Durogesic Dtrans 100micrograms/Hour Transdermal Patch
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APPROVED | |
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By Nafisa Potrick at |
Assessed against UK PIL dated Jan-13
Durogesic® DTrans® 100 micrograms/hour Transdermal Patch
_(fentanyl)_
PATIENT INFORMATION LEAFLET
Durogesic DTrans Patch is available in the following strengths: 12 micrograms/hour,
25 micrograms/hour, 50 micrograms/hour, 75 micrograms/hour and 100 micrograms/hour.
This leaflet only applies to the 100 micrograms/hour Durogesic DTrans Patch.
Important things you need to know about Durogesic DTrans Patch
• The Durogesic DTrans Patch contains a strong pain killer
• Ensure that old Durogesic DTrans Patch is removed before applying a new one
• Durogesic DTrans Patch must not be cut
• Do not expose the Durogesic DTrans Patch 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 Durogesic DTrans Patch every 3 days (72 hours)
• If your breathing becomes shallow and weak take the Durogesic DTrans Patch off and seek medical help
The rest of this leaflet includes more detail and other important information on the safe and effective use of this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor, nurse or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist
In this leaflet
1. What Durogesic DTrans Patch is and what it is used for
2. Before you use Durogesic DTrans Patch
3. How to use Durogesic DTrans Patch
4. Possible side effects
5. How to store Durogesic DTrans Patch
6. Further information
1. WHAT DUROGESIC DTRANS PATCH IS AND WHAT IT IS USED FOR
The name of your medicine is Durogesic DTrans 100 micrograms/hour Transdermal Patch. It is called Durogesic DTrans Patch in this leaflet.
The Durogesic DTrans Patch helps to relieve pain that is very bad and long-lasting.
Durogesic DTrans Patch contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids. The medicine passes slowly into your body through your skin.
2. BEFORE YOU USE DUROGESIC DTRANS PATCH
Durogesic DTrans Patch can be used in children aged 2 to 16 years who have previously used opioid painkillers. If the Durogesic DTrans Patch has been prescribed for your child, the 'you' stated everywhere below should be read as 'your child'.
Do not use Durogesic DTrans Patch if:
• You are allergic to fentanyl, Durogesic DTrans Patch or anything in Durogesic DTrans Patch (listed in section 6 overleaf)
• You have pain which lasts only for a short period
• Your child who is in pain is under 2 years old
• Your child has not been treated with strong painkillers such as morphine
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 Patch.
Take special care with Durogesic DTrans Patch
• Like some other strong painkillers, Durogesic DTrans Patch may make you unusually drowsy, and breathe more slowly or weakly. Very rarely these breathing difficulties can be life-threatening or even fatal in people who have not used strong morphine-related painkillers (like Durogesic DTrans Patch) or morphine before. If you, or your partner or carer, notice that you or your child are breathing much more slowly or weakly then:
• Take the patch off
• Call a doctor, or go to your nearest hospital, straight away
• Keep moving and talking as much as possible
• If you develop a fever while wearing Durogesic DTrans Patch, tell your doctor as this may affect the way the medicine passes through your skin
• Don't expose the Durogesic DTrans Patch to direct heat such as heating pads, electric blankets, hot-water bottles, heated water beds, heat or tanning lamps, intensive sun bathing, prolonged hot baths, saunas or hot whirlpool spa baths. These may affect the way the medicine is absorbed through the skin
• Check with your doctor or pharmacist before using this medicine if you have ever had:
• Problems with your lungs or breathing
• Problems with your heart or blood pressure and blood volume, liver or kidneys
• Brain tumours
• Persistent headaches or a head injury
Your doctor might need to check you more closely.
• If you are very ill, very thin or elderly, you may be more sensitive to the effects of the Durogesic DTrans Patch
• If you suffer from a condition in which muscles become weak and tire easily, known as myasthenia gravis, talk to your doctor or pharmacist before using Durogesic DTrans Patch
• Like many other strong painkillers, repeated use of the Durogesic DTrans Patch may make you become tolerant to the medicine or become dependent on it
• Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs
• Durogesic DTrans Patch may cause constipation, talk to your doctor or pharmacist for advice on how to prevent constipation.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Durogesic DTrans Patch.
Other makes of Durogesic DTrans Patch
There are other makes of fentanyl transdermal patch available, but they are not all the same. If your Durogesic DTrans Patch looks different from one you have used before you should check with your doctor or pharmacist before using it.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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 Patch if you buy any medicines from your pharmacy.
In particular, tell your doctor or pharmacist if you are taking:
• Other medicines for pain, such as other opioid painkillers (buprenorphine, nalbuphine or pentazocine)
• Medicines for helping you sleep
• Medicines to help you calm down (tranquillisers) and medicines for mental conditions
• Medicines for relaxing your muscles
• Some medicines used to treat depression (such as citalopram, duloxetine escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine)
• Some medicines used to treat depression (called MAOIs). You should not take Durogesic DTrans Patch within 14 days of stopping these medicines.
• Nefazodone a medicine used to treat depression
• Some antihistamines (especially ones that make you sleepy)
• Some antibiotics used to treat infection, such as erythromycin, clarithromycin or troleandomycin
• Medicines used to treat fungal infection, such as itraconazole, ketoconazole, fluconazole or voriconazole
• Medicines used to treat HIV infection, such as ritonavir or nelfinavir
• Medicines used to treat an irregular heart beat, such as amiodarone, diltiazem or verapamil
• Rifampicin (for treatment of TB)
• Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital or phenytoin)
Your doctor will know which medicines are safe to take with Durogesic DTrans Patch. You may need to be closely monitored if you are taking some of the types of medicines listed above or if you stop taking some of the types of medicines listed above, as this may affect the strength of Durogesic DTrans Patch you need.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Durogesic DTrans Patch.
Operations or tests
If you think that you are going to have an anaesthetic, tell your doctor or dentist that you are using Durogesic DTrans Patch.
Using Durogesic DTrans Patch and drinking alcohol
Do not drink alcohol unless you have talked to your doctor first.
Durogesic DTrans Patch can make you drowsy or breathe more slowly. Drinking alcohol may make these effects worse.
Pregnancy and breast-feeding
You must tell your doctor before using Durogesic DTrans Patch if you are pregnant, think you may be pregnant or might become pregnant. Durogesic DTrans Patch should not be used during childbirth as the medication can affect the breathing of the newborn child.
Do not breast-feed whilst using Durogesic DTrans Patch. You should not breast-feed for 3 days after removing your Durogesic DTrans Patch. This is because small amounts of the medicine may pass into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
Driving and using machines
Durogesic DTrans Patch can make you drowsy. If this happens, do not drive or use any tools or machines.
3. HOW TO USE DUROGESIC DTRANS PATCH
Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Using and changing the Durogesic DTrans Patch
• There is enough medicine in each Durogesic DTrans Patch to last 3 days (72 hours)
• You should change your Durogesic DTrans Patch every third day, unless your doctor has told you differently
• Always remove the old Durogesic DTrans Patch before applying a new one
• Always change your Durogesic DTrans Patch at the same time of day every 3 days (72 hours)
• If you are using more than one Durogesic DTrans Patch, change all your Durogesic DTrans Patches at the same time
• Make a note of the day, date and time you apply a Durogesic DTrans Patch, to remind you when you need to change your patch
• The following table shows you which day of the week to change your Durogesic DTrans Patch:
|
Apply your patch on |
Change your patch at the same time on | |
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Monday |
>=> |
Thursday |
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Tuesday |
<=> |
Friday |
|
Wednesday |
l=> |
Saturday |
|
Thursday |
l=> |
Sunday |
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Friday |
■=> |
Monday |
|
Saturday |
l=> |
Tuesday |
|
Sunday |
>=> |
Wednesday |
Where to apply the Durogesic DTrans Patch Adults
• Apply the Durogesic DTrans Patch on a flat part of your upper body or arm
Children
• Always apply the Durogesic DTrans 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 Durogesic DTrans Patch remains stuck to the skin
• It is important that your child does not remove the Durogesic DTrans Patch and put it in their mouth as this could be life-threatening or even fatal
• It may take some time before the Durogesic DTrans Patch becomes fully effective. Therefore, your child might need additional painkillers until the Durogesic DTrans Patch becomes effective. Your doctor will advise you on this if it is needed
• Children should be monitored very closely for 48 hours after:
• The first Durogesic DTrans Patch has been put on
• A higher dose Durogesic DTrans Patch has been put on
For you or your child, do not apply the Durogesic DTrans Patch on:
• The same place twice in a row
• Sensitive areas that you move a lot, skin with cuts, spots or other skin blemishes
• 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
You should allow several days to pass before you put a new Durogesic DTrans Patch on the same area of skin.
Putting a Durogesic DTrans Patch on Step 1: Preparing the skin
• Make sure your skin is completely dry, clean and cool before you put the Durogesic DTrans 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 Durogesic DTrans Patch
• Do not stick a Durogesic DTrans Patch on straight after a hot bath or shower
Step 2: Open the pouch
• Each Durogesic DTrans Patch is sealed in its own pouch
• Tear or cut open the pouch at the notch, shown by the arrow
• Gently tear or cut off the edge of the pouch completely (if you use scissors, cut close to the sealed edge of the pouch to avoid damaging the Durogesic DTrans Patch)
• Grasp both sides of the opened pouch and pull apart
• Take the Durogesic DTrans Patch out and use straight away
• Keep the empty pouch to dispose of the used Durogesic DTrans Patch later
• Use each Durogesic DTrans Patch once only
• Do not take the Durogesic DTrans Patch out of its pouch until you are ready to use it
• Inspect the Durogesic DTrans Patch for any damage
• Do not use the Durogesic DTrans Patch if it has been divided, cut or looks damaged
• Never divide or cut the Durogesic DTrans Patch
Step 3: Peel and press
• Make sure that the Durogesic DTrans 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 Durogesic DTrans Patch. Try not to touch the sticky side of the Durogesic DTrans Patch
• Press this sticky part of the Durogesic DTrans Patch onto the skin
• Remove the other part of the backing and press the whole Durogesic DTrans 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 Durogesic DTrans Patch
• As soon as you take a Durogesic DTrans Patch off, fold it firmly in half so that the sticky side sticks to itself
• Put it back in its original pouch and put the pouch in the bin with your household rubbish
• Even used Durogesic DTrans Patch contains some medicine which may harm children, so keep your used Durogesic DTrans Patch out of the reach and sight of children
Step 5: Wash
• Wash your hands afterwards with clean water
More about using Durogesic DTrans Patch
How quickly will the Durogesic DTrans Patch work?
• It may take up to a day before your first Durogesic DTrans Patch is working completely
• Your doctor may give you extra painkillers for the first day or so
• After this, the Durogesic DTrans 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
If you forget to change your Durogesic DTrans Patch
• If you forget, change your Durogesic DTrans Patch as soon as you remember and make a note of the day and time. Change the Durogesic DTrans Patch again after 3 days (72 hours) as usual
• If you are very late changing your Durogesic DTrans Patch, you should talk to your doctor because you might need some extra painkillers, but do not apply an extra Durogesic DTrans patch
If you use too many Durogesic DTrans Patch or the wrong strength Durogesic DTrans Patch
If you have stuck on too many Durogesic DTrans Patch or the wrong strength Durogesic DTrans patch, take the Durogesic DTrans Patch 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.
If a Durogesic DTrans Patch falls off
• If a Durogesic DTrans Patch falls off before it needs changing, stick a new one on straight away and make a note of the day and time. Use a new area of skin on:
• Your upper body or arm
• Your child's upper back
• Leave another 3 days (72 hours) before changing the new Durogesic DTrans Patch as usual
• If your Durogesic DTrans Patch keeps falling off, talk to your doctor, nurse or pharmacist
If a Durogesic DTrans Patch sticks to another person
• Only use the Durogesic DTrans Patch on the skin of the person who it was prescribed for
• Make sure the Durogesic DTrans Patch does not get rubbed off and sticks to your partner or child, especially while sharing a bed or in close contact
• If a Durogesic DTrans Patch accidentally sticks to another person, take it off straight away and talk to a doctor
How long will you use the Durogesic DTrans Patch for?
Durogesic DTrans Patch is for long-term pain. Your doctor will be able to tell you how long you can expect to use the Durogesic DTrans Patch.
If your pain gets worse
• If your pain gets worse while you are using the Durogesic DTrans Patch, your doctor may try a higher strength Durogesic DTrans Patch, or give you extra painkillers (or both)
• If increasing the strength of the Durogesic DTrans Patch does not help, your doctor may stop the Durogesic DTrans Patch
If you want to stop using the Durogesic DTrans Patch
• Talk to your doctor before you stop using the Durogesic DTrans Patch
• 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 Durogesic DTrans Patch, don't start again without asking your doctor first.
You might need a different Durogesic DTrans Patch strength when you restart
Everyday activities while using the Durogesic DTrans Patch
• The Durogesic DTrans Patch is waterproof
• You can shower or bathe while wearing a Durogesic DTrans Patch, but do not scrub the Durogesic DTrans Patch itself
• If your doctor agrees, you can exercise or play sport while wearing the Durogesic DTrans Patch
• You can also swim while wearing the Durogesic DTrans Patch, but:
• Don't use hot whirlpool spa baths
• Don't put a tight or elasticated band over the Durogesic DTrans Patch
• Don't expose the Durogesic DTrans Patch to direct heat such as heating pads, hot-water bottles, electric blankets, heated water beds, heat or tanning lamps, intensive sun bathing, prolonged hot baths or saunas. These may affect the way the medicine is absorbed through the skin
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Durogesic DTrans Patch can cause side effects, although not everybody gets them.
Take the Durogesic DTrans Patch off and tell your doctor, or go to your nearest hospital, straight away if you notice or suspect any of the following. You may need urgent medical treatment.
• Feeling unusually drowsy, breathing more slowly or weakly than expected.
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 Patch or morphine) before. If you, or your partner or carer, notice that you or your child are breathing much more slowly or weakly, follow the guidance above and keep moving and talking as much as possible
• Sudden swelling of the face or throat, severe irritation, reddening or blistering of your skin.
These may be signs of a severe allergic reaction. This only happens in a small number of people
• Convulsions, fits or seizures. This affects less than 1 in 100 people.
The following side effects have also been reported
Very common (affects more than 1 in 10 people):
• Feeling sick (nausea) or being sick (vomiting), constipation
• Dizziness, drowsiness or not being able to sleep
• Headache
Common (affects less than 1 in 10 people):
• Allergic reaction
• Awareness of unusual heart beats (also called palpitations), fast heart rate
• High blood pressure
• Loss of appetite or dry mouth
• Feeling nervous, worried or depressed
• Confusion, hallucinations (seeing, feeling or hearing things that are not there)
• Sensation of pins and needles, shaking, feeling giddy
• Muscle spasms
• Stomach ache, indigestion, difficulty passing urine
• Diarrhoea
• Feeling cold, excessive sweating
• General feelings of discomfort, tiredness, weakness
• Swelling of hands, ankles or feet
• Itchy skin, rashes or redness of the skin
Uncommon (affects less than 1 in 100 people):
• Flu-like symptoms
• Slow heart rate
• Low blood pressure
• Decreased feeling of sensitivity, especially in the skin
• Bluish colouration of the skin
• Feeling agitated, disorientated, excited or unusually carefree
• Loss of memory
• Eczema and/or other skin disorders including dermatitis where the patch is placed
• Disorders of sexual function
• Complete obstruction of the intestine
• Muscle twitching
• Fever, body temperature changes
• Drug withdrawal effects (such as sickness, feeling sick, diarrhoea, anxiety or shivering)
Rare side effects (probably affecting less than 1 in 1,000 people):
• Tiny pupils
• Incomplete obstruction of the small or large intestine
The following side effects have been reported during clinical trials in children (up to 18 years of age):
Very common side effects (probably affecting more than 1 in 10 people):
• Headache
• Feeling or being sick
• Constipation, diarrhoea
• Itching
Common side effects (probably affecting up to 1 in 10 people):
• Allergic reaction
• Loss of appetite, stomach pain
• Not being able to sleep, drowsiness, tiredness, feeling weak
• Feeling worried or depressed, hallucinations (seeing, feeling or hearing things that are not there), dizziness
• Shaking, decreased feeling or sensitivity, especially in the skin
• Dry mouth
• Rash, excessive sweating, redness of the skin
• Muscle spasms
• Difficulty passing urine
• Swelling of hands, ankles or feet
• Skin reactions where the patch is placed
Uncommon side effects (probably affecting less than 1 in 100 people):
• Confusion
• Sensation of pins and needles
• Tiny pupils
• Feeling giddy
• Bluish colouration of the skin, eczema and/or other skin disorders including dermatitis where the patch is placed
• Drug withdrawal effects (such as sickness, feeling sick, diarrhoea, anxiety or shivering), flu-like symptoms
If you get any of these side effects, tell your doctor, nurse or pharmacist.
Skin rashes, itching or sweating (affects less than 1 in 10 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.
There have been reports of newborn infants experiencing withdrawal effects after their mothers have used Durogesic DTrans Patch for a long time during pregnancy.
Like many other strong painkillers, repeated use of the patches may make you become tolerant to the medicine or become dependent on it.
If you get any of these side effects, tell your doctor, nurse or pharmacist.
If you switch from a different painkiller to Durogesic DTrans Patch, you may notice effects such as sickness, feeling sick, diarrhoea, anxiety or shivering. Tell your doctor if you notice any of these effects.
If you notice any other side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist..
Reporting of side effects
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. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE DUROGESIC DTRANS PATCH How long to keep Durogesic DTrans Patch for
Do not use Durogesic DTrans Patch 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 your medicine appears to be discoloured or show any other signs of deterioration, take them back to your pharmacist who will advise you what to do.
Where you should keep the patches
Keep all patches (used and unused) out of the sight and reach of children. This medicinal product does not require any other special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
The active substance in Durogesic DTrans Patch is fentanyl.
Each transdermal patch contains 16.8 milligrams of fentanyl (absorption rate approx 100 micrograms/hour: active surface area 42.0cm2).
The other ingredients are polyacrylate Duro-Tak 87-4287,
polyethylene terephthalate/ethylene vinyl acetate laminate, grey printing ink and
siliconised polyester film.
What a Durogesic DTrans Patch looks like and contents of the pack
Durogesic DTrans Patch is a rectangular shaped, clear patch with Durogesic® 100pg fentanyl/h printed in grey on one side with a sticky back so that it can be stuck onto the skin.
Durogesic DTrans Patch is available in cartons containing five patches.
Your doctor will have prescribed the number and strength of patches which is best for you.
Durogesic DTrans Patch is manufactured by: Janssen-Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence Holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX. PL No: 21828/0352 | POM | | CD |
Durogesic® and DTrans® are registered trademarks of Janssen-Cilag.
For information in large print, tape, CD or Braille, please call 01302 552940 and ask for the Regulatory Department.
The leaflet revision date is: 03.12.13
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