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YEMEX 50 MICROGRAM/HOUR TRANSDERMAL PATCH

Active substance(s): FENTANYL

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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).
• 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

1

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 youʼll 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 Parkinsonʼs 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.
Apply your patch on
day
Monday



Wednesday



Tuesday

Thursday
Friday

Saturday
Sunday







Where to apply the patch

Change your patch at
the same time on
Thursday
Friday

Saturday
Sunday

Monday

Tuesday

Wednesday

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 childʼs 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, donʼt 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.

4

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
HEXAL AG,
Industriestr. 25, 83607 Holzkirchen,
Germany.

This leaflet was last revised in 07/2014

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.

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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