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Victanyl hourTransdermal Patch (Fentanyl)

Victanyl 25 micrograms/hour Transdermal Patch

Victanyl 50 micrograms/hour Transdermal Patch

Victanyl 75 micrograms/hour Transdermal Patch

Victanyl 100 micrograms/hourTransdermal Patch

Fentanyl

1.   WHAT VICTANYL IS AND WHAT IT IS USED FOR

Fentanyl 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.

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

2.   BEFORE YOU USE VICTANYL

Do not use Victanyl

•     if you are hypersensitive (allergic) to Fentanyl or any of the other ingredients of the product.

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

•     if your central nervous system is severely impaired, for instance by brain injury.

Take special care with Victanyl

WARNING:

Victanyl is a medicinal product that could be life-threatening to children.

This is also the case with used transdermal patches.

Due to the dosage strength of this product, use in children is not recommended.

Bear in mind that the design of this medicinal product could be tempting to a child.

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

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 Fentanyl.

•     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)

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 electric blankets, hot-water bottles, sauna, solarium or hot 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.

Tolerance, physical or psychological dependence may develop if you useVictanylfora 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

Victanyl should not be administered to children under 12 years of age because there is limited experience of use in children. An exception can be made if the doctor has expressly prescribed Victanyl.

Using 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.

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 depression (antidepressants) 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)

•     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)

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.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

  • Using Victanyl with food and drink

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.

  • 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.

Fentanyl-ALT

3.   HOW TO USE VICTANYL

Always use Victanyl exactly as your doctor has told you. You should 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 Victanyl 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.

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.

•     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.

•     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.

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 is greater when the treatment is stopped suddenly, you should never stop treatment with Victanyl independently but always consult your doctor first.

FentanylPatch100mg

4.  POSSIBLE SIDE EFFECTS

Like all medicines, Victanyl 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 10,000patients
Very rare less than 1 in 10,000 patients, including isolated reports

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

Other side effects

Very common: Somnolence, headache, dizziness, nausea, vomiting, constipation, sweating, itching.Itching will usually disappear within one day after the patch has been removed.
Common: Feeling unusually drowsy or tired (depressant effect on brain function), nervousness, loss of appetite, dry mouth, stomach pain, skin reactions at the attachment site.
Uncommon: Unnatural feeling of happiness, memory loss, difficulties in sleeping, hallucinations, agitation, tremor, sensitivity disturbances, speech disorders, fall or rise in the blood pressure and heart rate, difficulties in breathing, diarrhoea, difficulty in passing urine, skin rash, skin reddening (erythema).Skin rash and skin reddening will usually disappear within one day after the patch has been removed.
Rare: Irregular heartbeat, dilated blood vessels, hiccup, water retention in the tissues, feeling cold.
Very rare: Generalised acute allergic reactions with a fall in the blood pressure and/or difficulty in breathing (anaphylactic reactions), delusional ideas, states of excitement, loss of physical strength, depression, anxiety, confusion, sexual dysfunction, withdrawal symptoms, coordination disturbances, seizures (including clonic and grand mal seizures), diminished visual acuity, impaired respiration (respiratory depression), respiratory arrest (apnoea), painful bloating, block of the digestion channel, urinary bladder pain, passing water less than normal (reduced urine excretion).

If you have been using Victanyl for sometime, 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.

5.   HOW TO STORE VICTANYL

Keep out of the reach and sight of children, even after use. High quantities of the drug remain in the transdermal patches even after use.

Do not use Victanyl 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 25 °C.

Special precautions for disposal

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.

Fentanyl2ml

6.   FURTHER INFORMATION

Victanyl 25 micrograms/hour Transdermal Patch

What Victanyl 25 micrograms/hourTransdermal 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/hourTransdermal Patch

What Victanyl 50 micrograms/hourTransdermal 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/hourTransdermal Patch

What Victanyl 75 micrograms/hourTransdermal 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/hourTransdermal Patch

What Victanyl 100 micrograms/hourTransdermal 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.

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