Package leaflet: Information for the user

Nicorette invisipatch 25 mg/16 h transdermal patch Nicorette invisipatch 15 mg/16 h transdermal patch Nicorette invisipatch 10 mg/16 h transdermal patch

(nicotine)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you have not been able to stop smoking after 6 months of treatment with Nicorette Invisipatch.

What is in this leaflet: 1. What Nicorette invisipatch is and what it is used for 2. What you need to know before you use Nicorette invisipatch 3. How to use Nicorette invisipatch 4. Possible side effects 5 How to store Nicorette invisipatch 6. Contents of the pack and other information

1. What Nicorette invisipatch is and what it is used for

Nicorette invisipatch is a medicinal product helping you to stop smoking.

Nicorette invisipatch is used to treat tobacco dependence, to relieve cravings for smoking (nicotine) and nicotine withdrawal symptoms, which helps the motivated smokers to stop smoking.

When you stop smoking and providing your body with nicotine from tobacco, you can experience unpleasant feelings called withdrawal symptoms. By using Nicorette invisipatch you can prevent or reduce these unpleasant feelings - by using Nicorette invisipatch patches you continue to provide your body with small amount of nicotine in its pure form, which does not bring about health risks associated with smoking.

Health risks associated with smoking are caused by toxins contained in tobacco. Counselling advice and support usually improve your chances to quit smoking. If possible, use the medicine as a part of a smoking withdrawal program.

If used as recommended, Nicorette invisipatch helps you to control potential rise in your weight after you stop smoking.

2. What you need to know before you use Nicorette invisipatch

Do not use Nicorette invisipatch - 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 of age. - If you are non-smoker.

1/10 Warnings and precautions

Talk to your doctor or pharmacist before taking Nicorette invisipatch if you: - have ever suffered from a serious cardio-vascular event or were hospitalized within the last 4 weeks due to abnormal heart condition (e.g. stroke, myocardial infarction, arrhythmia (heart rhythm disorder), unstable angina pectoris) - have had cardio-vascular bypass surgery or angioplasty (surgery on arteries) - suffer from high blood pressure which is not being controlled by medicines - suffer from liver disease and/or severe kidney disease - have diabetes, as when you stop smoking you may need to lower insulin dosage - have an overactive thyroid gland (hyperthyroidism) or a tumour of the adrenal gland (phaeochromocytoma) - have stomach or duodenal ulcers

Children and adolescents Nicorette invisipatch is not to be used in patients under 18 years of age. Doses of nicotine that are well tolerated by adult smokers during treatment may cause serious symptoms of poisoning in children and may prove fatal. Even if already used, patches contain enough nicotine to do harm to children. Keep both used and unused patches out of sight and reach of children.

Other medicines and Nicorette invisipatch Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important if you take medicines containing: theophylline to treat asthma tacrine for Alzheimer’s disease clozapine for schizophrenia ropinirole to treat Parkinson’s disease

Nicorette invisipatch with food and drink Food and drink intake has no influence on the effect of this medicine.

Pregnancy and breast-feeding Before using any medicine, consult your doctor or pharmacist.

As smoking can cause severe damage to foetus or your infant, you should stop smoking during pregnancy and breast-feeding, if possible you should do so without using medicines containing nicotine.

Nicotine is found in breast milk in the amounts that may harm infants. Do not use Nicorette invisipatch during breast-feeding.

If you cannot stop smoking without using medicines that contain nicotine, use Nicorette products only after consulting your doctor.

Driving and using machines No effects on the ability to drive cars or use machines have been observed.

3. How to use Nicorette invisipatch

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not exceed the maximum dose. You should try your best to stop smoking completely during the treatment with Nicorette invisipatch.

Nicorette invisipatch may be used alone or in combination with either [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray].

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Use in children and adolescents Safety and efficacy in children and adolescents have not been assessed. Nicorette invisipatch must not be used by children and adolescents under 18 years of age.

Adults (elderly included)

Treatment with patch alone:

Treatment with Nicorette invisipatch usually takes 12 weeks. The amount of nicotine in a patch is usually high at the beginning and smaller later during the treatment, which means gradual decreasing of nicotine needed and eventual stop of smoking. Treatment with Nicorette invisipatch imitates fluctuation of plasma nicotine level observed in smokers without nicotine intake during sleep. Nicotine excreted from Nicorette patches, that are used only during the active part of a day (effect lasts 16 hours), does not cause sleep disorders observed in patients who get nicotine during sleep.

Smokers with high level of nicotine dependence (Fagerström test for nicotine dependence corresponding to or higher than 6, or smoking more than 20 cigarettes a day) are recommended to start their treatment with Nicorette invisipatch 25 mg/16 h (one patch a day), see Table 1. The initial treatment should last 8 weeks.

After 8 weeks, the dose of nicotine contained in patches should be decreased gradually. Therefore, Nicorette invisipatch 15 mg/16 h should be used for 2 weeks (one patch a day), followed by Nicorette invisipatch 10 mg/16 h used for 2 weeks as well (one patch a day).

Smokers with lower level of nicotine dependence (Fagerström test for nicotine dependence lower than 6, or smoking less than 20 cigarettes a day) are recommended to start their treatment with Nicorette invisipatch 15 mg/16 h (one patch a day), see Table 2. The initial treatment should last 8 weeks.

After 8 weeks, the dose of nicotine contained in patches should be decreased gradually. Therefore, Nicorette invisipatch 10 mg/16 h should be used for 4 weeks (one patch a day – step 3, see Table 2).

Table 1) Dosage scheme in smokers with high level of nicotine dependence Dosage Treatment period Step 1 Nicorette invisipatch 25 mg/16 h one patch a day first 8 weeks – initial phase

Step 2 Nicorette invisipatch 15 mg/16 h one patch a day following 2 weeks

Step 3 Nicorette invisipatch 10 mg/16 h one patch a day last 2 weeks

Table 2) Dosage scheme in smokers with lower level of nicotine dependence Dosage Treatment period Step 1 Nicorette invisipatch 15 mg/16 h one patch a day first 8 weeks – initial phase

Step 2 Nicorette invisipatch 10 mg/16 h one patch a day last 4 weeks

Using patches longer than 6 months is generally not recommended. If you need to use the product longer than recommended to prevent taking up smoking again, consult your doctor.

3/10 Treatment with patch in combination with either [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray].

If you feel that nicotine craving occurs despite the use of nicotine medications, you can use Nicorette patch in combination with either [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray].

Read the leaflet for the Nicorette product you use with the patch before taking it. The leaflet is enclosed in each package.

Smokers with high level of nicotine dependence (Fagerström test for nicotine dependence corresponding to or higher than a score of 6, or smoking more than 20 cigarettes a day) are recommended to start their treatment with Nicorette invisipatch 25 mg/16 h (one patch a day) in combination with either [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray] as described in Table 3. The initial treatment should last 8 weeks.

After 8 weeks, the dose of nicotine contained in patches should be decreased gradually. Therefore, Nicorette invisipatch 15 mg/16 h should be used for 2 weeks (one patch a day), followed by Nicorette invisipatch 10 mg/16 h used for 2 weeks as well (one patch a day). The dose of [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray] to use in combination with the patches are described in Table 3.

Smokers with lower level of nicotine dependence (Fagerström test for nicotine dependence lower than a score of 6, or smoking less than 20 cigarettes a day) are recommended to start their treatment with Nicorette invisipatch 15 mg/16 h (one patch a day) in combination with either [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray] as described in Table 4. The initial treatment should last 8 weeks.

After 8 weeks, the dose of nicotine contained in patches should be decreased gradually. Therefore, Nicorette invisipatch 10 mg/16 h should be used for 4 weeks (one patch a day), see Table 4. The doses of [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray] to use in combination with the patches are described in Table 4.

Table 3) Dosage scheme for combination therapy in smokers with high level of nicotine dependence Treatment Dose of Nicorette invisipatch Flexible formulation Daily dose of the period One of the following flexible formulation in products can be used at combination with the a time. patch As needed. Usually 5 to [insert name of 2mg 6 gums per day (max: 16 gums] gums a day) As needed. Use one spray first and if your cravings do not disappear Step 1: within a few minutes, use first 8 the second spray. If 2 Nicorette invisipatch 25 mg/16 h one weeks – sprays are required, patch a day [insert name of the initial future doses may be Oromucosal spray phase delivered as 2 1mg/spray] consecutive sprays. Do not use more than 2 sprays at a time or 2 sprays per hour for 16 hours. The maximum dose is 32 sprays over 16

4/10 hours in any 24-hour period. Start reducing the number of sprays per day from week 7. [insert name of 2mg As needed (max: 16 gums] gums a day). [insert name of the As needed but continue Oromucosal spray reducing. 1mg/spray] Do not use more than 2 Step 2: Nicorette invisipatch 15 mg/16 h one sprays at a time or 2 following patch a day sprays per hour for 16 2 weeks hours. The maximum dose is 32 sprays over 16 hours in any 24-hour period.

[insert name of 2mg As needed (max: 16 gums] gums a day).

As needed but continue reducing. Do not use more than 2 Step 3: last Nicorette invisipatch 10 mg/16 h one [insert name of the sprays at a time or 2 2 weeks patch a day Oromucosal spray sprays per hour for 16 1mg/spray] hours. The maximum dose is 32 sprays over 16 hours in any 24-hour period.

If needed but reduce the number of gums. Treatment should be stopped when the dose is reduced to 1-2 chewing [insert name of 2mg gums per day. gums] Do not take more than 16 gums a day. Consult your doctor if you need to use [insert Using patches longer than 6 months is name of 2mg gums] for generally not recommended. If you need After 12 longer than 12 months. to use the product longer than weeks Consult your doctor if recommended to prevent taking up you need to use [insert smoking again, consult your doctor. name of the Oromucosal spray 1mg/spray] for longer than 6 months. [insert name of the Do not use more than 2 Oromucosal spray sprays at a time or 2 1mg/spray] sprays per hour for 16 hours. The maximum dose is 32 sprays over 16 hours in any 24-hour period.

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Table 4) Dosage scheme for combination therapy in smokers with lower level of nicotine dependence Treatment Dose of Nicorette invisipatch Flexible formulation Daily dose of the period One of the following flexible formulation in products can be used at combination with the a time. patch Step 1: Nicorette invisipatch 15 mg/16 h one [insert name of 2mg As needed. Usually 5 to first 8 patch a day gums] 6 gums per day (max: 16 weeks – gums a day) initial [insert name of the As needed. Use one phase Oromucosal spray spray first and if your 1mg/spray] cravings do not disappear within a few minutes use the second spray. If 2 sprays are required, future doses may be delivered as 2 consecutive sprays. Do not use more than 2 sprays at a time or 2 sprays per hour for 16 hours. The maximum dose is 32 sprays over 16 hours in any 24-hour period. Start reducing the number of sprays per day from week 7. Step 2: Nicorette invisipatch 10 mg/16 h one [insert name of 2mg As needed (max: 16 following patch a day gums] gums a day). 2 weeks [insert name of the As needed but continue Oromucosal spray reducing. 1mg/spray] Do not use more than 2 sprays at a time or 2 sprays per hour for 16 hours. The maximum dose is 32 sprays over 16 hours in any 24-hour period.

[insert name of 2mg If needed but reduce the gums] number of gums. Treatment should be stopped when the dose is reduced to 1-2 chewing Using patches longer than 6 months is gums per day. generally not recommended. If you need Do not take more than 16 After 12 to use the product longer than gums a day. weeks recommended to prevent taking up Consult your doctor if smoking again, consult your doctor. you need to use [insert name of 2mg gums] for longer than 12 months. [insert name of the Consult your doctor if Oromucosal spray you need to use [insert 1mg/spray] name of the Oromucosal

6/10 spray 1mg/spray] for longer than 6 months. Do not use more than 2 sprays at a time or 2 sprays per hour for 16 hours. The maximum dose is 32 sprays over 16 hours in any 24-hour period.

Way of administration: Each day stick only one patch on clean and dry skin without hairs (e.g. hip, shoulder, chest, etc.), so that you can change the place of application every day and therefore prevent possible skin irritation. For perfect adherence avoid using cosmetics, lotions and powders at places of application. At best, a patch should be applied immediately after waking up in the morning and removed before going to sleep, so that it can work 16 hours, which suits the needs of smokers and leaves the sleep undisturbed.

1. Wash your hands before applying a patch. 2. To open a sachet use scissors and cut it as indicated. Stick a patch on clean and dry skin without hairs (e.g. hip, shoulder, chest, etc.). 3. Remove one part of a silver aluminium layer as far as possible, but avoid touching the sticking part of a patch with your fingers! 4. Put the sticking part of a patch on your skin and remove the rest of a silver aluminium layer. 5. Press a patch firmly to your skin, using your fingers or palm. 6. Smooth the whole patch out by your fingertips to secure perfect adherence.

If wrongly applied or unstuck, use a new patch. Do not use it during night, i.e. not longer than 16 hours! Used patches should be disposed of safely.

If you unfortunately forget to remove a patch in the evening, you can remove it in the morning and continue your treatment as usual, using a new patch.

If you use more Nicorette invisipatch than you should Overdosing of nicotine may occur if you smoke and take Nicorette invisipatch at the same time and/or use other forms of nicotine replacement therapy or have weak nicotine dependence.

If you use more patches than recommended, or if a child unfortunately uses or swallows a patch, consult your doctor or see a medical service immediately. Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in children and may prove fatal.

The symptoms of overdose are feeling sick (nausea), vomiting, too much saliva, stomach pain, diarrhoea, sweating, headache, dizziness, changed hearing and feeling very weak. At high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, difficulty breathing, extreme tiredness, circulatory collapse and convulsions. If any symptoms of overdose occur, stop using the product and consult a doctor or a pharmacist. The surface of the skin where the patch was applied should be washed with water and dried (no soap should be used).

If you have any further questions about 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.

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Nicorette invisipatch can give the same side effects as other forms of nicotine administration. The side effects generally depend on the dose taken.

Effects related to stopping smoking (nicotine withdrawal) Some of the unwanted effects that you experience when stopping smoking can be withdrawal symptoms due to decreases in nicotine intake. These effects include:  Irritability, aggression, impatience or frustration  Feeling anxious, restless or having difficulty concentrating  Night time awakening or sleep disturbance  Increased appetite or weight gain  Feeling low  Urges to smoke (craving)  Lowering of heart rate  Bleeding gums or mouth ulcers  Dizziness or light-headedness  Cough, sore throat, stuffy or runny nose  Constipation

If you notice any of the following serious rare side effects, stop using Nicorette Invisipatch and contact a doctor immediately (signs of angioedema):  Swollen face, tongue or pharynx  Difficulty in swallowing  Hives and difficulties in breathing

Very common: may affect more than 1 in 10 people - itchy skin

Common: may affect up to 1 in 10 people - dizziness, headache, hives, stomach pain, vomiting, feeling sick, skin blushing rash.

Uncommon: may affect up to 1 in 100 people - abnormal dream, application site reactions, chest discomfort and pain, feeling tired (fatigue), feeling unwell, heart pounding, hypersensitivity, hypertension, increase of heart rate, increased sweating, muscle pain, pain in arm or leg, skin flushing, tingling, weakness, feeling like breathing requires more effort than usual (dyspnoea).

Very rare: may affect up to 1 in 10 000 people - temporary irregular heart activity

Not known: frequency cannot be estimated from the available data - Allergic reactions including swelling of the face and mouth (angioedema or anaphylaxis), redness of the skin.

Combination therapy Before using Nicorette Invisipatch in combination with [to be completed nationally depending on what is registered amongst Nicorette 2mg gums and Nicorette 1mg/spray mouthspray], read carefully the side effects section of the package leaflet of [to be completed nationally depending on what is registered amongst Nicorette 2mg gums and Nicorette 1mg/spray mouthspray]

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

8/10 You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nicorette invisipatch

Keep this medicine out of the sight and reach of children.

Store below 25C, keep the pouch tightly closed in order to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Nicorette invisipatch contains

- The active substance is nicotine. One 10mg patch of 9.0cm2 size contains 15.75 mg of nicotine, one 15mg patch of 13.5cm2 size contains 23.62 mg of nicotine, and one 25mg patch of 22.5cm2 size contains 39.37 mg of nicotine. - Content of nicotine in each patch is 1.75 mg/cm2. The other ingredients are: Nicotine layer: polyethylenterephthalate (PET) film, medium-chain triglycerides, basic butylated methacrylate-copolymer. Acrylate layer: acrylic adhesive solution, potassium hydroxide, croscarmellose sodium, aluminium acetylacetonate. Release liner: polyethylenterephthalate (PET) film, single side aluminised, both sides siliconised.

What Nicorette invisipatch looks like and contents of the pack

Beige, semi-transparent, rectangular patch with rounded edges and light-brown “Nicorette” printing is placed on an easily removable layer coated with aluminium and silicon and is formed by nicotine layer and adhesive acrylic layer.

Patches are sealed in multilayer pouches. The pouches are stored in a box.

Pack sizes Nicorette invisipatch 25 mg/16 h: 7, 14, 28 patches Nicorette invisipatch 15 mg/16 h: 7, 14, 28 patches Nicorette invisipatch 10 mg/16 h: 7, 14 patches

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder McNeil AB Norrbroplatsen 2 251 09 Helsingborg Sweden

9/10 Manufacturer LTS LOHMANN THERAPIE-SYSTEME AG ANDERNACH, Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Czech Republic, Slovak Republic: Nicorette invisipatch Bulgaria, Romania: Nicorette Clear

This leaflet was last revised in [To be completed nationally]

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