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MEZOLAR MATRIX 100 MICROGRAM/HOUR TRANSDERMAL PATCH

Active substance: FENTANYL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Mezolar Matrix 12 microgram/hour transdermal patch
Mezolar Matrix 25 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.
• 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
• These patches contain a strong pain killer.
• Ensure that the 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.
In this leaflet:
1.
What Mezolar Matrix is and what it is used for
2.
Before you use Mezolar Matrix
3.
How to use Mezolar Matrix
4.
Possible side effects
5.
How to store Mezolar Matrix
6.
Further information

1

What Mezolar Matrix is and what it is
used for

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

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

Children:
Mezolar Matrix 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

Before you use Mezolar Matrix

Do not use Mezolar Matrix
• if you are allergic (hypersensitive) to fentanyl,
colophonium resin (hydrogenated), soya, peanuts
or any of the other ingredients of Mezolar Matrix
• if you suffer from short-term pain (e.g. after a
surgical procedure)
• if your central nervous system is severely impaired,
e.g. by brain injury
• if you have severe breathing problems (respiratory
depression)
Take special care with Mezolar Matrix

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.
Your doctor will use the treatment with Mezolar Matrix
as a part of an integrated treatment of pain and will
regularly monitor you for your individual response to
Mezolar Matrix.

Before starting to use Mezolar Matrix 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, respiratory depression or any lung disease
slow irregular heartbeat
low blood pressure
low blood volume
impaired liver function
impaired kidney function
if you have had a head injury or brain disease (e.g.
a brain 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 disease causing fatigue and
weakness of the muscles (myasthenia gravis).

Like some other strong painkillers, Mezolar Matrix may
make you unusually drowsy, and breathe more slowly
or weakly. If you, or your partner or carer, notice that
you or your child are breathing much more slowly or
weakly:
• Take the patch off
• Call a doctor, or go to your nearest hospital, straight
away
• Keep moving and talking as much as possible

If you develop a fever while wearing Mezolar Matrix
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
Tolerence, physical or psychological dependence may
develop if you use Mezolar Matrix for a longer period.
However, this is rarely seen during treatment of pain
due to cancer.
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 lower dose.
The patches should not be cut into smaller parts,
because the quality, efficacy and safety of such
divided patches have not been demonstrated.

Use in children and adolescents
In general, Mezolar Matriz should only be used in
children and adolescents aged 2 years or older who
have previously been treated with other opioids (e.g.
morphine). Mezolar Matrix should not be used in
infants and toddlers under 2 years of age.

To guard against accidental ingestion by children,
caution should be used when choosing the application
site for Mezolar Matrix (see section 3. “How to use
Mezolar Matrix”) and the adhesion of the patch should
be monitored closely.

Taking other medicines
Please tell your doctor if you use barbiturates (used for
treating sleep disorders), buprenorphine, nalbuphine
or pentazocine (other strong painkillers). It is not
recommended to use those together with Mezolar
Matrix.
Please tell your doctor if you are taking MAO inhibitors
(e.g. moclobemide against depression or selegiline
against Parkinsonʼs disease) or have taken them
within the last 14 days. If these medicines are taken
together this may enhance their toxicity.
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 (tranquillisers)
• medicines used for treating psychological disorders
(neuroleptics)
• 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 (antihistamines/antiemetics)
• other strong-acting painkillers (opioids)
• some medicines for back pain or other painful
musculoskeletal conditions (skeletal muscle
relaxants)
• alcohol

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 may increase the effects and side
effects of Mezolar Matrix. This applies, for example, to:
• ritonavir, (used to treat AIDS)
• ketoconazole, itraconazole, (used to treat fungal
diseases)
• diltiazem (used to treat heart disease)
• macrolide antibiotics (used to treat infections),

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.

Using Mezolar Matrix with food and drink
Simultaneous use of Mezolar Matrix and alcoholic
beverages increases the risk of severe adverse
reactions, and may cause breathing difficulties, a fall of
blood pressure, profound sedation and coma. During
the treatment with Mezolar Matrix do not drink
alcoholic beverages.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine.

Safe use during pregnancy has not been established.
Do not use Mezolar Matrix during labour and delivery
(including caesarean section) because fentanyl passes
the placenta and may cause difficulties in breathing in
the foetus or in the new-born infant. If you get
pregnant during treatment with Mezolar Matrix
transdermal patch, consult your doctor. Do not use
Mezolar Matrix if you are pregnant or breast-feeding
unless your doctor considers the treatment essential –
ask your doctor for advice. Fentanyl passes into breast
milk and may cause sedation and respiratory
depression in the breast-fed infant. Breast-feeding
should therefore, be discontinued for at least 72 hours
after the removal of Mezolar Matrix. Long-term
treatment during pregnancy may cause withdrawal
symptoms in the newborn infant.
Driving and using machines
You should not drive or use machines without first
asking your doctor for advice.
During treatment with Mezolar Matrix certain
undesirable effects may occur (for example
drowsiness, apathy or sickness). 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. This should be kept in mind
when doing things that require your full attention, for
instance whilst driving a car. Because of their effects
or side effects, one of the factors that can reduce your
ability to drive a motor vehicle or perform other tasks
that demands increased concentration safely is your
use of medicines.
Important information about some of the
ingredients of Mezolar Matrix
Mezolar Matrix contains soya oil. If you are allergic to
peanut or soya, do not use this medicinal product.

3

How to use Mezolar Matrix

Always use Mezolar Matrix exactly as your doctor has
told you. You should 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.

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 advice 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,
moisturizers, oils or talc before applying the patch.
• Do not stick a patch on straight after a bath or
shower.

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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 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.

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 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.

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 extra
painkillers, but do not apply an extra patch.

If you use to 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 and 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
product, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Mezolar Matrix can cause side
effects, although not everybody gets them.
The assessment of side effects is based on the
following frequency data:
Very common

affects more than 1 user in
10

Uncommon

affects 1 to 10 users in 1000

Common
Rare

Very rare

Not known

affects 1 to 10 users in 100
affects 1 to 10 users in
10,000

affects less than 1 user in
10,000

frequency cannot be
estimated from the available
data

If any of the following serious, very rare side effects
occur you should discontinue treatment and
immediately contact your doctor or visit a hospital:
• severe respiratory depression (severe
breathlessness, rattling breath)
• complete block of the digestion channel (convulsive
pain, vomiting, flatulence).

• feeling nervous, worried or depressed, not being
able to sleep
• confusion, hallucinations (seeing, feeling or hearing
things that are not there)
• sensation of pins and needles, shaking, feeling
giddy
• muscle spasms
• feeling cold, sweating
• pink eye
• difficulties in breathing
• swelling and irritation inside the nose
• yawning
• diarrhoea
• dry mouth
• stomach ache, indigestion, difficulty passing urine
• itchy skin, rashes or redness of the skin general
feelings of discomfort and weakness
• swelling of hands, ankles or feet
Uncommon:
• memory loss
• feeling agitated, disorientated, excited or unusually
carefree
• decreased feeling of sensitivity, especially in the
skin
• seizures (including clonic and grand mal seizures)
• speech disorders
• loss of memory
• low blood pressure and slow heart rate
• bluish colouration of the skin
• complete obstruction of the intestine
• eczema and/or other skin disorders including
dermatitis where the patch is placed
• difficulties in breathing including breathlessness
• muscle twitching
• disorders of sexual function
• flu-like symptoms
• body temperature changes
• drug withdrawal effects (such as sickness, feeling
sick, diarrhoea, anxiety or shivering)

Rare:
• tiny pupils
• poor or indistinct vision
• irregular heart beat
• stopping breathing (respiratory arrest or apnoea)
• difficulty breathing (impaired respiration, respiratory
depression)
• incomplete obstruction of the small or large intestine
• enlarged (dilated) blood vessels
• hiccups
• skin reactions where the patch is placed
Very rare:
• painful bloating
• bladder pain
• passing less water than normal (reduced urine
excretion).

Not known:
• serious and rapid allergic reactions causing a fall in
blood pressure and/or difficulty in breathing
• abnormally slow breathing
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.

Children
Children and adolescents treated with fentanyl
transdermal patches experience side effects similar to
the side effects observed in adults.
There is no specific risk for children and adolescent,
when used as directed.
Very common side effects in children observed in
clinical trials were fever, vomiting and nausea.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5

How to store Mezolar Matrix

Keep out of the reach and sight of children, even after
use. Significant quantities of the active substance
remain in the transdermal patches even after use.

Do not use Mezolar Matrix 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 and kept in the outer package until discarded
safely or delivered to the pharmacy.

6

Further information

What Mezolar Matrix 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 Mezolar Matrix looks like and contents of the
pack
Mezolar Matrix 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.
Mezolar Matrix 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 approved in 11/2011 (to be
amended after approval).

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

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

Very common:
• drowsiness (somnolence)
• headache
• dizziness
• feeling or being sick (nausea or vomiting)
• constipation
• fever

Common:
• allergic reaction
• awareness of unusual heart beats (also called
palpitations), fast heart rate
• high blood pressure
• feeling unusually drowsy or tired
• loss of appetite

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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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