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VICTANYL 12MCG/HOUR TRANSDERMAL PATCH

Active substance(s): FENTANYL / FENTANYL / FENTANYL

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Package leaflet: Information for the user

Victanyl 12micrograms/hour
Transdermal Patch
Fentanyl
Important things you need to know about Victanyl Transdermal Patches
• 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).
• 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.
• F ollow 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 or pharmacist.
•  T his 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.
• I f 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.

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

Your doctor will know which medicines are safe to take with Victanyl patches. 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 Victanyl patches you need.
In particular, tell your doctor or pharmacist if you are taking:
•O
 ther medicines for pain, such as other opioid painkillers (such as buprenorphine, nalbuphine or
pentazocine).
•M
 edicines for helping you sleep (such as temazepam, zaleplon, or zolpidem).
•M
 edicines 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).
•M
 edicines for relaxing your muscles (such as cyclobenzaprine or diazepam).
• S ome 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.
• S ome medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid,
phenelzine, selegiline, or tranylcypromine).You should not take Victanyl patches within 14 days of
stopping these medicines. – see below for more information.
• S ome antihistamines, especially ones that make you sleepy (such as chlorpheniramine, clemastine,
cyproheptadine, diphenhydramine, or hydroxyzine).
• S ome antibiotics used to treat infection, (such as erythromycin or clarithromycin).
•M
 edicines used to treat fungal infection, (such as itraconazole, ketoconazole, fluconazole or
voriconazole).
•M
 edicines used to treat HIV infection, (such as ritonavir).
•M
 edicines used to treat an irregular heart beat, (such as amiodarone, diltiazem or verapamil).
•M
 edicines to treat tuberculosis (such as rifampicin).
• S ome medicines used to treat epilepsy (such as carbamazepine, phenobarbital or phenytoin).
• S ome medicines used to treat nausea or motion sickness (such as phenothiazines).
• S ome medicines used to treat heartburn or ulcers (such as cimetidine).
• S ome medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
• S ome medicines used to treat cancer of the blood (such as idelalisib).

Victanyl patches with antidepressants

1 What Victanyl is and what it is used for
The name of your medicine is Victanyl Transdermal Patch. It is called ‘Victanyl patch’ or just ‘patch’ in this
leaflet.
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.
Victanyl patch contains a medicine called fentanyl. It belongs to a group of strong painkillers called
opioids.

The risk of side effects increases if you are taking medicines such as certain antidepressants. Victanyl
patches 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 heart beat, high body temperature, overactive reflexes, lack
of coordination, muscle stiffness, nausea, vomiting and diarrhoea.

Operations

If you think that you are going to receive anaesthesia, tell your doctor or dentist that you are using
Victanyl patches.

Victanyl patches with alcohol

Do not drink alcohol while using Victanyl patches unless you have talked to your doctor first.

2 What you need to know before you use Victanyl
Do not use Victanyl patches if you

• a re allergic to fentanyl, soya, peanut or any of the other ingredients of this medicine (listed in
section 6)
•h
 ave pain which lasts only for a short period, such as sudden pain or pain after having an operation
•h
 ave 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 Victanyl patches.

Warnings and precautions
Victanyl can have life threatening side effects in people who are not already regularly using prescribed
opioid medicines.
Victanyl 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 Victanyl patches
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
• have ever had problems with your heart, liver, kidneys, or low blood pressure
• have ever had a brain tumour
• have ever had persistent headaches or a head injury
• are elderly - you may be more sensitive to the effects of this medicine.
• have a condition called ‘myasthenia gravis’ in which muscles become weak and tire easily.
• have ever abused or been dependent on alcohol, prescription medicines or illegal drugs.
• have chronic constipation.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using
Victanyl patches.

Side effects and Victanyl patches

• Victanyl patches 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 Victanyl 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 Victanyl patches, tell your doctor - this may increase the amount of
medicine that passes through your skin.
•V
 ictanyl patches may cause constipation, talk to your doctor or pharmacist for advice on how to prevent
or relieve constipation.
•R
 epeat, long term use of the patches may make the medicine less effective (you become ‘tolerant’ to it)
or you may become dependant on it.
•R
 espiratory depression may persist beyond the removal of the Victanyl patch.
• S ee 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.

Children

Victanyl patches should not be used in children aged
less than 2 years because the safety and efficacy have
not been established.
Victanyl patches should only be used in children above 2
years of age who are already using opioid medication.

Other medicines and Victanyl patches

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 Victanyl patches if you buy any
medicines from your pharmacy.

Victanyl patches 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. Victanyl patches should not be used during
pregnancy unless you have discussed this with your doctor.
Victanyl patches should not be used during childbirth as the medication can affect the breathing of the
newborn child.
Do not use Victanyl patches if you are breastfeeding. You should not breastfeed for 3 days after removing
your Victanyl patch. This is because the medicine may pass into breast milk.

Driving and using machines

Victanyl patches 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.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
•D
 o not drive while taking this medicine until you know how it affects you.
• I t is an offence to drive if this medicine affects your ability to drive.
•H
 owever, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided
with the medicine and
- It was not affecting your ability to drive safely.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this
medicine.

Victanyl contains soya oil

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

3 How to use Victanyl
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
Your doctor will decide which strength of Victanyl patches 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).
•Y
 ou should change your patch every third day, unless your doctor has told you differently.
•A
 lways remove the old patch before applying a new one.
•A
 lways change your patch at the same time of day every 3 days (72 hours).
• I f you are using more than one patch, change all your patches at the same time.
•M
 ake 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

Where to apply the patch
Adults
•A
 pply the patch on a flat part of your upper body or arm (not over a joint).
Children
•A
 lways apply the patch to the upper back to make it difficult for your child to reach it or take it off.
• E very so often check that the patch remains stuck to the skin.
• I t 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.
continued...

BBBA1117

Fentanyl (Victanyl) 12 microgram Transdermal Patch PIL - UK
approved for print/date

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Technical
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Change your patch on
Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

S.Anson
04.08.17
10.08.17
DR

Date sent:
04.08.17
Date received: 07.08.17

Dimensions:
280 x 480
Min Body Text Size: 8pts
Supplier:
Luye Pharma

Colours

Non Printing Colours

1. Black

1. Text Free Area

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

•W
 atch your child very closely for 48 hours after:
- T he first patch has been put on.
-A
 higher dose patch has been put on.
• I t 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.
Adults and Children
Do not apply the patch on:
• The same place twice in a row.
•A
 reas that you move a lot (joints), skin that is irritated or with cuts.
• I rradiated skin.
• S kin 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.

Putting a patch on
Step 1: Preparing the skin
•M
 ake sure your skin is completely dry, clean and cool before you put the patch on.
• I f you need to clean the skin, just use cold water.
•D
 o not use soap or any other cleansers, creams, moisturisers, oils or talc before applying the patch.
•D
 o not stick a patch on straight after a hot bath or shower.
Step 2: Open the sachet
• E ach patch is sealed in its own sachet.
•A
 dvice for opening child resistant sachet: You’ll find a mark which shows you how
to cut the sachet (using scissors!), cut close to the sealed edge of the sachet to
avoid damaging the patch).
•R
 ip the sachet alongside using the resulting cuts.
•O
 pen the sachet, take the patch out and use straight away.
•K
 eep the empty sachet to dispose of the used patch later.
•U
 se each patch once only.
•D
 o not take the patch out of its sachet until you are ready to use it.
• I nspect the patch for any damage.
•D
 o not use the patch if it has been divided, cut or looks damaged.
•N
 ever divide or cut the patch.
Step 3: Peel and press
•M
 ake sure that the patch will be covered by loose clothing and not stuck under a
tight or elasticated band.
•C
 arefully 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.
•P
 ress this sticky part of the patch onto the skin.
•R
 emove the other part of the backing and press the whole patch onto the skin
with the palm of your hand.
•H
 old for at least 30 seconds. Make sure it sticks well, especially the edges

Step 4: Disposing of the patch
•A
 s soon as you take a patch off, fold it firmly in half so that the sticky side sticks to itself.
•P
 ut it back in its original sachet and dispose of the sachet as instructed by your pharmacist.
•K
 eep 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

• F eeling 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 Victanyl patches or morphine) before.
(Uncommon, this may affect up to 1 in 100 people).
• S udden 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).
• F its (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):
•N
 ausea, vomiting, constipation
• F eeling sleepy (somnolence)
• F eeling dizzy
•H
 eadache.
Common (may affect up to 1 in 10 people):
•A
 llergic reaction
• L oss of appetite
•D
 ifficulty sleeping
•D
 epression
• F eeling anxious or confused
• S eeing, feeling, hearing, or smelling things that are not there (hallucinations)
•M
 uscle tremors or spasms
•U
 nusual feeling in the skin, such as tingling or crawling feelings (paraesthesia)
• S pinning sensation (vertigo)
•H
 eart beat feels fast or uneven (palpitations, tachycardia)
•H
 igh blood pressure
•B
 eing short of breath (dyspnoea)
•D
 iarrhoea
•D
 ry mouth
• S tomach pain or indigestion
• E xcessive sweating
• I tching, skin rash or redness of the skin
•B
 eing unable to pass urine or empty bladder completely
• F eeling very tired, weak or generally unwell
• Feeling cold
• S wollen hands, ankles or feet (peripheral oedema).
Uncommon (may affect up to 1 in 100 people):
• F eeling agitated or disoriented
• F eeling extremely happy (euphoria)
•D
 ecreased feeling or sensitivity, especially in the skin (hypoaesthesia)
• L oss of memory
•B
 lurred vision
• S low heart beat (bradycardia) or low blood pressure
•B
 lue colour to the skin caused by low oxygen in the blood (cyanosis)
• L oss of contractions of the gut (ileus)
• I tchy skin rash (eczema), allergic reaction or other skin disorders where the patch is placed
• F lu‑like illness
• F eeling of body temperature change
• F ever
•M
 uscle twitching
•D
 ifficulty getting and keeping an erection (impotence) or problems having sex.
Rare side effects (may affect up to 1 in 1000 people):
•C
 onstricted pupils (miosis)
• S topping 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

•A
 lways wash your hands after you have handled the patch
using clean water only

If you switch from a different painkiller to Victanyl patches or if you suddenly stop using Victanyl patches
you may notice withdrawal effects such as sickness, feeling sick, diarrhoea, anxiety or shivering. Tell your
doctor if you notice any of these effects.

More about Victanyl patches

There have been reports also of newborn infants experiencing withdrawal effects after their mothers
have used Victanyl for a long time during pregnancy.

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.
•Y
 ou 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 not sunbathe, have
long, hot baths or saunas. If you do, you may increase the amount of medicine you get from the
patch

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Victanyl
Where you should keep the patches

Keep all patches (used and unused) out of the sight and reach of children. High quantities of the drug
remain in the transdermal patches even after use.

How quickly will the patches work?

• I t may take some time for your first patch to have its maximum effect.
•Y
 our doctor may give you other painkillers as well for the first day or so.
•A
 fter 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.

How long to keep Victanyl patches for

Do not use Victanyl patches after the expiry date which is stated on the package. The expiry date refers to
the last date of that month. If the patches are out of date, take them to your pharmacy.

How long will you use the patches for?

• Victanyl 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

• I f 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)
• I f 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

• I f 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.
• I f 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

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.
Do not throw away any medicines via wastewater or household waste. These measures will help protect
the environment

6 Contents of the pack and other information
What Victanyl 12micrograms/h patches contains

• The active substance is fentanyl.
Each patch releases 12.5micrograms fentanyl per hour. Each patch of 4.25cm2 contains 2.55mg fentanyl.
The other ingredients are:
Matrix components: Aloe vera leaf extract oil (on the basis of soya oil tocopherol acetate), pentaerythriol
esters of hydrogenated colophony, poly(2-ethylhexylacrylate, vinylacetate) (50:50).
Release liner: Polyethylene terephtalate, polyester, siliconized.
Backing foil with imprint: polyethylene terephthalate foil, blue printing colour.

• I f a 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 of skin on:
- Your upper body or arm
- Your child’s upper back
• L et 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.
• I f your patches keep falling off, talk to your doctor, pharmacist or nurse.

What Victanyl looks like and contents of the pack

If you want to stop using the patches

Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland

• Talk to your doctor before you stop using these patches.
• I f you have been using them for some time your body may have got used to them. Stopping suddenly
may make you feel unwell.
• I f 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 traces of the patch remain on the skin after its removal, these can be cleaned off using copious amounts
of soap and water. No alcohol or other solvents may be used for cleaning, as these may penetrate the skin
due to the effect of the patch.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Victanyl is an opaque, rectangular shaped patch with round corners with a sticky back so that it can be
stuck onto the skin. The transdermal patches have the imprint ‘Fentanyl 12µg/h’ on the backing foil.
Each transdermal patch is packed individually into sealed child resistant pouch.
Victanyl is available in packs of 5 transdermal patches.

Manufacturer
Luye Pharma AG
Am Windfeld 25, Miesbach
83714
Germany
This leaflet was last revised in August 2017.

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.

BBBA1117

If you would like a
leaflet with larger text,
please contact
01271 385257.
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Fentanyl (Victanyl) 12 microgram Transdermal Patch PIL - UK
approved for print/date

Proof Round

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA1117

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
04.08.17
10.08.17
DR

Date sent:
04.08.17
Date received: 07.08.17

Dimensions:
280 x 480
Min Body Text Size: 8pts
Supplier:
Luye Pharma

Colours

Non Printing Colours

1. Black

1. Text Free Area

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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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