VICTANYL 12MCG/HOUR TRANSDERMAL PATCH - patient leaflet, side effects, dosage

Patient leaflet - VICTANYL 12MCG/HOUR TRANSDERMAL PATCH

Victanyl 12 micrograms/hour Transdermal Patch

Fentanyl

This medicine contains Fentanyl which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop using it suddenly.

Important things you need to know about Victanyl Transdermal Patches

Do not use if you have not been prescribed an opioid medicine before
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, electric blankets, heating pads, sunbathe, saunas)
Do not soak in a hot bath or take a hot shower whilst wearing a patch
If you experience a fever tell your doctor immediately
Follow the dosage instructions carefully and only change your patch at the same time of day every 3 days (72 hours)
If you feel you need to replace your patch before 72 hours speak to your doctor, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it
If your breathing becomes shallow and weak, take the patch off and seek medical help.
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 (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.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet :

jlWhat Victanyl is and what it is used for

2]What you need to know before you use Victanyl

2|How to use Victanyl

4lPossible side effects

^iHow to store Victanyl

6|Contents of the pack and other information

ijWhat Victanyl is and what it is used for

The name of your medicine is Victanyl Transdermal Patch. It is called ‘Victanyl’, ‘Victanyl patch’ or just ‘patch’ in this leaflet.

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

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.

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.

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:

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 patches 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 patches with antidepressants

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 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 patches 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 patches.

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 patches 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 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.
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.

Victanyl contains soya oil

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

31 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 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).
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:

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.

Step 2: Open the sachet

Each patch is sealed in its own sachet.
Advice for opening child resistant sachet: You’ll find a mark which shows you how !~~l to cut the sachet (using scissors, cut close to the sealed edge of the sachet to avoid

/ZU damaging the patch).

P— Rip the sachet alongside using the resulting cuts.
Open the sachet, 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.

Step 4: Disposing of the patch

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 patches

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 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 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 a 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.

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.

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 patches 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.

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.

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 intentially when it has not been prescribed for them.

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 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.

^Contents of the pack and other information

What Victanyl 12micrograms/h patches contains

The active substance is fentanyl.

What Victanyl looks like and contents of the pack

Victanyl is an opaque and colourless 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 12pg/h’ on the backing foil.

Each transdermal patch is packed individually into a sealed child resistant pouch.

Victanyl is available in packs of 5 transdermal patches.

Marketing Authorisation Holder

Accord, Barnstaple, EX32 8NS, UK

Manufacturer

Luye Pharma AG

Am Windfeld 35, Miesbach

83714

Germany

This leaflet was last revised in August 2021.

If you would like a leaflet with larger text, please contact 01271 385257.

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