Package Insert: Information for the User
Abattra 25micrograms/hour transdermal patch EFG
Fentanilo
Read this package insert carefully before starting to use this medication, as it contains important information for you.
1.What isAbattraand how it is used
2.What you need to know before starting to useAbattra
3.How to useAbattra
4.Possible adverse effects
5.Storage ofAbattra
6.Contents of the package and additional information
This medication is calledAbattra.
The patches help to relieve very strong and persistent pain:
Abattracontains a medication called fentanil. It belongs to a group of strong pain-relieving medications called opioids.
Do not useAbattra:
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 usingthis medication.
Warnings and precautions
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If the patch sticksto another person
The patch should only be used on the skin of the person to whom it was prescribed by the doctor. There have been some cases where the patch stuck accidentally to another person by close physical contact or by sharing the same bed as the patch wearer. If the patch sticks accidentally to another person (especially a child), the medication from the patch can pass through the skin of the other person and may cause severe adverse effects, such as difficulty breathing, slow or weak breathing that can be fatal. In case the patch sticks to the skin of another person, remove it immediately and seek medical attention.
Be extra careful with Abattra
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 Abattra.
While using the patch, report to your doctor if you have breathing problems while sleeping.Opioids likeAbattracan cause sleep-related breathing disorders such as sleep apnea (pauses in breathing while sleeping) and sleep-related hypoxemia (low oxygen levels in the blood). Talk to your doctor if you, your partner, or caregiver observe any of the following symptoms:
Your doctor may decide to modify the dose.
While using the patch, report to your doctor if you notice a change in the pain you feel.If you feel:
Do not change the dose on your own. Your doctor may decide to modify the dose or change the treatment.
Side effects and Abattra
See section 4 for the complete list of possible side 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, you may increase the amount of medication released from the patch.
Use in athletes
Inform athletes that this medication contains a component that may result in a positive analytical result in doping control.
Symptoms of withdrawal when stopping Abattra
Do not stop using this medication abruptly. You may experience withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhea, loss of appetite, tremors, chills, or sweating. If you want to stop using this medication, talk to your doctor first. Your doctor will tell you how to do it, usually the dose will be gradually reduced to minimize unpleasant withdrawal effects.
Long-term use and tolerance
This medication contains fentanyl, an opioid medication. Repeated use of opioid analgesics may make the medication less effective (you become accustomed to it, known as medication tolerance). You may also become more sensitive to pain while using Abattra, known as hyperalgesia. Increasing the dose of the patches may help reduce pain for a while, but it may also be harmful. If you notice that your medication becomes less effective, talk to your doctor. Your doctor will decide whether it is better for you to increase the dose or gradually reduce the use of Abattra.
Dependence and addiction
The repeated use of this medication may also cause dependence, abuse, and addiction, which may lead to a potentially fatal overdose. The risk of these side effects may increase with a higher dose and longer duration of use. Dependence or addiction may make you feel that you no longer have control over the amount of medication you need to use or how often you need to use it. You may feel that you need to continue using your medication, even if it no longer helps to relieve your pain.
The risk of becoming dependent or addicted to Abattra varies from person to person. You may have a higher risk of becoming dependent or addicted to Abattra if:
If you observe any of the following signs while using Abattra, it could be a sign that you have become dependent or addicted:
If you notice any of these signs, talk to your doctor to analyze the best course of treatment for you, even when it is appropriate to stop and how to stop safely.
Other medications and Abattra
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
This includes over-the-counter medications and herbal remedies. You should also inform your pharmacist that you are using Abattra if you buy any medication at the pharmacy.
Your doctor will know which medications can be taken safely with Abattra. They may need to monitor you closely if you are taking any of the types of medications listed below or if you stop taking any of the types of medications listed, as this may affect the dose of Abattra you need.
Especially, inform your doctor or pharmacist if you are taking:
Use of Abattra with antidepressants
The risk of side effects increases if you are taking certain antidepressants. Abattra may interact with these medications and you may experience changes in 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 serotonin syndrome). If used together, your doctor may want to monitor you closely to detect such side effects, especially when starting treatment or when changing the dose of your medication.
Use with central nervous system depressants, including alcohol and some narcotics
The concomitant use of Abattra and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Abattra along with sedatives, your doctor should limit the dose and duration of concomitant treatment.
Inform your doctor about all sedatives you are taking and follow your doctor's recommendations closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Communicate with your doctor when you experience these symptoms.
Do not drink alcohol while using Abattra unless you have first talked to your doctor.
Surgery
If you think you will receive anesthesia, inform your doctor or dentist that you are using Abattra.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.
Abattra should not be used during pregnancy, unless you have talked to your doctor.
Abattra should not be used during delivery, as the medication may affect the newborn's breathing.
Prolonged use ofAbattraduring pregnancy may cause withdrawal symptoms (such as loud crying, feeling restless, convulsions, poor feeding, and diarrhea) in your newborn, which may be potentially fatal if not recognized and treated. Talk to your doctor immediately if you think your newborn may have withdrawal symptoms.
Do not use Abattra if you are breastfeeding. Do not breastfeed for 3 days after removing the Abattra patch. This is because the medication may pass into breast milk.
Driving and operating machinery
Abattra may affect your ability to drive and operate machinery or tools, 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.
Abattra contains soy oil
This medication contains soy oil. In rare cases, soy oil may cause allergic reactions.
Do not use it in case of an allergy to peanuts or soy.
Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
Before starting treatment and frequently during treatment, your doctor will also explain what you can expect from the use of Abattra, when and for how long you should use it, when to contact your doctor, and when to discontinue it (see also section 2, Withdrawal symptoms when stopping Abattra).
Your doctor will decide what concentration of this medication 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.
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 Abattra
Activities during the use of patches
How long do the patches take to act?
How long will you have 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.
Symptoms 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 cause side effects, 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 to the nearest hospital immediately. You may need urgent medical treatment.
Follow the previous recommendations and have the person wearing the patch move and speak 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 asAbattraor morphine) before. (Rare, may affect up to 1 in 100 patients).
They can 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 1,000 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 medication less effective (you become accustomed to it or become more sensitive to pain) or may cause dependence.
If you switch from another analgesic toAbattraor stop usingAbattraabruptly, you may experience withdrawal symptoms, such as dizziness, feeling sick, diarrhea, anxiety, or tremors. Inform your doctor if you notice any of these effects.
There have also been reports of newborn babies experiencing withdrawal symptoms after their mothers usedAbattrafor an extended period during pregnancy.
Reporting side effects
If you experience any type of side effect, consult your doctor, pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Where to Store the Patches
Keep all patches (used and unused) out of sight and reach of children.
This medication does not require special storage conditions.
Store this medication in a protected and secure location where other people cannot access it. It can be very harmful and cause death to people who may accidentally or intentionally use this medication when not prescribed.
How Long You Can Store AbattraAbattra
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 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 adheres to itself. Then, they should be safely disposed of by placing them in the original package and keeping them out of sight and reach of other people, especially children, until they are safely disposed of. Unused patches should be returned to the pharmacy.
Medications should not be thrown away through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This way, you will help protect the environment.
Composition ofAbattra
The active ingredient is fentanil.
Abattra25 μg/h: Each transdermal patch contains 5.1 mg of fentanil on a surface of 8.5 cm2and releases 25 micrograms of fentanil per hour.
The other components are:
Matrix components:Extract of aloe vera oil (based on soybean oil
tocopherol acetate), colophony resin, poly(2-ethylhexyl acrylate, vinyl acetate) (50:50)
Removable coating:Polyethylene terephthalate, polyester, siliconized
Supporting film printed:Polyethylene terephthalate film, printing ink
Appearance of the product and contents of the package
Transdermal patch.
Opaque, colorless, rectangular patch with rounded corners and printed on aluminum backing: “Fentanyl 25 μg/h “in individually sealed sachets.
Abattrais available in packages of 5, 10, and 20 transdermal patches.
Only some package sizes may be marketed.
Marketing Authorization Holder:
Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850 - Torrejón de Ardoz
Spain
Responsible for manufacturing:
Luye Pharma AG
Am Windfeld, 35
Miesbach-83714
Germany
or
Laboratorios Medicamentos Internacionales, S.A. (Medinsa)
C/ Solana, 26
28850 – Torrejón de Ardoz, Madrid
Spain
or
Acino AG
Leopoldstraße, 115
80804 – Munich
Germany
This medicine is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:
Germany: Fentavera 12/25/50/75/100 Mikrogramm/Stunde transdermal Pflaster
Spain:Abattra12/25/50/75/100 micrograms/hour transdermal patch EFG
United Kingdom (Northern Ireland): Fencino 12/25/50/75/100 micrograms/h transdermal patch
Revision date of this leaflet: April 2024
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.