Package leaflet: information for the user

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Yemex 12 microgram/hour transdermal patch Yemex 25 microgram/hour transdermal patch Yemex 50 microgram/hour transdermal patch Yemex 75 microgram/hour transdermal patch Yemex 100 microgram/hour transdermal patch

Fentanyl

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

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    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).

ASANDOZ

•    These patches contain a strong pain killer.

•    Ensure that old patches are removed before applying a new one.

•    Patches must not be cut.

•    Do not expose the patches to a heat source (such as a hot water bottle).

•    If you develop a fever tell your doctor immediately.

•    Follow the dosage instructions carefully and only change your patch every 72 hours.

•    If your breathing becomes shallow and weak

take off the patch and seek medical help.

What is in this leaflet:

1.    What Yemex is and what it is used for

2.    What you need to know before you use Yemex

3.    How to use Yemex

4.    Possible side effects

5.    How to store Yemex

6.    Contents of the pack and other information

What Yemex is and what it is used for

Yemex belongs to a group of strong painkillers called opioids.

The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body.

Adults:

Yemex is used for treatment of severe and long-lasting pain that can only adequately be managed with strong pain relievers.

Children:

Yemex is used for the long term treatment of severe and long-lasting pain in children aged 2 years or older who have previously been treated with other strong pain relievers.

2 What you need to know before you use Yemex

Do NOT use Yemex

•    if you are allergic to fentanyl, colophonium resin (hydrogenated), soya, peanuts or any of the other ingredients of Yemex (listed in section 6)

•    if you suffer from pain which lasts only for a short period (e.g. after a surgical procedure)

•    if you suffer from severe breathing problems

•    for children in pain under 2 years of age

•    for children which have not been treated before with strong painkillers such as morphine.

Warnings and precautions

WARNING:

Yemex is a medicinal product that could be life-threatening to children.

This is also the case with used transdermal patches.

Bear in mind that the design of this medicinal product could be tempting to a child.

Yemex can have life-threatening

side effects in persons that are not using

prescribed opioid medicines on a regular basis.

Talk to your doctor before using Yemex if you suffer from any of the following disorders, because the risk of side effects is higher and/or your doctor may need to prescribe a lower dose of Yemex.

•    asthma, breathing difficulties or any lung disease

•    low blood pressure

•    low blood volume

•    impaired liver function

•    impaired kidney function

•    if you have had a head injury or brain tumour, signs of increased intracranial pressure (e.g. headache, visual disturbances), reduced consciousness or coma

•    slow irregular heartbeat

•    if you suffer from a disease causing tiredness and weakness of the muscles (myasthenia gravis)

•    chronic constipation.

Increased body temperature may cause too much medicine to pass through the skin. Therefore

•    inform your doctor if you develop a fever during treatment

•    avoid exposing the patch on the skin to direct heat such as heating pads, electric blankets, hot-water bottles, heated water beds, heat or tanning lamps, intensive sun bathing, prolonged hot baths, saunas or hot whirlpool spa baths.

If you are an older patient or if you are in a very bad physical condition (cachectic) your doctor will monitor you more carefully, because it may be necessary to prescribe a lower dose.

Yemex may cause constipation, talk to your doctor or pharmacist for advice on how to prevent constipation.

Decreasing relief of pain (tolerance), physical or psychological dependence may develop if you use Yemex for a longer period. However, this is rarely seen during treatment of pain.

Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs.

The patches should not be cut into smaller parts, because the quality, efficacy and safety of such divided patches have not been demonstrated.

Children

The use of Yemex is not recommended in children under 2 years of age. Do not use in children who have not been treated before with strong painkillers such as morphine.

Other medicines and Yemex

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

If you take concomitantly medicines that affect brain function it is more likely that you’ll have side effects especially difficulty in breathing. This applies, for example, to:

•    medicines used for treating anxiety (anxiolytics) and uneasiness (tranquillizers)

•    medicines used for treating psychological disorders (neuroleptics, antipsychotics)

•    anaesthetics, if you think you are going to have an anaesthetic, tell the doctor or dentist that you are using Yemex

•    medicines used for treating sleep disorders (hypnotics, sedatives)

•    medicines used for treating allergies or travel sickness (sedating antihistamines/antiemetics)

•    other strong-acting painkillers (opioids)

•    some medicines for relaxing your muscles, e.g. used to treat back pain (skeletal muscle relaxants)

•    alcohol.

You should not take the medicines listed below at the same time as you are using Yemex, unless you are closely monitored by your doctor.

These medicines are inhibitors of the enzyme CYP3A4 in the liver and may increase the effects and side effects of Yemex. This applies, for example, to:

•    ritonavir and nelfinavir (used to treat HIV infection)

•    ketoconazole, itraconazole, fluconazole and voriconazole (used to treat fungal infections)

•    verapamil, diltiazem and amiodarone (used to treat heart disease)

•    some macrolide antibiotics (used to treat infections) e.g. erythromycin, clarithromycin, troleandomycin

•    naphazodone (used to treat depression)

Inductors of the enzyme CYP3A4 may reduce the effects of Yemex. This applies, for example, to:

•    rifampicin (antibiotic)

•    carbamazepine, phenobarbital or phenytoin (medicines used to treat epilepsy)

If you stop treatment with the above medicines, your doctor will monitor you carefully, since effects of Yemex may increase.

Tell your doctor if you are using certain medicines to treat depression known as

•    Selective Serotonin Re-uptake Inhibitors (SSRI)

•    Serotonin Norepinephrine Re-uptake Inhibitors (SNRI)

•    Monoamine Oxidase Inhibitors (MAOI) (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, tranylcypromine).

Your doctor needs to know if you are taking any of the above medicines, since concomitant use may increase the risk of serotonin syndrome, a potentially life-threatening condition.

You should not use Yemex if you are taking Monoamine Oxidase Inhibitors (MAOI; medicines used to treat depression or Parkinson’s disease) or have taken them within the last 14 days.

Please tell your doctor if you use buprenorphine, nalbuphine or pentazocine (other strong painkillers). It is not recommended to use those together with Yemex.

Yemex with alcohol

You should not consume alcohol during Yemex treatment. Alcohol increases the risk of severe side effects of Yemex.

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 using this medicine.

•    Do not use Yemex during labour and delivery (including caesarean section) because fentanyl may cause breathing problems in the new-born child.

•    If you get pregnant during treatment with Yemex, consult your doctor. Do not use Yemex if you are pregnant unless your doctor considers the treatment essential - ask your doctor for advice. Safe use during pregnancy has not been established.

•    Fentanyl passes into the breast milk and may cause sedation and respiratory depression in the breast-fed infant. Discard any breast milk produced during treatment or within 72 hours after the removal of the last patch.

Driving and using machines

Yemex has major influence on the ability to drive and use machines. This has to be expected especially at the beginning of treatment, at any change of dosage as well as in connection with alcohol or tranquillizers. If you have been using the same dose of Yemex for a longer period of time, your doctor may decide that you are permitted to drive and use dangerous machines. Do not drive or operate dangerous machines while using Yemex, unless your doctor has told you that such is permitted.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

-    The medicine has been prescribed to treat a medical or dental problem and

-    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine

Yemex contains soya oil

If you are allergic to peanut or soya, do not use this medicine.

3 How to use Yemex

Always use Yemex exactly as your doctor has told you.

Check with your doctor or pharmacist if you are not

sure.

Using and changing the patches

•    There is enough medicines in each patch to last 3 days (72 hours).

•    You should change your patch every third day, unless your doctor has told you otherwise.

•    Always remove the old patch before applying the new one.

•    Always change your patch at the same time of day every 3 days (72 hours)

•    Make a note of the day, date and time you apply a patch to remind you when you need to change your patch.

•    The following table shows you which day of the week to change your patch.

Where to apply the patch Adults

• Apply the patch on a flat part of your upper body or arm.

The area must not have been treated with radiotherapy.

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Children

•    Always apply the patch to the upper back to make it difficult for your child to reach it or take it off.

•    Every so often check that the patch remains stuck to the skin.

•    It is important your child does not remove the patch and put it in their mouth as this could be life-threatening or even fatal.

•    It may take some time before the patch becomes fully effective. Therefore, your child may need additional painkillers until the patch becomes effective. Your doctor will advise you on this if it is needed.

•    Children need to be monitored very closely for 48 hours after:

-    The first patch has been put on

-    A higher dose patch has been put on.

For you and your child, do not apply the patch on:

•    The same area twice in a row.

•    Sensitive areas that you move a lot, cuts, spots or other skin blemishes.

•    Skin that is very hairy, if there is a hair, do not shave it (shaving irritates the skin). Instead clip the hair as close to the skin as possible.

You should allow several days to pass before you put a new patch on the same area of skin.

Putting a patch on

Step 1: Preparing the skin

•    Make sure your skin is completely clean, dry and cool before you out the patch on.

•    If you need to clean the skin, just use cold water.

•    Do not use soap or any other cleansers, creams, moisturisers, oils or talc before applying the patch.

•    Do not stick a patch on straight after a bath or shower.

Step 2: Open the pouch

•    Each patch is sealed in its own pouch.

•    Tear or cut off the edge of the pouch completely (if you use scissors, cut close to the sealed edge of the pouch to avoid damaging the patch).

•    Grasp both side of the opened pouch and pull apart.

•    Take the patch out and use straight away.

•    Keep the empty pouch to dispose of the used patch later.

•    Use each patch once only.

•    Do not take the patch out of its pouch until you are ready to use it.

•    Inspect the patch for any damage.

•    Do not use the patch if it has been divided, cut or looks damaged.

•    Never divide or cut the patch.

Step 3: Peel and press

•    Make sure that the patch will be covered by loose clothing and not stuck under a tight or elasticated band.

•    Carefully peel one half of the shiny plastic backing away from the centre of the patch. Try not to touch the sticky side of the patch.

•    Press this sticky part of the patch onto the skin.

•    Remove the other part of the backing and press the whole patch onto the skin with the palm of your hand.

•    Hold for at least 30 seconds. Make sure it sticks well, especially the edges.

Step 4: Disposing of the Patch

•    As soon as you take the patch off, fold it firmly in half so that the sticky side sticks to itself.

•    Put it back in its original pouch and put the pouch in the bin with your household rubbish.

•    Even used patches contain some medicine which may harm children, so keep your used patches out of reach and sight of children.

Step 5: Wash

Wash your hands afterwards with clean water. Especially for use in children:

1.    Always apply the patch to the upper back to make it difficult for your child to reach it or take it off.

2.    Every so often check that the patch remains stuck to the skin.

3.    It is important that your child does not remove the patch and put it in their mouth as this could be life-threatening or even fatal.

4.    Children should be monitored very closely for 48 hours after:

-    the first patch has been put on

-    a higher dose patch has been put on.

More about using Yemex patches

How quickly will the patches work?

•    It may take up to a day before your first patch is working completely.

•    Your doctor may give you extra painkillers for your first day or so.

•    After this, the patch should help to relieve pain continuously so that you can stop taking other painkillers. However, your doctor may still prescribe extra painkillers from time to time.

If you forget to change the patch:

•    Do not under any circumstances use a double dose.

•    If you forget to change your patch, change it as soon as you remember and make a note of the day and time. Change the patch again after 3 days (72 hours) as usual.

•    If you are very late changing your patch, you should talk to your doctor because you might need extra painkillers, but do not apply an extra patch.

If you use too many patches or the wrong strength patch

•    If you have stuck on too many patches or the wrong strength patch, take the patches off and contact a doctor or the nearest hospital straight away.

Signs of an overdose include trouble breathing or shallow breathing, tiredness, extreme sleepiness, unable to think clearly, walk and talk normally and feeling faint, dizzy or confused.

If the patch falls off

•    If the patch falls off before it needs changing, stick a new one on straight away and make a note of the day and time. Use a new area on:

-    On your upper body or arm

-    Your child’s upper back.

•    Leave another 3 days (72 hours) before changing the new patch as usual.

•    If your patch keeps falling off, talk to your doctor, nurse or pharmacist.

If the patch sticks to another person

•    Only use the patch on the skin of the person who it is prescribed for.

•    Make sure the patch does not get rubbed off and sticks to your partner, especially in bed.

•    If a patch accidently sticks to another person, take it off straight away and talk to your doctor.

If the pain gets worse

•    If your pain gets worse while you are using these patches, your doctor may try a higher strength patch, or give you extra painkillers (or both).

•    If increasing the strength of the patch does not help, your doctor may stop the patches.

If you want to stop using the patches

•    Talk to your doctor before you stop using these patches.

•    If you have been using them for some time your body may have got used to them. Stopping suddenly may make you feel unwell.

•    If you stop using the patches, don’t start again without asking your doctor first. You might need a different strength patch when you restart.

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

difficulties can be life threatening or even fatal especially in people who have not used strong opioid painkillers before. If you notice any of the above, follow the guidance above and keep moving as much as possible.

Side effects

Very common may affect more than 1 in 10 people

•    Feeling sick or being sick

•    Constipation, dizziness, sleepiness

•    Headache.

Common, may affect up to 1 in 10 people

•    Feeling your heartbeat, fast heart rate

•    Muscle spasms

•    Shaking, sensation of pins and needles

•    Feeling breathless

•    Diarrhoea

•    Dry mouth, loss of appetite

•    Stomach ache, indigestion

•    Difficulty passing urine

•    Excessive sweating, feeling cold

•    Itchy skin, rashes or redness of the skin

•    High blood pressure

•    General feeling of discomfort, tiredness, weakness

•    Swelling of hands, ankles or feet

•    Allergic reaction

•    Feeling nervous, worried or depressed

•    Not able to sleep

•    Confusion, seeing, feeling or hearing things that are not there (hallucinations)

•    A feeling of dizziness or “spinning”.

Uncommon, may affect up to 1 in 100 people

•    Slow heart rate

•    Bluish colouration of the skin

•    Decreased feeling of sensitivity, especially in the skin

•    Fits

•    Muscle twitching

•    Loss of memory

•    Severe breathing difficulties

•    Complete blockage of the gut

•    Disorders of sexual function

•    Eczema and/or other skin disorders including dermatitis where the patch is placed

•    Low blood pressure

•    Flu-like symptoms

•    Fever, body temperature changes

•    Drug withdrawal effects (such as sickness, feeling sick, diarrhoea, anxiety or shivering)

•    Feeling agitated, disorientated, excited or unusually carefree.

Rare, may affect up to 1 in 1,000 people

•    Tiny pupils

•    Incomplete blockage of the gut

•    Transient cessation of breathing, reduced breathing

•    Irregular heart beat.

Frequency not known, cannot be estimated from the available data

•    Abnormal slow breathing

•    Severe and sometimes fatal allergic reaction affecting the whole body.

If you have been using Yemex for some time, it might happen that Yemex will become less effective for you so that a dose adjustment will be necessary (tolerance may develop). Physical and psychological dependence may develop as well and you might experience withdrawal symptoms, if you do suddenly stop using the patches. Withdrawal symptoms may be nausea, vomiting, diarrhoea, anxiety and shivering.

Children and adolescents

The side effect profile in children and adolescents was similar to that observed in adults.

Very common side effects reported were fever, headache, vomiting feeling sick, constipation, diarrhoea and pruritus.

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 Yellow Card Scheme: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Yemex

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

Significant quantities of the active substance remain in the transdermal patches even after use.

Do not use Yemex after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Store in the original package.

For environmental and safety reasons, used as well as unused and out of date patches must be discarded safely or returned to the pharmacy for disposal. Used patches should be folded in half with the sticky sides together. Put back used patches in the outer package and discard safely or whenever possible hand in to your pharmacist.

6 Contents of the pack and other information

What Yemex contains

•    The active substance is fentanyl. Each transdermal patch (5.25, 10.5, 21,31.5 or 42 cm² absorption surface area) contains:

2.89 mg, 5.78 mg, 11.56 mg, 17.34 mg or 23.12 mg fentanyl (which corresponds to a release rate of 12, 25, 50, 75 or 100 microgram/hour of fentanyl)

•    The other ingredients are:

Protective film (removed before the patch is stuck onto the skin):

Poly(ethylene terephthalate) foil, siliconised

Self-adhesive matrix layer:

Colophonium resin (hydrogenated), Poly(2-ethylhexyl acrylate-co-vinyl acetate), Soya-bean oil, refined Water impermeable cover film:

Poly(ethylene terephthalate).

What Yemex looks like and contents of the pack

Yemex is a transparent rounded oblong patch with an adhesive membrane and covered with a protective film (to be removed prior to the application of the patch) so that it can be stuck onto the skin.

Yemex is available in packs with 3, 5, 7, 10, 14, 16 and 20 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer

HEXALAG,

Industriestr. 25, 83607 Holzkirchen,

Germany.

This leaflet was last revised in 07/2014

4 Possible side effects

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

Serious side effects

If any of the following serious, side effects occur you should discontinue treatment and immediately contact your doctor or visit a hospital:

•    severe breathlessness, rattling breath (severe respiratory depression)

•    convulsive pain, vomiting, flatulence (complete block of the digestion channel).

Take the patch off and tell your doctor or go to your nearest hospital straight away if you notice or suspect any of the following. You may need urgent medical treatment.

•    Feeling unusually drowsy, breathing slowly or weakly than expected. Very rarely these breathing

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