Document: NiQuitin Clear transdermal patch ENG PL change

• NiQuitin Clear transdermal patch PL
• NiQuitin Clear transdermal patch ENG PL

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Package leaflet: Information for the user

NiQuitin Clear 7 mg/24 hours,

NiQuitin Clear 14 mg/24 hours

NiQuitin Clear 21 mg/24 hours

Sustained-release transdermal patch

Nicotine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 10 weeks of treatment with NiQuitin Clear

What is in this leaflet:

1. What NiQuitin Clear is and what it is used for

2. What you need to know before you use NiQuitin Clear

3. How to use NiQuitin Clear

4. Possible side effects

5. How to store NiQuitin Clear

6. Contents of the pack and other information

NiQuitin Clear is used in stopping smoking. The active substance in NiQuitin Clear is nicotine. It acts as a temporary aid so that you can stop smoking. It works to alleviate nicotine withdrawal symptoms as a result of stopping smoking. If possible, you should use NiQuitin Clear as part of a smoking cessation programme.

NiQuitin Clear are transparent, rectangular sustained release patches, which releases a uniform amount of nicotine through the skin into the body over a period of 24 hours.

NiQuitin Clear is less harmful than smoking, as NiQuitin Clear does not contain the tar and carbon monoxide of cigarette smoke.

Do not use NiQuitin Clear:

• if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).

• if you are a non-smoker, occasional smoker or a child.

• if you have had a myocardial infarction or stroke within the last few months.

• if you suffer from unstable heart cramps (angina pectoris), Prinzmetal’s angina or severe cardiac arrhythmias.

NiQuitin Clear may only be used by adolescents (aged 12-17 years) if recommended by a doctor.

Warnings and precautions

Talkwith your doctor or pharmacist before using NiQuitin Clear:

• if you have, or have recently had, inflammation of the skin or other skin problems.

• if you have severely impaired liver or kidney function.

• if you have active gastric ulcer or an overactive thyroid.

• if you have diabetes and are using insulin.

• if you have been diagnosed with a tumour in the adrenal glands (phaeochromocytoma).

• if you have ever experienced seizures.

If you get skin redness, swelling or rash you should stop using the patch and consult your doctor or pharmacist.

Children

The amount of nicotine tolerated by adult smokers can cause symptoms of poisoning and even be life-threatening if NiQuitin Clear is used or swallowed by children. Even used NiQuitin Clear patches contain enough residual nicotine to be harmful to children.

Therefore keep NiQuitin Clear patches out of the reach of children and dispose of used patches in a child-safe manner.

Other medicines and NiQuitin Clear

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Adjustment of the dose by your doctor may be required when taking the following medicines: Asthma medicine (theophylline), antidepressiva (imipramine, clomipramine), analgesics (pentazocine, phenacetin), anti-inflammatory agents (phenylbutazone), agents for dementia (Alzheimer’s disease) (tacrine) or antidiabetics (insulin).

Stopping smoking, with or without NiQuitin Clear, can alter the reaction to other medicines being taken at the same time.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

There is a risk of the foetus being affected. Discuss with your doctor before using NiQuitin Clear if you are pregnant or are trying to become pregnant. If you are pregnant and unable to stop smoking, you may use NiQuitin Clear under the supervision of your doctor.

Discuss with your doctor before using NiQuitin Clear if you are breast-feeding. Nicotine is excreted in breast milk and may affect the infant.

Driving and using machines

As far as is known, NiQuitin Clear has no effect on the ability to drive or use machines.

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.

It is important that you stop smoking completely when you stop smoking with the aid of NiQuitin Clear patches. No other nicotine products, e.g. nicotine chewing gum, must be used at the same time as the patches.

Dosage

For smokers who smoke more than 10 cigarettes a day it is recommended that the following dosing schedule be observed:

Dose Duration

Step 1 NiQuitin Clear 21 mg/24 hours 1 patch every day for the first 6 weeks, then

Step 2 NiQuitin Clear 14 mg/24 hours 1 patch every day for the next 2 weeks, then

Step 3 NiQuitin Clear 7 mg/24 hours 1 patch every day for the last 2 weeks.

Light smokers (those smoking fewer than 10 cigarettes a day) are advised to observe the following dosing schedule:

Dose Duration

Step 2 NiQuitin Clear 14 mg/24 hours 1 patch every day for the first 6 weeks, then

Step 3 NiQuitin Clear 7 mg/24 hours 1 patch every day for the last 2 weeks.

Patients using NiQuitin Clear 21 mg who experience excessive side effects that do not resolve within a few days should transfer to the following dosing schedule:

Dose Duration

Step 2 NiQuitin Clear 14 mg/24 hours 1 patch every day for the rest of the first 6 weeks, then

Step 3 NiQuitin Clear 7 mg/24 hours 1 patch every day for the last 2 weeks.

Consult a doctor if the symptoms persist.

Instructions for use

• NiQuitin Clear patches should be affixed once a day.

• Affix NiQuitin Clear patches at the same time each day, preferably soon after waking, to a clean, dry, hairless area of skin. Avoid areas with skinfolds (such as over a joint) or when he skin creases when you move.

• Do not affix NiQuitin Clear patches to areas of skin that are red, irritated or damaged.

• NiQuitin Clear patches should be worn continuously, for 24 hours. If desired, patches can be removed before going to sleep. However, 24-hour use is recommended for optimum effect against the urge to smoke in the morning.

• A patch should not be worn for longer than 24 hours.

• After 24 hours the used patch should be removed and a new patch affixed to a different area of skin.

• When you have removed a patch, fold it in half with the adhesive side inwards and place it in the empty sachet of the patch that is to be newly applied. Dispose of the sachet with the used patch inside with care, keep out of the reach of children.

• An area of skin used for a patch should not be used again for a new patch for at least seven days.

• Do not use several patches at the same time.

How do you affix NiQuitin Clear?

• The NiQuitin Clear patch should be affixed immediately after opening the sachet.

• Cut the sachet open along the dotted line or fold the sachet over this line and tear it open, being careful not to damage the patch.

• Carefully remove the patch from the sachet. A transparent protective layer covers the adhesive side of the patch – the side that will be put on your skin.

• Remove one half of the protective layer from the middle, with the adhesive layer facing you. Hold the patch by the outermost edge (touching the adhesive layer as little as possible) and remove the other half of the protective layer.

• Apply the adhesive layer of the NiQuitin Clear patch straightaway to your skin. Press the patch firmly to your skin with the palm of your hand for at least 10 seconds. Ensure that the patch sticks to the skin well, particularly along the edges.

• Always wash your hands just with water after you have affixed the NiQuitin Clear patch. (Soap can increase the absorption of nicotine).

If used correctly, water is not harmful to NiQuitin Clear patches. You can bathe, swim or shower for short periods whilst using NiQuitin Clear patches.

For how long may you use NiQuitin Clear?

• For optimum results the full 10-week course of treatment (8 weeks for light smokers or patients using a lower strength, as described above) should be completed.

• The treatment should not last for longer than 10 consecutive weeks.

• NiQuitin Clear users who do not succeed in quitting or who resume smoking can however start a new course of treatment at a later date.

If you use more NiQuitin Clear than you should

• The surface of the skin can be washed with water and dried. Do not use soap as it can increase the absorption of nicotine through the skin.

• After removing the patch, nicotine will still be released into the bloodstream for several hours due to storage of nicotine in the skin.

• If possible show the doctor the packet or this leaflet.

If you forget to use NiQuitin Clear or the patches falls off:

• Forgetting a dose does not have any adverse consequences. Nicotine values in the blood will fall, however, and this may cause protection against nicotine withdrawal symptoms to be temporarily less. You should continue with the stated dose as soon as possible.

• NiQuitin Clear patches generally adhere well. Should a patch nevertheless fall off, affix a new patch to a different area of clean, dry, hairless skin. Keep to the original times.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Reactions at the site of application, including transient rash, itching, burning, tingling sensation, numbness, swelling, pain and rash are the most common side-effects of NiQuitin Clear. The majority of the skin reactions are not severe and quickly resolve after the patch has been removed. In the event of severe or persistent skin complaints, whether they are at the site where the patch was affixed or not, consult your doctor and stop using NiQuitin Clear.

Other possible side-effects may be:

• Very common (affect more than 1 user in 10):

  • sleep disorders including abnormal dreams and insomnia

  • nausea

  • vomiting

  • headache

  • dizziness.

• Common (affects 1 to 10 users in 100):

  • nervousness

  • chest pain

  • pain in limb

  • pain

  • weakness

  • muscle pain

  • joint pain

  • increased sweating

  • indigestion

  • dry mouth

  • constipation

  • respiratory distress

  • pharyngitis

  • cough

  • shaking

  • palpitations

  • diarrhoea

  • fatigue.

• Uncommon (affects 1 to 100 users in 1000):

  • heart palpitations

  • Malaise

  • influenza-like illness

  • allergy.

• Very rare (affects less then 1 in 10.000 users):

  • allergic or contact dermatitis.

  • photosensitivity

• Frequency not known, cannot be estimated from available data

  allergic shock (anaphylactic reactions)

These side-effects may, however, also be the result of stopping smoking.

Some people experience sleep disturbances, including vivid dreams. Since these can be due to the fact that you have stopped smoking rather than to the patch, you should continue to wear the patch for a day or two. If the symptoms persist, try removing the patch before you go to bed (after about 16 hours) and put a new one on when you wake up. If the patch is removed after 16 hours, it will however be less effective at suppressing the craving that many smokers experience on waking.

Reporting of side effects

If you getany side effects, talk to your doctor or pharmacist.This includes any possible side effectsnot listed in this leaflet. 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.

• Store below 30C

• Keep this medicine out of sight and reach of children

• Do not use this medicine after the expiry date which is stated on the carton after “exp”. The expiry date refers to the last day of that month.

• Keep all patches in the carton, in their protective sachets, until you are ready to use one

• Do not use NiQuitin Clear from sachets which are damaged or open.

What NiQuitin Clear contain:

• The active substance is nicotine

• The other ingredients are ethylene vinyl acetate copolymer, polyethylene terephthalate/ethylene vinyl acetate, polyethylene film, polyisobutylene and white printing ink (titanium dioxide, E 171).

NiQuitin Clear is available in three strengths:

Step 1: NiQuitin Clear 21 mg/24 hours; contains 114 mg nicotine and releases 21 mg nicotine over 24 hours.

Step 2: NiQuitin Clear 14 mg/24 hours; contains 78 mg nicotine and releases 14 mg nicotine over 24 hours.

Step 3: NiQuitin Clear 7 mg /24 hours; contains 36 mg nicotine and releases 7 mg nicotine over 24 hours.

What NiQuitin Clear look like and contents of the pack:

Each sustained released patch is rectangular and is comprised of a clear backing and a protective liner. Each patch is contained in a laminate sachet. There are 7, 14 or 21, 28 or 42 patches in a pack. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

<To be completed locally>

Manufacturer

Catalent UK Packaging Limited, Wingates Industrial Park, Lancaster Way, Westhoughton, Bolton, BL5 3XX, UK

or

FAMAR A.V.E., Avlon Plant, 48th km National Road Athens – Lamia, Avlona Attiki, 19011 Greece.

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

Sweden: NiQuitin Clear Depotplåster 7 mg/24 timmar, 14mg/24 timmar, 21 mg/24 timmar

The Netherlands: NiQuitin Clear 7 mg/24 uur, 14 mg/24uur, 21 mg/24 uur

This leaflet was last approved in

15 September 2015