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Opiodur 12 25 50 75 & 100 micrograms/hour transdermal patch
Opiodur®
12 micrograms/hour transdermal patch
25 micrograms/hour transdermal patch
50 micrograms/hour transdermal patch
75 micrograms/hour transdermal patch
100 micrograms/hour transdermal patch
fentanyl
This medicine contains fentanyl which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop using it suddenly.
1. What Opiodur® is and what it is used for
2. What you need to know before you use Opiodur®
3. How to use Opiodur®
4. Possible side effects
5. How to store Opiodur®
6. Contents of the pack and other information
The name of your medicine is Opiodur®.
This medicine has been prescribed for you for relieving pain that is very bad and long lasting:
It contains fentanyl which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
Fentanyl is a strong opioid and should not be used unless you have previously been prescribed other 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 Opiodur®.
Using this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.
Addiction can cause withdrawal symptoms when you stop using this medicine. Withdrawal symptoms can include 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. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine.
It is important that you do not stop using the medicine suddenly as you will be more likely to experience withdrawal symptoms.
Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
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 patch wearer. 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 immediately and seek 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 Opiodur®.
While using the patch, tell your doctor if you have breathing problems while sleeping. Opioids like Opiodur® 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.
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 Opiodur®. 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 Opiodur®.
Repeated use of Opiodur® 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 Opiodur® if:
If you notice any of the following signs whilst using Opiodur®, 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.
Tell your doctor or pharmacist if you are taking or 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 Opiodur® if you buy any medicine from your pharmacy.
Your doctor will know which medicines are safe with Opiodur®. 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 Opiodur® 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. Opiodur® 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 heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting and diarrhoea - (these could be signs of Serotonin Syndrome). If used together, your doctor may want to closely monitor your for such sides effects in particular when starting treatment or when the dose of your medicine is changed.
Concomitant use of Opiodur® 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 Opiodur® 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 Opiodur® unless you have talked to your doctor first.
If you think that you are going to receive anaesthesia tell your doctor or dentist that you are using Opiodur®.
Do not use Opiodur® if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby.
If you use Opiodur® during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not use Opiodur® while you are breastfeeding as fentanyl passes into breast milk and will affect your baby.
Opiodur® 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 tools or machines. Do not drive while taking this medicine until you know how it affects you. Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Before starting treatment and regularly during treatment, your doctor will also discuss with you what you may expect from using Opiodur®, when and how long you need to use it, when to contact your doctor, and when you need to stop it (see section 4 `If you stop using Opiodur®' below).
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 should have discussed with you, how long the course of patches will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop using the medicine.
Your doctor will decide which strength of Opiodur® is most suitable for you, taking into account the severity of your pain, your general condition and the type of pain treatment that you have received so far.
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
Always wash your hands after you have handled the patch using clean water only.
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 have stuck on too many patches or the wrong strength patch, take the patches off and contact a doctor or the nearest hospital 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 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)
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.
When you stop using Opiodur®, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.
If you notice any of the following signs whilst using Opiodur®, it could be a sign that you have become addicted.
If you notice any of these signs, it is important you talk to your doctor
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 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 Opiodur® after the expiry date, which is stated on the carton and sachet. The expiry date refers to the last day of that month.
If the patches are out of date, take them to your pharmacy.
Do not store above 25°C.
Store in the original sachet in order to protect from moisture.
A used or unused patch accidently 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 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.
Opiodur® transdermal patch is rectangular with rounded corners, printed on its backing with:
Each patch has a sticky back so that it can be stuck onto the skin. The patch is covered by two transparent oversized protective films which are both removed prior to application.
Opiodur® is available in packs of 3, 4, 5, 8, 9, 10, 16, 19 or 20 transdermal patches.
Not all pack sizes may be marketed
Marketing Authorisation Holder:
Under license by
Manufacturer:
This leaflet was last revised in March 2024
1065040982