Prospect: information for the user
Fendivia 12 micrograms/hour transdermal patch
Fendivia 25 micrograms/hour transdermal patch
Fendivia 50 micrograms/hour transdermal patch
Fendivia 75 micrograms/hour transdermal patch
Fendivia 100 micrograms/hour transdermal patch
fentanyl
Read this prospect carefully before starting to use the medication, as it contains important information for you.
6. Contents of the package and additional information
The name of your medication is Fendivia
The patches help to relieve very strong and persistent pain:
Fendivia contains a medication called fentanil. It belongs to a group of strong pain-relieving medications called opioids.
Do not use Fendivia:
Do not use this medication if you or your child is in any of the above circumstances. If you are unsure, consult your doctor or pharmacist before using Fendivia.
Warnings and precautions
If the patch sticks to another person
The patch must be used only on the skin of the person for whom the doctor prescribed it. There have been some cases where the patch has accidentally stuck to another family member by close physical contact or sharing the same bed with the person wearing the patch. If the patch accidentally sticks to another person (particularly a child), the medication from the patch may pass through the other person's skin and may cause severe adverse effects, such as difficulty breathing, slow or weak breathing that can be fatal. In the event that the patch sticks to someone else's skin, it must be removed immediately and the person must see a doctor.
Be especially careful with Fendivia
Consult your doctor or pharmacist beforeusing this medication if you are in any of the following circumstances. Your doctor will have to monitor you more closely:
If you meet any of the above conditions (or if you are unsure), consult your doctor or pharmacist before using Fendivia.
While using the patch, inform your doctor if you have difficulty breathing while sleeping.
Opioids like Fendivia can cause sleep-related respiratory disturbances, such as sleep apnea (breathing interruptions during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Inform your doctor if you, your partner, or caregiver notice that you have any of the following symptoms:
• pauses in breathing during sleep
• waking up at night due to difficulty breathing
• difficulty staying asleep
• excessive daytime sleepiness.
Your doctor may decide to change your dose.
While using the patch, inform your doctor if you notice a change in the pain you feel.If you feel:
• the pain is no longer relieved by the patch
• an increase in pain
• a change in how you feel the pain (for example, you feel pain in another part of your body)
• pain when something touches your body that you would not expect to hurt.
Do not change the dose yourself. Your doctor may decide to change your dose or treatment.
Adverse effects and Fendivia
See section 4 for the complete list of possible adverse effects.
When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, hot tubs, or heat lamps or tanning beds. Do not take the sun or long hot baths and do not use saunas or hot tubs. If you do, it may increase the amount of medication released from the patch.
Long-term use and tolerance
This medication contains fentanyl, an opioid. Repeated use of opioid analgesics can make the medication less effective (your body becomes accustomed to it, known as pharmacological tolerance). It is also possible that you may become more sensitive to pain when using Fendivia. This is known as hyperalgesia. Increasing the dose of the patches may continue to reduce pain for a while, but it may also be harmful. If you notice that the
medication is losing its effectiveness, consult your doctor. Your doctor will decide whether it is better to increase the dose or to gradually reduce the use of Fendivia.
Dependence and addiction
The repeated use of Fendivia can also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use. Dependence or addiction may cause you to feel a lack of control over the amount of medication you should use or how often you should use it. You may feel the need to continue using the medication even if it does not help to relieve pain.
The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Fendivia may be higher if:
• You or someone in your family has ever abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood problems (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for another mental illness.
If you notice any of the following symptoms while using Fendivia, it could be a sign of dependence or addiction.
• You need to use the medication for a longer time than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medication for reasons other than those prescribed, such as "to stay calm" or "to help you sleep".
• You have made repeated and unsuccessful attempts to stop using the medication or control its use.
• You feel unwell when you stop using the medication, and you feel better once you take it again ("withdrawal symptoms").
If you notice any of these signs, consult your doctor to determine the best course of treatment for you, when it is appropriate to stop the medication, and how to do it safely.
Withdrawal symptoms when stopping Fendivia
Do not stop using this medication suddenly. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heart beating (palpitations), increased high blood pressure, nausea, vomiting, diarrhea, loss of appetite, tremors, chills, or sweating may occur. If you want to stop using this medication, talk to your doctor first. Your doctor will advise you on how to do it, usually by gradually reducing the dose to minimize unpleasant withdrawal symptoms as much as possible.
Using Fendivia with other medications
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications purchased without a prescription and herbal remedies. You should also inform your pharmacist that you are using Fendivia if you buy any medication at the pharmacy.
Your doctor will know which medications can be used safely with Fendivia. You may need to be closely monitored if you are using any of the types of medications listed below or if you stop using any of the types of medications listed, as this may affect the dose of Fendivia you need.
Especially, inform your doctor or pharmacist if you are using:
Using Fendivia with antidepressants
The risk of adverse effects increases if you are using medications such as certain antidepressants. Fendivia may interact with these medications, and you may experience changes in your mental state such as agitation, seeing, feeling, hearing, or smelling things that are not there (hallucinations), and other effects such as changes in blood pressure, rapid heartbeat, high body temperature, hyperactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea (these may be signs of the serotonin syndrome). If used together, your doctor may want to monitor you closely to detect such adverse effects, especially when starting treatment or changing the dose of your medication.
Using Fendivia with central nervous system depressants, including alcohol and some narcotics
The concurrent use of Fendivia and sedatives, such as benzodiazepines or related medications, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, concurrent use should be considered only when there are no other possible treatment options.
However, if your doctor has prescribed Fendivia and sedatives simultaneously, the dose and duration of treatment should be limited by your doctor.
Inform your doctor of all sedatives you are using, and follow the recommended dose by your doctor.
It may be helpful to inform your family and friends of the signs and symptoms mentioned above. Talk to your doctor if you experience any of these symptoms.
Use in athletes
Inform athletes that this medication contains a component that may result in a positive analytical result in the doping control test.
Operations
If you think you will receive anesthesia, inform your doctor or dentist that you are using Fendivia.
Using Fendivia with alcohol
Do not drink alcohol while using Fendivia, unless you have talked to your doctor first.
Fendivia may make you feel sleepy or breathe more slowly. Drinking alcohol may worsen these effects.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication
Fendivia should not be used during pregnancy, unless you have talked to your doctor.
Fendivia should not be used during childbirth, as the medication may affect the newborn's breathing.
Prolonged use of Fendivia during pregnancy may cause withdrawal symptoms (such as loud crying, nervousness, convulsions, poor feeding, and diarrhea) in your newborn baby that may be life-threatening if not recognized and treated. Talk to a doctor immediately if you think your baby may have withdrawal symptoms.
Do not use Fendivia if you are breastfeeding. Do not breastfeed for 3 days after removing the Fendivia patch. This is because the medication may pass into breast milk.
Driving and operating machinery
Fendivia may affect your ability to drive and operate machinery, as it may cause drowsiness or dizziness. If so, do not drive or operate tools or machinery. Do not drive while using this medication until you know how it affects you.
Talk to your doctor or pharmacist if you have doubts about whether it is safe for you to drive while using this medication.
Follow exactly the administration instructions of this medication indicated by your doctor.In case of doubt,consult your doctor or pharmacist again.
Your doctor will decide what concentration of Fendivia is most suitable for you, taking into account the intensity of your pain, your general condition, and the type of pain treatment you have received so far.
Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of Fendivia, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2, withdrawal symptoms when stopping the use of Fendivia).
How to apply and change the patches
Apply the patch on | Change the patch on | |
Monday | Thursday | |
Tuesday | Friday | |
Wednesday | Saturday | |
Thursday | Sunday | |
Friday | Monday | |
Saturday | Tuesday | |
Sunday | Wednesday |
Where to apply the patch
Adults
Children
Adults and children:
Do not apply the patch to
How to apply the patch
Step 1: Prepare the skin
Step 2: Open the package
Step 3: Peel and press
Step 4: Dispose of the patch
Step 5: Wash your hands
More information about using Fendivia
Activities during patch use
How long do the patches take to act?
For how long will you need to use the patches?
If the pain worsens
If you use too many patches or a patch with the wrong dose
If you have applied too many patches or a patch with the wrong dose, remove them and contact your doctor immediately, go to the hospital, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount applied.
The signs of overdose include breathing problems or weak breathing, fatigue, extreme drowsiness, inability to think clearly or walk or talk normally, and dizziness or confusion. An overdose can also cause a brain disorder known as toxic leukoencephalopathy.
If you forget to change the patch
If the patch falls off
If you want to stop using the patches
If you have any other questions about using this medication, ask your doctor or pharmacist.
Like all medicines, this medicine can produce side effects, although not everyone will experience them.Although not everyone will experience them.
If you, or your partner or caregiver, observe any of the following signs in the person wearing the patch, remove the patch and call a doctor or go immediately to the nearest hospital. You may need urgent medical treatment.
Follow the previous recommendations and have the person wearing the patch move and talk as much as possible. In very rare cases, these breathing difficulties can compromise life or even be fatal, especially in people who have not used strong opioid analgesics (such as Fendivia or morphine) before. (Rare, may affect up to 1 in 100 patients).
They may all be signs of a severe allergic reaction. (Frequency cannot be estimated from available data).
The following side effects have also been reported
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Rare (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1000 people)
Unknown frequency (cannot be estimated from available data)
You may notice rashes, redness, or a mild itching sensation on the skin where the patch is applied. It is usually mild and disappears after removing the patch. If not, or if the patch irritates your skin a lot, inform your doctor.
Repeated use of the patches may make the medicine less effective (you become accustomed or may become more sensitive to pain), or you may become dependent.
If you switch from another analgesic to Fendivia or if you stop using Fendivia abruptly, you may experience withdrawal symptoms, such as dizziness, nausea, diarrhea, anxiety, or tremors. Inform your doctor if you notice any of these effects.
Cases of newborn babies experiencing withdrawal symptoms after their mothers used Fendivia for an extended period during pregnancy have also been reported.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly throughthe Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.
Keep all patches (used and unused) out of sight and reach of children.
Store this medication in a safe and secure location where other people cannot access it. It may cause serious harm and be fatal to people who use this medication by accident or intentionally when not prescribed.
How Long Can Fendivia Be Stored
Do not use this medication after the expiration date that appears on the box and on the package after CAD. The expiration date is the last day of the month indicated. If the patches are expired, take them to the pharmacy.
How to Dispose of Used Patches or Unused Patches
Accidental exposure of another person to used and unused patches, especially in children, may result in a fatal outcome.
Used patches should be folded firmly in half, so that the adhesive side of the patch adheres to itself. Then they should be safely disposed of by placing them in the original package and storing them out of sight and reach of other people, especially children, until they are safely disposed of.
Medications should not be thrown down the drain or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.
The active principle is: Fentanyl.
The patches are available in 5 different doses (see table below).
Name of the patch | Each patch contains: | Each patch releases a dose of: | The active surface area of each patch is: |
Fendivia 12 micrograms/hour transdermal patch | 1.38 mg | 12 micrograms/hour | 4.2 cm2 |
Fendivia 25 micrograms/hour transdermal patch | 2.75 mg | 25 micrograms/hour | 8.4 cm2 |
Fendivia 50 micrograms/hour transdermal patch | 5.5 mg | 50 micrograms/hour | 16.8 cm2 |
Fendivia 75 micrograms/hour transdermal patch | 8.25 mg | 75 micrograms/hour | 25.2 cm2 |
Fendivia 100 micrograms/hour transdermal patch | 11 mg | 100 micrograms/hour | 33.6 cm2 |
The other components are: Dipropylglycol, hydroxypropyl cellulose, dimethicone, silicone adhesive (amine-resistant), ethylene-vinyl acetate (EVA, release membrane), polyethylene terephthalate (PTE, outer plastic sheet), polyester coated with fluoropolymer (protective sheet) and printing ink.
Appearance of the product and contents of the package
Fendivia is a transparent and rectangular transdermal patch. Each patch is packaged in a heat-sealed, child-resistant, paper, aluminum, and polyethylene terephthalate (PET) envelope.
Each transdermal patch has printed in a specific color the commercial name, active principle, and dose:
Fendivia 12 micrograms/hour: brown print
Fendivia 25 micrograms/hour: red print
Fendivia 50 micrograms/hour: green print
Fendivia 75 micrograms/hour: light blue print
Fendivia 100 micrograms/hour: gray print
The patches are supplied in cardboard containers containing 1, 3, 5, 10, and 20 patches. Only some package sizes may be marketed.
Holder of the marketing authorization and responsible for manufacturing
Holder of the marketing authorization
ISTITUTO GENTILI S.r.l.
Via San Giuseppe Cottolengo 15
20143 Milan, Italy
Responsible for manufacturing:
LTS Lohmann Therapie-Systeme AG
Lohmannstrasse 2
D – 56626 Andernach
Germany
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
Local representative:
FERRER FARMA, S.A.
Av. Diagonal, 549, 5th Floor,
08029 Barcelona (Spain)
This medication is authorized in the member states of the European Economic Area with the following names:
Matrifen: Cyprus
Quatrofen: Sweden
Fendivia: Spain
Last review date of this leaflet: 12-06-2024
More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
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