Tilofyl patches (fentanyl)

How does it work?

Tilofyl patches contain the active ingredient fentanyl, which is a type of medicine called an opioid analgesic (painkiller). (NB. Fentanyl patches are also available without a brand name, ie as the generic medicine.)

The opioids are a group of very strong painkillers that are related to morphine. They work by mimicking the action of naturally occurring pain-reducing chemicals called endorphins. Endorphins are found in the brain and spinal cord and reduce pain by combining with opioid receptors.

Fentanyl mimicks the action of natural endorphins by combining with the opioid receptors in the brain and spinal cord. This blocks the transmission of pain signals sent by the nerves to the brain. Therefore, even though the cause of the pain may remain, less pain is actually felt.

Tilofyl skin patches are used to treat relieve long-term, ongoing severe pain caused by conditions such as cancer, when other painkillers do not provide sufficient pain relief.

The patch is applied to the skin of the torso or upper arm and worn continuously for 72 hours before being replaced. The fentanyl is steadily absorbed from the patch through the skin into the bloodstream, to provide continuous relief from pain.

Some people may also require extra doses of a short-acting painkiller from time to time for 'breakthrough' pain.

What is it used for?

Long-term, ongoing severe pain due to cancer

Long-term, ongoing severe pain not relieved by ordinary painkillers.

Warning!

It is important that you carefully follow the instructions you have been given with this medicine.

Tilofyl patches should be applied to a clean, dry, non-hairy, non-irritated, non-irradiated area of skin on the torso or upper arm. If you need to clean the skin before sticking on the patch use only water, not soap or other cleansers. Don't stick the patch on straight after a hot bath or shower, wait for the skin to cool down first, and don't use talc, creams or moisturisers before applying the patch as they may prevent it sticking.

Each patch should be worn for 72 hours and then removed. New patches should be applied to a different place on the torso or upper arm, and you should avoid using the same area for at least seven days. If a patch falls off before it needs changing, stick a new one on straight away, and remember this replacement will need changing after 72 hours.

Removed patches should be folded in half, sticky side innermost, and placed inside the open sachet or a piece of tin foil, for careful disposal away from children or animals. This is because used patches may still contain some active ingredient that may be harmful to children or animals.

The patches should not be divided, cut or damaged in any way.

While you are wearing the patch you should avoid exposing it to external heat sources, such as hot water bottles, electric blankets, heat lamps, saunas or hot whirlpool spa baths, as heat can increase the absorption of the fentanyl into the body, resulting in a greater risk of side effects. However, you can shower, bath or swim while wearing the patch. If you get a fever (high temperature) while wearing a patch you should let your doctor know, as this could also increase the absorption of the fentanyl into your body.

This medicine may cause drowsiness and various other side effects that could impair your mental or physical ability to safely drive or operate machinary. You should be aware of how you react to this medicine before driving or operating machinary.

Alcohol should be avoided while using this medicine, as it may increase the risk of drowsiness.

If this medicine is used for prolonged periods of time, the body can become tolerant to it and it may become less effective at relieving pain. This means that with time, higher doses may be needed to control pain. With prolonged use the body may also become dependent on the medicine. As a result, withdrawal symptoms can occur if the medicine is stopped suddenly. For this reason, when a person no longer needs this medicine it may be necessary to reduce treatment gradually to avoid withdrawal symptoms.

Use with caution in

Elderly people

Weak or debilitated people

Decreased kidney function

Decreased liver function

Lung disease such as asthma or chronic obstructive pulmonary disease

Slow, shallow breathing (respiratory depression)

Brain tumour

Increased pressure in the brain (raised intracranial pressure)

Impaired conciousness

Unresponsive unconscious states (comatose states)

Slow abnormal heart rhythms (bradyarrhythmias)

Low blood pressure (hypotension)

Fever (pyrexia).

Not to be used in

Acute (short-term) pain

Breastfeeding.

This medicine is not recommended for children.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine for use during pregnancy has not been established. It should not be used during pregnancy, particularly during the third trimester, unless considered essential by your doctor. Seek medical advice from your doctor.

Significant amounts of this medicine may pass into breast milk and could cause drowsiness and breathing problems in a nursing infant. It should not be used by breastfeeding mothers. Mothers who need to use this medicine should not breastfeed while using the patches, or for 72 hours after the last patch is removed. Seek further medical advice from your doctor.

Label warnings

This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.

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