Opiodur 50 Micrograms/Hour Transdermal Patch
Package leaflet: Information for the patient
Opiodur
12 micrograms/hour transdermal patch 25 micrograms/hour transdermal patch 50 micrograms/hour transdermal patch 75 micrograms/hour transdermal patch 100 micrograms/hour transdermal patch
Fentanyl
• These patches contain a strong painkiller.
• 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 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 or pharmacist.
- This medicine has been prescribed for you. 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 any side effects talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Opiodur is and what it is used for
2. What you need to know before you use Opiodur
3. How to use Opiodur
4. Possible side effects
5. How to store Opiodur
6. Contents of the pack and other information
1. What Opiodur is and what it is used for Fentanyl is one of a group of strong painkillers called opioids.
The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body.
Adults
Opiodur is used for treatment of severe and long-lasting pain that can only adequately be managed with strong pain relievers (opioids).
Children
Long term management of severe chronic pain in children receiving opioid therapy from 2 years of age.
What you need to know before you use Opiodur
2.
Do not use Opiodur:
- if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from pain which lasts only for a short period e.g. after a surgical procedure
- if your central nervous system is severely impaired, for instance by brain injury
- if you suffer from severe respiratory depression.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Opiodur.
WARNING:
Opiodur is a medicinal product that could be life-threatening to children.
This is also the case with used transdermal patches.
Bear in mind that the design of this medicinal product could be tempting to a child which in severe cases may lead to a fatal outcome.
Opiodur can have life-threatening side effects in persons that are not using prescribed opioid medicines on a regular basis.
Patch sticking to another person
The patch should be used only on the skin of the person for whom it was ordered by the doctor. Cases have been reported where a patch was accidentally stuck to a family member while in close physical contact or sharing the same bed as the patch wearer. A patch sticking to another person (particularly a child) may result in an overdose. In case the patch sticks to the skin of another person, take the patch off immediately and seek medical attention.
Take special care with Opiodur
Like some other strong painkillers, use Opiodur 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 [Invented name]) 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 Opiodur, tell your doctor as this may affect the way the medicine passes through your skin
• Don’t 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
Before starting to use Opiodur you should inform your doctor if you suffer from any of the below disorders, because the risk of side effects is higher and/or your doctor may need to prescribe a lower dose of fentanyl.
- asthma, respiratory depression or any lung disease
- low blood pressure or low blood volume
- impaired liver function
- impaired kidney function
- if you have had a head injury, a brain tumour, signs of increased
intracranial pressure (e.g. headache, visual disturbances), changes in your state of consciousness or loss of consciousness or coma
- slow irregular heartbeat (bradyarrhythmias)
- myasthenia gravis (a disease causing tiredness and weakness of the muscles).
• If you develop a fever while wearing Opiodur, tell your doctor as this may affect the way the medicine passes through your skin.
• Do not expose the patch to a direct heat source such as heating pads, hot water bottles, electric blankets, heat lamps, saunas and hot whirlpool spa baths. These may affect the way the medicine works.
It is allowed to stay outside in the sun, but you must protect the patch with some piece of clothing during hot summer days.
Tolerance, physical or psychological dependence may develop if you use Opiodur for a longer period. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs.
If you are an elderly patient your doctor will monitor you more carefully, because it may be necessary to prescribe a lower dose.
The patches should be not be cut into smaller parts, because the quality, efficacy and safety of such divided patches have not been demonstrated.
The use of fentanyl patches may lead to a positive doping test. The use of fentanyl patches as a doping agent may be hazardous to the health.
Children
Opiodur should not be administered to children under 2 years of age because there is limited experience of use in children under that age. An exception can be made if the doctor has expressly prescribed Opiodur.
Other medicines and Opiodur
Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines.
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
- anaesthetics, if you think you are going to have an anaesthetic, tell your doctor or dentist that you are using Opiodur
- 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 (MAOIs, e.g. moclobemide against depression or selegiline against Parkinson’s disease). You should not use Opiodur within 14 days of stopping these medicines.
- Nefazodone, a medicine used to treat depression
- Cimetidine, a medicine used to treat gastrointestinal diseases
- medicines used for treating allergies or travel sickness (antihistamines/antiemetics). Especially ones that make you sleepy.
- some antibiotics used to treat infection, such as erythromycin, clarithromycin or troleandomycin
- some antibiotics 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)
- Please inform you doctor, if you use certain medicines against depression known as selective serotonin reuptake inhibitors (SSRI,) serotonin-norepinephrine reuptake inhibitors (SNRI) or monoamine oxidase inhibitors (MAOH).
Your doctor has to know about every use of these medicines as in combination with Opiodur there may be an increased risk that a serotonin syndrome, a possibly life threatening Condition, may develop.
Your doctor will know which medicines are safe to take with Opiodur patches. You may need to be closely monitored if you are taking some of the types of medicines listed above as this may increase or prolong the therapeutic effects and side effects of Opiodur and thus may affect the strength of Opiodur you need.
Opiodur with food, drink and alcohol
You should not consume alcohol during fentanyl treatment. Alcohol may increase the risk of breathing problems. Simultaneous use of Opiodur and alcoholic beverages increases the risk of severe adverse reactions, and may cause breathing difficulties, a fall of blood pressure, profound sedation and coma.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
There are no adequate data from the use of Opiodur in pregnant women.
Opiodur should not be used during childbirth as the medication can affect the breathing of the newborn child. Do not use Opiodur during pregnancy unless clearly necessary. Fentanyl is excreted into the breast-milk and may cause side effects in the breast-fed infant as sedation and respiratory depression. Breastfeeding should therefore be discontinued during treatment and for at least 72 hours after removal of the patch.
Driving and using machines
Opiodur may impair mental and/or physical ability required for the performance of potentially hazardous tasks such as driving a car or operating machinery. This has to be expected especially at the beginning of treatment, at any change of dosage as well as in connection with alcohol or tranquilizers. If you have been using the same dose of Opiodur for a longer period of time, your doctor may decide that you are permitted to drive and use dangerous machines. Do not drive or operate dangerous machines while using Opiodur, unless your doctor has told you that such is permitted.
3. How to use Opiodur
Always use Opiodur exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will decide which strength of Opiodur is most suitable for you. Your doctor will base his judgement on: the severity of your pain, your general condition and the type of pain treatment that you have received so far.
According to your reaction the strength of the patch or the number of patches may need to be adjusted. The effect is reached within 24 hours after the first patch has been applied and its effects fall gradually after the patch is removed. Do not discontinue treatment without consulting your doctor.
Your first patch will start to work slowly, this may take as long as one day, so your doctor may give you extra painkillers until your fentanyl transdermal patch starts working completely. After this, Opiodur should help to relieve pain continuously and you should be able to stop taking these extra painkillers. However sometimes you may still need extra painkillers.
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 otherwise.
• Always remove the old patch before applying the new one.
• Always change your patch at the same time of day every 3 days (72 hours)
• 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.
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday
Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday
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 you 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 need to be monitored very closely for 48 hours after:
- The first patch has been put on
- A higher dose patch has been put on.
For you and your child, do not apply the patch on:
• The same place twice in a row
• Sensitive areas that you move a lot, cuts, spots or other skin blemishes.
• Skin that is very hairy, if there is a 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 patch on the same area of skin.
Putting a patch on
Step 1: Preparing the skin
• Make sure your skin is completely clean, dry 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 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)
• Grasp both sides of the opened pouch and pull apart
• Take the patch out and use it 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
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 the 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 sight and reach of children.
Step 5: Wash
Wash your hands afterwards with clean water.
More about using Opiodur 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 your first day or so.
• After this, the patch should help to relive pain continuously so that you can stop taking other painkillers. However, your doctor may still prescribe extra painkillers from time to time.
If your forget to change the 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 extra painkillers, but do not apply an extra patch.
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 an 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 the patch falls off
• If the 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 on:
- Your upper body or arm
- Your child’s upper back
• Leave another 3 days (72 hours) before changing the new patch as usual
• If your patch keeps 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 is 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 your doctor.
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.
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 strength patch 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, Opiodur can cause side effects, although not everybody gets them.
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 before. If you notice any of the above, follow the guidance above and keep moving as much as possible.
• Complete block of the digestion channel (convulsive pain, vomiting, flatulence).
Other side effects
Very common: may affect more than 1 in 10 people
Somnolence Feeling sick (nausea)
Being sick (vomiting)
Constipation
Dizziness
Headache.
Common: may affect up to 1 in 10 people
Allergic reaction (hypersensitivity). An allergic reaction may include rash, itching, difficulty of breathing or swelling of the face, lips, throat or tongue.
Awareness of unusual heart beats (also called palpitations), fast heart rate
High blood pressure
Lowered appetite
Sedation
Dry mouth
Difficulties in sleeping Depression Anxiety Confusion
Hallucinations (seeing, feeling or hearing things that are not there).
Sensation of pins and needles
Shaking
Feeling giddy
Muscle spasms
Stomach pain
Breathing difficulties
Indigestion
Difficulty passing urine
Diarrhoea
Feeling cold
Excessive sweating
General feelings of discomfort
Tiredness, weakness
Swelling of hands, ankles or feet (water retention in the tissues)
Itchy skin, rashes or redness of the skin (Skin rash, skin reddening and itching will usually disappear within one day after the patch has been removed).
Uncommon: may affect up to 1 in 100 people
Flu-like symptoms Slow heart rate Low blood pressure Breathing more slowly or weakly
Decreased feeling of sensitivity, especially in the skin Convulsions, fits or seizures 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, erectile dysfunction Complete obstruction of the intestine Muscle twitching
Feeling of body temperature changes
Drug withdrawal effects (such as sickness, feeling sick, diarrhoea, anxiety or shivering)
Speech disorder.
Rare: may affect up to 1 in 1,000 people
Tiny pupils Irregular heartbeat Dilated blood vessels
Stopping breathing, shallow or too slow breathing Incomplete obstruction of the small or large intestine Dermatitis at the application site Eczema at the application site.
Very rare: may affect up to 1 in 10,000 people
Painful gases in the stomach or the guts Unusual low production of urine Pain in the urine bladder.
Not known: frequency cannot be estimated from the available data
Generalised acute allergic reactions which can be life-threatening (anaphylactic shock)
Allergic reactions of different causes (anaphylacted or anaphylactoid reactions)
Abnormally slow breathing rate.
Like with other strong painkillers, repeated use of the patches may make you become tolerant to the medicine or become physical and/or psychological dependent on it.
Withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety and shivering are possible if you switch from a different painkiller to Opiodur or if you stop your therapy suddenly.
There have been very rare reports of newborn infants experiencing withdrawal effects after their mothers have used Opiodur for a long time during pregnancy.
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 Opiodur
Keep unused and used Opiodur patches out of children’s sight and reach.
Do not use this medicine after the expiry date, which is stated on the package. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original sachet in order to protect from moisture.
Handling the patch
High quantities of fentanyl remain in the patches even after use. Any unused medicinal product and any used transdermal patches should be folded so that the adhesive side of the patch adheres to itself and then they should be safely discarded. Accidental exposure to used and unused patches particularly in children may lead to a fatal outcome. Unused patches should be returned to the (hospital) pharmacy, according to the local requirements, as applicable.
These measures will help to protect the environment. Do not throw away any medicines via wastewater or household waste.
6. Contents of the pack and other information
What Opiodur contains
• The active substance is: fentanyl.
Each Opiodur 12 micrograms/hour transdermal patch contains 1.375 mg of fentanyl in a patch size of 5 cm2, releasing 12 micrograms of fentanyl per hour.
Each Opiodur 25 micrograms/hour transdermal patch contains 2.75 mg of fentanyl in a patch size of 10 cm2, releasing 25 micrograms of fentanyl per hour.
Each Opiodur 50 micrograms/hour transdermal patch contains 5.5 mg of fentanyl in a patch size of 20 cm2, releasing 50 micrograms of fentanyl per hour.
Each Opiodur 75 micrograms/hour transdermal patch contains 8.25 mg of fentanyl in a patch size of 30 cm2, releasing 75 micrograms of fentanyl per hour.
Each Opiodur 100 micrograms/hour transdermal patch contains 11.0 mg of fentanyl in a patch size of 40 cm2, releasing 100 micrograms of fentanyl per hour.
• The other ingredients are:
Overlay liner
Polyethylene terephthalate film with fluorocarbon release coating.
Backing Layer
Pigmented polyethylene terephthalate/ethylene vinyl acetate copolymer film Drug adhesive Layer
Silicone adhesive (dimethicone, silicate resin)
Dimethicone
Rate controlling membrane Ethylene vinyl acetate copolymer film
Skin adhesive Layer
Silicone adhesive (dimethicone, silicate resin)
Dimethicone
Protective liner
Polyethylene terephthalate film with fluorocarbon release coating
Printing ink Red ink
What Opiodur looks like and contents of the pack
Opiodur transdermal patch is a rectangular, tan coloured patch which is placed between two clear protective layers which need to be removed prior to application. The patches are imprinted in red ink with:
Fentanyl 12 pg/h Fentanyl 25 pg/h Fentanyl 50 pg/h Fentanyl 75 pg/h Fentanyl 100 pg/h
Opiodur is available in packs of 3, 4, 5, 8, 9, 10, 16, 19 or 20 transdermal patches.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Special Concept Development (UK) Limited,
Units 1- 7, Colonial Way,
Watford, Hertfordshire,
WD24 4YR,
United Kingdom.
Manufacturer:
Lavipharm S.A., Agias Marinas str, 19002 Peania, Attica,
Greece.