicotinell 1 mg lozenge is recommended for smokers with a moderate to very strong dependence, ie. over 20 cigarettes a day, or smokers who take their first cigarette within 30 minutes of waking up.
It is highly recommended that the combination treatment be used together with advice and support from healthcare professionals.
You should completely stop smoking when you start treatment with transdermal patches in combination with Nicotinell 1 mg lozenges and do not smoke during the entire treatment period.
NOTE: Read the package leaflet of Nicotinell Mint 1 mg lozenges before use.
Initial combination treatment:
Start treatment with a patch 21 mg / 24 hours in combination with Nicotinell 1 mg lozenge. Use at least 4 lozenges (1 mg) per day. In most cases, 5-6 lozenges are enough. Do not use more than 15 lozenges per day. Normally, treatment should last for 6-12 weeks. Thereafter, the nicotine dose is gradually reduced.
Read the instructions for use of the patch above.
Reduction of nicotine dose after the first 6-12 weeks:
This can be done in 2 ways.
Option 1: Use patches with lower strength, ie. 14 mg / 24 hours patches for 3-6 weeks followed by the 7 mg / 24 hours patch for an additional 3-6 weeks along with the initial dose of a Nicotinell 1 mg lozenge. Thereafter, the number of lozenges is gradually reduced. A treatment period longer than 6 months is not normally recommended. However, some former smokers may need treatment longer to not return to smoking, the treatment should not exceed 9 months.
Option 2:
Discontinue treatment with patches and gradually reduce the number of 1 mg lozenges. A treatment period longer than 6 months is not normally recommended. However, some former smokers may need treatment longer to not return to smoking, the treatment should not exceed 9 months.
| Period | Band-Aid | Lozenge 1 mg |
|---|---|---|
| Initial treatment (followed by options 1 or 2 below) | ||
| First 6-12 weeks | 1 patch 21 mg / 24 hours | If necessary, 5-6 lozenges per day are recommended |
| Nicotine dose reduction – option 1 | ||
| Next 3-6 weeks | 1 patch 14 mg / 24 hours | Continue to use lozenges if necessary |
| Subsequent 3-6 weeks | 1 patch 7mg / 24 hours | Continue to use lozenges if necessary |
| Up to a total of 9 months | – | Gradually reduce the number of lozenges |
| Reduction of nicotine dose – alternative 2 | ||
| Up to a total of 9 months | – | Continue to reduce the number of lozenges gradually |
Contact a doctor or pharmacist if you are still using patches or lozenges after 9 months.
If you use more Nicotinell transdermal patches than you should
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.
Even small amounts of nicotine are dangerous for children and can lead to severe cases of poisoning that can be fatal.
Symptoms of overdose include paleness, sweating, increased salivation, vomiting, abdominal pain, diarrhea, headache, dizziness, hearing and vision impairment, tremor, confusion, and weakness. Fatigue, drop in blood pressure, collapse of circulation, difficulty breathing, and twitching can occur in large overdoses.
POSSIBLE SIDE EFFECTS
Like all medicines, Nicotinell transdermal patches can cause side effects, although not everybody gets them.
Nicotinell transdermal patches can cause the same side effects as nicotine smoking.
Some side effects can also be symptoms of nicotine withdrawal, which occur due to reduced nicotine intake in connection with quitting smoking. Symptoms of nicotine withdrawal may include depression, irritability, nervousness, restlessness, mood swings, anxiety, drowsiness, decreased concentration, insomnia, and sleep disorders. Those who quit smoking may suffer from weakness, headaches, dizziness, cough, or flu-like illness.
The most common side effects of Nicotinell transdermal patches are skin irritation such as itching and redness under the patch.
Very common (may affect more than 1 user in 10):
- Sleep disorders including vivid dreams and insomnia, dizziness, headache, nausea, vomiting
- Reactions at the application site. The reactions are often less severe and transient after removal of the patch. Pain or a feeling of heaviness in the area around which the patch is applied may occur.
Common (may affect up to 1 in 10 people):
- Nervousness, tremor, palpitations, shortness of breath, inflammation of the throat, cough, increased sweating, joint pain, muscle aches, pain at the application site, weakness, fatigue.
Uncommon (may affect up to 1 in 100 people):
- Hypersensitivity, increased heart rate , discomfort, flu-like symptoms .
Rare (may affect up to 1 in 1,000 people):
- Irregular heartbeat.
Very rare (may affect up to 1 in 10,000 people):
- Anaphylactic reaction , indigestion ( dyspepsia ), upper abdominal pain, diarrhea, dry mouth , constipation, allergic rash (often less severe and rapidly transient after removal of the patch), contact dermatitis (often less severe and rapid transient after removal of the patch), hypersensitivity of the skin to light.
For combination therapy: Read the package leaflet for Nicotinell 2 mg medical chewing gum and Nicotinell 1 mg lozenge respectively.
HOW TO STORE NICOTINELL DEPOSIT PATCHES
Keep out of sight and reach of children.
Do not store above 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 are folded (with the sticky side inwards) and stored safely so that children do not have access to them. Used patches also contain enough residual nicotine to be harmful to children.
Return used patch to a pharmacy. The 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.
FURTHER INFORMATION
Content declaration
- The active substance is nicotine.
- Other ingredients are:
Outer film: aluminized polyester film with a beige-colored outer surface.
Matrix and adhesive lamellas: copolymer of acrylic methacrylic esters (Eudragit E 100), copolymer based on acrylic esters, and vinyl acetate (Durotak 387-2516), medium-chain triglycerides (Miglyol 812).
Cover film: polyester film treated with aluminum and silicon (removed before applying the patch to the skin).
The patch is available in three different strengths:
Nicotinell 7 mg / 24 h transdermal patch contains 17.5 mg of nicotine.
Nicotinell 14 mg / 24 h transdermal patch contains 35.0 mg of nicotine.
Nicotinell 21 mg / 24 h transdermal patch contains 52.5 mg of nicotine.
What the medicine looks like and contents of the pack
Each transdermal patch is circular and consists of a beige surface, a silver-colored intermediate layer, and a transparent protective layer. Each patch is in a protective package.
Nicotinell transdermal patches are sold in packs of 7 or 21 transdermal patches in each.
Marketing Authorisation Holder
GlaxoSmithKline Consumer Healthcare ApS
PO Box 61
2610 Rødovre
Denmark
Manufacturer
LTS Lohmann Therapie-Systeme AG, Lohmannstrasse 2, 56626 Andernach, Germany