DUROGESIC DTRANS 12 MCG/HR TRANSDERMAL PATCH - patient leaflet, side effects, dosage

Patient leaflet - DUROGESIC DTRANS 12 MCG/HR TRANSDERMAL PATCH

Durogesic®

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

Durogesic and DTrans are registered trademarks

=1= Durogesic® DTrans’

GB – AW_173981

Important things you need to know about Durogesic DTrans transdermal patches

These patches contain a strong pain killer
Ensure that old patches are removed before applying a new one
Patches must not be cut
Do not expose the patches to a heat source (such as a hot water bottle)
If you develop a fever tell your doctor immediately
Follow the dosage instructions carefully and only change your patch every 3 days (72 hours)
If your breathing becomes shallow and weak take the patch off and seek medical help

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again
If you have any further questions, ask your doctor, pharmacist or nurse
This medicine has been prescribed for you (or your child) only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
If you get side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Durogesic DTrans is and what it is used for

What you need to know before you use Durogesic DTrans

How to use Durogesic DTrans

Possible side effects

How to store Durogesic DTrans

Contents of the pack and other information

What Durogesic DTrans is and what it is used for

The name of your medicine is Durogesic DTrans

The patches help relieve pain that is very bad and long-lasting:

in adults who need continuous pain treatment
in children above 2 years of age who are already using opioid medication and who need continuous pain treatment.

Durogesic DTrans contains a medicine called fentanyl.

It belongs to a group of strong painkillers called opioids.

What you need to know before you use Durogesic DTrans

Do not use Durogesic DTrans if:

You are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6)
You have pain which lasts only for a short period, such as sudden pain or pain after having an operation
You have breathing difficulties, with slow or shallow breathing

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.

Warnings and precautions

Durogesic DTrans can have life-threatening side effects in people who are not already regularly using prescribed opioid medicines.
Durogesic DTrans is a medicine that could be life-threatening to children, even if the patches have been used. Bear in mind that a sticky patch (unused or used) could be tempting to a child and if it sticks to a child’s skin or they put it in their mouth, the result may be fatal.

Patch sticking to another person

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.

Take special care with Durogesic DTrans 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:

You have ever had problems with your lungs or breathing
You have ever had problems with your heart, liver, kidneys, or low blood pressure
You have ever had a brain tumour
You have ever had persistent headaches or a head injury
You are elderly – you may be more sensitive to the effects of this medicine.
You have a condition called ‘myasthenia gravis’ in which muscles become weak and tire easily.
You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
You are a smoker.
You have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illness.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Durogesic DTrans.

Side effects and Durogesic DTrans

Durogesic DTrans may make you unusually drowsy, and make your breathing more slow or shallow. Very rarely these breathing problems can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers (like Durogesic DTrans or morphine) before. If you, or your partner or carer, notice that the person wearing the patch is unusually drowsy, with slow or shallow breathing: – Take the patch off
– Call a doctor, or go to your nearest hospital straight away
– Keep the person moving and talking as much as possible

If you get a fever while using Durogesic DTrans, tell your doctor – this may increase the amount of medicine that passes through your skin
Durogesic DTrans may cause constipation, talk to your doctor or pharmacist for advice on how to prevent or relieve constipation.
Repeated, long-term use of the patches may make the medicine less effective (you get used to it or you may become more sensitive to pain), or you may become dependent on it. 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 DTrans. Also if you have concern that you may become dependent, you can consult your doctor on this.

See section 4 for a full list of possible side effects.

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.

Other medicines and Durogesic DTrans

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:

Other medicines for pain, such as other opioid painkillers (such as buprenorphine, nalbuphine, or pentazocine).
Medicines for helping you sleep (such as temazepam, zaleplon, or zolpidem).
Medicines to help you calm down (tranquillisers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental conditions (anti-psychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
Medicines for relaxing your muscles (such as cyclobenzaprine or diazepam).
Some medicines used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). – see below for more information
Some medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You should not take Durogesic DTrans within 14 days of stopping these medicines. – see below for more information
Some antihistamines, especially ones that make you sleepy (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
Some antibiotics used to treat infection (such as erythromycin or clarithromycin).
Medicines used to treat fungal infection (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
Medicines used to treat HIV infection (such as ritonavir).
Medicines used to treat an irregular heart beat (such as amiodarone, diltiazem, or verapamil).
Medicines to treat tuberculosis (such as rifampicin).
Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
Some medicines used to treat nausea or motion sickness (such as phenothiazines).
Some medicines used to treat heartburn or ulcers (such as cimetidine).
Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
Some medicines used to treat cancer of the blood (such as idelalisib).

Durogesic DTrans with antidepressants

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.

Use with central nervous system depressants, including alcohol and some narcotic drugs

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.

Operations

If you think that you are going to receive anaesthesia tell your doctor or dentist that you are using Durogesic DTrans.

Pregnancy and breastfeeding

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.

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.

Driving and using machines

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.

Do not drive while taking this medicine until you know how it affects you.
It is an offence to drive if this medicine affects your ability to drive.
However, you would not be committing an offence if: – The medicine has been prescribed to treat a medical or dental problem and
– You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
– It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

How to use Durogesic DTrans

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.

Using and changing the patches

There is enough medicine in each patch to last 3 days (72 hours).
You should change your patch every third day, unless your doctor has told you differently.
Always remove the old patch before applying a new one.
Always change your patch at the same time of day every 3 Days (72 hours).
If you are using more than one patch, change all your patches at the same time.
Make a note of the day, date and time you apply a patch, to remind you when you need to change your patch.
The following table shows you when to change your patch:

Apply your patch on Change your patch on

Monday	^	Thursday
Tuesday	^	Friday
Wednesday	^	Saturday
Thursday	^	Sunday
Friday	^	Monday
Saturday	^	Tuesday
Sunday	^	Wednesday

Where to apply the patch

Adults

Apply the patch on a flat part of your upper body or arm (not over a joint).

Children

Always apply the patch to the upper back to make it difficult for your child to reach it or take it off.
Every so often check that the patch remains stuck to the skin.
It is important that your child does not remove the patch and put it in their mouth as this could be lifethreatening or even fatal.
Watch your child very closely for 48 hours after:
– The first patch has been put on
– A higher dose patch has been put on

It may take some time for the patch to have its maximum effect. Therefore, your child might need to use other painkillers as well until the patches become effective. Your doctor will talk to you about this.

Adults and Children:

Do not apply the patch on

The same place twice in a row.
Areas that you move a lot (joints), skin that is irritated or with cuts.
Skin that is very hairy. If there is hair, do not shave it (shaving irritates the skin). Instead, clip the hair as close to the skin as possible.

Putting a patch on

Step 1: Preparing the skin

Make sure your skin is completely dry, clean and cool before you put the patch on
If you need to clean the skin, just use cold water
Do not use soap or any other cleansers, creams, moisturisers, oils or talc before applying the patch
Do not stick a patch on straight after a hot bath

or shower

Step 2: Open the sachet

Each patch is sealed in its own sachet
Tear or cut open the sachet at the notch, shown by the arrow
Gently tear or cut off the edge of the sachet completely (if you use scissors, cut close to the sealed edge of the sachet to avoid damaging the patch)
Grasp both sides of the opened sachet and pull apart
Take the patch out and use straight away
Keep the empty sachet to dispose of the used patch later
Use each patch once only
Do not take the patch out of its sachet until you are ready to use it
Inspect the patch for any damage
Do not use the patch if it has been divided, cut or looks damaged
Never divide or cut the patch

Step 3: Peel and press

Make sure that the patch will be covered by loose clothing and not stuck under a tight or elasticated band
Carefully peel one half of the shiny plastic backing away from the centre of the patch. Try not to touch the sticky side of the patch
Press this sticky part of the patch onto the skin
Remove the other part of the backing and press the whole patch onto the skin with the palm of your hand
Hold for at least 30 seconds. Make sure it sticks well, especially the edges

Step 4: Disposing of the patch

As soon as you take a patch off, fold it firmly in half so that the sticky side sticks to itself
Put it back in its original sachet and dispose of the sachet as instructed by your pharmacist
Keep used patches out of sight and reach of children – even used patches contain some medicine that may harm children and may even be fatal

Step 5: Wash

Always wash your hands after you have handled the patch using clean water only

More about using Durogesic DTrans

Everyday activities while using the patches

The patches are waterproof
You can shower or bathe while wearing a patch, but do not scrub the patch itself
If your doctor agrees, you can exercise or play sport while wearing the patch
You can also swim while wearing the patch, but:
– Don’t use hot whirlpool spa baths
– Don’t put a tight or elasticated band over the patch

While you are wearing the patch do not expose it to direct heat such as heating pads, electric blankets, hot-water bottles, heated water beds, heat or tanning lamps. Do no sunbathe, have long hot baths or saunas. If you do, you may increase the amount of medicine you get from the patch.

How quickly will the patches work?

It may take some time for your first patch to have its maximum effect.
Your doctor may give you other painkillers as well for the first day or so
After this, the patch should help to relieve pain continuously so that you can stop taking other painkillers. However, your doctor may still prescribe extra painkillers from time to time

How long will you use the patches for?

Durogesic DTrans patches are for long-term pain. Your doctor will be able to tell you how long you can expect to use the patches

If your pain gets worse

If your pain gets worse while you are using these patches, your doctor may try a higher strength patch, or give you additional painkillers (or both)
If increasing the strength of the patch does not help, your doctor may decide to stop the use of the patches

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.

If you forget to change your patch

If you forget, change your patch as soon as you remember and make note of the day and time. Change the patch again after 3 days (72 hours) as usual.
If you are very late changing your patch, you should talk to your doctor because you might need some extra painkillers, but do not apply an extra patch.

If a patch falls off

If a patch falls off before it needs changing, stick a new one on straight away and make note of the day and time. Use a new area of skin on:
– Your upper body or arm
– Your child’s upper back

Let your doctor know this has happened and leave the patch on for another 3 days (72 hours) or as directed by your doctor, before changing the new patch as usual
If your patches keep falling off, talk to your doctor, pharmacist or nurse

If you want to stop using the patches

Talk to your doctor before you stop using these patches
If you have been using them for some time your body may have got used to them. Stopping suddenly may make you feel unwell
If you stop using the patches, don’t start again without asking your doctor first. You might need a different patch strength when you restart

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you or your partner, or carer, notice any of the following about the person wearing the patch, take the patch off and call a doctor, or go to your nearest hospital, straight away. You may need urgent medical treatment.

Feeling unusually drowsy, breathing that is more slow or shallow than expected.

Follow the advice above and keep the person who was wearing the patch moving and talking as much as possible. Very rarely these breathing difficulties can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers (like Durogesic DTrans or morphine) before. (Uncommon, this may affect up to 1 in 100 people)

Sudden swelling of the face or throat, severe irritation, reddening or blistering of your skin.

These may be signs of a severe allergic reaction. (frequency cannot be estimated from the available data)
Fits (seizures). (Uncommon, this may affect up to 1 in 100 people.)
Reduced consciousness or loss of consciousness.

(Uncommon, these may affect up to 1 in 100 people)

The following side effects have also been reported

Very common (may affect more than 1 in 10 people)

Nausea, vomiting, constipation
Feeling sleepy (somnolence)
Feeling dizzy
Headache

Common (may affect up to 1 in 10 people)

Allergic reaction
Loss of appetite
Difficulty sleeping
Depression
Feeling anxious or confused
Seeing, feeling, hearing, or smelling things that are not there (hallucinations)
Muscle tremors or spasms
Unusual feeling in the skin, such as tingling or crawling feelings (paraesthesia)
Spinning sensation (vertigo)
Heart beat feels fast or uneven (palpitations, tachycardia)
High blood pressure
Being short of breath (dyspnoea)
Diarrhoea
Dry mouth
Stomach pain or indigestion
Excessive sweating
Itching, skin rash or redness of the skin
Being unable to pass urine or empty bladder completely
Feeling very tired, weak or generally unwell
Feeling cold
Swollen hands, ankles or feet (peripheral oedema)

Uncommon (may affect up to 1 in 100 people)

Feeling agitated or disoriented
Feeling extremely happy (euphoria)
Decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
Loss of memory
Blurred vision
Slow heart beat (bradycardia) or low blood pressure
Blue colour to the skin caused by low oxygen in the blood (cyanosis)
Loss of contractions of the gut (ileus)
Itchy skin rash (eczema), allergic reaction or other skin disorders where the patch is placed
Flu-like illness
Feeling of body temperature change
Fever
Muscle twitching
Difficulty getting and keeping an erection (impotence) or problems having sex

Rare side effects (may affect up to 1 in 1,000 people)

Constricted pupils (miosis)
Stopping breathing from time to time (apnoea)

The following side effects have also been reported, but their exact frequency is unknown:

Lack of male sex hormones (androgen deficiency).
Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not really there, sleep disturbance, nightmares).

5 how to store durogesic dtrans

Where you should keep the patches

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.

How long to keep Durogesic DTrans for 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.

How to dispose of used patches or patches you no longer use

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.

6 contents of the pack and other information

What Durogesic DTrans contains

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.

Other ingredients in the patch are:

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.

What Durogesic DTrans looks like and contents of the pack

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 |J.g 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 |J.g 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 |J.g 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 |J.g 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 |J.g fentanyl/h” in grey printing ink.

The patches come in individually wrapped heat-sealed (acrylonitrile film) pouches, and come in cartons containing 3, 4, 5, 8, 10, 16, 20 or 30 patches.

Not all pack sizes may be marketed.

Marketing Authorization Holder Manufacturer

JANSSEN-CILAG LTD, 50–100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG, UK

Manufacturer:

Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovenia, Sweden	Durogesic
Germany	Durogesic SMAT
Ireland, United Kingdom	Durogesic DTrans
Spain	Durogesic Matrix

For information in large print, tape, CD or Braille, telephone 0800 7318450.

This leaflet was last revised in August 2020.