How it should be used
See also section Warnings.
Read the medication guide and, if available, the instructions for use from the pharmacy before you start using this medicine and each time you get a refill. Learn how to use, store and dispose of the patches correctly. If you have any questions, ask your doctor or pharmacist.
Use this medication on a regular schedule as directed by your doctor, not as needed for sudden (breakthrough) pain.
Before you start using this medicine, ask your doctor or pharmacist if you should stop taking or change how you use other opioid medicines. It can take up to 24 hours before you get pain relief from the fentanyl patch. Other pain relievers (such as paracetamol, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about the safe use of fentanyl with other medicines.
Apply this medicine to the skin as directed by your doctor. Do not apply to burns, cuts, irritated skin or skin that has been exposed to radiation (x-ray treatment). Choose a dry, non-hairy area on a flat part of the body, such as the chest, sides, back or upper arms. For young children or people who are unable to think clearly (eg due to dementia), you should place the patch on the upper back to reduce the chance of it being removed or put in the mouth. If there is hair on the skin, use scissors to cut the hair as close to the skin as possible. Do not shave your hair as this may cause skin irritation. If necessary, use water to clean the area. Do not use soap, oils, creams or alcohol on the application site. Dry the skin well before applying the patch.
The patch is usually changed every 72 hours. To avoid irritation, use a new area each time. Be sure to remove the old patch before applying a new patch. The used patch still contains enough fentanyl to cause serious harm, even kill a child or pet, so fold it in half with the sticky sides together and dispose of it properly. Do not let children see you apply a patch, and do not put the patch where children can see it. Children have found plasters that have fallen off or removed plasters from sleeping adults and put them in their mouths or on their bodies with fatal outcomes. (See also section Warning).
Do not use the patch if it appears broken, cut or damaged. Take the patch out of the sealed bag, peel off the protective film and apply it to the skin immediately. Press firmly in place with the palm of your hand for 30 seconds, making sure the contact is complete (especially around the edges). If the prescribed dose is for more than one patch, make sure that the edges of the patches do not touch or overlap. Wash your hands after applying the patch.
If you have problems with the patch not sticking to the application site, you can tape the edges in place with first aid tape. If this problem persists, ask your doctor for advice. If the patch falls off before 72 hours, a new patch can be placed in another place on the skin. Be sure to let your doctor know if this happens.
If you accidentally come into contact with the sticky layer on the skin or handle a cut or damaged patch, wash the area thoroughly with clean water. If the patch comes off and accidentally sticks to another person’s skin, immediately remove the patch, wash the area with water, and get medical help right away. Do not use soap, alcohol or other products to wash the area.
The dosage is based on your medical condition and response to treatment. Do not use more plasters than prescribed, change them more often or use them for longer than prescribed.
If you suddenly stop taking this medicine, it can lead to withdrawal, especially if you have been using it for a long time or in high doses. To prevent withdrawal, your doctor may reduce your dose slowly. Tell your doctor or pharmacist right away if you have withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, suicidal thoughts), watery eyes, runny nose, nausea, diarrhea, sweating, muscle pain, or sudden changes in behavior.
When this medicine is used for a long time, it may not work as well. Talk to your doctor if this medicine stops working well.
Although it helps many people, this medication can sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse or dependence on drugs/alcohol). Use this medicine exactly as prescribed to reduce the risk of addiction. Ask your doctor or pharmacist for more information.
Tell your doctor if your pain does not improve or if it gets worse.
Side effects
Warnings and precautions
Storage
Store at room temperature protected from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medicines out of the reach of children and pets. See also the Warning section.
Do not flush medicines down the toilet or pour them down the drain unless you are told to do so. Dispose of this product properly when it has expired or is no longer needed (see also How to use section). For more information, read the instructions for use, or consult your pharmacy or local waste management company.
Interactions with other medicinal products
See also section Warnings.
Drug interactions can change how your medicines work or increase your risk of serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/over-the-counter and herbal medicines) and share it with your doctor and pharmacist. Do not start, stop or change the dosage of any medication without your doctor’s approval.
Some products that may interact with this drug include: certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), naltrexone.
Other medicines can affect the excretion of fentanyl from your body, which can affect how fentanyl works. Examples include cimetidine, nefazodone, azole antifungals including itraconazole/ketoconazole, calcium channel blockers such as diltiazem/verapamil, HIV drugs such as nelfinavir/ritonavir, macrolide antibiotics including clarithromycin/erythromycin, rifamycins including rifampin, certain anticonvulsant drugs including carbamazepine, among others.
Taking MAO inhibitors with this drug can cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this drug. Most MAO inhibitors should also not be taken for two weeks before treatment with this medicine. Ask your doctor when to start or stop taking this medicine.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may increase if this medicine is used with other medicines that can also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioids for pain or cough (eg codeine, hydrocodone), alcohol, marijuana (cannabis), medicines for sleep or anxiety (eg alprazolam, lorazepam, zolpidem) , muscle relaxants (eg carisoprodol, cyclobenzaprine) or antihistamines (eg cetirizine, diphenhydramine).
Check the labels of all your medications (such as allergy or cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist how to use these products safely.
The risk of serotonin syndrome/toxicity increases if you also take other drugs that increase serotonin. Some examples are street drugs such as MDMA/”ecstasy”, St. John’s wort, certain antidepressants (such as SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when starting or increasing the dose of these drugs.
This medicine may interfere with certain laboratory tests (including amylase/lipase levels), which may lead to false test results. Make sure laboratory personnel and all your doctors know that you are using this medicine.
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