Ionsys - patient leaflet, side effects, dosage

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Penn Pharmaceutical Services Ltd

23–24 Tafarnaubach Industrial Estate

Tredegar

Gwent, South Wales

NP22 3AA

United Kingdom

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to special and restricted medical prescription (see Annex I: Sum Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MAR AUTHORISATION

Periodic safety update reports

The requirements for submission of periodic safety update re out in the list of Union reference dates (EURD list) provided 2001/83/EC and any subsequent updates published on the The marketing authorisation holder shall submit the first product within 6 months following authorisation.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP sho bmitted:

• At the reques uropean Medicines Agency;
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or ult of an important (pharmacovigilance or risk minimisation) milestone being

tional risk minimisation measures

Prior to launch of IONSYS in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.

The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where IONSYS is launched all healthcare professionals who are expected to prescribe, dispense or administer IONSYS are informed through an information letter on having access to / are provided with the following items:

• Summary of Product Characteristics (SmPC) and Package Leaflet
• IONSYS Instructions for Use and Disposal

Educational material (including prescriber checklist) for the healthcare professionals

The Healthcare provider educational Programme shall contain the following key messages:

• Information on the adequate use of the product with regards to medication errors (including accidental exposure), Device malfunction/fa­ilure, Product Disposal and Misuse/abuse/di­version/addic­tion and dependence.
• Information highlighting that IONSYS is a patient-controlled device to be used in a hospital setting only and that standard practices for monitoring patients using such devices should be followed by healthcare professionals.
• Information to aid healthcare professionals in selecting patients appropriate for treatment with IONSYS.
• The importance of the healthcare professional ensuring that the patient understands ho operate the IONSYS system and that only he/she can press the dosing button durin
• The importance of reading the “IONSYS Instructions for Use and Disposal” inc troubleshooting guide and ensuring that the patient understands what to do in th of a device failure/malfun­ction.

Checklist for monitoring inadequate product disposal to ensure healt understand the dangers of inappropriate handling and accidental exp system.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

• 1. NAME OF THE MEDICINAL PRODUCT

IONSYS 40 micrograms per dose transdermal system Fentanyl

• 2. STATEMENT OF ACTIVE SUBSTANCE(S) 1 system contains fentanyl hydrochloride equivalent to 9.7 mg of fentanyl.

1 system delivers 40 micrograms fentanyl per dose, to a maximum of 80 doses (3.2

• 3. LIST OF EXCIPIENTS

  , sodium hydroxide, acid, cetylpyridinium ive adhesive tape (ECAT), utylene, rosin ester, siliconised

  
  

Also contains: glycol-modified polyethylene terephthalate, purified w polacrilin, polyvinyl alcohol, trisodium citrate dihydrate, anhydrou chloride monohydrate, sodium chloride, silver foil, electrically polyisobutyle­ne/silver chloride/carbon black, polyisobutene, polyester.

• 4. PHARMACEUTICAL FORM AND CONTENTS

  6 transdermal systems

  
  

  5. METHOD AND ROUTE

  
  

  ADMINISTRATION

  
  

Read the package leaflet before use.

Transdermal use

Do not use if seal on the tray or the sachet containing the drug unit are broken or damaged.

6.	SPECIAj	W WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
	OF THE	SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

Use immediately after opening.

Package leaflet: Information for the Patient

IONSYS 40 micrograms per dose transdermal system fentanyl

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, 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 effect listed in this leaflet. See section 4.

What IONSYS is and what it is used for

IONSYS is a transdermal system (to be applied on intact skin) that contains a strong analgesic (pain reliever) medicine called fentanyl.

IONSYS is used to treat short-term used in hospital only.

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.

tor if you do not feel better or if you feel worse.

2. What you need to know before you use IONSYS

not use IONSYS:

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.

Warnings and precautions

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.

Important things to be aware of

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 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 you and CYP3A5), inform your doctor.

IONSYS with food, drink and alcohol

Do not drink alcohol or grapefruit juice whilst you are wearing IONSYS because it can increase the risk of experiencing dangerous side effects.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

3. How to use IONSYSr or

Always use this medicine exactly as your doctor or nurse has told you. Check wi nurse if you are not sure about how to use IONSYS or forget your instructions.

The recommended dose

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 y an activity that may increase

your pain (such as physical therapy, getting out of bed, etc.). e you are given a new IONSYS

you may find you initially need to have more doses to reli ur pain than later on during treatment.

Using IONSYS

• Do not let you ily or friends start IONSYS for you. Only you know how much pain

you are having, and only you should operate IONSYS to start a dose of medicine. To make sure you get the correct amount of medicine, press IONSYS as soon as you start to feel pain. Do not touch the sticky side of IONSYS. This side of the system contains material called “gels” which you should not normally come into contact with. Swallowing or touching these gels may cause life-threatening breathing difficulties or death , even after you have stopped using the system and it has been removed. Do not let these touch your mouth or eyes.

If you do accidentally touch the gels on the underside of the system:

• - Alert a nurse or doctor right away

• - Rinse your hands with large amounts of water

• - Do not use soap, alcohol, or other solvents to remove the gels because they may increase the medicine’s ability to go through the skin.

The doctor or nurse will put IONSYS on your skin, and take it off or replace it when needed. Only let the doctor or nurse place or remove IONSYS.

• - Do not take it off or attempt to put it back on yourself.

• - Do not let the IONSYS system get wet because it could stop working or fall off.

How to use IONSYS

The doctor or nurse will get IONSYS ready to use and attach it to your upper outer arm or chest.

The slow blinking green light means IONSYS is ready to dose.

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 green light blinks faster.

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.

You will hear IONSYS beep once each time you start a dose. If it beeps at any other time, or more than once, tell your doctor or nurse immediately. They will check that IONSYS is working properly.

If you use more IONSYS than you should

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.

4. Possible side effects

(may affect more than 1 in 10 people) sick (nausea) or being sick (vomiting) ing of skin at the patch site

Common (may affect up to 1 in 10 people)

• 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

Uncommon (may affect up to 1 in 100 people)

• 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
• chills
• back pain, pain in arms or legs
• pain, bumps, or dry skin at the patch sit
• high blood pressure
• fall in blood pressure when standi
• decreased bowel activity
• slow breathing rate
• body pain

000 people)

blocked or runny nose cose/potassium in blood serum rmal 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

Reporting of side effects

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 By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store IONSYS

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 medi

6. Contents of the pack and other information

What IONSYS contains

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 tere

anode hydrogel: polacrilin, purified water, sodium oxide, polyvinyl alcohol

cathode hydrogel: purified water, sodium chloride, um 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.

ontents of the pack

and is made up of an electronic controller (the top housing) and a

using). The controller is made of white plastic with the identifier

tal display, a light window, and a dosing button. The drug unit is blue on the

he controller and has a red bottom housing containing the hydrogels, one of fentanyl hydrochloride.

Marketing Authorisation Holder

Incline Therapeutics Europe Ltd 21 St. Thomas Street

Bristol

BS1 6JS

United Kingdom

Tel: +44 (0)800 587 4149 or +44 (0)203 684 6344

Email:

Manufacturer

Penn Pharmaceutical Services Ltd

Instructions for use and disposal

• 3. Application of IONSYS

  
  
  
  

  Rotating circle during dosing

  
  

• 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.

4. Instructing the patient how to use IONSYS

Remember that only the patient may touch the dosing button. Tell your patient the following:

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.

• 5. Removal and disposal of IONSYS

  
  

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.

Dispose of the folded hydrogel housing in accordance with local requirements for opioid medicinal products

spose of remainder of the system, containing electronics, cording to hospital procedures for battery waste.

IONSYS Troubleshooting

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
— N° beeps —Blank display	Low battery or defective system	1. Do not use the system. 2. Dispose of system per above Step 5 -Removal and Disposal of IONSYS. 3. Place a new system on a different skin site.
	Poor skin contact	1. If IONSYS appears to be loose or lifting from the skin, secure it to patient’s skin by pressing the edges firmly or by applying non-allergenic tape. 2. If using tape, apply it along the edges of IONSYS system, do not cover the dosing button or display. 3. If system beeps again, then remove and

Blinking red for 15 seconds —Beeping for [iOn 15 seconds Steady p*' number IONSYS is not securely adhered Tape along long edges		dispose of system, and place a new system on a different skin site.
Blinking red Beeping O continuously . ®~7-----Steady number	System error	1. Remove system from patient. 2. Hold down dosing button until beeping stops and display goes blank. 3. Dispose of system per above Step 5 -Removal and Disposal of IONSYS. 4. Place a new system on a different skin site.
No light 4– —No beeps Mr ■$—-----Blinking number	End of use at 24 hours or 80 doses <^p	1. Remove system from patient. 2. Hold down dosing button until display goes blank. 3. Dispose of system per above Step 5 -Removal and Disposal of IONSYS. 4. Place a new system on a different skin site.

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.

J*

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