Durogesic

The size of the Durogesic leaflet made it unsuitable for photographic reproduction. The information it contains is reproduced below.

What you need to know about your Durogesic patch

Why should I read this leaflet?

This leaflet is important. Please read it carefully before you start using your Durogesic patch. It may be helpful to ask your partner or helper to read this leaflet as well. This leaflet explains how to use your Durogesic patches properly, and also answers some common questions about Durogesic. If you have any further questions please ask your doctor, nurse or pharmacist.

Do not use for any other purpose than the one prescribed. Remember that only a doctor can prescribe this medicine for you. Durogesic is not for children. You must not give it to someone else.

What is the name of this product and its ingredients?

The name of this product is Durogesic.

The medicine inside your Durogesic patch is fentanyl. Durogesic patches come in four different strengths:

  1. The Durogesic 25 patch contains 2.5 mg of fentanyl and gives a dose of 25 micrograms of fentanyl every hour.
  2. The Durogesic 50 patch contains 5 mg of fentanyl and gives a dose of 50 micrograms of fentanyl every hour.
  3. The Durogesic 75 patch contains 7.5 mg of fentanyl and gives a dose of 75 micrograms of fentanyl every hour.
  4. The Durogesic 100 patch contains 10 mg of fentanyl and gives a dose of 100 micrograms of fentanyl every hour.

The other ingredients in Durogesic patches are not medicines. They are ethanol, hydroxyethylcellulose and purified water. The patch does not contain preservatives or artificial colours. The patch is made from clear plastic. It is stuck to your body with its own silicone medical adhesive.

What is Durogesic?

Durogesic is an oblong shaped transparent patch with a sticky back so that it can be stuck onto the skin. The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body. A patch should be used only once. Each patch lasts for three days.

Durogesic patches usually come in cartons containing 5 patches, but your doctor will have prescribed the number and strength of patches which is best for you.

What kind of medicine is the Durogesic patch?

Durogesic patches contain fentanyl. Fentanyl is one of a group of strong painkillers called opioids, which must be used only under a doctor's instruction.

Name and address of the product licence holder and manufacturer

The product licence is held by: Janssen-Cilag Ltd, Saunderton, High Wycombe, Buckinghamshire, HP14 4HJ .

It is manufactured for Janssen-Cilag Ltd by: Alza Corporation, Vacaville, California, USA.

What do Durogesic patches do?

Durogesic patches help relieve very bad and long-lasting pain. They do this by slowly letting the painkiller, fentanyl, pass from the patch, through the skin and into the body.

Who cannot use Durogesic patches?

Have you ever been told you are allergic to Durogesic patches or fentanyl? If so then do not use Durogesic patches without first checking with your doctor.

Durogesic patches are only suitable for long-lasting pain and are not suitable for pain which lasts only for a short period.

What should I know before using Durogesic patches?

If any of the following apply to you then please tell your doctor before using Durogesic patches because your doctor might need to check you more closely:

  • problems with your lungs or breathing.
  • problems with your heart, liver or kidneys.
  • headaches or head injury.

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

If you develop fever while wearing Durogesic patches tell your doctor since this may affect the way the drug passes through the skin.

Like some other strong painkillers, Durogesic patches may make some people unusually drowsy, and breathe more slowly or weakly than expected. If you, or your partner or helper, notice that you are breathing much more slowly or weakly than expected then take the Durogesic patch off immediately. Call a doctor straight away. While waiting for the doctor you must keep moving and talking as much as possible.

Can Durogesic patches be used during pregnancy?

You must talk to your doctor before using Durogesic patches if you are pregnant, or are planning to get pregnant.

Can Durogesic patches be used when breast feeding?

No. The medicine in Durogesic patches can get into breast milk.

Can I drive or use machines while using Durogesic patches?

Durogesic patches can make some people drowsy, so do not drive or use machines if you are affected since this will be dangerous.

Can I take other medicines if I am using Durogesic patches?

Always tell your doctor if you have recently taken, or are still taking, any other medicines. You should also tell your pharmacist you are using Durogesic patches if you buy any medicines from your pharmacy.

There are some medicines that we know can affect the way Durogesic patches work. These medicines include some other painkillers, sleeping pills, tranquillizers, muscle relaxants and some antihistamines. Your doctor will know which medicines are safe to take with Durogesic.

If you think you are going to have an anaesthetic, tell the doctor or dentist that you are using Durogesic patches .

Can I drink alcohol while using Durogesic patches?

Durogesic patches can make some people drowsy, so avoid drinking alcohol without consulting your doctor, because it might make you feel more drowsy than usual.

Using the Durogesic patches

Follow your doctor's instructions carefully.

When to use the patch?

There is enough painkiller (fentanyl) in each patch to last three days. So, unless your doctor has told you differently, you should change your patch at the same time of day every third day. If you are using more than one patch you should change all your patches on the same day.

This calendar will help you remember to change your patch every three days.

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The patch should be stuck onto flat skin on your upper body or upper arm. The skin should not have any

than expected then take the Durogesic patch off immediately. Call a doctor straight away. While waiting for the doctor, keep moving and talking as much as possible.

Occasionally Durogesic patches can also cause the following:

  • sickness or feeling sick - drowsiness
  • hallucinations - skin rashes
  • dizziness
  • confusion
  • feeling 'high' or unusually care-free - difficulty going to the toilet

If any of these effects are particularly troublesome or if you have any other side effects tell your doctor.

You may sometimes notice redness or slight itching of the skin caused by 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, then tell your doctor.

What can I do while wearing Durogesic patches?

Durogesic patches are waterproof. You can shower or bath while wearing a Durogesic patch, but do not scrub the patch itself. You can also swim while wearing your Durogesic patch, but do not wear your patch under a tight or elasticated band.

You should avoid exposing the Durogesic patch area to direct heat, e.g. heating pads, hot-water bottles, electric blankets, heat lamps, saunas or hot spa baths as this may affect the way the drug is released from the patch.

Cover your Durogesic patch with clothing if you sunbathe or use a sunbed.

Make sure that your Durogesic patch does not get rubbed off and stick to your partner, especially while you are in bed.

If you want to, and your doctor agrees, you can exercise or play sport while wearing your Durogesic patch .

How long should I keep my Durogesic patches?

Once the pouch is opened the patch must be used straight away. Do not use Durogesic patches after the expiry date on the pouch. If they are out of date then take them to your pharmacy. If your doctor has told you that you no longer need to use Durogesic patches then you must take any unused patches to your pharmacy.

Where should I keep Durogesic patches?

Like all medicines, you should always keep used and unused Durogesic patches safely out of the reach of children and animals. Keep Durogesic patches dry and at room temperature (below 25°C). Do not keep your patches in the bathroom or where they might get too hot, damp or wet.

What if the patch leaks?

Durogesic patches are sealed and should not leak. If the patch does leak onto your skin wash it off straight away with lots of water. Do not use soap or other cleansers. Fold the leaking patch gently in half so that the sticky side sticks to itself. Then put this patch back into its pouch or a plastic bag. You should then stick a new patch on as shown in this leaflet. Please take the leaking patch to your pharmacist.

What do I do with my used Durogesic patches?

Always keep used patches safely out of the reach of children and animals.

As soon as you take a patch off fold it firmly in half so that the sticky side sticks to itself and put it back into its original pouch. Now put the pouch in the bin you use for your household rubbish. Even used patches contain some active medicine which may harm children or animals. So make sure your used patches are always kept well away from children or animals.

This information leaflet was revised in November 1995.