DUROGESIC DTRANS 50 MICROGRAMS / HR TRANSDERMAL PATCH - patient leaflet, side effects, dosage

Patient leaflet - DUROGESIC DTRANS 50 MICROGRAMS / HR TRANSDERMAL PATCH

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

1. 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.

2. 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.
Store this medicine in a safe and secure place, where other people cannot access it – see section 5 for more information.

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.

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:

breathing pauses during sleep
night awakening due to shortness of breath
difficulties staying asleep
excessive drowsiness during the day.

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:

your pain is no longer relieved by the patch
an increase in pain
there is a change in how you feel the pain (for example, you feel pain in another part of your body)
pain when something touches your body that you wouldn’t expect to hurt you.

Do not change the dose yourself. Your doctor may decide to change your dose or treatment.

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.

Withdrawal symptoms when stopping Durogesic DTrans

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.

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, 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, vomiting 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 lifethreatening. 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.

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 lifethreatening 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 breast-feeding. You should not breastfeed for 3 days after removing your Durogesic DTrans patch. This is because this 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.

3. 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:

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 life threatening 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 which 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 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

Do not suddenly stop taking this medicine. 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. See also section 2 ‘Withdrawal symptoms when stopping Durogesic DTrans’.
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.

4. 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 package 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.

How long to keep Durogesic DTrans for

Do not use Durogesic DTrans after the expiry date which is stated on the carton and pouch. 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.

If the patches become discoloured or show any signs of deterioration, consult your pharmacist who will tell you what to do.

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

The active substance in Durogesic DTrans is fentanyl.

The patches come in 5 different strengths

Each 12 micrograms/hr transdermal patch contains 2.1 milligrams of fentanyl.

(absorption rate approximately 12 micrograms/hour; active surface area 5.25 cm2).

Each 25 micrograms /hr transdermal patch contains 4.2 milligrams of fentanyl.

(absorption rate approximately 25 micrograms/hour; active surface area 10.5 cm2).

Each 50 micrograms /hr transdermal patch contains 8.4 milligrams of fentanyl.

(absorption rate approximately 50 micrograms/hour; active surface area 21 cm2).

Each 75 micrograms /hr transdermal patch contains 12.6 milligrams of fentanyl.

(absorption rate approximately 75 micrograms/hour; active surface area 31.5 cm2).

Each 100 micrograms /hr transdermal patch contains 16.8 milligrams of fentanyl.

(absorption rate approximately 100 micrograms/hour; active surface area 42 cm2).

The other ingredients in the patch are: copolymer of polyethylene terephthalate and ethylene vinyl acetate, siliconized polyethylene terephthalate, polyacrylate Duro-Tak 87–4287.

Each patch is identified using a different colour of printing ink: Durogesic DTrans 12 micrograms/hr transdermal patch: Orange Durogesic DTrans 25 micrograms/hr transdermal patch: Red Durogesic DTrans 50 micrograms/hr transdermal patch: Green Durogesic DTrans 75 micrograms/hr transdermal patch: Blue Durogesic DTrans 100 micrograms/hr transdermal patch: Grey

What Durogesic DTrans look like and contents of the pack

Durogesic DTrans are:

Rectangular shaped, translucent, transdermal patches with rounded corners, marked with the product name, strength and a border in coloured ink. The patch has a sticky back so that it can be stuck onto the skin.

Each patch is marked

Durogesic 12 pg fentanyl/h with orange printing ink, or

Durogesic 25 pg fentanyl/h with red printing ink, or

Durogesic 50 pg fentanyl/h with green printing ink, or

Durogesic 75 pg fentanyl/h with blue printing ink, or

Durogesic 100 pg fentanyl/h, with grey printing ink.

The patches come in individual pouches and come in cartons containing five patches.

Your doctor will have prescribed the number and strength of patches which is best for you.

Manufacturer and product licence holder

Manufactured by Janssen-Pharmaceutica NV., Turnhoutseweg 30, B-2340 Beerse, Belgium.

Procured from within the EU by product licence holder Star

Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.

Repackaged by Servipharm Ltd.

Durogesic DTrans 12 micrograms/hr Transdermal Patch -PL 20636/2327

Durogesic DTrans 25 micrograms /hr Transdermal Patch -PL 20636/2328

Durogesic DTrans 50 micrograms /hr Transdermal Patch -PL 20636/2329

Durogesic DTrans 75 micrograms /hr Transdermal Patch -PL 20636/2330

Durogesic DTrans 100 micrograms /hr Transdermal Patch -PL 20636/2331

Leaflet revision and issue date (Ref.) 02.07.21[18]

Durogesic is a trademark of Johnson and Johnson. Dtrans is trademark of Alza Corporation.

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