VICTANYL 75 MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance: FENTANYL

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Victanyl 25 micrograms/hour Transdermal Patch
Victanyl 50 micrograms/hour Transdermal Patch
Victanyl 75 micrograms/hour Transdermal Patch
Victanyl 100 micrograms/hour Transdermal Patch
Fentanyl
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.

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.
•   his medicine has been prescribed for you. Do not pass it on to others.
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It may harm them, even if their signs of illness are the same as yours.
•   f you get any side effects, talk to your doctor or pharmacist. This includes
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any possible side effects not listed in this leaflet.

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

Children and adolescents

In general, Victanyl should only be used in children and adolescents aged 2 years
or older who have previously been treated with other opioids (e.g. morphine).
Victanyl 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 Fentanyl transdermal patch (see section 3. “How to
use Victanyl”) and the adhesion of the patch should be monitored closely.

What is in this leaflet:
1 What Victanyl is and what it is used for
2 What you need to know before you use Victanyl
3 How to use Victanyl
4 Possible side effects
5 How to store Victanyl
6 Contents of the pack and other information
1

Other medicines and Victanyl

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any 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 Victanyl.

What Victanyl is and what it is used for

Fentanyl is one of a group of strong painkillers called opioids.
The painkiller, Fentanyl, slowly passes from the patch, through the skin and into the
body.

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.

Adults:
Victanyl is used for treatment of severe long-lasting pain that can only adequately
be managed with strong pain relievers.

If you take concomitantly 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 (tranquillisers)
• medicines used for treating psychological disorders (neuroleptics)
•  naesthetics, if you think you are going to have an anaesthetic, tell the doctor or
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dentist that you are using Victanyl
• medicines used for treating sleep disorders (hypnotics, sedatives)
•  edicines used for treating allergies or travel sickness (antihistamines/
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antiemetics)
• other strong-acting painkillers (opioids)
• some medicines for back pain or other painful musculoskeletal conditions

(skeletal muscle relaxants)
• alcohol

Children:
Victanyl 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.
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What you need to know before you use Victanyl
Do not use Victanyl

• f you are allergic to Fentanyl or any of the other ingredients of this medicine
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(listed in section 6).
• f you suffer from pain which lasts only for a short period, e.g. after a surgical
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procedure.
• f your central nervous system (brain and spinal cord) is severely impaired, for
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instance by brain injury.
• if you have severe problems breathing (respiratory depression).

You should not take the medicines listed below at the same time as you are using
Victanyl, unless you are closely monitored by your doctor. These medicines may
increase the effects and side effects of Victanyl. 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)

Warnings and Precautions
WARNING:
Victanyl 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.
Victanyl can have life-threatening side-effects in persons that are not using
prescribed opioid drugs on a regular basis.

Victanyl with alcohol

Simultaneous use of Victanyl 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 Victanyl do not drink
alcoholic beverages

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.
Do not use Victanyl during labour and delivery (including caesarean section)
because fentanyl passes the placenta and may cause respiratory depression in the
newborn child. If you get pregnant during treatment with Victanyl, consult your
doctor. Victanyl should not be used during pregnancy and breast-feeding unless
clearly necessary. Safe use during pregnancy has not been established. Fentanyl
passes into the breast-milk and may cause side effects in the breast-fed infant as
sedation and respiratory depression. Any breast milk produced during treatment or
within 72 hours after the removal of the last patch should be discarded.

Before starting to use Victanyl 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
• low blood pressure
• impaired liver function
• impaired kidney function
• f you have had a head injury, a brain tumour, signs of increased intracranial
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pressure (e.g. headache, visual disturbances), changes in your state of
consciousness or loss of consciousness or coma
• slow irregular heartbeat (bradyarrhythmias)
• myasthenia gravis (a disease causing tiredness and weakness of the muscles)
Inform your doctor if you develop a fever during the treatment, as the increased
body temperature may cause too much medicine to pass through the skin. For the
same reason you should avoid exposing the patch on the skin to direct heat such as
heating pads, electric blankets, heated water beds, heat or tanning lamps, intensive
sunbathing, hot water bottles, prolonged hot baths, saunas and hot whirlpool spa
baths. It is allowed to stay outside in the sun, but you must protect the patch with
some piece of clothing during hot summer days. The fentanyl transdermal patch
contains metal. The patch should be removed before MRI scan since it can overheat
during an MRI scan and cause skin burns in the immediate area of the patch.
Tolerance, physical or psychological dependence may develop if you use Victanyl
for a longer period. However, this is rarely seen during treatment of pain due to
cancer.

AAAE4322

Driving and using machines

Victanyl 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 Victanyl 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 Victanyl unless your doctor has told you that such
is permitted.
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How to use Victanyl

Always use this medicine exactly as your doctor or pharmacist has told you.Check
with your doctor or pharmacist if you are not sure.
Your doctor will decide which strength of Victanyl is most suitable for you.
Your doctor will base his judgement on: the severity of your pain, your general
condition and the type of pain treatment that you have received so far. According
to your reaction the strength of the patch or the number of patches may need to
be adjusted. The effect is reached within 24 hours after the first patch has been
applied and its effects fall gradually after the patch is removed. Do not discontinue
treatment without consulting your doctor.
Your first patch will start to work slowly, this may take as long as one day, so your
doctor may give you extra painkillers until your fentanyl transdermal patch starts
working completely. After this, the Victanyl should help to relieve pain continuously
and you should be able to stop taking these extra painkillers. However sometimes
you may still need extra painkillers.

continued...

Use in children and adolescents

Uncommon: 
Agitation, disorientation, euphoric mood, memory loss, decreased
feeling of sensitivity, especially in the skin, fits, (including clonic and
grand mal seizures), speech disorders, fall in the blood pressure
and heart rate, blueness of skin, impaired breathing (respiratory
depression), bowel obstruction, eczema, dermatitis,. Rash, skin
reddening and itching will usually disappear within one day after the
patch has been removed. Muscle twitching, male impotence, sexual
dysfunction, skin reactions at the attachment site, influenza like
illness, drug withdrawal syndrome, feeling hot and cold.

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

How to apply Victanyl

•  ind a flat part of your upper body (trunk) or upper arm, where the skin is without
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hair, cuts, spots or other skin blemishes. The body part must not have been
irradiated in connection with radiation therapy.
•  f the skin is hairy, then cut the hair with scissors. Do not shave, as shaving irritates
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the skin. If the skin needs washing, wash with water. Do not use soap, oil, lotions,
alcohol or other cleansers that may irritate the skin. The skin must be completely
dry before applying the patch.
• Patches should be inspected prior to use. Patches that are cut, divided, or

damaged in any way should not be used.
• The Victanyl patch should be removed from the protective pouch by first folding

the notch (located close to the tip of the arrow on the pouch label) and then
carefully tearing the pouch material. If scissors are used to open the pouch, this
should be done close to the sealed edge so as not to damage the patch inside.
•  he patch must be stuck on immediately after opening the package. When the
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release liner has been removed, the patch is applied by pressing it firmly onto the
skin with the palm of the hand for approximately 30 seconds to make sure that
the patch sticks well to the skin. Pay special attention to see that the patch sticks
properly at the edges.
•  Victanyl transdermal patch is used for 72 hours (3 days). On the outer package
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you can write the date and time you applied the patch. This may help you
remember when to change your patch.
•  he patch application site should not be exposed to heat from external heat
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sources (see “Take special care with Victanyl”).
•  s the transdermal patch is protected by an outer waterproof backing film, it can
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also be worn while showering.
•  n children, the upper back is the preferred location to apply the patch, to
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minimize the potential of the child removing the patch.

Rare: 
Constriction of the pupil of the eye, irregular heartbeat, dilated
blood vessels, stopping breathing (apnoea), too shallow or too
slow breathing, which does not meet the needs of the body
(hypoventilation), hiccup, block of the digestion channel.
Very rare: 
Generalised acute allergic reactions with a fall in the blood pressure
and/or difficulty in breathing (anaphylaxis/anaphylactic reactions),
delusional ideas, states of excitement, confusion, poor vision, painful
bloating, passing water less than normal (reduced urine excretion),
urinary bladder pain.
The following side effects may also occur but it is not known how frequently;

Anaphylactic shock/reaction, slow breathing.
 you have been using Victanyl for some time, it might happen that
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Victanyl will become less effective for you so that a dose adjustment
will be necessary (tolerance may develop).

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.

Additional side effects in children and adolescents

Children and adolescents treated with fentanyl transdermal patch 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 you get any side effects, talk to your doctor or pharmacist. This includes any side
effects not listed in this leaflet.

How to change the transdermal patch

•  emove the patch after the period your doctor has told you. In most cases this is
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after 72 hours (3 days), in some patients after 48 hours (2 days). Usually the patch
does not come off by itself. If traces of the transdermal patch remain on the skin
after its removal, these can be cleaned off using copious amounts of soap and
water.
•  old the used patch in half so that the sticky edges adhere to each other. Put back
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used patches in the outer package and hand in to your pharmacist.
•  pply a new patch as described above but on another part of the skin. At least 7
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days should elapse before the same part is used again.

5

If you have stuck on more patches than prescribed, remove the patches and
contact your doctor or hospital on their opinion of the risk.

Storage conditions

Do not store above 25 °C.

The most common sign of overdose is reduced ability to breathe. Symptoms are
that the person breathes abnormally slowly or weakly. If this should occur – remove
the patches and contact a doctor immediately. While waiting for the doctor, keep
the person awake by talking to or shaking her/him now and then.
Other signs and symptoms of overdose are drowsiness, low body temperature,
slow heart rate, decreased muscle tone, low blood pressure, deep sedation, loss of
muscle co-ordination, constriction of the pupils and convulsions.
Do not under any circumstances use a double dose to make up for a forgotten
dose.
You should change your patch at the same time of day every three days (every 72
hours), unless directed otherwise by your doctor. If you forget, then change your
patch as soon as you remember. If you are very late changing your patch then you
should contact your doctor because you might need some extra painkillers.

If you stop using Victanyl

If you wish to interrupt or stop the treatment, you should always talk to your doctor
about the reasons for discontinuation and your continued treatment.
Prolonged use of Victanyl can cause physical dependence. If you do stop using the
patches you may feel unwell.
As the risk of withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety and
muscular tremor) is greater when the treatment is stopped suddenly, you should
never stop treatment with Victanyl independently but always consult your doctor
first.
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.
The assessment of side effects is based on the following frequency data:
Very common more than 1 in 10 patients
Common less than 1 in 10, but more than 1 in 100 patients
Uncommon less than 1 in 100, but more than 1 in 1000 patients
Rare less than 1 in 1000, but more than 1 in 10,000 patients
Very rare less than 1 in 10,000 patients, including isolated reports
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) or complete block of
the digestion channel (convulsive pain, vomiting, flatulence).
If you experience a serious side effect, your doctor may decide to monitor you for
24 hours since fentanyl can still affect the body for some time after the removal of
the patch.
Other side effects
Very common: Somnolence, headache, dizziness, nausea, vomiting, constipation.
Common: 
Pink eye, loss of appetite, sedation, difficulty in sleeping, depression,
generalised fear, confusional state, hallucinations, nervousness,
involuntary shakiness, pins and needles, dizziness at height,
unpleasant sensations of irregular and/or forceful beating of the
heart, high blood pressure, difficulties in breathing, diarrhoea, dry
mouth, reduced or absent saliva flow, stomach pain, indigestion,
excessive sweating, skin reaction on the application site, itching, rash,
skin reddening (erythema) muscle spasms, difficulty passing water
(urine), feeling unusually drowsy or tired (depressant effect on brain
function), loss of physical strength, general discomfort (malaise),
feeling cold.

AAAE4322

Keep this medicine out of the sight and reach of children, even after use.
High quantities of the drug remain in the transdermal patches even after use.
Do not use this medicine after the expiry date which is stated on the package.
The expiry date refers to the last day of that month.

If you use more Victanyl than you should

If you forget to use Victanyl

How to store Victanyl

Special precautions for disposal

For environmental and safety reasons, used as well as unused and out of date
patches must be discarded 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 or delivered to the pharmacy.
6

Contents of the pack and other information

Victanyl 25 micrograms/hour Transdermal Patch

What Victanyl 25 micrograms/hour Transdermal Patch contains
•  he active substance is Fentanyl.
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Each patch releases 25 micrograms fentanyl per hour . Each patch of 7.5 cm2
contains 4.125 mg Fentanyl.

Victanyl 50 micrograms/hour Transdermal Patch

What Victanyl 50 micrograms/hour Transdermal Patch contains
•  he active substance is Fentanyl.
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Each patch releases 50 micrograms fentanyl per hour . Each patch of 15 cm2
contains 8.25 mg Fentanyl.

Victanyl 75 micrograms/hour Transdermal Patch

What Victanyl 75 micrograms/hour Transdermal Patch contains
•  he active substance is Fentanyl.
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Each patch releases 75 micrograms fentanyl per hour . Each patch of 22.5 cm2
contains 12.375 mg Fentanyl.

Victanyl 100 micrograms/hour Transdermal Patch

What Victanyl 100 micrograms/hour Transdermal Patch contains
•  he active substance is Fentanyl.
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Each patch releases 100 micrograms fentanyl per hour . Each patch of 30 cm2
contains 16.5 mg Fentanyl.
•  he other ingredients are:
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Adhesive layer: Polyacrylate adhesive layer
Backing film: Polypropylene foil, blue printing ink
Release liner: Polyethylene terephthalate foil (siliconised)

What Victanyl looks like and contents of the pack

Victanyl is a transparent, transdermal patch with a sticky back so that it can be
stuck onto the skin. The transdermal patches are equipped with a blue imprint with
the strength.
Victanyl is available in packs of 3, 4, 5, 8, 10, 16 or 20 transdermal patches.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegur 76-78
220 IS Hafnarfjordur
Iceland
Manufacturer
Actavis Nordic A/S
Ørnegårdsvej 16
2820 gentofte
Denmark
This leaflet was last revised in: December 2012

Actavis, Barnstaple, EX32 8NS, UK

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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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