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).

•    If you develop a fever tell your doctor immediately.

•    Follow the dosage instructions carefully and only change your patch 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.

•    This medicine has been prescribed for you 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:

3    What Victanyl is and what it is used for

What you need to know before you use Victanyl How to use Victanyl

4    Possible side effects Jj How to store Victanyl

~6 Contents of the pack and other information

j 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.

Victanyl patch contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids. The medicine passes slowly into your body through your skin.

Victanyl patches can be used in children aged 2 to 16 years who have previously used opioid painkillers. If the patches have been prescribed for your child, the 'you' stated everywhere below should be read as 'your child.

4 What you need to know before you use Victanyl Do not use Victanyl patches

•    if you are allergic to fentanyl, soya, peanut or any of the other ingredients of this medicine (listed in section 6)

•    if you suffer from pain which lasts only for a short period, e.g. after a surgical procedure

•    if your child who is in pain is under 2 years old

•    if you have severe problems breathing (respiratory depression)

•    if your child has not been treated with strong painkillers such as morphine.

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

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 which in some cases may lead to a fatal outcome.

Victanyl can have life threatening side effects in persons that are not using prescribed opioid medicines on a regular basis.

Patch sticking to another person

The patch should be used only on the skin of the person for whom it has been prescribed. Cases have been reported where a patch was accidentally stuck to a family member while in close physical contact or sharing the same bed as the patch wearer. A patch sticking to another person (particularly a child) may result in an overdose. In case the patch sticks to the skin of another person, take the patch off immediately and seek medical attention. See also section 3 below.

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.

Take special care with Victanyl patches

•    Like some other strong painkillers, Victanyl patches may make you unusually drowsy, and breathe more slowly or weakly. Very rarely these breathing difficulties can be life threatening or even fatal in people who have not used strong morphine related painkillers (like Victanyl) or morphine before. If you, or your partner or carer, notice that you or your child are breathing much more slowly or weakly then:

-    Take the patch off.

-    Call a doctor, or go to your nearest hospital, straight away.

-    Keep moving and talking as much as possible.

•    If you develop a fever while wearing Victanyl patches, tell your doctor as this may affect the way the medicine passes through your skin.

•    Don't expose the patch to direct heat such as heating pads, electric blankets, hot water bottles, heated water beds, heat or tanning lamps, intensive sun bathing, prolonged hot baths, saunas or hot whirlpool spa baths. These may affect the way the medicine is absorbed through the skin.

•    Check with your doctor or pharmacist before using this medicine if you have ever had:

-    Problems with your lungs or breathing.

-    Problems with your heart or blood pressure and blood volume, liver or kidneys.

-    Brain tumours.

-    Persistent headaches or a head injury.

Your doctor might need to check you more closely.

•    If you are very ill, very thin or elderly, you may be more sensitive to the effects of the patches.

•    If you suffer from a condition in which muscles become weak and tire easily, known as myasthenia gravis, talk to your doctor or pharmacist before using Victanyl patches.

•    Like many other strong painkillers, repeated use of the patches may make you become tolerant to the medicine or become dependent on it.

•    Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs.

•    Victanyl may cause constipation, talk to your doctor or pharmacist for advice on how to prevent constipation.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Victanyl patches.

Other makes of patch

There are other makes of fentanyl transdermal patch available, but they are not all the same. If your patch looks different from one you have used before you should check with your doctor or pharmacist before using it.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken 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.

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

•    Other medicines for pain, such as other opioid painkillers (buprenorphine, nalbuphine or pentazocine).

•    Medicines for helping you sleep.

•    Medicines to help you calm down (tranquillisers) and medicines for mental conditions.

•    Medicines for relaxing your muscles.

•    Some medicines used to treat depression (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine).

•    Some medicines used to treat depression (called MAOIs). You should not take Victanyl within 14 days of stopping these medicines.

•    Nefazodone a medicine used to treat depression.

•    Some antihistamines (especially ones that make you sleepy).

•    Some antibiotics used to treat infection, such as erythromycin, clarithromycin or troleandomycin.

•    Medicines used to treat fungal infection, such as itraconazole, ketoconazole, fluconazole or voriconazole.

•    Medicines used to treat HIV infection, such as ritonavir or nelfinavir.

•    Medicines used to treat an irregular heart beat, such as amiodarone, diltiazem or verapamil.

•    Rifampicin (for treatment of TB).

•    Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital or phenytoin).

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 above or if you stop taking some of the types of medicines listed above, as this may affect the strength of Victanyl you need.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Victanyl patches.

Operations or tests

If you think that you are going to have an anaesthetic, tell your doctor or dentist that you are using Victanyl.

Victanyl with alcohol

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

Victanyl patches can make you drowsy or breathe more slowly. Drinking alcohol may make these effects worse.

Pregnancy and breast feeding

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

Do not breast feed whilst using Victanyl patches. You should not breast feed for 3 days after removing your Victanyl patch. This is because small amounts of the medicine may pass into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast feeding.

Driving and using machines

Victanyl patches can make you drowsy. If this happens, do not drive or use any tools or machines.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking 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 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.

How to use Victanyl

Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Using and changing the patches

•    There is enough 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 which day of the week to change your patch:

Adults

•    Apply the patch on a flat part of your upper body or arm.

Children

•    Always apply the patch to the upper back to make it difficult for your child to reach it or take it off.

•    Every so often check that the patch remains stuck to the skin.

•    It is important that your child does not remove the patch and put it in their mouth as this could be life threatening or even fatal.

•    It may take some time before the patch becomes fully effective. Therefore, your child might need additional painkillers until the patches become effective. Your doctor will advise you on this if it is needed.

•    Children should be monitored very closely for 48 hours after:

-    The first patch has been put on.

-    A higher dose patch has been put on.

For you or your child, do not apply the patch on:

•    The same place twice in a row.

•    Sensitive areas that you move a lot, skin with cuts, spots or other skin blemishes.

•    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.

You should allow several days to pass before you put a new patch on the same area of skin.

Putting a patch on

•    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.

Only open the pouch immediately before use of the patch.

Advice for opening child resistant sachet:

1)    You'll find a mark which shows you how to cut the sachet (using scissors!).

2)    Rip the sachet alongside using the resulting cuts.

3)    Open the sachet and take out the patch.

Then remove the pull-off foil from half of the patch. It is important to avoid touching the adhesive surface.

After sticking half of the patch onto the skin, you can remove the other half of the pull-off foil.

Firmly press the patch onto the skin with your flat hand for 30 - 60 seconds. Ensure that the adhesive edges stick well.

Make sure that the patch will be covered by loose clothing and not stuck under a tight or elasticated band.

After applying the patch, wash your hands without using cleaning agents.

A patch that has been divided, cut or damaged in any way should not be used.

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 pouch and put the pouch in the bin with your household rubbish.

Even used patches contain some medicine which may harm children and may be fatal, so keep your used patches out of the sight and reach of children.

How quickly will the patches work?

•    It may take up to a day before your first patch is working completely.

•    Your doctor may give you extra painkillers for 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.

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 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 or the nearest hospital 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 a patch falls off

•    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

•    Leave another 3 days (72 hours) before changing the new patch as usual.

•    If your patches keep falling off, talk to your doctor, nurse or pharmacist.

If a patch sticks to another person (See also section 2 above)

•    Only use the patch on the skin of the person who it was prescribed for.

•    Make sure the patch does not get rubbed off and stick to your partner or child, especially while sharing a bed or in close contact.

•    If a patch accidentally sticks to another person, take it off straight away and seek immediate medical attention.

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

•    If your pain gets worse while you are using these patches, your doctor may try a higher strength patch, or give you extra painkillers (or both).

•    If increasing the strength of the patch does not help, your doctor may stop the patches.

If you want to stop using the patches

•    Talk to your doctor before you stop using these patches.

•    If you have been using them for some time your body may have got used to them. Stopping suddenly may make you feel unwell.

•    If you stop using the patches, don't start again without asking your doctor first. You might need a different patch strength when you restart.

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.

•    Don't expose the patch to direct heat such as heating pads, hot water bottles, electric blankets, heated water beds, heat or tanning lamps, intensive sun bathing, prolonged hot baths or saunas. These may affect the way the medicine is absorbed through the skin.

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.

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

•    Feeling unusually drowsy, breathing more slowly or weakly than expected.

Very rarely these breathing difficulties can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers (like Victanyl or morphine) before. If you, or your partner or carer, notice that you or your child are breathing much more slowly or weakly, follow the guidance above and keep moving and talking as much as possible.

•    Sudden swelling of the face or throat, severe irritation, reddening or blistering of your skin.

These may be signs of a severe allergic reaction. This only happens in a small number of people

•    convulsions, fits or seizures. This affects fewer than 1 in 100 people.

•    reduced consciousness or loss of consciousness. These affect fewer than 1 in 100 people.

The following side effects have also been reported

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

•    feeling sick (nausea) or being sick (vomiting), constipation

•    dizziness, drowsiness or not being able to sleep

•    headache.

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

•    allergic reaction

•    awareness of unusual heart beats (also called palpitations), fast heart rate

•    high blood pressure

•    loss of appetite or dry mouth

•    feeling nervous, worried or depressed

•    confusion, hallucinations (seeing, feeling or hearing things that are not there)

•    sensation of pins and needles, shaking, feeling giddy

•    muscle spasms

•    stomach ache, indigestion, difficulty passing urine

Continued top of next column

•    diarrhoea

•    feeling cold, excessive sweating

•    general feelings of discomfort, tiredness, weakness

•    swelling of hands, ankles or feet

•    itchy skin, rashes or redness of the skin.

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

•    flu like symptoms

•    slow heart rate

•    low blood pressure

•    decreased feeling of sensitivity, especially in the skin

•    blurred vision

•    bluish colouration of the skin

•    feeling agitated, disorientated, excited or unusually carefree

•    loss of memory

•    eczema and/or other skin disorders including dermatitis where the patch is placed

•    disorders of sexual function

•    complete obstruction of the intestine

•    muscle twitching

•    fever, body temperature changes

•    drug withdrawal effects (such as sickness, feeling sick, diarrhoea, anxiety or shivering).

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

•    tiny pupils

•    incomplete obstruction of the small or large intestine.

Additional side effects in children and adolescents

The following side effects have been reported during clinical trials in children (up to 18 years of age):

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

•    headache

•    feeling or being sick

•    constipation, diarrhoea

•    itching.

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

•    allergic reaction

•    loss of appetite, stomach pain

•    not being able to sleep, drowsiness, tiredness, feeling weak

•    feeling worried or depressed, hallucinations (seeing, feeling or hearing things that are not there), dizziness

•    shaking, decreased feeling or sensitivity, especially in the skin

•    dry mouth

•    rash, excessive sweating, redness of the skin

•    muscle spasms

•    difficulty passing urine

•    swelling of hands, ankles or feet

•    skin reactions where the patch is placed.

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

•    confusion

•    sensation of pins and needles

•    tiny pupils

•    feeling giddy

•    bluish colouration of the skin, eczema and/or other skin disorders including dermatitis where the patch is placed

•    drug withdrawal effects (such as sickness, feeling sick, diarrhoea, anxiety or shivering), flu-like symptoms.

If you get any of these side effects, tell your doctor, nurse or pharmacist.

Skin rashes, itching or sweating (affects less than 1 in 10 people). 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.

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

Like many other strong painkillers, repeated use of the patches may make you become tolerant to the medicine or become dependent on it.

If you get any of these side effects, tell your doctor, nurse or pharmacist.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

How to store Victanyl

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.

Storage conditions

This medicinal product does not require any special storage conditions.

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.

Handling the patch

Used patches should be folded so that the adhesive side of the patch adheres to itself and then they should be safely discarded. Accidental exposure to used and unused patches particularly in children may lead to a fatal outcome. Unused patches should be returned to the (hospital) pharmacy.

q 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.

What Victanyl looks like and contents of the pack

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 12pg/h' on the backing foil.

Victanyl is available in packs of 5 transdermal patches.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76-78 220 HafnarfjorSur Iceland

Manufacturer

Acino AG

Am Windfeld 25, Miesbach 83714 Germany

This leaflet was last revised in July 2015.

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

Actavis, Barnstaple, EX32 8NS, UK

AAAI1664