Exmo 7mg/24hours, 14mg/24hours and 21mg/24hours Transdermal Patches

Nicotine

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

This medicine is available without prescription. However, you still need to use Exmo 7mg/24hours , 14mg/24hours, 21mg/24hours Transdermal Patches / carefully to get the best results from it.

-    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.

-    You must talk to a doctor if your symptoms worsen or do not improve after 6 months.

-    The full name of this medicine is Exmo 7mg/24hours , 14mg/24hours, 21mg/24hours Transdermal Patches but within the leaflet it will be referred to as Exmo transdermal patches.

What is in this leaflet

1.    What Exmo transdermal patches are and what they are used for

2.    What you need to know before you use

3.    How to use

4.    Possible side effects

5.    How to store

6.    Contents of the pack and other information

1. What Exmo transdermal patches are and what they are used for

Exmo transdermal patches belongs to a group of medicines which are used to help you stop smoking.

Exmo is a transdermal patch and is similar to a plaster which has the medicine contained on the side that sticks to your skin.

This medicinal product is used to relieve the nicotine withdrawal symptoms in nicotine dependency in those wishing to quit smoking.

2. What you need to know before you use Do not use Exmo transdermal patches

-    if you only smoke occasionally or if you are a non smoker.

-    if are are allergic (hypersensitive) to nicotine or any of the other ingredients of Exmo transdermal patches (see section 6 for a full list of ingredients).

If you are not sure if you should use Exmo transdermal patches you must consult your doctor or pharmacist for advice.

Warnings and precautions

You must check with your doctor before using Exmo transdermal patches if you have recently had a heart attack, chest pain (including a condition called “Prinzmetal’s angina”), severe irregular heartbeat, uncontrolled high blood pressure or recent stroke.

You should ask your doctor or a healthcare professional for advice before taking Exmo transdermal patches:

-    if you have problems with your heart or blood vessels, a severe high blood pressure or if you have heart failure,

-    if you have problems with brain blood vessels or obstruction of vessels in your arms or legs,

-    if you are diabetic,

-    if you have an overactive thyroid gland or a tumour of the adrenal glands

(pheochromocytoma),

-    if you have liver and/or kidney disease

-    if you have an active stomach or duodenal ulcer,

-    if you have skin disease,

-    if you have ever had allergic reactions that involve swelling of the lips, face and throat (angioedema) or itchy skin rash (urticaria).

The correct dose for adults could seriously poison or even be fatal to small children. It is

therefore essential that you keep the used and unused transdermal patches out of the sight and reach of children at all times. After use, fold the patch in two before discarding it.

Other medicines and Exmo transdermal patches

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

Stopping smoking and/or Exmo transdermal patches may change the way that other medicines work and you may not get the benefit from one or both products.

This is especially important if you use other medicines which contain:

-    theophylline (to treat asthma)

-    tacrine (for Alzheimer’s disease)

-    clozapine (for schizophrenia)

-    ropinirole (to treat Parkinson’s disease)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is very important to stop smoking during pregnancy because it can result in poor growth of your baby. It can also lead to premature births and even stillbirths.

Ideally you should try to give up smoking without the use of medicines. If you cannot manage this, Exmo transdermal patches may be recommended to help as the risk to the developing baby is less than that expected from continued smoking. Nicotine in any form may cause harm to your unborn baby. Therefore Exmo transdermal patches should only be used after consulting the healthcare professional who is managing your pregnancy, your family doctor, or a doctor in a centre that is specialised in helping people quit smoking.

Exmo transdermal patches like smoking itself should be avoided during breast-feeding as nicotine is found in breast milk and may affect your child. If you have been unable to stop smoking, it is better to use gums or lozenges rather than patches. Exmo transdermal patches should only be used during breast-feeding under the advice of your doctor.

Driving and using machines

There is no evidence of any risk associated with driving or operating machinery when the patch is used according to the recommended dose but remember that smoking cessation can cause behavioural changes.

3. How to use

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

In order to successfully quit smoking with this treatment, you should completely stop smoking. Do not use Exmo transdermal patches with another nicotine product such as gums or lozenges at the same time, unless you are under strict medical supervision.

Use in children and adolescents

Exmo transdermal patches should not be used by smokers under 18 years of age without recommendation from a healthcare professional.

Three strengths of this medicinal product are available: Exmo transdermal patches 7 mg/24 hours, Exmo transdermal patches 14 mg/24 hours and Exmo transdermal patches 21 mg/24 hours. The correct strength for you is worked out by the number of cigarettes you smoke per day or by using the Fagerstrom’s test at the end of this leaflet.

Ask your pharmacist or doctor for advice, possibly in the context of specialised assistance in quitting smoking or choosing or adjusting your dose of Exmo transdermal patches.

The strength of your Exmo transdermal patches transdermal patch may need to change during your treatment. This is because your dependence on nicotine will change. Sometimes the dose of nicotine in your Exmo transdermal patches transdermal patch is too low for you, sometimes it is too high.

The dose should be increased if you experience withdrawal symptoms such as:

-    if you still have a very strong urge to smoke

-    if you are irritable

-    if you have difficulty sleeping

-    if you become agitated or impatient

-    if you have difficulty concentrating

Consult your pharmacist or doctor for advice; it may be necessary to adjust the dosage.

The dose should be decreased if you experience signs of overdose such as:

-    if you are feeling sick (nausea) or vomiting

-    if you have stomach pain or diarrhoea

-    if you have excessive salivation

-    if you are sweating

-    if you have headache, dizziness, reduced hearing, visual disturbance

-    if you feel a general weakness (having very little energy)

Standard treatment is in 3 phases:

1)    Initial phase: will help you to quit smoking.

2)    Treatment follow-up: this phase consolidates quitting and begins nicotine withdrawal.

3)    Treatment withdrawal: this phase helps you to finish your treatment.

The entire treatment lasts 3 months on average. It may, however, vary depending on individual response. The total duration of treatment should not exceed 6 months.

	Initial phase 3 to 4 weeks	Treatment follow-up 3 to 4 weeks	Treatment withdrawal 3 to 4 weeks
Score of 5 or more on Fagerstrom's test or smokers of 20 or more cigarettes / day	21 mg/24 hours	14 mg/24 hours or 21 mg/24 hours*	7 mg/24 hours or 14 mg/24 hours and then 7 mg/24 hours*

Do not remove the Exmo transdermal patches transdermal patch from its sealed protective sachet until

you are ready to use it.

Where to apply the patch:

-    The patch should be placed on a non-hairy, clean, dry area of your body or the upper, outer part of your arm. Choose an area that is free from lesions (cuts, scratches, burns or bruises) and not irritated in any way. Avoid mobile zones on your body such as the joints subject to friction from clothes.

-    To prevent interference with the adhesive properties of the patch, no cream, lotion or powder should be applied to the skin area where the medicinal product is to be applied.

How to apply the patch:

-    Using a pair of scissors, carefully cut open the sachet and remove the patch. Do not cut the patch.

-    Remove the pre-cut protective liner which covers the sticky side of the patch. This is the side which has the medicine in it and which will be in contact with your skin. Hold the patch at the edge and touch the sticky side as little as possible.

-    Immediately after removing the protective liner place the patch on the selected area of skin. Apply the complete and uncut patch on the skin.

-    Press the patch firmly on your skin with the palm of your hands for about 10 seconds. Make sure it sticks well to your skin, especially around the edges.

-    Leave the patch in place for 24 hours.

When to change the patch:

-    Change the Exmo transdermal patches transdermal patch every 24 hours. Choose a different place on your skin to apply the next patch. Do not return to a previously used skin site for at least one week.

-    If your patch falls off, put on a new one. Remove the patch at your regular time and keep your schedule the same. You can also leave the new patch in place for 24 hours if you wish to change the time of application.

How to dispose of the patch:

-    When you remove the patch from your skin, you must fold it into two with the sticky side that touched your skin folded inwards before discarding it in a secure place to avoid children getting hold of it.

During handling, avoid contact with the eyes and nose and wash your hands after application.

The patches should not come in contact with water. If you wish to keep the patch on while showering/swimming etc, you can cover it completely with a waterproof adhesive dressing (plaster).

Frequency of administration

Use one patch per 24 hours.

Duration of treatment

The duration of treatment is restricted to 6 months.

In the event that your withdrawal symptoms worsen or do not improve, or of persistent craving or difficulty discontinuing use of this medicinal product, consult your doctor.

If you use more Exmo transdermal patches than you should

In the event of accidental overdose or if a child has sucked or stuck a transdermal patch to their skin, immediately remove the patch, wash the skin with water and without soap, and contact a doctor or an emergency department at your local hospital.

Signs and symptoms of overdose may include:

-    irregular or fast heart beat ,

-    shortness of breath

-    feeling completely exhausted and unable to move,

-    very pronounced fall in blood pressure that may lead to unconsciousness (circulatory collapse)

-    coma or fits (convulsions)

-    general weakness (having very little energy)

-    sweating

-    excessive salivation

-    feeling sick (nausea) or vomiting

-    stomach pain or diarrhoea

-    headache, hearing and visual disturbances.

If you forget to use Exmo transdermal patches

Just use the patch as soon as you remember, then go on as before. Do not use two patches at the same time.

If you have any further questions on the use of this product, ask a healthcare professional.

4. Possible side effects

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

If you experience sudden wheezing, swelling of your lips, tongue and throat or body, rash,

fainting or difficulties in swallowing, stop using Exmo transdermal patches and contact a doctor

immediately. These may be symptoms of a serious allergic reaction (angioedema). This is a rare

side effect (may affect up to 1 in 1,000 people).

Very common (may affect more than 1 in 10 people)

-    Redness and itching at the application site (where you have stuck the Exmo transdermal patch to the skin on your body).

Common (may affect up to 1 in 10 people)

-    Swelling (oedema) and burning sensation. These effects are usually caused by not changing the site of application each day. Changing the site each day will allow any irritation to disappear naturally and cause you very little discomfort. In the event of a severe skin reaction which will not go away, you should stop treatment and consult your doctor or pharmacist to find another form of nicotine replacement to help you quit smoking.

-    Localised muscle pain.

-    Other common effects due to either the patch or giving up smoking may include: feeling sick (nausea), headache, dizziness or sleep disturbance. These effects are often mild and will wear off naturally and rapidly once you have removed the patch.

Uncommon (may affect up to 1 in 100 people)

-    Irregular or forceful heartbeats (palpitations), vomiting, abnormal dreams.

Rare (may affect up to 1 in 1,000 people) - Hives, rash, itching.

Not known (frequency cannot be estimated from the available data)

- Pins and needles (paraesthesia) where the patch has been applied, that can spread beyond the site of patch application.

Mouth ulcers may be related to quitting smoking and not to your treatment.

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

5. How to store

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

Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions.

Store the patch in the original sachet in order to protect from light.

Any used patches must be folded into two with the sticky side inwards before discarding it in a secure place to avoid children getting hold of it.

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

6. Contents of the pack and other information

What Exmo transdermal patches contains

-    The active substance is nicotine.

Each 7 mg/24 hours transdermal patch contains 15.76 mg of nicotine in a patch size of 9.67 cm², releasing 7 mg of nicotine per 24 hours.

Each 14 mg/24 hours transdermal patch contains 31.51 mg of nicotine in a patch size of 19.33 cm², releasing 14 mg of nicotine per 24 hours.

Each 21 mg/24 hours transdermal patch contains 47.27 mg of nicotine in a patch size of 29 cm², releasing 21 mg of nicotine per 24 hours.

-    The other ingredients are the following:

Backing film:

Polyester/ medium density polyethylene film (Scotchpak 9735)

Adhesive silicone layer (contains the nicotine):

Polydimethylsiloxane crosslinked with silicate resin (BIO-PSA SA7-4207)

Adhesive Acrylic layer:

Acrylate-Vinylacetate copolymer solution (Duro-Tak 87-2194)

Removable release liner:

Polyester, silicone Printing ink:

Titanium dioxide, LT Isoparaffinic hydrocarbon, Polyamide resin, Polyethylene wax, Polytetrafluoroethylene

What Exmo transdermal patches looks like and contents of the pack

The patches are square with round corners, with “Nicotine 7 mg/day”, “Nicotine 14 mg/day” or “Nicotine 21 mg/day” printed randomly all over the patches. Each patch is packed in its own child-resistant protective sachet. The sachet material is a multi-laminate, child-resistant pouchstock composed of coated paper, adhesive, OPA (nylon), adhesive, aluminium, adhesive and polyacrylonitrile-copolymer (PAN). The PAN layer is in contact with the transdermal patch.

The patches are available in boxes of 7, 14, 21 and 28 patches.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland

Manufacturer

Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str.

Dupnitza 2600 Bulgaria

Enestia Belgium NV Klocknerstraat 1 B-3930 Hamont-Achel Belgium

This leaflet was last revised in November 2012

If you would like a leaflet with larger text, please contact 01271 311257.

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Actavis

Pil Spec no    Actavis, Barnstaple, EX32 8NS, UK

FAGERSTROM’S TEST

This test measures your degree of dependence on nicotine. With your score from this test you will then be able to select the patch strength most suitable to you.

In order to evaluate your degree of dependence, take Fagerstrom’s test.

How long after waking up do you s -    within 5 minutes -    6 to 30 minutes -    31 to 60 minutes -    after 60 minutes	moke your first cigarette? 3 2 1 0	Your score
Do you find it difficult not to smoke in places where it is prohibited? -    yes : 1 -    no : 0

Which cigarette of the day would be the most difficult to give up?

-    the first : 1 -    another : 0
How many cigarettes do you smoke -    10 or less -    11 to 20 -    21 to 30 -    31 or more	per day? 0 1 2 3
Do you smoke more frequently in the morning than in the afternoon? -    yes : 1 -    no : 0
Do you smoke when you are sick and have to stay in bed almost all day? -    yes : 1 -    no : 0
TOTAL NUMBER OF POINTS

•    Score from 0 to 2: you are not dependent on nicotine.

-    You can quit smoking without needing nicotine replacement therapy. If, however, you are worried about quitting or if you are not sure how to select the patch strength, consult your pharmacist or doctor.

•    Score from 3 to 4: you are weakly dependent on nicotine.

Score from 5 to 6: you are moderately dependent on nicotine.

-    The use of nicotine replacement therapy will increase your probability of success. Ask your pharmacist or doctor for advice to help you choose the treatment most appropriate to you.

•    Score from 7 to 10: you are strongly or very strongly dependent on nicotine.

-    The use of nicotine replacement therapy is recommended to help you overcome your nicotine dependence. The treatment is to be used at a sufficient and appropriate dose.

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