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

Fentanyl

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: j 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 3 How to store Victanyl q Contents of the pack and other information

J What Victanyl is and what it is used for

Victanyl is one of a group of strong painkillers called opioids.

The painkiller, Fentanyl, slowly passes from the patch, through the skin and into the body.

Adults:

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

Children:

Victanyl is used for the long term treatment of severe and long-lasting pain in children aged 2 years or older who have previously been treated with other strong pain relievers.

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

•    if you are allergic to Fentanyl 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 central nervous system (brain and spinal cord) is severely impaired, for instance by brain injury.

•    if you have severe problems breathing (respiratory depression).

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 was ordered by the doctor. 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.

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.

Before starting to use Victanyl you should inform your doctor if you suffer from any of the below disorders, because the risk of side effects is higher and/or your doctor may need to prescribe a lower dose of Victanyl.

•    asthma, respiratory depression or any lung disease

•    low blood pressure

•    impaired liver function

•    impaired kidney function

•    if you have had a head injury, a brain tumour, signs of increased intracranial pressure (e.g. headache, visual disturbances), changes in your state of consciousness or loss of consciousness or coma

•    slow irregular heartbeat (bradyarrhythmias)

•    myasthenia gravis (a disease causing tiredness and weakness of the muscles)

•    if you take antidepressants or antipsychotics, please refer to the section 'Other medicines and Victanyl'

Inform your doctor if you develop a fever during the treatment, as the increased body temperature may cause too much medicine to pass through the skin. For the same reason you should avoid exposing the patch on the skin to direct heat such as heating pads, electric blankets, heated water beds, heat or tanning lamps, intensive sunbathing, hot water bottles, prolonged hot baths, saunas and hot whirlpool spa baths. It is allowed to stay outside in the sun, but you must protect the patch with some piece of clothing during hot summer days. The Victanyl transdermal patch contains metal. The patch should be removed before MRI scan since it can overheat during an MRI scan and cause skin burns in the immediate area of the patch.

Tolerance, physical or psychological dependence may develop if you use Victanyl for a longer period. However, this is rarely seen during treatment of pain due to cancer.

If you are an elderly patient or if you are in a very bad physical condition (cachectic) your doctor will monitor you more carefully, because it may be necessary to prescribe a lower dose.

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

Children and adolescents

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

To guard against accidental ingestion by children, caution should be used when choosing the application site for Victanyl transdermal patch (see section 3. "How to use Victanyl") and the adhesion of the patch should be monitored closely.

Other medicines and Victanyl

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

Please tell your doctor if you use barbiturates (used for treating sleep disorders), buprenorphine, nalbuphine or pentazocine (other strong painkillers). It is not recommended to use those together with Victanyl.

Please tell your doctor if you are taking MAO inhibitors (e.g. moclobemide against depression or selegiline against Parkinson's disease) or have taken them within the last 14 days. If these medicines are taken together this may enhance their toxicity.

The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics. Victanyl may interact with these medicines and you may experience mental status changes (e.g. agitation, hallucinations, coma), and other effects such as body temperature above 38°C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g nausea, vomiting, diarrhoea). Your doctor will tell you whether Victanyl is suitable for you.

If you take concomitantly medicines that affect brain function it is more likely that you'll have side effects especially difficulty in breathing. This applies, for example, to:

•    medicines used for treating anxiety (tranquillisers)

•    medicines used for treating psychological disorders (neuroleptics)

•    anaesthetics, if you think you are going to have an anaesthetic, tell the doctor or dentist that you are using Victanyl

•    medicines used for treating sleep disorders (hypnotics, sedatives)

•    medicines used for treating allergies or travel sickness (antihistamines/ antiemetics)

•    other strong-acting painkillers (opioids)

•    some medicines for back pain or other painful musculoskeletal conditions (skeletal muscle relaxants)

•    alcohol

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

•    ritonavir (used to treat AIDS)

•    ketoconazole, itraconazole (used to treat fungal diseases)

•    diltiazem (used to treat heart disease)

•    cimetidine (used to treat gastrointestinal diseases)

•    macrolide antibiotics (used to treat infections)

Victanyl with alcohol

Simultaneous use of Victanyl and alcoholic beverages increases the risk of severe adverse reactions, and may cause breathing difficulties, a fall of blood pressure, profound sedation and coma. During the treatment with Victanyl do not drink alcoholic beverages

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

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

Driving and using machines

Victanyl has major influence on the ability to drive and use machines. This has to be expected especially at the beginning of treatment, at any change of dosage as well as in connection with alcohol or tranquilizers. If you have been using the same dose of Victanyl for a longer period of time, your doctor may decide that you are permitted to drive and use dangerous machines. Do not drive or operate dangerous machines while using Victanyl unless your doctor has told you that such is permitted.

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.

^ How to use Victanyl

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

Your doctor will decide which strength of Victanyl is most suitable for you.

Your doctor will base his judgement on: the severity of your pain, your general condition and the type of pain treatment that you have received so far. According to your reaction the strength of the patch or the number of patches may need to be adjusted. The effect is reached within 24 hours after the first patch has been applied and its effects fall gradually after the patch is removed. Do not discontinue treatment without consulting your doctor.

Your first patch will start to work slowly, this may take as long as one day, so your doctor may give you extra painkillers until your fentanyl transdermal patch starts working completely. After this, the Victanyl should help to relieve pain continuously and you should be able to stop taking these extra painkillers. However sometimes you may still need extra painkillers.

Use in children and adolescents

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

How to apply Victanyl

•    Find a flat part of your upper body (trunk) or upper arm, where the skin is without hair, cuts, spots or other skin blemishes. The body part must not have been irradiated in connection with radiation therapy.

•    If the skin is hairy, then cut the hair with scissors. Do not shave, as shaving irritates the skin. If the skin needs washing, wash with water. Do not use soap, oil, lotions, alcohol or other cleansers that may irritate the skin. The skin must be completely dry before applying the patch.

•    Patches should be inspected prior to use. Patches that are cut, divided, or damaged in any way should not be used.

•    The Victanyl patch should be removed from the protective pouch by first folding the notch (located close to the tip of the arrow on the pouch label) and then carefully tearing the pouch material. If scissors are used to open the pouch, this should be done close to the sealed edge so as not to damage the patch inside.

•    The patch must be stuck on immediately after opening the package. When the release liner has been removed, the patch is applied by pressing it firmly onto the skin with the palm of the hand for approximately 30 seconds to make sure that the patch sticks well to the skin. Pay special attention to see that the patch sticks properly at the edges.

•    A Victanyl transdermal patch is used for 72 hours (3 days). On the outer package you can write the date and time you applied the patch. This may help you remember when to change your patch.

•    The patch application site should not be exposed to heat from external heat sources (see "Take special care with Victanyl").

•    As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.

•    In children, the upper back is the preferred location to apply the patch, to minimize the potential of the child removing the patch.

How to change the transdermal patch

•    Remove the patch after the period your doctor has told you. In most cases this is after 72 hours (3 days), in some patients after 48 hours (2 days). Usually the patch does not come off by itself. If traces of the transdermal patch remain on the skin after its removal, these can be cleaned off using copious amounts of soap and water.

•    Fold the used patch in half so that the sticky edges adhere to each other. Put back used patches in the outer package and hand in to your pharmacist.

•    Apply a new patch as described above but on another part of the skin. At least 7 days should elapse before the same part is used again.

If you use more Victanyl than you should

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

The most common sign of overdose is reduced ability to breathe. Symptoms are that the person breathes abnormally slowly or weakly. If this should occur - remove the patches and contact a doctor immediately. While waiting for the doctor, keep the person awake by talking to or shaking her/him now and then.

Other signs and symptoms of overdose are drowsiness, low body temperature, slow heart rate, decreased muscle tone, low blood pressure, deep sedation, loss of muscle co-ordination, constriction of the pupils and convulsions.

If you forget to use Victanyl

Do not under any circumstances use a double dose to make up for a forgotten dose.

You should change your patch at the same time of day every three days (every 72 hours), unless directed otherwise by your doctor. If you forget, then change your patch as soon as you remember. If you are very late changing your patch then you should contact your doctor because you might need some extra painkillers.

If you stop using Victanyl

If you wish to interrupt or stop the treatment, you should always talk to your doctor about the reasons for discontinuation and your continued treatment.

Prolonged use of Victanyl can cause physical dependence. If you do stop using the patches you may feel unwell.

As the risk of withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety and muscular tremor) is greater when the treatment is stopped suddenly, you should never stop treatment with Victanyl independently but always consult your doctor first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects

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

The assessment of side effects is based on the following frequency data:

Very common more than 1 in 10patients Common less than 1 in 10, but more than 1 in 100patients Uncommon less than 1 in 100, but more than 1 in 1000patients Rare less than 1 in 1000, but more than 1 in 10,000 patients Very rare less than 1 in 10,000 patients, including isolated reports

If any of the following serious, very rare side effects occur you should discontinue treatment and immediately contact your doctor or visit a hospital: severe respiratory depression (severe breathlessness, rattling breath) or complete block of the digestion channel (convulsive pain, vomiting, flatulence).

If you experience a serious side effect, your doctor may decide to monitor you for 24 hours since fentanyl can still affect the body for some time after the removal of the patch.

Other side effects

Very common: Somnolence, headache, dizziness, nausea, vomiting, constipation.

Common:    Pink eye, loss of appetite, sedation, difficulty in sleeping, depression,

generalised fear, confusional state, hallucinations, nervousness, involuntary shakiness, pins and needles, dizziness at height, unpleasant sensations of irregular and/or forceful beating of the heart, high blood pressure, difficulties in breathing, diarrhoea, dry mouth, reduced or absent saliva flow, stomach pain, indigestion, excessive sweating, skin reaction on the application site, itching, rash, skin reddening (erythema) muscle spasms, difficulty passing water (urine), feeling unusually drowsy or tired (depressant effect on brain function), loss of physical strength, general discomfort (malaise), aaag9788    feeling cold.

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

Rare:    Constriction of the pupil of the eye, irregular heartbeat, dilated blood

vessels, respiratory arrest (apnoea), too shallow or too slow breathing, which does not meet the needs of the body (hypoventilation), hiccup, block of the digestion channel.

Very rare:    Generalised acute allergic reactions with a fall in the blood pressure

and/or difficulty in breathing (anaphylaxis/anaphylactic reactions), delusional ideas, states of excitement, confusion, poor vision, painful bloating, passing water less than normal (reduced urine excretion), urinary bladder pain.

The following side effects may also occur but it is not known how frequently; Anaphylactic shock/reaction, slow breathing.

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

Physical dependence may develop as well and you might experience withdrawal symptoms, if you do suddenly stop using the patches. Withdrawal symptoms may be nausea, vomiting, diarrhoea, anxiety and shivering.

Additional side effects in children and adolescents

Children and adolescents treated with fentanyl transdermal patch experience side effects similar to the side effects observed in adults.

There is no specific risk for children and adolescent, when used as directed.

Very common side effects in children observed in clinical trials were fever, vomiting and nausea.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

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: 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 unused and used Victanyl patches out of children's reach.

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

Do not store above 30°C.

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.

^ Contents 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:

Adhesive layer: Polyacrylate adhesive layer Backing film: Polypropylene foil, blue printing ink Release liner: Polyethylene terephthalate foil (siliconised)

What Victanyl looks like and contents of the pack

Victanyl is a transparent, transdermal patch with a sticky back so that it can be stuck onto the skin. The transdermal patches are equipped with a blue imprint with the strength.

Victanyl is available in packs of 3, 4, 5, 8, 10, 16 or 20 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf Reykjavikurvegur 76-78 IS-220 Hafnarfjordur Iceland

Manufacturer

Actavis Group PTC ehf Reykjavikurvegur 76-78 IS-220 Hafnarfjordur Iceland

This leaflet was last revised in: November 2015

^actavis

Actavis, Barnstaple, EX32 8NS, UK