Fentanyl Mylan contains a medicine called fentanyl . It belongs to a group of strong painkillers called opioids.
<\/p>\n\n\n\n
Fentanyl contained in Fentanyl Mylan may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
<\/p>\n\n\n\n
What you need to know before you use Fentanyl Mylan<\/h2>\n\n\n\nDo not use Fentanyl Mylan<\/h2>\n\n\n\n- if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).<\/li>
- if you suffer from pain that lasts only a short period of time, such as sudden pain or pain after a surgical procedure<\/li>
- if you have difficulty breathing with slow or shallow breathing.<\/li><\/ul>\n\n\n\n
Do not use this medicine if any of the above apply to you or your child. If you have any further questions, ask your doctor or pharmacist before using Fentanyl Mylan.<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n- Fentanyl Mylan can cause life-threatening side effects in people who are not already regularly taking prescription opioid medicines. <\/li>
- Fentanyl Mylan is a drug that can be life-threatening for children. This also applies to used patches. Keep in mind that a self-adhesive patch (unused or used) can be attractive to a child and if the patch sticks to the child’s skin or if the child puts it in his mouth, it can be fatal.<\/li><\/ul>\n\n\n\n
Depot patches that have adhered to another person<\/strong><\/p>\n\n\n\nThe patch should only be used on the skin of the person prescribed by the doctor. There are reported cases where a patch was accidentally stuck to a family member during close physical contact or when a bed was shared with the wearer of the patch. A patch that has adhered to another person (especially a child) can cause drugs to pass through the other person’s skin and cause serious side effects such as difficulty breathing with slow and shallow breathing, which can be fatal. If the patch has adhered to another person’s skin, remove the patch immediately and consult a physician.
<\/p>\n\n\n\n
Take special care with Fentanyl Mylan<\/strong><\/p>\n\n\n\nTalk to your doctor or pharmacist before using this medicine if any of the following apply to you – your doctor may need to examine you more carefully about:<\/p>\n\n\n\n
- Have you ever had problems with your lungs or breathing?<\/li>
- Have you ever had problems with your heart, liver, kidneys, or had low blood pressure?<\/li>
- You’ve ever had a brain tumor<\/li>
- Have you ever had a prolonged headache or a head injury<\/li>
- You are older – you may be more sensitive to the effects of this medicine<\/li>
- You have a disease called myasthenia gravis when the muscles become weak and tired quickly<\/li>
- Have you ever abused or been addicted to alcohol, prescription drugs, or illegal drugs.<\/li><\/ul>\n\n\n\n
If any of the above apply to you (or you feel unsure), talk to your doctor or pharmacist before using Fentanyl Mylan.
<\/p>\n\n\n\n
Side effects and <\/strong>Fentanyl Mylan<\/strong><\/p>\n\n\n\n- Fentanyl Mylan can make you unusually sleepy and cause you to breathe more slowly and shallowly. In very rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have never used strong painkillers with opioids (such as Fentanyl Mylan or morphine). If you or your partner or caregiver notice that the person wearing the patch is unusually sleepy and is breathing slowly or shallowly:<\/li>
- Remove the patch<\/li>
- Call a doctor or go to the nearest hospital immediately<\/li>
- Make sure the person is moving and talking as much as possible<\/li>
- If you get a fever while using Fentanyl Mylan, tell your doctor – it may cause an increased amount of medicine to pass through your skin.<\/li>
- Fentanyl Mylan can cause constipation. Consult a doctor or pharmacist for help in preventing or treating constipation.<\/li>
- Repeated, long-term treatment with the patches may make the medicine less effective (you will become “tolerant” of it) or make you addicted to it.<\/li><\/ul>\n\n\n\n
See section 4 for a complete list of possible side effects.
<\/p>\n\n\n\n
When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or sun lamps. You should not sunbathe, take long hot baths, bathe or take hot whirlpool baths. If you do this, you may get an increased amount of medication from the patch.<\/p>\n\n\n\n
Other medicines and Fentanyl Mylan<\/h2>\n\n\n\n
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. You should also tell the pharmacy staff that you are using Fentanyl Mylan if you buy any medicines at the pharmacy.
<\/p>\n\n\n\n
Your doctor will know which medicines are safe to take with Fentanyl Mylan. If you are taking any of the types of medicines listed below or if you stop taking any of these, you may need to be closely monitored as it may affect the dose of FentanylMylan you need.
<\/p>\n\n\n\n
Above all, tell your doctor or pharmacist if you are taking:<\/p>\n\n\n\n
- Other analgesics such as sm\u00e4rtillande drugs with opioid ‘s (such as buprenorphine, nalbuphine or pentazocine)<\/li>
- Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem)<\/li>
- Medicines that make you feel calmer (sedatives such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental problems (antipsychotics such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines)<\/li>
- Muscle relaxants (such as cyclobenzaprine or diazepam )<\/li>
- Some medicines used to treat depression, called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine ) – see below for more information<\/li>
- Some medicines for depression or Parkinson’s disease called MAO inhibitors(such as isocarboxazid, phenelzine, selegiline, or tranylcypromine<\/a>). You should not take Fentanyl Mylan within 14 days of stopping these medicines – see below for more information<\/li>
- Some antihistamines, especially those that make you sleepy (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine)<\/li>
- Some antibiotics used for infection (such as erythromycin or clarithromycin)<\/li>
- Medicines for fungal infections (such as itraconazole, ketoconazole , fluconazoleor voriconazole)<\/li>
- Drugs for HIV – infection’s (such as ritonavir)<\/li>
- Drugs for irregular heartbeat (such as amiodarone, diltiazem, or verapamil)<\/li>
- Medicines for tuberculosis (such as rifampicin)<\/li>
- Some medicines for epilepsy (such as carbamazepine, phenobarbital, or phenytoin)<\/li>
- Some medicines for nausea or motion sickness (such as phenothiazines)<\/li>
- Some medicines for heartburn or stomach ulcers (such as cimetidine)<\/li>
- Some medicines for angina (chest pain) or high blood pressure (such as nicardipine)<\/li>
- Some medicines are used to treat blood cancer (such as idelalisib).<\/li><\/ul>\n\n\n\n
Fentanyl Mylan with antidepressants<\/strong><\/p>\n\n\n\nThe risk of side effects is increased if you take medicines such as certain medicines for depression. Fentanyl Mylan can interact with these drugs and you may experience that your mental status changes so that you, for example, feel anxious or see, feel, hear or feel the smell of something that does not exist (hallucinations) and experience other effects such as altered blood pressure, rapid heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea.
<\/p>\n\n\n\n
Use with medicines that suppress the central nervous system, including alcohol and certain narcotic drugs<\/strong><\/p>\n\n\n\nTell your doctor if you are taking other medicines that suppress your central nervous system ( CNS depressants). CNS depressants are, for example, drugs that make you sleep, alleviate anxiety, or diminish attention (see also “Other drugs and FentanylMylan”). Alcohol and certain narcotic drugs also suppress the central nervous system. Taking these types of medicines along with Fentanyl Mylan can cause severe drowsiness, impaired attention, difficulty breathing with slow or shallow breathing, coma, and death. Do not drink alcohol while using FentanylMylan if you have not consulted your doctor first. Operations If you think you may be anesthetized\/anesthetized, tell your doctor or dentist that you are using Fentanyl Mylan.<\/p>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
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 taking this medicine.
<\/p>\n\n\n\n
Fentanyl Mylan should not be used during pregnancy unless you have first discussed this with your doctor.
<\/p>\n\n\n\n
Fentanyl Mylan should not be used during childbirth, as it may affect the breathing of the newborn baby.
<\/p>\n\n\n\n
Do not use Fentanyl Mylan if you are breast-feeding. You should not breast-feed for 3 days after removing the Fentanyl Mylan transdermal patch. The reason for this is that the drug can pass into breast milk.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Fentanyl Mylan may affect your ability to drive and use machines or tools as it may make you drowsy or dizzy. If this happens, do not drive or use any tools or machines. Do not drive while using this medicine until you know how it affects you.
<\/p>\n\n\n\n
If you are not sure if it is safe for you to drive a vehicle while you are taking this medicine, talk to your doctor or pharmacist.
<\/p>\n\n\n\n
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
<\/p>\n\n\n\n
3. How to use Fentanyl Mylan<\/h2>\n\n\n\n
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
<\/p>\n\n\n\n
Your doctor will decide which strength of Fentanyl Mylan is most suitable for you. The doctor bases his assessment on how severe your pain is, your general condition, and the type of pain treatment you have received so far.
<\/p>\n\n\n\n
Use and change patches<\/strong><\/p>\n\n\n\n- There is enough medicine in each patch to last for 3 days (72 hours).<\/strong><\/li>
- You should change your patch every three days unless your doctor has told you otherwise.<\/li>
- Always remove the old patch before<\/strong> applying the new one.<\/li>
- Always change patches at the same time<\/strong> of day every three days (72 hours).<\/li>
- If you use more than one patch, change all patches at once.<\/li>
- Write down the day, date, and time you put on the patch, so you know when you need to change your patch.<\/li>
- The following table shows you when it is time to change patches:<\/li>
- <\/li><\/ul>\n\n\n\n
- if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).<\/li>
- if you suffer from pain that lasts only a short period of time, such as sudden pain or pain after a surgical procedure<\/li>
- if you have difficulty breathing with slow or shallow breathing.<\/li><\/ul>\n\n\n\n
Do not use this medicine if any of the above apply to you or your child. If you have any further questions, ask your doctor or pharmacist before using Fentanyl Mylan.<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
- Fentanyl Mylan can cause life-threatening side effects in people who are not already regularly taking prescription opioid medicines. <\/li>
- Fentanyl Mylan is a drug that can be life-threatening for children. This also applies to used patches. Keep in mind that a self-adhesive patch (unused or used) can be attractive to a child and if the patch sticks to the child’s skin or if the child puts it in his mouth, it can be fatal.<\/li><\/ul>\n\n\n\n
Depot patches that have adhered to another person<\/strong><\/p>\n\n\n\n
The patch should only be used on the skin of the person prescribed by the doctor. There are reported cases where a patch was accidentally stuck to a family member during close physical contact or when a bed was shared with the wearer of the patch. A patch that has adhered to another person (especially a child) can cause drugs to pass through the other person’s skin and cause serious side effects such as difficulty breathing with slow and shallow breathing, which can be fatal. If the patch has adhered to another person’s skin, remove the patch immediately and consult a physician.
<\/p>\n\n\n\nTake special care with Fentanyl Mylan<\/strong><\/p>\n\n\n\n
Talk to your doctor or pharmacist before using this medicine if any of the following apply to you – your doctor may need to examine you more carefully about:<\/p>\n\n\n\n
- Have you ever had problems with your lungs or breathing?<\/li>
- Have you ever had problems with your heart, liver, kidneys, or had low blood pressure?<\/li>
- You’ve ever had a brain tumor<\/li>
- Have you ever had a prolonged headache or a head injury<\/li>
- You are older – you may be more sensitive to the effects of this medicine<\/li>
- You have a disease called myasthenia gravis when the muscles become weak and tired quickly<\/li>
- Have you ever abused or been addicted to alcohol, prescription drugs, or illegal drugs.<\/li><\/ul>\n\n\n\n
If any of the above apply to you (or you feel unsure), talk to your doctor or pharmacist before using Fentanyl Mylan.
<\/p>\n\n\n\nSide effects and <\/strong>Fentanyl Mylan<\/strong><\/p>\n\n\n\n
- Fentanyl Mylan can make you unusually sleepy and cause you to breathe more slowly and shallowly. In very rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have never used strong painkillers with opioids (such as Fentanyl Mylan or morphine). If you or your partner or caregiver notice that the person wearing the patch is unusually sleepy and is breathing slowly or shallowly:<\/li>
- Remove the patch<\/li>
- Call a doctor or go to the nearest hospital immediately<\/li>
- Make sure the person is moving and talking as much as possible<\/li>
- If you get a fever while using Fentanyl Mylan, tell your doctor – it may cause an increased amount of medicine to pass through your skin.<\/li>
- Fentanyl Mylan can cause constipation. Consult a doctor or pharmacist for help in preventing or treating constipation.<\/li>
- Repeated, long-term treatment with the patches may make the medicine less effective (you will become “tolerant” of it) or make you addicted to it.<\/li><\/ul>\n\n\n\n
See section 4 for a complete list of possible side effects.
<\/p>\n\n\n\nWhen wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or sun lamps. You should not sunbathe, take long hot baths, bathe or take hot whirlpool baths. If you do this, you may get an increased amount of medication from the patch.<\/p>\n\n\n\n
Other medicines and Fentanyl Mylan<\/h2>\n\n\n\n
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. You should also tell the pharmacy staff that you are using Fentanyl Mylan if you buy any medicines at the pharmacy.
<\/p>\n\n\n\nYour doctor will know which medicines are safe to take with Fentanyl Mylan. If you are taking any of the types of medicines listed below or if you stop taking any of these, you may need to be closely monitored as it may affect the dose of FentanylMylan you need.
<\/p>\n\n\n\nAbove all, tell your doctor or pharmacist if you are taking:<\/p>\n\n\n\n
- Other analgesics such as sm\u00e4rtillande drugs with opioid ‘s (such as buprenorphine, nalbuphine or pentazocine)<\/li>
- Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem)<\/li>
- Medicines that make you feel calmer (sedatives such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental problems (antipsychotics such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines)<\/li>
- Muscle relaxants (such as cyclobenzaprine or diazepam )<\/li>
- Some medicines used to treat depression, called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine ) – see below for more information<\/li>
- Some medicines for depression or Parkinson’s disease called MAO inhibitors(such as isocarboxazid, phenelzine, selegiline, or tranylcypromine<\/a>). You should not take Fentanyl Mylan within 14 days of stopping these medicines – see below for more information<\/li>
- Some antihistamines, especially those that make you sleepy (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine)<\/li>
- Some antibiotics used for infection (such as erythromycin or clarithromycin)<\/li>
- Medicines for fungal infections (such as itraconazole, ketoconazole , fluconazoleor voriconazole)<\/li>
- Drugs for HIV – infection’s (such as ritonavir)<\/li>
- Drugs for irregular heartbeat (such as amiodarone, diltiazem, or verapamil)<\/li>
- Medicines for tuberculosis (such as rifampicin)<\/li>
- Some medicines for epilepsy (such as carbamazepine, phenobarbital, or phenytoin)<\/li>
- Some medicines for nausea or motion sickness (such as phenothiazines)<\/li>
- Some medicines for heartburn or stomach ulcers (such as cimetidine)<\/li>
- Some medicines for angina (chest pain) or high blood pressure (such as nicardipine)<\/li>
- Some medicines are used to treat blood cancer (such as idelalisib).<\/li><\/ul>\n\n\n\n
Fentanyl Mylan with antidepressants<\/strong><\/p>\n\n\n\n
The risk of side effects is increased if you take medicines such as certain medicines for depression. Fentanyl Mylan can interact with these drugs and you may experience that your mental status changes so that you, for example, feel anxious or see, feel, hear or feel the smell of something that does not exist (hallucinations) and experience other effects such as altered blood pressure, rapid heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea.
<\/p>\n\n\n\nUse with medicines that suppress the central nervous system, including alcohol and certain narcotic drugs<\/strong><\/p>\n\n\n\n
Tell your doctor if you are taking other medicines that suppress your central nervous system ( CNS depressants). CNS depressants are, for example, drugs that make you sleep, alleviate anxiety, or diminish attention (see also “Other drugs and FentanylMylan”). Alcohol and certain narcotic drugs also suppress the central nervous system. Taking these types of medicines along with Fentanyl Mylan can cause severe drowsiness, impaired attention, difficulty breathing with slow or shallow breathing, coma, and death. Do not drink alcohol while using FentanylMylan if you have not consulted your doctor first. Operations If you think you may be anesthetized\/anesthetized, tell your doctor or dentist that you are using Fentanyl Mylan.<\/p>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
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 taking this medicine.
<\/p>\n\n\n\nFentanyl Mylan should not be used during pregnancy unless you have first discussed this with your doctor.
<\/p>\n\n\n\nFentanyl Mylan should not be used during childbirth, as it may affect the breathing of the newborn baby.
<\/p>\n\n\n\nDo not use Fentanyl Mylan if you are breast-feeding. You should not breast-feed for 3 days after removing the Fentanyl Mylan transdermal patch. The reason for this is that the drug can pass into breast milk.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Fentanyl Mylan may affect your ability to drive and use machines or tools as it may make you drowsy or dizzy. If this happens, do not drive or use any tools or machines. Do not drive while using this medicine until you know how it affects you.
<\/p>\n\n\n\nIf you are not sure if it is safe for you to drive a vehicle while you are taking this medicine, talk to your doctor or pharmacist.
<\/p>\n\n\n\nYou are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
<\/p>\n\n\n\n3. How to use Fentanyl Mylan<\/h2>\n\n\n\n
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
<\/p>\n\n\n\nYour doctor will decide which strength of Fentanyl Mylan is most suitable for you. The doctor bases his assessment on how severe your pain is, your general condition, and the type of pain treatment you have received so far.
<\/p>\n\n\n\nUse and change patches<\/strong><\/p>\n\n\n\n
- There is enough medicine in each patch to last for 3 days (72 hours).<\/strong><\/li>
- You should change your patch every three days unless your doctor has told you otherwise.<\/li>
- Always remove the old patch before<\/strong> applying the new one.<\/li>
- Always change patches at the same time<\/strong> of day every three days (72 hours).<\/li>
- If you use more than one patch, change all patches at once.<\/li>
- Write down the day, date, and time you put on the patch, so you know when you need to change your patch.<\/li>
- The following table shows you when it is time to change patches:<\/li>
- <\/li><\/ul>\n\n\n\n
![\"fig](\"https:\/\/www.fass.se\/res\/RootMedia\/Mylan\/Media\/Fentanyl\/Figur1.jpg\")
<\/a><\/figure>\n\n\n\n![\"fig](\"https:\/\/www.fass.se\/res\/RootMedia\/Mylan\/Media\/Fentanyl\/Figur2.jpg\")
<\/a><\/figure>\n\n\n\n![\"fig](\"https:\/\/www.fass.se\/res\/RootMedia\/Mylan\/Media\/Fentanyl\/Figur3.jpg\")
<\/a><\/figure>\n\n\n\n![\"fig](\"https:\/\/www.fass.se\/res\/RootMedia\/Mylan\/Media\/Fentanyl\/Figur4.jpg\")
<\/a><\/figure>\n\n\n\n![\"fig](\"https:\/\/www.fass.se\/res\/RootMedia\/Mylan\/Media\/Fentanyl\/Figur5.jpg\")
<\/a><\/figure>\n\n\n\n![\"fig](\"https:\/\/www.fass.se\/res\/RootMedia\/Mylan\/Media\/Fentanyl\/Figur6.jpg\")
<\/a><\/figure>\n\n\n\n![\"fig](\"https:\/\/www.fass.se\/res\/RootMedia\/Mylan\/Media\/Fentanyl\/Figur7.jpg\")
<\/a><\/figure>\n\n\n\n![\"fig](\"https:\/\/www.fass.se\/res\/RootMedia\/Mylan\/Media\/Fentanyl\/Figur8.jpg\")
<\/a><\/figure>\n\n\n\n