Ionsys
fentanyl
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or your nurse.
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 any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What IONSYS is and what it is used for
Before you use IONSYS
How to use IONSYS
Possible side effects
How to store IONSYS
Contents of the pack and other information
What IONSYS is
Medicinal product no longer authorised
IONSYS is a transdermal system (to be applied on intact skin) that contains a strong analgesic (pain reliever) medicine called fentanyl.
What IONSYS is used for
IONSYS is used to treat short-term moderate to severe pain in adults after an operation. IONSYS is used in hospital only.
How IONSYS works
IONSYS is a small device applied to the skin of your upper arm or chest. It works by delivering fentanyl through your skin to relieve your pain.
You must talk to a doctor if you do not feel better or if you feel worse.
if you are allergic (hypersensitive) to fentanyl, or any of the other ingredients of IONSYS (listed in section 6).
if you suffer from severe breathing problems or cystic fibrosis.
Talk to your doctor or nurse before using IONSYS if:
you have a severe or persistent lung disease, or any breathing problems
you have a very slow heart rate, low blood pressure, or other serious heart problem
you have problems with your liver or kidneys
you have severe headaches, have had a significant head injury, or have a brain tumour
you have any difficulty hearing as you will need to be able to hear the device’s ‘beep(s)’ to know if it is working properly or if there is a problem
you have abnormally slow bowel movements or severe constipation
you have had a chest or upper abdominal operation
you are severely obese or have a condition called sleep apnoea that causes interrupted breathing during sleep and which can occur in severely obese individuals.
IONSYS should be removed prior to certain procedures such as cardioversion (electrical current used to restore normal heart rhythm), defibrillation (electric shock given to the heart) or diathermy (electrical current used in physical therapy or surgery). IONSYS should also be removed prior to a magnetic resonance imaging (MRI) procedure, X-ray or CT scan.
If you have a history of drug abuse, inform your doctor.
If you have a genetic condition (polymorphism) which affects certain enzymes in your body (CYP3A4 and CYP3A5), inform your doctor.
If you are an older patient your doctor will monitor you more carefully as IONSYS may affect you more than a younger patient.
IONSYS is not recommended for children and adolescents under 18 years of age due to the lack of data in these patients.
Medicinal product no longer authorised
Tell your doctor or nurse if you are using, have recently used or might use any other medicines. Some medicines can affect the way IONSYS works, or make it more likely that you will have side effects.
Tell your doctor or nurse if:
you are taking medicines that might make you sleepy such as sleeping tablets, tranquilisers, medicines for anxiety or medicines for allergies (anti-histamines);
you are taking muscle relaxants (prescribed for back pain), or if you are undergoing general anaesthesia;
you are taking medicines for HIV infection (such as ritonavir, nelfinavir, amprenavir or fosamprenavir);
you are taking medicines for fungal infections (such as ketoconazole, itraconazole or fluconazole);
you are taking medicines for bacterial infections (such as troleandomycin, clarithromycin or erythromycin);
you are taking medicines used to help treat nausea and vomiting (such as aprepitant);
you are taking medicines used for high blood pressure or heart problems (such as diltiazem and verapamil);
you are taking pain killers called partial agonists like buprenorphine, nalbuphine, pentazocine;
you are taking medicines for depression called monoamine-oxidase (MAO) inhibitors. Tell your doctor or nurse if you have taken them within the last 14 days before using IONSYS;
you are using medicines for topical use (i.e. medicines that are applied on the skin).
Do not drink alcohol or grapefruit juice whilst you are wearing IONSYS because it can increase the risk of experiencing dangerous side effects.
You must tell your doctor before using IONSYS if you are pregnant or planning to become pregnant. Your doctor will discuss the possible risks and potential benefits of using IONSYS while you are pregnant.
IONSYS should not be administered during childbirth. If you are given IONSYS during childbirth your baby may need to be given an antidote when it is born. Prolonged treatment with fentanyl, the active substance in IONSYS, may cause withdrawal symptoms in the newborn baby.
Do not use IONSYS if you are breast-feeding. Fentanyl can pass into the breast milk and may cause side effects to the breast-fed child. You should not start breast-feeding until the IONSYS system has been removed for 24 hours.
IONSYS may make you feel sleepy, dizzy or cause blurred vision. Do not drive, operate machines or power tools when you leave hospital if you experience any of these side effects.
Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor or nurse if you are not sure about how to use IONSYS or forget your instructions.
Each dose of IONSYS delivers 40 micrograms of fentanyl.
You control your own treatment under the guidance of your doctor or nurse in hospital. IONSYS only delivers the medicine when you activate it, so you control how much medicine you receive. You can take a dose whenever you need it for your pain, or just before you do an activity that may increase your pain (such as physical therapy, getting out of bed, etc.). Each time you are given a new IONSYS you may find you initially need to have more doses to relieve your pain than later on during treatment.
Medicinal product no longer authorised
Each IONSYS works for one day (24 hours) and contains 80 doses. IONSYS will stop working after one day (24 hours) or after 80 doses have been delivered, whichever one comes first. The green light
will switch off and the number of doses delivered will flash on and off. No more doses can be
delivered after this and IONSYS will be removed by your doctor or nurse.
Your doctor or nurse will remove the IONSYS system before you leave hospital. After IONSYS has been removed, it may leave small reddish marks at the skin site. This is common, and nothing to worry about. The red area will fade over the next few days to a week.
The doctor or nurse will put IONSYS on your skin, and take it off or replace it when needed.
The doctor or nurse will get IONSYS ready to use and attach it to your upper outer arm or chest.
To start a dose from IONSYS, press and release the dosing button twice within 3 seconds. You will know you have started a dose when you hear a beep.
You will know the dose is being delivered when the
Each dose will last for 10 minutes. IONSYS will ignore additional button presses during this 10-minute dosing period.
You will know the 10-minute dosing period is complete when the fast blinking green light becomes slow again. The digital display will show the number of doses that have been delivered.
IONSYS is ready to be used again and you may start another dose at any time you need it. However, only press the button when you need pain relief.
Medicinal product no longer authorised
IONSYS is designed so that you can’t use too much, provided that only you operate it, and that only you use it when you need pain relief.
If you do use more IONSYS than you should then you may experience shortness of breath, difficulty breathing, rapid and shallow breathing, or feeling faint. If you experience any of these symptoms then tell your doctor or nurse immediately.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur whilst using IONSYS:
feeling sick (nausea) or being sick (vomiting)
reddening of skin at the patch site
dizziness
headache
itching skin
low blood pressure
difficulty sleeping
constipation, stomach pain
blue skin colour (lips and finger tips)
swelling, itching, irritation or blistering of skin at the patch site
inability to pass water (urinate)
fever
flushing
anaemia (low blood count)
decreased appetite
anxiety
abnormal dreams or hallucinations (seeing or hearing things that are not there)
feeling confused or agitated
severe headache (migraine)
nervousness
pins and needles sensation
sleepiness
blurred vision
looking pale, feeling low in energy or tired
fast or irregular heartbeat
shortness of breath or interruptions in breathing
cough, hiccups
rash
excessive sweating
fainting
dry mouth
passing water (urinating) less frequently than normal
indigestion
passing wind, difficulty passing stools
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chills
back pain, pain in arms or legs
pain, bumps, or dry skin at the patch site
high blood pressure
fall in blood pressure when standing up
decreased bowel activity
slow breathing rate
body pain
sneezing, itchiness and blocked or runny nose
low calcium/glucose/potassium in blood serum
depression, abnormal thoughts
abnormal sense of taste
reduced sense of touch or sensation
vertigo
slow heart beat
lung disease
swelling of the abdomen, diarrhoea, burping/belching
tightness/tension in muscles, muscle pain
pain when urinating
chest pain, feeling of general discomfort or uneasiness
tingling, prickling, swelling or pain at site of IONSYS application
complications in wound healing
fluid retention/swelling in the body
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, or tray or sachet label, after “EXP”. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not refrigerate or freeze.
The hospital staff will store IONSYS. The used IONSYS will be disposed of by medical staff.
The active substance in IONSYS is fentanyl hydrochloride. Each IONSYS system contains fentanyl hydrochloride equivalent to 9.7 mg of fentanyl and delivers 40 micrograms fentanyl per dose, to a maximum of 80 doses (3.2 mg/24 hours).
The other ingredients are:
bottom housing unit: glycol-modified polyethylene terephthalate
Medicinal product no longer authorised
anode hydrogel: polacrilin, purified water, sodium hydroxide, polyvinyl alcohol
cathode hydrogel: purified water, sodium chloride, sodium citrate, polyvinyl alcohol, anhydrous citric acid, cetylpyridinium chloride
anode electrode: layers of silver foil and electrically conductive adhesive tape
cathode electrode: layers of polyisobutylene/silver chloride/carbon black composite material, silver foil, and electrically conductive adhesive tape
skin adhesive: polybutene, polyisobutylene, and rosin ester
protective liner: polyester film coated on one side with silicone.
IONSYS is a transdermal system and is made up of an electronic controller (the top housing) and a drug unit (the red bottom housing). The controller is made of white plastic with the identifier “IONSYS” and has a digital display, a light window, and a dosing button. The drug unit is blue on the side that connects to the controller and has a red bottom housing containing the hydrogels, one of which contains the fentanyl hydrochloride.
Each IONSYS carton contains 6 systems.
Bristol BS1 6JS
United Kingdom
Tel: +44 (0)800 587 4149 or +44 (0)203 684 6344
Email: medical.information@themedco.com
Penn Pharmaceutical Services Ltd
Tafarnaubach Industrial Estate Tredegar
Gwent, South Wales NP22 3AA
United Kingdom
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Medicinal product no longer authorised
| IONSYS (fentanyl 40 micrograms per dose transdermal system, maximum of 80 doses (3.2 mg/24 hours)). For single use only. IONSYS should not be used if the seal on the tray or the sachet containing the drug unit is broken or damaged. IONSYS will operate for 24 hours after it is applied or for 80 doses, whichever comes first, and will then become inoperative. Refer to the Summary of Product of Characteristics (SmPC) for more information about IONSYS. |
| 1. Preparation of the Application Site |
Only 1 IONSYS system should be applied at any given time.
Choose healthy, unbroken skin (non-irritated and non- irradiated skin) site on the chest or upper outer arm ONLY. IONSYS should not be placed on abnormal skin sites, such as scars, burns, and tattoos, or on skin on which topical medicines have been applied.
Excessive hair at the application site should be clipped (not shaved as this can irritate the skin) before application. IONSYS should not be applied to a previously used skin site.
The application site should be wiped with a standard alcohol swab and the skin should be allowed to dry completely before IONSYS is applied. No soaps, oils, lotions, or any other agents that might irritate the skin or alter its absorption characteristics, should be used to clean the application site.
When replacing an IONSYS system, the new system must be applied to a different site on the chest or upper outer arm.
Complete these steps before applying IONSYS to the patient:
Gloves should be worn during the assembly/handling of IONSYS. Open the tray by peeling back the tray lid. Remove the sachet and the controller. Open the sachet containing the drug unit starting at the pre-cut notch and then carefully tearing along the top of the sachet.
Remove the drug unit from the sachet and place on a hard, flat surface.
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Align the matching shapes of the controller and the drug unit and firmly press the two parts together at both ends.
Once assembled, the digital display of the controller will complete a short self-test during which there will an audible beep, the red light will flash once, and the digital display will flash the number “88”. At the end of the self-test, the display will show the number “0” and a green light will flash at a slow rate to indicate IONSYS is ready for application.
Medicinal product no longer authorised
| |
| 4. Instructing the patient how to use IONSYS Remember that only the patient may touch the dosing button. Tell your patient the following: |
Application of IONSYS
Remove and discard the clear plastic liner covering the adhesive. Take care not to touch the hydrogels.
Press IONSYS firmly in place for at least 15 seconds with the sticky side down on the skin of the chest or upper arm of the patient. Apply pressure with the fingers around the outer edges to ensure adhesion to the skin site. Do not press the dosing button.
If at any point during use IONSYS loosens from the skin, a non-allergenic tape may be used to secure the edges to ensure complete contact with the skin. When applying tape, care should be taken not to tape over the light window, the digital display, or the dosing button.
Each IONSYS may be used for 24 hours from the time of assembly or until 80 doses have been administered, whichever comes first. IONSYS will then shut down and will not deliver any further doses. If additional opioid analgesia is required, a new IONSYS should be applied to a different skin site, after removal and disposal of the previous IONSYS.
Patients should not wear more than one IONSYS at the same time. A used IONSYS should not be reapplied to patients.
The slow blinking green light means IONSYS is ready to dose.
To start a dose, press and release the dosing button 2 times within 3 seconds. You will hear one single beep upon successful dose initiation.
You will know the dose is being delivered when you see the fast blinking green light.
IONSYS will ignore any button presses during the 10-minute dosing period.
You will know the 10-minute dose is complete when the fast blinking green light returns to a slow blinking green light.
Call your doctor or nurse if you hear additional beeps.
See also instructions in SmPC Section 6.6.
Gloves must be worn while removing IONSYS from the skin and care should be taken to avoid touching the hydrogels. If the fentanyl hydrogel contacts the skin during removal, the contact area should be thoroughly rinsed with water without using any soap.
IONSYS may be removed at any time. However, once it has been removed, the same IONSYS should not be reapplied.
At the end of 24 hours of use, or after 80 doses have been delivered, remove IONSYS by gently lifting the red tab and loosening it from the skin application site. If the patient requires additional or continuation of pain relief, a new IONSYS may be applied to a new skin site on the upper outer arm or chest.
Hold the controller in one hand and pull the red tab with the other hand to separate the hydrogel housing from the system.
Fold the hydrogel housing in half with the sticky side facing in.
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Dispose of the folded hydrogel housing in accordance with local requirements for opioid medicinal products
Dispose of remainder of the system, containing electronics, according to hospital procedures for battery waste.
Each IONSYS is designed to deliver up to 80 10-minute doses of fentanyl over a period of 24 hours. The table below represents the different error messages that may occur, together with the probable
cause and the action to be taken.
Error message/feedback | Probable cause | Action required |
| Low battery or defective system |
|
Poor skin contact |
|
| dispose of system, and place a new system on a different skin site. | |
| System error |
|
| End of use at 24 hours or 80 doses |
|
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If device failure or malfunction is suspected by a healthcare professional, IONSYS should be immediately removed from the patient and The Medicines Company contacted straightaway.
The healthcare professional must ensure the patient understands that if they suspect a device failure or malfunction, they must inform a healthcare professional immediately.
