MEZOLAR MATRIX 25 MICROGRAM/HOUR TRANSDERMAL PATCH

Active substance: FENTANYL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Mezolar Matrix 12 microgram/hour transdermal patch
Mezolar Matrix 25 microgram/hour transdermal patch
Mezolar Matrix 37.5 microgram/hour transdermal patch
Mezolar Matrix 50 microgram/hour transdermal patch
Mezolar Matrix 75 microgram/hour transdermal patch
Mezolar Matrix 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 Mezolar Matrix is and what it is used for
2. What you need to know before you use
Mezolar Matrix
3. How to use Mezolar Matrix
4. Possible side effects
5. How to store Mezolar Matrix
6. Contents of the pack and other information

1

You should not take the medicines listed below
at the same time as you are using Mezolar
Matrix, 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 Mezolar Matrix. 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.

What Mezolar Matrix is and what it
is used for

Mezolar Matrix contains the active substance,
fentanyl which belongs to a group of strong
painkillers called opioids.
The painkiller, fentanyl, slowly passes from the
patch, through the skin and into the body.

Inductors of the enzyme CYP3A4 may reduce
the effects of Mezolar Matrix. 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 Mezolar Matrix may increase.

Fentanyl relieves severe long-lasting pain, that
can only adequately be managed with strong
painkillers (opioids).

Children:
Mezolar Matrix can be used in children aged 2
to 16 years who have previously used opioid
painkillers.

2

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.

What you need to know before
you use Mezolar Matrix

Do NOT use Mezolar Matrix
• 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.
• 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.

You should not use Mezolar Matrix 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).

Warnings and precautions
WARNING:
Mezolar Matrix 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.
Mezolar Matrix can have life-threatening
side-effects in persons that are not using
prescribed opioid medicines on a regular basis.

Please tell your doctor if you use buprenorphine,
nalbuphine or pentazocine (other strong
painkillers). It is not recommended to use
those together with Mezolar Matrix.
Using Mezolar Matrix with alcohol
You should not consume alcohol during Mezolar
Matrix treatment. Alcohol increases the risk of
severe side effects of Mezolar Matrix.

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 Mezolar Matrix during labour and
delivery (including caesarean section)
because fentanyl may cause breathing
problems in the new-born child.
• If you become pregnant during treatment with
Mezolar Matrix transdermal patch, consult
your doctor. Do not use Mezolar Matrix 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.

Talk to your doctor before using Mezolar Matrix
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 Mezolar Matrix.
• asthma, breathing difficulties or any lung disease
• low blood pressure or blood volume
• impaired liver function
• impaired kidney function
• if you have had a head injury, 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.

Driving and using machines
Mezolar Matrix 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 tranquilizers. If
you have been using the same dose of
Mezolar Matrix 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 Mezolar Matrix, unless your doctor has
told you that such is permitted.

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.

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

3

Decreasing relief of pain (tolerance), physical or
psychological dependence may develop if you use
Mezolar Matrix 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.

Always use this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.

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

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
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.

Children
The use of Mezolar Matrix 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 Mezolar Matrix
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

If you take concomitant 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 Mezolar Matrix
• medicines used for treating sleep disorders
(hypnotics, sedatives)
• medicines used for treating allergies or travel
sickness (sedating antihistamines/antiemetics)
• other strong-acting painkillers (opioids)
• medicines for relaxing your muscles, e.g. used
to treat back pain (skeletal muscle relaxants)
• alcohol.

draft: 44029557, 44029558, 44029559,
44029560, 44029561, 44029562
laetus code: 0000
mat.no.: 00000000

How to use Mezolar Matrix

Apply your patch on Change your patch
day
at the same time on
Monday

→ Thursday

Wednesday

→ Saturday

Tuesday

→ Friday

Thursday

→ Sunday

Friday

→ Monday

Saturday

→ Tuesday

Sunday

→ Wednesday
Continued on the next page >>

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Date prepared:
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Colours:
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Dimensions: 148 x 594 mm

Font size:
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Fonts:
Helvetica

4

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.

Possible side effects

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

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 should be monitored very closely
for 48 hours after:
- The first patch has been put on
- A higher dose patch has been put on.

Serious side effect
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).

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”.

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 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 bath
or shower.

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

Step 2: Open the pouch
• Each patch is sealed in its own pouch
• Fold along the red line and open the pouch
in the direction of the arrow, pulling slowly
and constantly
• Grasp both sides 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.

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

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.

If you have been using Mezolar Matrix for
some time, it might happen that Mezolar Matrix
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.

Step 5: Wash
Wash your hands afterwards with clean water.

More about using Mezolar Matrix 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.

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, diarrhea 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.

If you forget to change the patch
• Do not under any circumstance 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.

5

How to store Mezolar Matrix

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.

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.

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

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.

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.

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.

6

Contents of the pack and other
information

WHAT MEZOLAR MATRIX CONTAINS
The active substance is fentanyl. Each patch
releases 12.5, 25, 37.5, 50, 75, 100 micrograms
fentanyl per hour. Each patch of 5.25, 10.5,
15.75, 21, 31.5, 42 cm² contains 2.1, 4.2, 6.3,
8.4, 12.6, 16.8 mg fentanyl.
• The other ingredients are:
Release liner (removed before the patch is
stuck onto the skin):
Poly(ethylene terephthalate) foil, siliconised
Self-adhesive matrix layer:
Acrylic-vinylacetate copolymer
Backing film:
Poly(ethylene terephthalate) foil
Printing ink.

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 or child, especially
while sharing a bed or in close contact
• 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.

What Mezolar Matrix looks like and
contents of the pack
Mezolar Matrix is a transparent rounded
oblong imprinted patch with an adhesive
membrane and covered with a release liner (to
be removed prior to the application of the
patch) so that it can be stuck onto the skin.

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.

Mezolar Matrix is available in packs with 1, 2, 3,
4, 5, 7, 8, 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.

As the risk of withdrawal symptoms is greater
when the treatment is stopped suddenly, you
should never stop treatment with Mezolar
Matrix independently but always consult your
doctor first.

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

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

This leaflet was last revised in 04/2014.

draft: 44029557, 44029558, 44029559,
44029560, 44029561, 44029562
laetus code: 0000
mat.no.: 00000000

00000000
SZ00000LT000

Artwork Proof Box
Ref: V011 - Brand alignment (includes all CDS changes) + nat. ph.
Proof no.
008.1

Date prepared:
10/04/2014

Colours:
Black
Dimensions: 148 x 594 mm

Font size:
8pt
Fonts:
Helvetica

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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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