DUROGESIC DTRANS 12 MCG/HR TRANSDERMAL PATCH

500000/PL1a

PACKAGE LEAFLET: INFORMATION FOR THE USER

Durogesic DTrans 12 mcg/hr Transdermal Patch Durogesic DTrans 25 mcg/hr Transdermal Patch Durogesic DTrans 50 mcg/hr Transdermal Patch Durogesic DTrans 75 mcg/hr Transdermal Patch Durogesic DTrans 100 mcg/hr Transdermal Patch
Fentanyl
Durogesic and DTrans are registered trademarks

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 In this leaflet 1 What Durogesic DTrans patches are and what they are used for 2 Before you use Durogesic DTrans patches 3 How to use Durogesic DTrans patches 4 Possible side effects 5 How to store Durogesic DTrans patches 6 Further information

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.

1 What Durogesic DTrans patches are and what they are used for
The name of your medicine is Durogesic DTrans 12 mcg/hr transdermal patch, Durogesic DTrans 25 mcg/hr transdermal patch, Durogesic DTrans 50 mcg/hr transdermal patch, Durogesic DTrans 75 mcg/hr transdermal patch or Durogesic DTrans 100 mcg/hr transdermal patch. It is called Durogesic DTrans patch or just patch in this leaflet. The patches help 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 patches come in five strengths (see section 6 overleaf). The medicine passes slowly into your body through your skin.

2 Before you use Durogesic DTrans patches
Durogesic DTrans patches can be used in children aged 2 to 16 years who have previously used opioid painkillers. If the patches have been prescribed for your child, the you stated everywhere below should be read as your child.

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 patches 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 (called MAOIs) You should not take Durogesic DTrans 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 Your doctor will know which medicines are safe to take with Durogesic DTrans patches. You may need to be closely monitored if you are taking some of the types of medicines listed above as this may affect the strength of Durogesic DTrans 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 patches.

Do not use Durogesic DTrans patches if:
You are allergic to fentanyl, Durogesic or anything in Durogesic DTrans patches (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 patches.

Take special care with Durogesic DTrans patches
Like some other strong painkillers, Durogesic DTrans patches 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) 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 patches, tell your doctor as this may affect the way the medicine passes through your skin Dont expose the 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 patches 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 patches. Like many other strong painkillers, repeated use of the patches 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 If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Durogesic DTrans patches.

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.

Using Durogesic DTrans patches and drinking alcohol
Do not drink alcohol unless you have talked to your doctor first. Durogesic DTrans patches 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 patches if you are pregnant, think you may be pregnant or might become pregnant. Durogesic DTrans patches 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 patches. 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 breast-feeding.

Other makes of patch
There are other makes of fentanyl transdermal patch available, but they are not all the same. If your patch looks different from one you have used before you should check with your doctor or pharmacist before using it.

Driving and using machines
Durogesic DTrans patches can make you drowsy. If this happens, do not drive or use any tools or machines.

3 How to use Durogesic DTrans patches
Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure For you or your child, do not apply the 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

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 which day of the week to change your patch: Apply your patch on Monday Tuesday Wednesday Thursday Friday Saturday Sunday Change your patch at the same time on Thursday Friday Saturday Sunday Monday Tuesday Wednesday

You should allow several days to pass before you put a new patch on the same area of skin. 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 pouch Each 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 patch)

Where to apply the patch
Adults Apply the patch on a flat part of your upper body or arm 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 It may take some time before the patch becomes fully effective. Therefore, your child might need additional painkillers until the patches become effective. Your doctor will advise you on this if it is needed Children should be monitored very closely for 48 hours after: The first patch has been put on A higher dose patch has been put on Grasp both sides of the opened pouch and pull apart Take the patch out and use straight away Keep the empty pouch to dispose of the used patch later Use each patch once only Do not take the patch out of its pouch 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 Turn over

3 How to use Durogesic DTrans patches (continued)
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 pouch and put the pouch in the bin with your household rubbish Even used patches contain some medicine which may harm children, so keep your used patches out of the reach and sight of children Step 5: Wash Wash your hands afterwards with clean water

If a patch falls off
If a 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 childs upper back Leave another 3 days (72 hours) before changing the new patch as usual If your patches keep falling off, talk to your doctor, nurse or pharmacist

If a patch sticks to another person
Only use the patch on the skin of the person who it was prescribed for Make sure the patch does not get rubbed off and sticks to your partner, especially in bed If a patch accidentally sticks to another person, take it off straight away and talk to a doctor

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 extra painkillers (or both) If increasing the strength of the patch does not help, your doctor may stop the patches

More about using Durogesic DTrans patches
How quickly will the patches work?
It may take up to a day before your first patch is working completely Your doctor may give you extra painkillers 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

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, dont start again without asking your doctor first. You might need a different patch strength when you restart

If you forget to change your patch
If you forget, change your patch as soon as you remember and make a 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

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: Dont use hot whirlpool spa baths Dont put a tight or elasticated band over the patch Dont expose the 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.

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 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.

4 Possible side effects
Like all medicines, Durogesic DTrans patches can cause side effects, although not everybody gets them. 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 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 patches, 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.

Take the 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 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 Body temperature changes Drug withdrawal effects (such as sickness, feeling sick, diarrhoea, anxiety or shivering)

5 How to store Durogesic DTrans patches
How long to keep Durogesic DTrans patches for
Do not use Durogesic DTrans patches 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.

Where you should keep the patches
Keep out of the reach and sight of children. This medicinal product does not require any other special storage conditions. If you notice any sign of discolouration or deterioration of your medicine, tell your pharmacist immediately. 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 patches is fentanyl. The patches come in 5 different strengths (see table below). Name of patch
Durogesic DTrans 12 mcg/hr transdermal patch Durogesic DTrans 25 mcg/hr transdermal patch Durogesic DTrans 50 mcg/hr transdermal patch Durogesic DTrans 75 mcg/hr transdermal patch Durogesic DTrans 100 mcg/hr transdermal patch

What Durogesic DTrans patches look like and contents of the pack
Rectangular shaped, clear patch marked "Durogesic 12 g fentanyl/h" in orange printing ink or "Durogesic 25 g fentanyl/h" in red printing ink or "Durogesic 50 g fentanyl/h" in green printing ink or "Durogesic 75 g fentanyl/h" in blue printing ink or "Durogesic 100 g fentanyl/h" in grey printing ink. Active surface area of each patch is:
5.25 square centimetres (cm2) 10.5 cm2 21 cm2 31.5 cm2 42 cm2

Each patch contains:
2.1 milligrams (mg) of fentanyl 4.2 mg fentanyl 8.4 mg fentanyl 12.6 mg fentanyl 16.8 mg fentanyl

Each patch gives a dose of:
12 micrograms (mcg) of fentanyl per hour 25 mcg per hour 50 mcg per hour 75 mcg per hour 100 mcg per hour

The patches come in individually wrapped heat-sealed (acrylonitrile film) pouches and usually come in cartons containing five patches, but your doctor will have prescribed the number and strength of patches which is best for you. Product Licence Holder and Manufacturer Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd, both at St James House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ. Manufactured by Janssen Pharmaceutica NV/SA, Turnhoutseweg 30, Beerse, B-2340, Belgium. Durogesic DTrans 12 Transdermal Patches PL No: 18067/0389 Durogesic DTrans 25 Transdermal Patches PL No: 18067/0390 Durogesic DTrans 50 Transdermal Patches PL No: 18067/0391 Durogesic DTrans 75 Transdermal Patches PL No: 18067/0392 Durogesic DTrans 100 Transdermal Patches PL No: 18067/0393


The other ingredients in the patch are: Polyester/ethyl vinyl acetate Polyacrylate adhesive Siliconised polyester film which is removed before use Each patch is identified using a different colour of printing ink: Durogesic DTrans 12 mcg/hr transdermal patch: Orange Durogesic DTrans 25 mcg/hr transdermal patch: Red Durogesic DTrans 50 mcg/hr transdermal patch: Green Durogesic DTrans 75 mcg/hr transdermal patch: Blue Durogesic DTrans 100 mcg/hr transdermal patch: Grey

POM

CD

Durogesic and DTrans are registered trademarks of Johnson & Johnson. This leaflet was last revised on 27th June 2012. To request a copy of this leaflet in Braille, large print or audio please call 01622 693000.
500000/PL1a