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The product code(s) for this leaflet is: PL 00242/0195.
Durogesic DTrans 12 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr Transdermal Patch
Durogesic® DTrans® 12 micrograms/hour transdermal patch
Durogesic® DTrans® 25 micrograms/hour transdermal patch
Durogesic® DTrans® 50 micrograms/hour transdermal patch
Durogesic® DTrans® 75 micrograms/hour transdermal patch
Durogesic® DTrans® 100 micrograms/hour transdermal patch
fentanyl
Durogesic and DTrans are registered trademarks
1. What Durogesic DTrans is and what it is used for
2. What you need to know before you use Durogesic DTrans
3. How to use Durogesic DTrans
4. Possible side effects
5. How to store Durogesic DTrans
6. Contents of the pack and other information
The name of your medicine is Durogesic DTrans
The patches help relieve pain that is very bad and long-lasting:
Durogesic DTrans contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids.
Do not use this medicine if any of the above apply to you or your child. If you are not sure, talk to your doctor or pharmacist before using Durogesic DTrans.
The patch should be used only on the skin of the person for whom it has been prescribed. There have been reports of patches accidentally sticking to a family member while in close physical contact or sharing the same bed as the person wearing the patch. A patch accidently sticking to another person (particularly a child) can cause the medicine in the patch to go through the skin of the other person and cause serious side effects such as breathing difficulties, with slow or shallow breathing which may be fatal. In case the patch sticks to the skin of another person, take the patch off right away and get medical attention.
Talk to your doctor or pharmacist before using this medicine if any of the following apply to you - your doctor may need to check you more closely if:
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Durogesic DTrans.
While using the patch, tell your doctor if you have breathing problems while sleeping. Opioids like Durogesic DTrans can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep-related hypoxaemia (low oxygen level in the blood). Tell your doctor if you, your partner or carer notice you have any of the following:
Your doctor may decide to change your dose.
While using the patch, tell your doctor if you notice a change in the pain you are feeling. If you feel:
Do not change the dose yourself. Your doctor may decide to change your dose or treatment.
See section 4 for a full list of possible side effects.
DUROGESIC, like other opioids, may affect the normal production of hormones in the body such as cortisol, prolactin, or sex hormones, particularly if you have taken DUROGESIC for long periods of time. The effects of these hormonal changes may include feeling or being sick (including vomiting), loss of appetite, tiredness, weakness, dizziness, low blood pressure, infertility, or decreased sex drive. In addition, female patients may experience changes in menstrual cycle, while male patients may experience impotence or enlarged breasts. If you notice any of these signs, speak to your doctor.
When you are wearing the patch do not expose it to direct heat such as heating pads, electric blankets, hot-water bottles, heated water beds or heat or tanning lamps. Do not sunbathe, have long hot baths or saunas or use hot whirlpool spa baths. If you do, you may increase the amount of medicine you get from the patch.
This medicine contains fentanyl which is an opioid medicine. Repeated use of opioid painkillers can result in the drug being less effective (you become accustomed to it, known as drug tolerance). You may also become more sensitive to pain while using DUROGESIC. This is known as hyperalgesia. Increasing the dose of your patches may help to further reduce your pain for a while, but it may also be harmful. If you notice that your medicine becomes less effective, talk to your doctor. Your doctor will decide whether it is better for you to increase the dose or to gradually decrease your use of DUROGESIC.
Repeated use of DUROGESIC can also lead to dependence, abuse and addiction which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use. Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to use or how often you need to use it. You might feel that you need to carry on using your medicine, even when it doesn’t help to relieve your pain.
The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent or addicted on DUROGESIC if:
If you notice any of the following signs whilst using DUROGESIC, it could be a sign that you have become dependent or addicted.
If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely.
Do not suddenly stop taking this medicine. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating may occur. If you want to stop taking this medicine, talk to your doctor first. Your doctor will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum.
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 Durogesic DTrans if you buy any medicines from your pharmacy.
Your doctor will know which medicines are safe to take with Durogesic DTrans. You may need to be closely monitored if you are taking some of the types of medicines listed below or if you stop taking some of the types of medicines listed below, as this may affect the strength of Durogesic DTrans you need.
In particular, tell your doctor or pharmacist if you are taking:
The risk of side effects increases if you are taking medicines such as certain antidepressants.
Durogesic DTrans may interact with these medicines and you may experience changes to mental status such as feeling agitated, seeing, feeling, hearing, or smelling things that are not there (hallucinations) and other effects such as changing blood pressure, fast heart beat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomitting and diarrhoea. (these could be signs of Serotonin Syndrome). If used together, your doctor may want to closely monitor you for such side effects in particular when starting treatment or when the dose of your medicine is changed.
Concomitant use of Durogesic DTrans and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe Durogesic DTrans together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Do not drink alcohol while using Durogesic DTrans unless you have talked to your doctor first.
If you are going to have an operation, or have just had an operation, please tell the doctor at the hospital if you are currently treated with Durogesic DTrans transdermal patch to discuss your pain management.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Durogesic DTrans should not be used during pregnancy unless you have discussed this with your doctor.
Durogesic DTrans should not be used during childbirth as the medication can affect the breathing of the newborn child.
Prolonged use of Durogesic DTrans during pregnancy can cause withdrawal symptoms (such as high-pitched cry, jitteriness, fits, poor feeding and diarrhoea) in your newborn baby that could be life-threatening if not recognised and treated. Talk to your doctor immediately if you think your baby may have withdrawal symptoms.
Do not use Durogesic DTrans if you are breastfeeding. You should not breastfeed for 3 days after removing your Durogesic DTrans patch. This is because the medicine may pass into breast milk.
Durogesic DTrans can affect your ability to drive and use machines or tools as it may make you sleepy or dizzy. If this happens, do not drive or use any tools or machines.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Always use this medicine 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 Durogesic DTrans is most suitable for you, taking into account the severity of your pain, your general condition and type of pain treatment that you have received so far.
Before starting treatment and regularly during treatment, your doctor will also discuss with you what you may expect from using DUROGESIC, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also section 2 ‘Withdrawal symptoms when stopping DUROGESIC’).
Apply your patch on Change your patch on
Monday Thursday
Tuesday Friday
Wednesday Saturday
Thursday Sunday
Friday Monday
Saturday Tuesday
Sunday Wednesday
Adults
Children
Adults and Children:
Do not apply the patch on
Step 1: Preparing the skin
Step 2: Open the sachet
Step 3: Peel and press
Step 4: Disposing of the patch
Step 5: Wash
Everyday activities while using the patches
How quickly will the patches work?
How long will you use the patches for?
If your pain gets worse
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 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. An overdose may also result in a brain disorder known as toxic leukoencephalopathy.
If you forget to change your patch
If a patch falls off
If you want to stop using the patches
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1 000 people)
The following side effects have also been reported, but their exact frequency is unknown:
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.
Repeated use of the patches can make the medicine become less effective (you get used to it or you may become more sensitive to pain), or you can become dependent on it.
If you switch from a different painkiller to Durogesic DTrans or if you suddenly stop using Durogesic DTrans, you may notice withdrawal effects such as sickness, feeling sick, diarrhoea, anxiety or shivering. Tell your doctor if you notice any of these effects.
There have been reports also of newborn infants experiencing withdrawal effects after their mothers have used Durogesic DTrans for a long time during pregnancy.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep all patches (used and unused) out of the sight and reach of children.
Store in the original pouch in order to protect from light. This medicine does not require any special temperature storage conditions.
Store this medicine in a safe and secure place, where other people cannot access it. It can cause serious harm and be fatal to people who may take this medicine by accident, or intentionally when it has not been prescribed for them.
Do not use Durogesic DTrans after the expiry date, which is stated on the carton and sachet. The expiry date refers to the last date of that month. If the patches are out of date, take them to your pharmacy.
If your doctor has told you that you no longer need to use the patches, take any unused patches to your pharmacy.
A used or unused patch accidentally sticking to another person, especially a child, may be fatal.
Used patches should be folded firmly in half so that the sticky side of the patch sticks to itself. Then they should be safely discarded by putting them back into the original sachet and stored out of sight and reach of other people, especially children, until safely disposed. Ask your pharmacist how to throw away medicines you no longer use.
Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.
Durogesic DTrans 12 micrograms/hour
The active substance in Durogesic DTrans is fentanyl. Each patch contains 2.1 mg of fentanyl, which delivers a dose of 12 micrograms/hour.
Durogesic DTrans 25 micrograms/hour
The active substance in Durogesic DTrans is fentanyl. Each patch contains 4.2 mg of fentanyl, which delivers a dose of 25 micrograms/hour.
Durogesic DTrans 50 micrograms/hour
The active substance in Durogesic DTrans is fentanyl. Each patch contains 8.4 mg of fentanyl, which delivers a dose of 50 micrograms/hour.
Durogesic DTrans 75 micrograms/hour
The active substance in Durogesic DTrans is fentanyl. Each patch contains 12.6 mg of fentanyl, which delivers a dose of 75 micrograms/hour.
Durogesic DTrans 100 micrograms/hour
The active substance in Durogesic DTrans is fentanyl. Each patch contains 16.8 mg of fentanyl, which delivers a dose of 100 micrograms/hour.
Backing Layer: Film, Polyester/Ethylene Vinyl Acetate Copolymer,
Protective Liner: Film, Siliconized Polyester,
Drug Layer: Polyacrylate Adhesive
Inks (on backing):
The Durogesic DTrans 12 micrograms/hour patch also contains orange printing ink.
The Durogesic DTrans 25 micrograms/hour patch also contains red printing ink.
The Durogesic DTrans 50 micrograms/hour patch also contains green printing ink.
The Durogesic DTrans 75 micrograms/hour patch also contains blue printing ink.
The Durogesic DTrans 100 micrograms/hour patch also contains grey printing ink.
Durogesic DTrans 12 micrograms/hour
Durogesic DTrans is a translucent rectangular patch with rounded corners. Each patch is 5.25 cm2, and is marked with a border and “Durogesic 12 μg fentanyl/h” in orange printing ink.
Durogesic DTrans 25 micrograms/hour
Durogesic DTrans is a translucent rectangular patch with rounded corners. Each patch is 10.5 cm2, and is marked with a border and “Durogesic 25 μg fentanyl/h” in red printing ink.
Durogesic DTrans 50 micrograms/hour
Durogesic DTrans is a translucent rectangular patch with rounded corners. Each patch is 21.0 cm2, and is marked with a border and “Durogesic 50 μg fentanyl/h” in green printing ink.
Durogesic DTrans 75 micrograms/hour
Durogesic DTrans is a translucent rectangular patch with rounded corners. Each patch is 31.5 cm2, and is marked with a border and “Durogesic 75 μg fentanyl/h” in blue printing ink.
Durogesic DTrans 100 micrograms/hour
Durogesic DTrans is a translucent rectangular patch with rounded corners. Each patch is 42.0 cm2, and is marked with a border and “Durogesic 100 μg fentanyl/h” in grey printing ink.
The patches come in individually wrapped heat-sealed (acrylonitrile film or cyclic olefin copolymer) pouches, and come in cartons containing 3, 4, 5, 8, 10, 16, 20 or 30 patches.
Not all pack sizes may be marketed.
Manufacturer:
For information in large print, tape, CD or Braille, telephone 0800 7318450.
This leaflet was last revised in January 2025.