VICTANYL 25 MICROGRAMS / HOUR TRANSDERMAL PATCH - patient leaflet, side effects, dosage

Patient leaflet - VICTANYL 25 MICROGRAMS / HOUR TRANSDERMAL PATCH

jlWhat Victanyl is and what it is used for

^iWhat you need to know before you use Victanyl

31How to use Victanyl

4lPossible side effects

51How to store Victanyl

6Kontents of the pack and other information

llW

hat Victanyl is and what it is used for

The name of your medicine is Victanyl.

This medicine has been prescribed for you to 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.

The patch contains Fentanyl which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop using it suddenly. Your doctor should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely.

^iWhat you need to know before you use Victanyl

Fentanyl is a strong opioid and should not be used unless you have previously been prescribed other opioids.

Do not use Victanyl if you:

are allergic to fentanyl or any of the other ingredients in this medicine (listed in section 6).
have pain which lasts only for a short period, such as sudden pain or pain after having an operation
have breathing difficulties, with slow or shallow breathing.

Do not use this medicine if any of the above apply to you or your child. If you are not sure, talk to your doctor or pharmacist before using Victanyl.

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.
Store this medicine in a safe and secure place, where other people cannot access it – see section 5 for more information.
are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
feel you need to use more Victanyl patches to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your doctor who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Using this medicine regularly, particularly for a long time, can lead to addiction. Your doctor should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely. Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor about your treatment. Addiction can cause withdrawal symptoms when you stop using this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your doctor will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop using the medicine suddenly as you will be more likely to experience withdrawal symptoms. Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Using higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

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

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 chronic constipation.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Victanyl.

While using the patch, tell your doctor if you have breathing problems while sleeping. Opioids like fentanyl can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep-related hypoxaemia (low oxygen level in the blood). Tell your doctor if you, your partner or carer notice you have any of the following: breathing pauses during sleep, night awakening due to shortness of breath, difficulties staying asleep, or excessive drowsiness during the day. Your doctor may decide to change your dose.

Side effects and Victanyl

Victanyl 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, tell your doctor – this may increase the amount of medicine that passes through your skin.
Victanyl may cause constipation, talk to your doctor or pharmacist for advice on how to prevent or relieve constipation.

See section 4 for a full list of possible side effects.

When you are wearing the patch do not expose it to direct heat such as heating pads, electric blankets, hot-water bottles, heated water beds, or heat or tanning lamps. Do not sunbathe, have long hot baths or saunas or use hot whirlpool spa baths. If you do, you may increase the amount of medicine you get from the patch.

The fentanyl transdermal patch contains metal. The patch should be removed before MRI scans since it can overheat during an MRI scan and cause skin burns in the immediate area of the patch.

Other medicines and Victanyl

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, if you buy any medicines from your pharmacy.

Your doctor will know which medicines are safe to take with Victanyl. 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 you need.

In particular, tell your doctor or pharmacist if you are taking:

Other medicines for pain, such as other opioid painkillers (such as buprenorphine, nalbuphine or pentazocine).
Medicines for helping you sleep (such as temazepam, zaleplon, or zolpidem).
Medicines to help you calm down (tranquillisers such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental conditions (anti-psychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
Medicines for relaxing your muscles (such as cyclobenzaprine or diazepam).
Some medicines used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) – see below for more information.
Some medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid, phenelzine, selegiline or tranylcypromine). You should not use Victanyl within 14 days of stopping these medicines – see below for more information.
Some antihistamines, especially ones that make you sleepy (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
Some antibiotics used to treat infection (such as erythromycin or clarithromycin).
Medicines used to treat fungal infection (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
Medicines used to treat HIV infection (such as ritonavir).
Medicines used to treat an irregular heartbeat (such as amiodarone, diltiazem, or verapamil).
Medicines to treat tuberculosis (such as rifampicin).
Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital or phenytoin).
Some medicines used to treat nausea or motion sickness (such as phenothiazines).
Some medicines used to treat heartburn or ulcers (such as cimetidine).
Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
Some medicines used to treat cancer of the blood (such as idelalisib).

Victanyl with antidepressants

The risk of side effects increases if you are taking medicines such as certain antidepressants. Victanyl may interact with these medicines and you may experience changes to mental status such as feeling agitated, seeing, feeling, hearing or smelling things that are not there (hallucinations) and other effects such as changing blood pressure, fast heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting and diarrhoea (these could be signs of serotonin syndrome). If used together, your doctor may want to closely monitor you for such side effects in particular when starting treatment or when the dose of your medicine is changed.

Use with Central Nervous System Depressants, including alcohol and some narcotic drugs

Concomitant use of Victanyl with sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor does prescribe Victanyl together with sedative medicines, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all sedative medicines you are taking, and follow your doctors dose recommendations closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

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

Operations

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

Pregnancy and breastfeeding

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 taking this medicine.

Do not use Victanyl patches if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby. If you use Victanyl patches during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Victanyl should not be used during childbirth as the medication can affect the breathing of the newborn child.

Do not use Victanyl patches while you are breastfeeding as fentanyl passes into breast milk and will affect your baby. 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 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.
It is an offence to drive if this medicine affects your ability to drive.
However, you would not be committing an offence if:
– The medicine has been prescribed to treat a medical or dental problem and
– You have used 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 using this medicine.

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 should have discussed with you, how long the course of patches will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop using the medicine.

Your doctor will decide which strength of Victanyl is most suitable for you, taking into account the severity of your pain, your general condition and type of pain treatment that you have received so far.

Using and changing the patches

There is enough medicine in each patch to last 3 days (72 hours).
You should change your patch every third day, unless your doctor has told you differently.
Always remove the old patch before applying a new one.
Always change your patch at the same time of day every 3 days (72 hours).
If you are using more than one patch, change all your patches at the same time.
Make a note of the day, date and time you apply a patch, to remind you when you need to change your patch.
The following table shows you when to change your patch:

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

Where to apply the patch

Adults

Apply the patch on a flat part of your upper body or arm (not over a joint).

Children

Always apply the patch to the upper back to make it difficult for your child to reach it or take it off.
Every so often check that the patch remains stuck to the skin.
It is important that your child does not remove the patch and put it in their mouth as this could be life threatening or even fatal.
Watch your child very closely for 48 hours after:
The first patch has been put on
A higher dose patch has been put on
It may take some time for the patch to have its maximum effect. Therefore, your child might need to use other painkillers as well until the patches become effective. Your doctor will talk to you about this.

Adults and Children:

Do not apply the patch on

The same place twice in a row.
Areas that you move a lot (joints), skin that is irritated or with cuts.
Irradiated skin.
Skin that is very hairy. If there is hair, do not shave it (shaving irritates the skin). Instead, clip the hair as close to the skin as possible.

Putting a patch on

Step 1: Preparing the skin

Make sure your skin is completely dry, clean and cool before you put the patch on
If you need to clean the skin, just use cold water
Do not use soap or any other cleansers, creams, moisturisers, oils or talc before applying the patch
Do not stick a patch on straight after a hot bath or shower.
Each patch is sealed in its own sachet
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
Take the patch out and use straight away
Keep the empty sachet to dispose of the used patch later
Use each patch once only
Do not take the patch out of its sachet until you are ready to use it
Inspect the patch for any damage
Do not use the patch if it has been divided, cut or looks damaged
Never divide or cut the patch.
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.
As soon as you take a patch off, fold it firmly in half so that the sticky side sticks to itself
Put it back in its original sachet and dispose of the sachet as instructed by your pharmacist
Keep used patches out of sight and reach of children – even used patches contain some medicine which may harm children and may even be fatal.
Always wash your hands after you have handled the patch using clean water only.

More about using Victanyl

Everyday activities while using the patches

The patches are waterproof
You can shower or bathe while wearing a patch, but do not scrub the patch itself
If your doctor agrees, you can exercise or play sport while wearing the patch
You can also swim while wearing the patch, but:
– Don’t use hot whirlpool spa baths
– Don’t put a tight or elasticated band over the patch

While you are wearing the patch do not expose it to direct heat such as heating pads, electric blankets, hot water bottles, heated water beds, heat or tanning lamps. Do not sunbathe, have long hot baths or saunas. If you do, you may increase the amount of medicine you get from the patch.
It may take some time for your first patch to have its maximum effect.
Your doctor may give you other painkillers as well for the first day or so
After this, the patch should help to relieve pain continuously so that you can stop taking other painkillers. However, your doctor may still prescribe extra painkillers from time to time.
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 while you are using these patches, your doctor may try a higher strength patch, or give you additional painkillers (or both)
If increasing the strength of the patch does not help, your doctor may decide to stop the use of the patches.

If you use more Victanyl patches than you should or use the wrong strength patch

If you have stuck on too many patches or the wrong strength patch, take the patches off and contact a doctor straight away.

Signs of overdose include trouble breathing or shallow breathing, tiredness, extreme sleepiness, being unable to think clearly, walk or talk normally and feeling faint, dizzy or confused.

If you forget to change your patch

If you forget, change your patch as soon as you remember and make note of the day and time.
Change the patch again after 3 days (72 hours) as usual.
If you are very late changing your patch, you should talk to your doctor because you might need some extra painkillers, but do not apply an extra patch.
If a patch falls off before it needs changing, stick a new one on straight away and make note of the day and time. Use a new area of skin on:
– Your upper body or arm
– Your child’s upper back

Let your doctor know this has happened and leave the patch on for another 3 days (72 hours) or as directed by your doctor, before changing the new patch as usual
If your patches keep falling off, talk to your doctor, pharmacist or nurse.
Do not suddenly stop using this medicine. If you want to stop using this medicine, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop using this medicine.
If you stop using the patches, don’t start again without asking your doctor first. You might need a different patch strength when you restart.

If 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.

jlPossible side effects

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

If you or your partner, or carer, notice any of the following about the person wearing the patch, take the patch off and call a doctor, or go to your nearest hospital, straight away. You may need urgent medical treatment.

Feeling unusually drowsy, breathing that is more slow or shallow than expected.

Follow the advice above and keep the person who was wearing the patch moving and talking as much as possible. Very rarely these breathing difficulties can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers (like Victanyl or morphine) before. (Uncommon, may affect up to 1 in 100 people)

Sudden swelling of the face or throat, severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction. (Not known, frequency cannot be estimated from the available data).
Fits (seizures). (Uncommon, may affect up to 1 in 100 people).
Reduced consciousness or loss of consciousness. (Uncommon, may affect up to 1 in 100 people.)

The following side effects have also been reported

Very common (may affect more than 1 in 10 people):

Nausea, vomiting, constipation
Feeling sleepy (somnolence)
Feeling dizzy
Headache.

Common (may affect up to 1 in 10 people):

Allergic reaction
Loss of appetite
Difficulty sleeping
Depression
Feeling anxious or confused
Seeing, feeling, hearing, or smelling things that are not there (hallucinations)
Muscle tremors or spasms
Unusual feeling in the skin, such as tingling or crawling feelings (paraesthesia)
Spinning sensation (vertigo)
Heartbeat feels fast or uneven (palpitations, tachycardia)
High blood pressure
Being short of breath (dyspnoea)
Diarrhoea
Dry mouth
Stomach pain or indigestion
Excessive sweating
Itching, skin rash or redness of the skin
Being unable to pass urine or empty bladder completely
Feeling very tired, weak or generally unwell
Feeling cold
Swollen hands, ankles or feet (peripheral oedema).

Uncommon (may affect up to 1 in 100 people):

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

Rare side effects (may affect up to 1 in 1,000 people):

Constricted pupils (miosis)
Stopping breathing from time to time (apnoea).

Not known (frequency cannot be estimated from the available data):

Dependence and addiction (see section “How do I know if I am addicted?”)
Lack of male sex hormones (androgen deficiency)
Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not really there, sleep disturbance, nightmares).

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.

Drug Withdrawal

When you stop using Victanyl patches, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

How do I know if I am addicted?

If you notice any of the following signs whilst using Victanyl patches, it could be a sign that you have become addicted.

– You need to use the medicine for longer than advised by your doctor
– You feel you need to use more than the recommended dose
– You are using the medicine for reasons other than prescribed
– When you stop using the medicine you feel unwell, and you feel better once using the medicine again If you notice any of these signs, it is important you talk to your doctor.

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 at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

^iHow to store Victanyl

Where you should keep the patches

Keep all patches (used and unused) out of the sight and reach of children.

Store this medicine in a safe and secure place, where other people cannot access it. It can cause serious harm and be fatal to people who may take this medicine by accident, or intentionally when it has not been prescribed for them.

How long to keep Victanyl for

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

Storage conditions

Do not store above 30 °C.

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 of.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

GKontents of the pack and other information

Victanyl 25 micrograms/hour Transdermal Patch

What Victanyl 25 micrograms/hour Transdermal Patch contains

The active substance is Fentanyl.

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

The active substance is Fentanyl.

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

The active substance is Fentanyl.

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

The active substance is Fentanyl.

Each patch releases 100 micrograms fentanyl per hour. Each patch of 30 cm2 contains 16.5 mg Fentanyl.

The other ingredients are:

What Victanyl looks like and contents of the pack

Victanyl 25micrograms/hour is a transparent and colourless, transdermal patch with a sticky back so that it can be stuck onto the skin. The transdermal patches have a blue imprint on the backing foil “fentanyl 25mg/h”.

Victanyl 50micrograms/hour is a transparent and colourless, transdermal patch with a sticky back so that it can be stuck onto the skin. The transdermal patches have a blue imprint on the backing foil “fentanyl 50mg/h”.

Victanyl 75micrograms/hour is a transparent and colourless, transdermal patch with a sticky back so that it can be stuck onto the skin. The transdermal patches have a blue imprint on the backing foil “fentanyl 75mg/h”.

Victanyl 100micrograms/hour is a transparent and colourless, transdermal patch with a sticky back so that it can be stuck onto the skin. The transdermal patches have a blue imprint on the backing foil “fentanyl 100mg/h”.

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

Accord, Barnstaple, EX32 8NS, UK

Manufacturer

Luye Pharma AG, Am Windfeld 35, D-83714 Miesbach, Germany

This leaflet was last revised in: September 2021

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