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MYLAFENT 50 MICROGRAM/HOUR TRANSDERMAL PATCH
Active substance(s): FENTANYL / FENTANYL / FENTANYL
Mylafent 12 microgram/hour
Mylafent® 25 microgram/hour
Mylafent® 50 microgram/hour
Mylafent® 75 microgram/hour
Mylafent® 100 microgram/hour
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
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
symptoms 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.
• These patches contain a strong pain killer.
• Ensure that old patches are removed before applying a
• 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 the
patch off and seek medical help.
What is in this leaflet:
1. What Mylafent is and what it is used for.
2. What you need to know before you use Mylafent.
3. How to use Mylafent.
4. Possible side effects.
5. How to store Mylafent.
6. Contents of the pack and other information.
1. What Mylafent is and what it is used for
Fentanyl belongs to a group of strong painkillers called
opioids. The painkiller, fentanyl, slowly passes from the
patch, through the skin and into the body.
Mylafent is indicated in severe chronic pain which can be
adequately managed only with opioid analgesics.
Children and adolescents:
Mylafent is used for the long term treatment of severe and
long lasting pain in children and adolescents aged 2 years
or older who have previously been treated with other strong
pain relievers and for the long term management of severe
chronic pain in children receiving opioid therapy.
2. What you need to know before you use Mylafent
Do not use Mylafent
• if you are allergic to fentanyl or any of the other
ingredients of this medicine (listed in section 6).
• if you suffer from pain which lasts only for a short period
(e.g. after a surgical procedure).
• if your central nervous system is severely impaired, e.g.
by brain injury.
Do not use this medicine if any of the above apply to you
or your child. If you are not sure, talk to your doctor or
pharmacist before using Mylafent.
Warnings and precautions
• Mylafent is a medical product that could be life
threatening to children. This is also the case with used
• Bear in mind that the design of this medicinal product
could be tempting to a child which in some cases may
lead to a fatal outcome.
• Mylafent can have life-threatening side effects in persons
that are not using prescribed opioid medicines on a
Talk to your doctor or pharmacist before using Mylafent.
Before starting to use Mylafent you should inform your
doctor if you suffer from any of the below disorders,
because the risk of side effects is higher and/or your doctor
may need to prescribe a lower dose of fentanyl:
• asthma, breathing difficulties or any lung disease
• slow irregular heartbeat (bradyarrhythmias)
• low blood pressure
• impaired liver function
• impaired kidney function
• if you have had a head injury or brain disease (e.g. a
tumour), signs of increased intracranial pressure (e.g.
headache, visual disturbances), changes in your state of
consciousness or loss of consciousness or coma
• if you suffer from a condition in which muscles become
weak and tire easily (myasthenia gravis).
Like some other strong painkillers, Mylafent may make you
unusually drowsy, and breathe more slowly or weakly. Very
rarely these breathing difficulties can be life-threatening or
even fatal in people who have not used strong morphinerelated painkillers (like Mylafent) or morphine before. If you,
or your partner or carer, notice that you or your child are
breathing much more slowly or weakly then:
* Take the patch off.
* Call a doctor, or go to your nearest hospital, straight
* Keep moving and talking as much as possible.
• If you develop a fever while wearing Mylafent, tell your
doctor as this may affect the way the medicine passes
through your skin.
• Do not expose the patch to a direct heat source such as
heating pads, hot-water bottles, electric blankets, heat
lamps, saunas and hot whirlpool spa baths. These may
affect the way the medicine works.
• You are allowed to stay outside in the sun, but you must
protect the patch with some piece of clothing during hot
If you use medicines that affect brain function it is more
likely that you will have side effects, especially difficulty
during breathing. This applies, for example, to:
• medicines used to treat anxiety (tranquilisers)
• some medicines used to treat depression
• medicines used for treating psychological disorders
• anaesthetics. If you think you are going to have an
anaesthetic, tell your doctor or dentist that you are using
• medicines used for treating sleep disorders (hypnotics,
• some medicines used for treating allergies or travel
sickness, especially ones that make you sleepy
• other strong-acting painkillers
You should not take the medicines listed below at the same
time as using Mylafent unless you are closely monitored by
These medicines may increase the effects and side effects
of Mylafent. This applies, for example to:
• Ritonavir or nelfinavir (used to treat HIV infection)
• Ketoconazole, itraconazole, fluconazole or voriconazole
(used to treat fungal infections)
• Some macrolide antibiotics e.g. erythromycin,
troleandomycin and clarithromycin (used to treat
• Cimetidine (used to treat gastrointestinal diseases)
• Diltiazem, verapamil or amiodarone (used to treat heart
Other medicines and Mylafent
Please tell your doctor or pharmacist if you are taking
barbiturates (used for treating sleep disorders),
buprenorphine, nalbuphine or pentazocine (other strong
painkillers). It is not recommended to use these together
Please tell your doctor if you are taking MAO inhibitors
(e.g. moclobemide against depression or selegiline against
Parkinson’s disease) or have taken them within the last
14 days. If these medicines are taken together this may
enhance their toxicity.
• There is enough medicine in each patch to last 3 days
• You should change your patch every third day, unless
your doctor has told you otherwise.
• Always remove the old patch before applying the new
• 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
Change your patch at
the same time on
• 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
• It is important your child does not remove the patch and
put it in their mouth as this could be life-threatening or
• It may take some time before the patch becomes fully
effective. Therefore, your child might need additional
painkillers until the patches become effective. Your
doctor will advise you on this if it is needed.
• Children need to be monitored very closely for 48 hours
o The first patch has been put on
o A higher dose patch has been put on
It is advised not to use Mylafent during labour and
delivery (including caesarean section) because fentanyl
may cause breathing problems in the newborn child. If
you get pregnant during treatment with Mylafent consult
your doctor. Do not use Mylafent if you are pregnant or
breast-feeding unless your doctor considers the treatment
necessary. Fentanyl passes into breast milk and may
cause side effects such as sedation and severe breathing
difficulties in the breast-fed infant. Any breast milk
produced during treatment or within 72 hours after the
removal of the last patch should be discarded.
Mylafent should not be administered to children under
2 years of age because there is limited experience of use
in children under that age. An exception can be made if the
doctor has expressly prescribed Mylafent.
Using and changing the patches
Mylafent with food, drink and alcohol
Simultaneous use of Mylafent and alcoholic beverages
increases the risk of severe adverse reactions, and may
cause breathing difficulties, a fall of blood pressure,
profound sedation and coma.
If you are an elderly 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
Children and adolescents
Mylafent can be used in children and adolescents aged 2 to
16 years who have previously used opioid painkillers.
Your doctor will decide which strength of Mylafent is most
suitable for you. Your doctor will base his judgement on: the
severity of pain, your general condition and the type of pain
treatment that you have received so far.
Where to apply the patch
• Apply the patch on a flat part of your upper body or arm
Pregnancy, breast-feeding and fertility
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.
Patch sticking to another person
The patch should be used only on the skin of the person
for whom it was ordered by the doctor. Cases have been
reported where a patch was accidentally stuck to a family
member while in close physical contact or sharing the same
bed as the patch wearer. A patch sticking to another person
(particularly a child) may result in an overdose. In case the
patch sticks to the skin of another person, take the patch
off immediately and seek medical attention.
Always use Mylafent exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
Tell your doctor or pharmacist if you are using, or have
recently used or might use any other medicines, including
medicines obtained without a prescription.
Decreasing relief of pain (tolerance), physical or
psychological dependence may develop if you use Mylafent
for a longer period. However, this is rarely seen during
treatment of pain due to cancer.
The patches should not be cut in to smaller parts, because
the quality, efficacy and safety of such divided patches
have not been demonstrated.
3. How to use Mylafent
Driving and using machines
Mylafent has major influence on the ability to drive and
use machines. This has to be expected especially at the
beginning of the treatment, at any change of dosage as well
as in connection with alcohol or tranquilizers. If you have
been using the same dose of Mylafent 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 Mylafent, 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
• 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.
For you or your child, do not apply the patch on:
• The same place twice in a row
• Sensitive areas that you move a lot, cuts, spots or other
• Skin that is very hairy. If there is 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 put 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 patch on straight after a hot bath or shower.
Step 2: Open the sachet
• 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) (figure 1 & figure 2).
• Hold for at least 30 seconds. Make sure it sticks well,
especially the edges. (figure 8).
• Grasp both sides of the opened pouch and pull apart
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 the
reach and sight of children.
Step 5: Wash
• Wash your hands afterwards with clean water.
• Take the patch out and use straight away (figure 4).
• 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
• 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 (figure 5).
• Press this sticky part of the patch onto the skin (figure 6).
• Remove the other part of the backing and press the
whole patch onto the skin with the palm of your hand
More about using Mylafent patches
How quickly will the patches work?
• It may take up to a day before your first patch is working
• 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
• If you forget, change your patch 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 some 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, being unable to
think clearly, walk or talk normally and feeling faint, dizzy or
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:
- Your upper body or arm
- Your child’s upper back
• Leave another 3 days (72 hours) before changing the
patch as usual.
• If your patches keep falling off, talk to your doctor, nurse
If your 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.
• Feeling unusually drowsy, breathing more slowly or
weakly than expected. Very rarely these breathing
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.
• Complete block of the digestion channel (convulsive
pain, vomiting, flatulence).
• Sudden signs of allergy such as rash, itching or hives on
the skin, swelling of the face, lips, tongue or other parts
of the body, shortness of breath, wheezing or trouble
Other side effects
Very common: may affect more than 1 in 10 people:
Drowsiness, dizziness, headache, feeling sick (nausea),
being sick (vomiting), constipation.
Common: may affect up to 1 in 10 people:
Allergic reactions, awareness of unusual heart beats (also
called palpitations), fast heart rate, high blood pressure,
feeling unusually drowsy, weak or tired, nervousness,
confused, depressed, not being able to sleep, loss of
appetite, dry mouth, stomach pain, indigestion, difficulty
passing urine, diarrhoea, difficulty in breathing, seeing,
feeling or hearing things that are not there (hallucinations),
sense of pins and needles, shaking, feeling giddy, spinning
sensation, muscle spasms, swelling of hands, ankles or
feet, feeling cold, excessive sweating, itchy skin, rashes or
redness of skin.
Uncommon: may affect up to 1 in 100 people:
Unnatural feeling of happiness, loss of memory, agitation,
disorientation, muscle twitching, decreased feeling of
sensitivity especially in the skin, bluish colouration of the
skin, speech disturbances, low blood pressure, slow heart
beat, complete obstruction of the intestine, disorders
of sexual function, body temperature changes, flu-like
symptoms, drug withdrawal effects (e.g. sickness, feeling
sick, anxiety, shivering, diarrhoea), a skin condition with
itching, redness and a burning feeling (eczema) or other
skin disorders including dermatitis.
Rare: may affect up to 1 in 1,000 people:
Small pupils, temporarily stopping breathing, slow
breathing, incomplete obstruction of the small or large
intestine, eczema or other skin disorders including
dermatitis where the patch is placed. Skin rash and skin
reddening will usually disappear within one day after the
patch has been removed.
This medicinal product does not require any special storage
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. High quantities
of fentanyl remain in the transdermal patch even after use.
Retain the outer package after removing the patch for use.
Handling the patch
Used patches should be folded so that the adhesive side
of the patch adheres to itself and kept in the outer package
and then they should be safely discarded or delivered to
the pharmacy. Accidental exposure to used and unused
patches particularly in children may lead to a fatal outcome.
Unused patches should be returned to the hospital
6. Contents of the pack and other information
What Mylafent contains
The active substance is fentanyl.
Each Mylafent 12 microgram/hour transdermal patch
contains 2.1 mg of fentanyl in a patch size 5.25 cm2,
releasing 12.5 micrograms of fentanyl per hour (the strength
is described as 12 microgram/hour but the release rate of
the patch is 12.5 microgram/hour).
Each Mylafent 25 microgram/hour transdermal patch
contains 4.2 mg of fentanyl in a patch size 10.5 cm2,
releasing 25 micrograms of fentanyl per hour.
Each Mylafent 50 microgram/hour transdermal patch
contains 8.4 mg of fentanyl in a patch size 21.0 cm2,
releasing 50 micrograms of fentanyl per hour.
Each Mylafent 75 microgram/hour transdermal patch
contains 12.6 mg of fentanyl in a patch size 31.5 cm2,
releasing 75 micrograms of fentanyl per hour.
Each Mylafent 100 microgram/hour transdermal patch
contains 16.8 mg of fentanyl in a patch size 42.0 cm2,
releasing 100 micrograms of fentanyl per hour.
The other ingredients are:
Polyacrylate adhesive, siliconised polyester film (protective
liner), polyethylene terephthalate/ethyl vinyl acetate film
(backing film) and white imprinting ink.
What Mylafent looks like and contents of the pack
Mylafent is a translucent rectangular patch printed with
white ink on a removable liner.
The following is printed on each patch:
Fentanyl 12 µg/h, Fentanyl 25 µg/h, Fentanyl 50 µg/h,
Fentanyl 75 µg/h or Fentanyl 100 µg/h
The patch is covered by a transparent protective liner,
which is removed prior to application to expose the sticky
back so that it can be stuck onto the skin.
The patches come in individually heat-sealed sachets that
are packaged in to a carton.
Not known: frequency cannot be estimated from the
There have been reports of newborn infants experiencing
withdrawal effects after their mothers have used fentanyl
patches for a long time during pregnancy.
Mylafent is available in packs of 3, 4, 5, 8, 10, 16 and
20 transdermal patches. Not all pack sizes may be
If you have been using Mylafent for some time, it might
happen that Mylafent will become less effective for you so
that a dose adjustment will be necessary (tolerance may
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Generics [UK] Limited, Station Close, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom
Physical 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.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
4. POSSIBLE SIDE EFFECTS
5. How to store Mylafent
Like all medicines, Mylafent can cause side effects,
although not everybody gets them.
Keep this medicine out of sight and reach of children, even
after use. Significant quantities of the fentanyl remain in the
transdermal patches even after use.
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:
Do not use Mylafent after the expiry date stated on the
carton and sachet. The expiry date refers to the last day of
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Mylafent is a registered trademark.
This leaflet was last revised in September 2014
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.