Niquitin

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Document: NiQuitin transdermal patch ENG PL change

Package leaflet: Information for the user

NiQuitin 7 mg/24 hours,

NiQuitin 14 mg/24 hours

NiQuitin 21 mg/24 hours

Sustained-release transdermal patch

Nicotine

Read all of this leaflet carefully before you starts 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 has 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 10 weeks of treatment with NiQuitin

What is in this leaflet:

1. What NiQuitin is and what it is used for

2. What you need to know before you use NiQuitin

3. How to use NiQuitin

4. Possible side effects

5. How to store NiQuitin

6. Contents of the pack and other information

What NiQuitin is and what it is used for

NiQuitin is used in stopping smoking. The active substance in NiQuitin 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 as part of a smoking cessation programme.

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

What you need to know before using NiQuitin

Do not use NiQuitin:

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

Warnings and precautions

Talk with your doctor or pharmacist before using NiQuitin:

if you have cardiovascular problems or high blood pressure.

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 is used or swallowed by children. Even used NiQuitin patches contain enough residual nicotine to be harmful to children.

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

Other medicines and NiQuitin

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, 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 if you are pregnant or are trying to become pregnant. If you are pregnant and unable to stop smoking, you may use NiQuitin under the supervision of your doctor.

Discuss with your doctor before using NiQuitin 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 has no effect on the ability to drive or use machines.

How to use NiQuitin

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

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

Step 3 NiQuitin 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 14 mg/24 hours 1 patch every day for the first 6 weeks, then

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

Patients using NiQuitin 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 14 mg/24 hours 1 patch every day for the rest of the first 6 weeks, then

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

Consult a doctor if the symptoms persist.

Instructions for use

NiQuitin patches should be affixed once a day.
Affix NiQuitin 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 patches to areas of skin that are red, irritated or damaged.
NiQuitin 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?

The NiQuitin 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 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 patch. (Soap can increase the absorption of nicotine).

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

For how long may you use NiQuitin?

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 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 than you should

Remove the patch immediately. Contact a doctor if symptoms of overdose are visible, if possible show the doctor the package or leaflet. Symptoms of overdose are: pallor, cold sweat, nausea, increased salivation, vomiting, abdominal pain, diarrhoea, headache, dizziness, impaired hearing and vision, shaking, mental confusion and weakness.

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 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 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.

Possible side effects

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. 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.

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 get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not 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.

How to store NiQuitin

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 from sachets which are damaged or open.

Contents of the pack and other information

What NiQuitin contain:

The active substance is nicotine
The other ingredients are ethylene vinyl acetate copolymer, polyethylene/aluminium/polyethylene terephthalate/ethylene vinyl acetate, polyethylene film, polyisobutylene and PMS 465 Brown Ink.

NiQuitin is available in three strengths:

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

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

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

What NiQuitin look like and contents of the pack:

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

Marketing Authorisation Holder and Manufacturer

Manufacturer

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

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 Depotplåster 7 mg/24 timmar, 14mg/24 timmar, 21 mg/24 timmar

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

This leaflet was last approved in

15 September 2015