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FENYLAT 25 MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance(s): FENTANYL / FENTANYL / FENTANYL

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Fenylat
12 / 25 / 50 / 75 / 100
micrograms/hour
Transdermal Patch
Fentanyl
Important things you need to know about
Fenylat Transdermal Patches
• Fenylat 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)
• Do not soak in a hot bath or take a hot shower
whilst wearing a patch.
• If you develop a fever tell your doctor
immediately
• Follow the dosage instructions carefully and
only change your patch at the same time of
day every 3 days (72 hours)
• If your breathing becomes shallow and weak
take the patch off and seek medical help
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, pharmacist or nurse
• This medicine has been prescribed for you
(or your child) 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 side effects talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Fenylat is and what it is used for
2. What you need to know before you use Fenylat
3. How to use Fenylat
4. Possible side effects
5. How to store Fenylat
6. Contents of the pack and other information

1

WHAT FENYLAT IS AND
WHAT IT IS USED FOR

The name of your medicine is Fenylat
The patches help relieve pain that is very bad and
long-lasting:
• in adults who need continuous pain treatment
• in children above 2 years of age who are
already using opioid medication and who need
continuous pain treatment.

Fenylat contains a medicine called fentanyl. It
belongs to a group of strong painkillers called
opioids.

2

WHAT YOU NEED TO KNOW
BEFORE YOU USE FENYLAT

Do not use Fenylat if:
• You are allergic to fentanyl, peanut, soya or
any of the other ingredients of this medicine
(listed in section 6)
• You have pain which lasts only for a short
period, such as sudden pain or pain after
having an operation
• You have breathing difficulties, with slow or
shallow breathing
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 Fenylat.
Warnings and precautions
• Fenylat can have life-threatening side effects
in people who are not already regularly using
prescribed opioid medicines.
• Fenylat is a medicine that could be
life-threatening to children, even if the
patches have been used. Bear in mind that a
sticky patch (unused or used) could be
tempting to a child and if it sticks to a child’s
skin or they put it in their mouth, the result
may be fatal.
Patch sticking to another person
The patch should be used only on the skin of the
person for whom it has been prescribed. There
have been reports of patches accidentally sticking
to a family member while in close physical contact
or sharing the same bed as the person wearing
the patch. A patch accidently sticking to another
person (particularly a child) can cause the
medicine in the patch to go through the skin of
the other person and cause serious side effects
such as breathing difficulties, with slow or
shallow breathing which may be fatal. In case the
patch sticks to the skin of another person, take
the patch off right away and get medical
attention.
Take special care with Fenylat
Talk to your doctor or pharmacist before using
this medicine if any of the following apply to you
- your doctor may need to check you more closely
if:
• You have ever had problems with your lungs
or breathing
• You have ever had problems with your heart,
liver, kidneys, or low blood pressure
• You have ever had a brain tumour
• You have ever had persistent headaches or a
head injury
• You are elderly - you may be more sensitive to
the effects of this medicine.
• You have a condition called ‘myasthenia
gravis’ in which muscles become weak and tire
easily.
• You have ever abused or been dependent on
alcohol, prescription medicines or illegal drugs.
If any of the above apply to you (or you are not
sure), talk to your doctor or pharmacist before
using Fenylat.

Side effects and Fenylat
• Fenylat may make you unusually drowsy, and
make your breathing more slow or shallow.
Very rarely these breathing problems can be
life-threatening or even fatal, especially in
people who have not used strong opioid
painkillers (like Fenylat or morphine) before. If
you, or your partner or carer, notice that the
person wearing the patch is unusually drowsy,
with slow or shallow breathing:
• Take the patch off
• Call a doctor, or go to your nearest hospital
straight away
• Keep the person moving and talking as
much as possible
• If you get a fever while using Fenylat, tell your
doctor - this may increase the amount of
medicine that passes through your skin
• Fenylat may cause constipation, talk to your
doctor or pharmacist for advice on how to
prevent or relieve constipation.
• Repeated, long term use of the patches may
make the medicine less effective (you become
‘tolerant’ to it) or you may become dependent
on it.
See section 4 for a full list of possible side effects.
When you are wearing the patch do not expose it
to direct heat such as heating pads, electric
blankets, hot-water bottles, heated water beds or
heat or tanning lamps. Do not sunbathe, have
long hot baths or saunas or use hot whirlpool spa
baths. If you do, you may increase the amount of
medicine you get from the patch.
Other medicines and Fenylat
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines that you buy
without a prescription or herbal medicines. You
should also tell your pharmacist that you are
using Fenylat if you buy any medicines from your
pharmacy.
Your doctor will know which medicines are safe
to take with Fenylat. You may need to be closely
monitored if you are taking some of the types of
medicines listed below or if you stop taking some
of the types of medicines listed below, as this may
affect the strength of Fenylat you need.
In particular, tell your doctor or pharmacist if you
are taking:
• Other medicines for pain, such as other opioid
painkillers (such as buprenorphine,
nalbuphine, or pentazocine).
• Medicines for helping you sleep (such as
temazepam, zaleplon, or zolpidem).
• Medicines to help you calm down
(tranquillisers, such as alprazolam,
clonazepam, diazepam, hydroxyzine, or
lorazepam) and medicines for mental
conditions (anti-psychotics, such as
aripiprazole, haloperidol, olanzapine,
risperidone, or phenothiazines).
• Medicines for relaxing your muscles (such as
cyclobenzaprine or diazepam).
• Some medicines used to treat depression called
SSRIs or SNRIs (such as citalopram, duloxetine,
escitalopram, fluoxetine, fluvoxamine,
paroxetine, sertraline, or venlafaxine). – see
below for more information

• Some medicines used to treat depression or
Parkinson’s disease called MAOIs (such as
isocarboxazid, phenelzine, selegiline, or
tranylcypromine).You should not take Fenylat
within 14 days of stopping these medicines. –
see below for more information
• Some antihistamines, especially ones that
make you sleepy (such as chlorpheniramine,
clemastine, cyproheptadine, diphenhydramine,
or hydroxyzine).
• Some antibiotics used to treat infection (such
as erythromycin or clarithromycin).
• Medicines used to treat fungal infection (such
as itraconazole, ketoconazole, fluconazole, or
voriconazole).
• Medicines used to treat HIV infection (such as
ritonavir).
• Medicines used to treat an irregular heart beat
(such as amiodarone, diltiazem, or verapamil).
• Medicines to treat tuberculosis (such as
rifampicin).
• Some medicines used to treat epilepsy (such as
carbamazepine, phenobarbital, or phenytoin).
• Some medicines used to treat nausea or
motion sickness (such as phenothiazines).
• Some medicines used to treat heartburn or
ulcers (such as cimetidine).
• Some medicines used to treat angina (chest
pain) or high blood pressure (such as
nicardipine).
• Some medicines used to treat cancer of the
blood (such as idelalisib).
Fenylat with antidepressants
The risk of side effects increases if you are taking
medicines such as certain antidepressants. Fenylat
may interact with these medicines and you may
experience changes to mental status such as
feeling agitated, seeing, feeling, hearing, or
smelling things that are not there (hallucinations)
and other effects such as changing blood
pressure, fast heartbeat, high body temperature,
overactive reflexes, lack of coordination, muscle
stiffness, nausea, vomitting and diarrhoea.
Operations
If you think that you are going to receive
anaesthesia tell your doctor or dentist that you
are using Fenylat.
Fenylat and alcohol
Do not drink alcohol while using Fenylat unless
you have talked to your doctor first. Fenylat can
make you drowsy or breathe more slowly.
Drinking alcohol may make these effects worse.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
using this medicine.
Fenylat should not be used during pregnancy
unless you have discussed this with your doctor.
Fenylat should not be used during childbirth as
the medication can affect the breathing of the
newborn child.
Do not use Fenylat if you are breastfeeding. You
should not breastfeed for 3 days after removing
your Fenylat patch. This is because the medicine
may pass into breast milk.

Driving and using machines
Fenylat can affect your ability to drive and use
machines or tools as it may make you sleepy or
dizzy. If this happens, do not drive or use any
tools or machines. Do not drive while using this
medicine until you know how it affects you.
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while
taking this medicine.

• Watch your child very closely for 48 hours
after:
• The first patch has been put on
• A higher dose patch has been put on
• It may take some time for the patch to have its
maximum effect. Therefore, your child might
need to use other painkillers as well until the
patches become effective. Your doctor will talk
to you about this.

Fenylat contains soya oil
If you are allergic to peanut or soya, do not use
this medicinal product.

Adults and Children:
Do not apply the patch on
• The same place twice in a row.
• Areas that you move a lot (joints), skin that is
irritated or with cuts.
• 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.

3

HOW TO USE FENYLAT

Always use this medicine exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Your doctor will decide which strength of
Fenylat is most suitable for you, taking into
account the severity of your pain, your general
condition and type of pain treatment that you
have received so far.
Using and changing the patches
• There is enough medicine in each patch to last
3 days (72 hours).
• You should change your patch every third day,
unless your doctor has told you differently.
• Always remove the old patch before applying
a new one.
• Always change your patch at the same time of
day every 3 Days (72 hours).
• If you are using more than one patch, change
all your patches at the same time.
• 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 when to
change your patch:
Apply your
patch on
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday









Change your
patch on
Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

Where to apply the patch
Adults
• Apply the patch on a flat part of your upper
body or arm (not over a joint).
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 that your child does not remove
the patch and put it in their mouth as this
could be life threatening or even fatal.

Putting a patch on
Step 1: Preparing the skin
• Make sure your skin is completely dry, clean
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 a patch on straight after a hot
bath or shower
Step 2: Open the sachet
• Each patch is sealed in its own sachet
• To open the sachet, first cut two notches, as
indicated by the arrows
• Next, gently tear off both edges of the sachet
completely (or, if you use scissors, cut close to
the sealed edge of the sachet to avoid
damaging the patch)

More about using Fenylat
Everyday activities while using the patches
• The patches are waterproof
• You can shower or bathe while wearing a
patch, but do not scrub the patch itself
• If your doctor agrees, you can exercise or play
sport while wearing the patch
• You can also swim while wearing the patch,
but:
- Don’t use hot whirlpool spa baths
- Don’t put a tight or elasticated band over
the patch
• While you are wearing the patch do not
expose it to direct heat such as heating pads,
electric blankets, hot-water bottles, heated
water beds, heat or tanning lamps. Do no
sunbathe, have long hot baths or saunas. If
you do, you may increase the amount of
medicine you get from the patch.
How quickly will the patches work?
• It may take some time for your first patch to
have its maximum effect.
• Your doctor may give you other painkillers as
well for the 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
• Grasp both sides of the opened sachet and pull
apart
• Take the patch out and use straight away
• Keep the empty sachet to dispose of the used
patch later
• Use each patch once only
• Do not take the patch out of its sachet 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 a patch off, fold it firmly
in half so that the sticky side sticks to itself
• Put it back in its original sachet and dispose of
the sachet as instructed by your pharmacist
• Keep used patches out of sight and reach of
children – even used patches contain some
medicine which may harm children and may
even be fatal
Step 5: Wash
• Always wash your hands after you have
handled the patch using clean water only

How long will you use the patches for?
• Fenylat patches are for long-term pain. Your
doctor will be able to tell you how long you
can expect to use the patches
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 additional
painkillers (or both)
• If increasing the strength of the patch does
not help, your doctor may decide to stop the
use of the patches
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 straight away.
Signs of overdose include trouble breathing or
shallow breathing, tiredness, extreme sleepiness,
being unable to think clearly, walk or talk
normally and feeling faint, dizzy or confused.
If you forget to change your patch
• If you forget, change your patch as soon as
you remember and make 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 a patch falls off
• If a patch falls off before it needs changing,
stick a new one on straight away and make
note of the day and time. Use a new area of
skin on:
• Your upper body or arm

• Your child’s upper back
• Let your doctor know this has happened and
leave the patch on for another 3 days (72
hours) or as directed by your doctor, before
changing the new patch as usual
• If your patches keep falling off, talk to your
doctor, pharmacist or nurse
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 patch strength when you
restart
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you or your partner, or carer, notice any of the
following about the person wearing the patch,
take the patch off and call a doctor, or go to
your nearest hospital, straight away. You may
need urgent medical treatment.
• Feeling unusually drowsy, breathing that is
more slow or shallow than expected.
Follow the advice above and keep the person
who was wearing the patch moving and
talking as much as possible. Very rarely these
breathing difficulties can be life-threatening
or even fatal, especially in people who have
not used strong opioid painkillers (like Fenylat
or morphine) before. (Uncommon, this may
affect up to 1 in 100 people)
• Sudden swelling of the face or throat, severe
irritation, reddening or blistering of your skin.
These may be signs of a severe allergic
reaction. (frequency cannot be estimated from
the available data.)
• Fits (seizures). (Uncommon, this may affect up
to 1 in 100 people.)
• Reduced consciousness or loss of consciousness.
(Uncommon, these may affect up to 1 in 100
people.)
The following side effects have also been
reported
Very common (may affect more than 1 in 10
people)
• Nausea, vomiting, constipation
• Feeling sleepy (somnolence)
• Feeling dizzy
• Headache
Common (may affect up to 1 in 10 people)
• Allergic reaction
• Loss of appetite
• Difficulty sleeping
• Depression
• Feeling anxious or confused
• Seeing, feeling, hearing, or smelling things
that are not there (hallucinations)

• Muscle tremors or spasms
• Unusual feeling in the skin, such as tingling or
crawling feelings (paraesthesia)
• Spinning sensation (vertigo)
• Heart beat feels fast or uneven (palpitations,
tachycardia)
• High blood pressure
• Being short of breath (dyspnoea)
• Diarrhoea
• Dry mouth
• Stomach pain or indigestion
• Excessive sweating
• Itching, skin rash or redness of the skin
• Being unable to pass urine or empty bladder
completely
• Feeling very tired, weak or generally unwell
• Feeling cold
• Swollen hands, ankles or feet (peripheral
oedema)

Scheme at www.mhra.gov.uk/yelllowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

Uncommon (may affect up to 1 in 100 people)
• Feeling agitated or disoriented
• Feeling extremely happy (euphoria)
• Decreased feeling or sensitivity, especially in
the skin (hypoaesthesia)
• Loss of memory
• Blurred vision
• Slow heart beat (bradycardia) or low blood
pressure
• Blue colour to the skin caused by low oxygen
in the blood (cyanosis)
• Loss of contractions of the gut (ileus)
• Itchy skin rash (eczema), allergic reaction or
other skin disorders where the patch is placed
• Flu-like illness
• Feeling of body temperature change
• Fever
• Muscle twitching
• Difficulty getting and keeping an erection
(impotence) or problems having sex

How to dispose of used patches or patches you
no longer use
A used or unused patch accidentally sticking to
another person, especially a child, may be fatal.
Used patches should be folded firmly in half so
that the sticky side of the patch sticks to itself.
Then they should be safely discarded by putting
them back into the original sachet and stored out
of sight and reach of other people, especially
children, until safely disposed. Ask your
pharmacist how to throw away medicines you no
longer use.

Rare side effects (may affect up to 1 in 1000
people)
• Constricted pupils (miosis)
• Stopping breathing from time to time
(apnoea)
You may notice rashes, redness or slight itching of
the skin at the site of the patch. This is usually
mild and disappears after you have removed the
patch. If it does not, or if the patch irritates your
skin badly, tell your doctor.
Repeated use of the patches may make the
medicine become less effective (you become
‘tolerant’ to it) or become dependent on it.
If you switch from a different painkiller to Fenylat
or if you suddenly stop using Fenylat, you may
notice withdrawal effects such as sickness, feeling
sick, diarrhoea, anxiety or shivering. Tell your
doctor if you notice any of these effects.
There have been reports also of newborn infants
experiencing withdrawal effects after their
mothers have used Fenylat for a long time during
pregnancy.
Reporting of side effects
If you get any side effects, talk to
pharmacist or nurse. This includes
side effects not listed in this leaflet.
report side effects directly via the

your doctor,
any possible
You can also
Yellow Card

5

HOW TO STORE FENYLAT

Where you should keep the patches
Keep all patches (used and unused) out of the
sight and reach of children.
How long to keep Fenylat for
Do not use Fenylat after the expiry date which is
stated on the carton and sachet. The expiry date
refers to the last date of that month. If the
patches are out of date, take them to your
pharmacy.
This medicinal product does not require any
special storage conditions.

6

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Fenylat contains
The active substance is fentanyl.
Fenylat 12 µg/h: 1 transdermal patch contains
2.55 mg fentanyl in a patch size of 4.25 cm2 and
releases 12.5 micrograms fentanyl per hour.
Fenylat 25 µg/h: 1 transdermal patch contains 5.1
mg fentanyl in a patch size of 8.5 cm2 and
releases 25 micrograms fentanyl per hour.
Fenylat 50 µg/h: 1 transdermal patch contains
10.2 mg fentanyl in a patch size of 17 cm2 and
releases 50 micrograms fentanyl per hour.
Fenylat 75 µg/h: 1 transdermal patch contains
15.3 mg fentanyl in a patch size of 25.5 cm2 and
releases 75 micrograms fentanyl per hour.
Fenylat 100 µg/h: 1 transdermal patch contains
20.4 mg fentanyl in a patch size of 34 cm2 and
releases 100 micrograms fentanyl per hour.
The other ingredients are:
Matrix components: Aloe vera leaf extract oil (on
the basis of soya oil tocopherol acetate),
colophonium resin, poly(2-ethylhexylacrylate,
vinylacetate) (50:50)
Release
liner:
Polyethylene
terephtalate,
polyester, siliconized
Backing foil with imprint: polyethylene
terephthalate foil, printing ink

What Fenylat looks like and contents of the pack
Transdermal patch
Opaque, colourless, rectangular shaped patch
with round corners and imprint on the backing
foil “Fentanyl 12 µg/h” in single sealed sachets.
Opaque, colourless, rectangular shaped patch
with round corners and imprint on the backing
foil: “Fentanyl 25 µg/h” in single sealed sachets.
Opaque, colourless, rectangular shaped patch
with round corners and imprint on the backing
foil: “Fentanyl 50 µg/h” in single sealed sachets.
Opaque, colourless, rectangular shaped patch
with round corners and imprint on the backing
foil: “Fentanyl 75 µg/h” in single sealed sachets.
Opaque, colourless, rectangular shaped patch
with round corners and imprint on the backing
foil: “Fentanyl 100 µg/h” in single sealed sachets.
Fenylat is available in packs containing 5, 10 and
20 transdermal patches.
Marketing Authorization Holder
Activase Pharmaceuticals Limited
11 Boumpoulinas,
P.C. 1060 Nicosia, Cyprus
Manufacturer
Luye Pharma AG
Am Windfeld 35,
83714 Miesbach
This leaflet was last revised in 12/2016.
A0125-0126-0127-0128-0129/O/PIL/A4

Expand Transcript

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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