Patient Medication Information: uses, side effects, how to take - Fentanyl Transdermal System 25
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed Fentanyl Transdermal System to help control the chronic (long-lasting) pain you are experiencing.
What it does:
What is Fentanyl Transdermal System?
Fentanyl Transdermal System is a thin, adhesive, rectangular patch that is placed on your skin. Fentanyl Transdermal System delivers an opioid medicine called fentanyl continuously through the skin and into the bloodstream to control your pain around the clock.
What to expect from Fentanyl Transdermal System Because the medicine in Fentanyl Transdermal System is gradually released from the patch and slowly absorbed through the skin, do not expect immediate pain relief after you apply your first patch. During this initial period, your doctor may ask you to take additional pain medication until you experience the full benefits of Fentanyl Transdermal System.
While most patients obtain adequate pain relief with Fentanyl Transdermal System, your pain may vary and occasionally break through. This is not unusual. If this occurs, your doctor may prescribe additional pain medication.
It is important to let your doctor know whether or not your pain is under control. If you frequently need additional short-acting pain medication, or if pain is waking you at night, you may need a change in your Fentanyl Transdermal System dose.
If you continue to have pain, call your doctor.
Always follow your doctor’s instructions carefully and do not change or stop your Fentanyl Transdermal System medication without first consulting with your doctor.
When it should not be used:
Because life-threatening decreases in breathing rate could occur, Fentanyl Transdermal System should not be used:
- for the relief of pain before or following surgery.
- for the relief of pain which is only mild, or expected to last less than several weeks.
- if you have acute or severe bronchial asthma.
- if you have difficulty in breathing.
For the same reason, do not start on Fentanyl Transdermal System unless you have already been taking a strong opioid medication.
Because constipation is a side-effect of opioids, Fentanyl Transdermal System should not be used if you have a type of intestinal blockage known as “paralytic ileus”.
Fentanyl Transdermal System is not for children under 18 years of age unless your doctor has decided otherwise.
Do not use Fentanyl Transdermal System if you know you are hypersensitive to fentanyl, other opioid-type medications, or any of the non-medicinal ingredients (see What the nonmedicinal ingredients are).
What the medicinal ingredient is:
Fentanyl
What the nonmedicinal ingredients are:
Backing Layer: polyester film
Drug Reservoir: alcohol, hydroxyethyl cellulose Release Membrane: ethylene-vinyl acetate
Contact Adhesive: silicone adhesive
What dosage form it comes in:
Fentanyl Transdermal System transdermal patch is supplied in cartons containing 5 individually packaged systems.
Fentanyl Transdermal System comes in four strengths: 2.5 mg, 5 mg, 7.5 mg and 10 mg fentanyl per patch, delivering 25, 50, 75 and 100 mcg fentanyl per hour respectively for 72 hours.
WARNINGS AND PRECAUTIONS
Fentanyl Transdermal System is not safe for everyone. Tell your doctor about all your medical conditions. Before using Fentanyl Transdermal System be sure to tell your doctor if:
you have any other medical conditions (such as
diseases of the heart, lung, brain, liver and kidney),
- you have pancreatitis, or other biliary tract diseases,
you are pregnant or plan to become pregnant, or are
breastfeeding,
you are taking any other medications (see
INTERACTIONS WITH THIS
MEDICATION).
you have ever had an allergic reaction to any other
medication,
you have a head injury or brain tumour,
- you have a history of drug abuse,
- you have chronic and severe constipation,
- you suffer from alcoholism.
This will help your doctor decide whether you should use Fentanyl Transdermal System and what extra care should be taken during its use.
Do not drive a car or operate machinery until you are sure that using the patch does not make you drowsy.
Fever/exposure to heat sources
At high temperatures, greater than usual quantities of fentanyl can be released into your body. If you have a fever, you should contact your doctor, who may adjust your dose if necessary. Increased release of fentanyl can also result from direct exposure to heat sources.
While wearing Fentanyl Transdermal System you should not expose the patch area to sources of heat such as heating pads, electric blankets, heated waterbeds, heat lamps, saunas and hot tubs, intensive sunbathing, etc., as this may increase the drug’s ability to go through the skin and therefore result in an overdose. This may also occur if you develop a fever.
Tolerance
Fentanyl Transdermal System may lead to tolerance in the long run. It is therefore possible that your doctor will prescribe a higher dose of Fentanyl Transdermal System after some time to produce the same result.
Dependence
There is a possibility that you may become dependent on Fentanyl Transdermal System with longer term use. Discuss with your doctor.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor about all the medications you take. Some medicines may cause serious or life-threatening side effects when used with Fentanyl Transdermal System. Your doctor will tell you if it is safe to take other medications while you are using Fentanyl Transdermal System.
Know the medicines you take. Keep a list of your medicines to show to your doctor and pharmacist.
It is extremely important to avoid alcohol and such medications as tranquilizers and sleeping pills when you are using Fentanyl Transdermal System since their combined effect may cause drowsiness, depressed breathing, low blood pressure and possibly coma.
To avoid any potential drug interactions, be sure to inform your doctor before taking any other medications while you are using Fentanyl Transdermal System, including
- certain antifungal drugs (e.g. ketoconazole),
- certain antiviral drugs (e.g. ritonavir),
some antibiotics (e.g. clarithromycin),
monoamine (MAO)
inhibitors (e.g. phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegiline),
over-the-counter
medications that may cause drowsiness (e.g.
antihistamines),
- muscle relaxants,
- anaesthetics,
- sedatives or hypnotics,
- phenothiazines,
- other opioid pain medication.
Drugs that cause a decrease in the ability of the liver to break down drugs including opioids can result in high levels of opioid in the bloodstream when taken at the same time as the patch is used. These drugs include some anti-fungals, some antibiotics, and some anti-virals. Talk to your doctor before starting Fentanyl Transdermal System if you are on one of these drugs.
Patients should not consume grapefruit juice while taking this medication as it may make the side effects worse.
PROPER USE OF THIS MEDICATION
You should already be taking some type of strong opioid medication before you begin using Fentanyl Transdermal System patches.
Your doctor will determine the strength of Fentanyl Transdermal System you should use based on your own particular needs. Do not change your dose without consulting your doctor. Do not wear more than one Fentanyl Transdermal System patch at a time, unless your doctor tells you to do so. Each patch can be used for up to 72 hours (3 days).
Do not stop using Fentanyl Transdermal System suddenly (see Discontinuation of Fentanyl Transdermal System).
Do not use Fentanyl Transdermal System if the pouch is torn upon purchasing, or if the patch is cut or damaged, or changed in any way.
Where to apply Fentanyl Transdermal System Select a dry, non-hairy area on your chest, back, flank or upper arm. If the area you choose has body hair, clip (do not shave) the hair close to the skin with scissors.
Do not put the patch on skin that is excessively oily, burned, broken out, cut, irritated or damaged in any way. If you need
to clean the skin where the patch will be applied, use only clear water. Soaps, oils, lotions, alcohol or other products may irritate the skin under the patch.
How to apply Fentanyl Transdermal System
Step 1.
Each patch is sealed in its own protective pouch. Do not remove the patch from the pouch until you are ready to use it. When you are ready, tear open the pouch at the notched corner.
Step 2.
A stiff protective liner covers the sticky side of the patch - the side that will be put on your skin. Hold the liner at the edge and pull the patch from the liner. Try not to touch the sticky side of the patch. Throw away the liner.
Step 3.
Immediately after you have removed the liner, apply the sticky side of the patch to a dry area of your chest, back, flank or upper arm. Press the patch firmly on your skin with the palm of your hand for about 30 seconds.
Not all adhesive products stick to all patients. If the patch does not stick well, or loosens after application, tape only the edges down with first aid tape.
In the event that the patch falls off before 3 days or 72 hours, discard it (see Disposing of Fentanyl Transdermal System.) and put a new one on at a different skin site. Be sure to let your doctor know that this has happened, and do not replace the new patch until 3 days (72 hours) after you put it on (or as directed by your doctor).
Step 4.
Wash your hands, with water only, when you have finished applying the patch.
Step 5.
Special labels are provided to help you remember when you
In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre immediately.
last put on your patch. After putting on the patch, write the date and time on a label, then stick the label on the patch.
Step 6.
After wearing the patch for 3 days, or as directed by your doctor, remove it (see Disposing of Fentanyl Transdermal System). Then choose a different place on your skin to apply a new patch and repeat steps 1 to 5 in order.
Do not apply the new patch to the same place as the last one.
Water and Fentanyl Transdermal System
You can bathe, swim, or shower while you are wearing Fentanyl Transdermal System. If the patch falls off, discard the patch properly (see Disposing of Fentanyl Transdermal System) and apply a new one at a different skin site, making sure the new skin area you choose is dry. Be sure to let your doctor know that this has happened, and do not replace the new patch until 3 days (72 hours) after you put it on (or as directed by your doctor).
Disposing of Fentanyl Transdermal System
Before putting on a new Fentanyl Transdermal System patch, remove the patch you have been wearing. Fold the used patch in half so the sticky side sticks to itself, and flush down the toilet immediately. A used Fentanyl Transdermal System patch can be very dangerous for, or even lead to death in babies, children, pets, and adults who have not been prescribed Fentanyl Transdermal System as considerable amount of drug remains in the patch after use. Do not put used Fentanyl Transdermal System patches in a trash can.
Wash your hands, with water only, after removing the patch.
Dispose of any patches that are left over from your prescription as soon as they are no longer needed. Remove the left-over patches from their protective pouches and remove the protective liners. Fold the patches in half and flush down the toilet. Do not flush the pouch or protective liner.
Fentanyl Transdermal System contains fentanyl, a drug with a high potential for abuse. Your discarded patches contain a considerable amount of drug, and flushing is an effective way to prevent theft or misuse by others.
Safety and handling
Fentanyl Transdermal System is sealed to keep the gel from getting on your hands or body. If the gel from the drug reservoir accidentally touches the skin, wash the area with large amounts of water. Do not use soap, alcohol, or other solvents to remove the gel because they may increase the drug’s ability to go through the skin.
Do not cut, damage or chew Fentanyl Transdermal System.
Fentanyl Transdermal System will not work properly, or may not be safe, if it is damaged in any way.
Do not let anyone else use your Fentanyl Transdermal System. A Fentanyl Transdermal System patch must be used only on the skin of the person whom it was prescribed. Fentanyl Transdermal System contains fentanyl, a drug with a high potential for abuse. Your patches must be protected from theft or misuse in the home or work environment.
Serious medical consequences, including death, have occurred when patches were accidentally transferred to other people, for example while hugging, sharing a bed or moving a patient. If your patch dislodges and accidentally sticks to the skin of another person, take the patch off immediately, wash the area with water, and get medical care for them right away. This is true for both fresh and used patches, as a considerable amount of drug remains in the patch after use.
Do not exceed the dose recommended by your doctor.
Overdose:
The most important sign of overdose is suppressed breathing. If a person is breathing abnormally slowly or weakly, remove the patch and seek emergency medical care immediately. Meanwhile, keep the person awake by talking or by shaking him/her every now and then.
Other signs of fentanyl overdose may include tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused, seizure and hallucination.
Missed Dose:
If a patch is left on for more than three days (72 hours), remove patch and apply a new patch following instructions given (see PROPER USE OF THIS MEDICATION).
Discontinuation of Fentanyl Transdermal System: Please do not suddenly stop taking Fentanyl Transdermal System as it may cause unwanted side effects such as nausea, vomiting, diarrhea, anxiety and shivering. Your doctor can discuss the best way for you to stop taking Fentanyl Transdermal System.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medications, Fentanyl Transdermal System may
cause unwanted effects. Most unwanted effects appear during the first month of treatment. These effects may be more pronounced if you have a fever. If you develop a fever while using the patch, contact your doctor right away.
The most frequently reported unwanted effects are nausea, vomiting, tiredness, constipation, sweating, dry mouth, confusion, and skin irritation at the application site.
Slowed breathing has been reported by a small number of patients using fentanyl transdermal system. If this occurs, contact your doctor immediately.
Be aware that removing the patch does not completely remove the source of drug, as drug is deposited under the skin and will continue to be released into the bloodstream over the next hours after the patch is removed.
Opioid Withdrawal Symptoms
Opioid withdrawal symptoms such as nausea, vomiting, diarrhea, anxiety and shivering are possible after converting from your previous opioid analgesic to Fentanyl Transdermal System, or converting from Fentanyl Transdermal System to another opioid. Contact your doctor if you experience these symptoms when switching to or from Fentanyl Transdermal System.
| SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT | ||
| THEM |
Serious and life-threatening breathing problems can happen because of an overdose or if the dose you are using is too high for you (see Overdose). If breathing problems develop, seek emergency medical care immediately.
There have been very rare reports of serious allergic reactions, such as Stevens-Johnson syndrome (rash and fever or sore eyes/mouth), airway constriction, swelling, and anaphylactic shock. In one case, it was the patient caretaker who experienced the allergic reaction, from applying the patch to the patient. If these symptoms develop seek emergency medical care immediately.
There have been rare reports of seizures (convulsions) in people using Fentanyl Transdermal System. If you notice anything unusual, please contact your doctor immediately.
This is not a complete list of side effects. For any unexpected effects while taking Fentanyl Transdermal System, contact your doctor or pharmacist.
HOW TO STORE IT
Keep Fentanyl Transdermal System out of the sight and reach of children.
Keep Fentanyl Transdermal System in its protective pouch until you are ready to use it. Store Fentanyl Transdermal System between 15o and 25oC. Do not refrigerate or freeze. Remember, the inside of your car can reach temperatures much higher than 25oC (77oF) on a sunny day. Do not carry pouch in your pocket as it may reach body temperature (36oC).
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: ----------------------------------------------------------------------
-
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://xxxx or by contacting the sponsor, ACTAVIS Group PTC ehf., at:xxxx.