Prospecto: information for the user

Feliben 52.5 micrograms/hour transdermal patches

Buprenorphine

1.What is Feliben and for what it is used

2.What you need to know before starting to use Feliben

3.How to use Feliben

4.Possible adverse effects

5.Storage of Feliben

6.Contents of the package and additional information.

Feliben is an analgesic (pain-relieving medication) indicated for relieving moderate to severe oncological pain and severe pain that does not respond to other types of analgesics.

Felibenacts throughthe skin.When thetransdermal patchis applied to the skin,theactive ingredient buprenorphinepases through the skininto the blood.

Buprenorphine is an opioid (relieves strong pain), which reduces pain by acting on the central nervous system (on specific nerve cells in the spinal cord and brain).Theeffect of the transdermal patchhas a duration ofup to threedays.Feliben is not ideal for the treatment of acute pain (short-term).

No use Feliben

• If you are allergic to buprenorphine, soy, peanuts, or any of the other components of this medication (listed in section 6).

• If you are addicted to powerful painkillers (opioids).

• If you have a disease that makes it difficult to breathe or can cause breathing difficulties.

• If you are taking monoamine oxidase inhibitors (certain medications for depression treatment) or have taken them in the last two weeks (see “Other medications and Feliben”).

• In case of myasthenia gravis (a severe muscle weakness condition).

• In case of delirium tremens (confusion and tremors after abstaining from alcohol) or occurs during an episode of high alcohol consumption.

• If you are pregnant.

Feliben should not be used to treat withdrawal syndrome in drug-dependent individuals.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Feliben if

• You have recently consumed a lot of alcohol;
• You have seizures or convulsions (attacks);
• You have altered consciousness (feeling dizzy or faint) for an unknown reason;
• You are in shock (a sign could be cold sweat);
• You have elevated intracranial pressure (for example after a head trauma or brain disease), without the possibility of artificial respiration;
• You have difficulty breathing or are taking another medication that can make you breathe more slowly or weakly (see “Other medications and Feliben”);
• You have liver problems;
• You have a tendency to abuse medications or drugs;
• You have depression or other diseases treated with antidepressants. The use of these medications with Feliben may cause serotonin syndrome, a potentially fatal disease (see “Use of Feliben with other medications”).

Please also note the following precautions:

• The fever and ambient temperature may lead to higher-than-normal buprenorphine levels in the blood. Also, ambient temperature may prevent the patch from sticking properly. Therefore, consult your doctor if you have a fever and do not expose yourself to heat sources (for example, sauna, infrared lamps, electric blankets, or hot water bags).

Tolerance, dependence, and addiction

This medication contains buprenorphine, an opioid substance. Repeated use of opioids can reduce the effectiveness of the medication (your body gets used to the medication, which is known as tolerance). Repeated use of Feliben can also cause dependence, abuse, and addiction, which can lead to a potentially fatal overdose. The risk of adverse effects may increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel like you no longer have control over the amount of medication you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may be at a higher risk of becoming dependent or addicted to Feliben if:

- You or a family member has a history of alcohol, prescription medication, or illicit substance abuse (“addiction”).

- You are a smoker.

- You have had problems with your mood (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health conditions.

If you notice any of the following signs while taking Feliben, it could be a sign that you have become dependent or addicted:

- You need to take the medication for a longer period than recommended by your doctor.

- You need to take more doses than recommended.

- It may be possible that you feel the need to continue taking your medication, even if it no longer helps to relieve pain.

- You are using the medication for reasons other than those prescribed, for example, “to calm down” or “to help you sleep”.

- You have made repeated and unsuccessful attempts to stop or control the use of the medication.

- You do not feel well when you stop taking the medication and feel better when you take it again (“withdrawal symptoms”).

If you notice any of these signs, talk to your doctor to address the most suitable treatment strategy for your case, including when it is appropriate to stop taking it and how to do it safely (see section 3 “If you interrupt treatment with Feliben”).

Athletes should be aware that this medication can cause a positive reaction in doping control tests.

Sleep-related respiratory disorders

Feliben may cause sleep-related respiratory disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. Contact your doctor if you or someone else observes these symptoms. Your doctor may consider reducing the dose.

Children and adolescents

• Feliben should not be used in individuals under 18 years of age, as there is no experience to date in this age group.

Use of Feliben with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications may increase the side effects of Feliben and, in some cases, may cause severe reactions. Do not take any other medication while taking Feliben without first consulting your doctor, especially:

• Feliben should not be taken with monoamine oxidase inhibitors (certain medications for depression treatment) or if you have taken this type of medication in the last two weeks.

• Feliben may cause drowsiness, vomiting, dizziness, or make you breathe more slowly or weakly in some patients. These adverse effects may intensify if taken at the same time as other medications that can cause the same effects. These other medications include other powerful painkillers (opioids), some sleep medications, tranquilizers, anesthetics, antidepressants, and neuroléptics (medications for the treatment of certain psychological diseases).

• The concomitant use of Feliben and sedative medications such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may put your life at risk. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Feliben along with sedative medications, your doctor should limit the dose and duration of concomitant treatment.

Please inform your doctor about all sedative medications you are taking and follow your doctor's recommended dose closely. It may be helpful to inform friends or family members to be alert to the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

• If Feliben is used with other medications that block the degradation of buprenorphine, the patch's action may be intensified. These medications include, for example, certain antibiotics/antifungals (e.g., containing erythromycin or ketoconazole) or medications for HIV (e.g., containing ritonavir).

• If Feliben is used with other medications that increase its degradation, the patch's action may be reduced. These medications include, for example, dexamethasone, certain medications for epilepsy treatment (e.g., containing carbamazepine or phenytoin) or antituberculosos (e.g., containing rifampicin).

• Antidepressants such as moclobemida, tranilcipromina, citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, duloxetina, venlafaxina, amitriptilina, doxepina, or trimipramina. These medications may interact with Feliben and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. Contact your doctor if you experience these symptoms.

• Gabapentina or pregabalina used to treat epilepsy or pain due to nerve problems (neuropathic pain).

• Medications for depression treatment;

• Medications used for allergy treatment and for vomiting or nausea during travel (antihistamines or antiemetics).

• Medications for the treatment of psychiatric disorders (antipsychotics or neuroléptics).

• Muscle relaxants

• Medications for Parkinson's disease treatment

Use of Feliben with food, drinks, and alcohol

You should avoid drinking alcohol while taking Feliben. Alcohol may increase certain effects of the patches and you may not feel well. If you drink orange juice, it may intensify the effects of Feliben.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is not enough experience with the use of Feliben to date in pregnant women. Therefore, Feliben should not be used if you are pregnant.

Buprenorphine, the active ingredient contained in the patch, inhibits milk production and passes into breast milk. Therefore, Feliben should not be used during breastfeeding.

Driving and operating machinery

Feliben may make you feel dizzy or drowsy, or have blurred or double vision, and alter your reflexes in such a way that you may not react quickly or adequately in unexpected situations.

This applies especially:

• At the beginning of treatment
• When changing doses
• When changing from another medication to this one
• When taking other medications that act on the brain
• When drinking alcohol

If this happens to you, do not drive or operate machinery while taking Feliben.

This also applies at the end of treatment with Feliben. Do not drive or operate machinery. Do not do so for at least 24 hours after the patch has been removed.

In case of doubt, consult your doctor or pharmacist.

Feliben contains soy oil. If you are allergic to peanuts or soy, do not use this medication.

Use this medication exactly as your doctor has told you to. If you are unsure, consult your doctor or pharmacist.

Before starting treatment and at regular intervals during treatment, your doctor will discuss with you what you can expect from the use of Feliben, when and for how long you should take it, when to contact your doctor, and when to stop taking it (see also "If you interrupt treatment with Feliben").

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Feliben is available in three doses:

Feliben 35 micrograms/hour transdermal patches, Feliben 52.5 micrograms/hour transdermal patches, and Feliben 70 micrograms/hour transdermal patches.

Your doctor has chosen this Feliben patch, as the most suitable for you. During treatment, your doctor may change the patch you use to a higher one if necessary. Use Feliben exactly as your doctor tells you to. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is:

Adults

Apply Feliben (as detailed below) and change it after a maximum of 3 days. To help you remember the frequency of change, note it on the packaging. If your doctor has told you to take other painkillers in addition to the transdermal patch, follow your doctor's instructions strictly, otherwise you will not benefit fully from treatment with Feliben.

Use in children and adolescents

Feliben should not be used in people under 18 years old, as there is no experience with this age group.

Older adults

No dose adjustment is required in older adults.

Patients with renal impairment / patients on dialysis

No dose adjustment is required in patients with renal impairment and those on dialysis.

Patients with liver impairment

In patients with liver impairment, the intensity and duration of Feliben's action may be affected. If you belong to this group of patients, your doctor will monitor you more closely.

Instructions for opening the child-resistant packaging:

1. Make a cut in the marked points on each side
2. Rip both marks along the thermosellable area
3. Open the packaging and remove the patch

Method of administration

Before applying the patch:

• Choose a clean, smooth, and hairless area of skin on the upper part of your body, preferably under the clavicle on the chest or on the upper back. Ask for help if you cannot apply the patch yourself.
• If the chosen area has hair, cut it with scissors. Do not shave it!
• Avoid areas of skin that are red, irritated, or have any other type of marks, such as large scars.
• The area of skin you choose must be dry and clean. If necessary, wash it with cold or warm water. Do not use soap or other detergents. After a hot bath or shower, wait until your skin is completely dry and cool. Do not apply lotions, creams, or ointments to the chosen area. This could prevent the patch from sticking properly.

Applying the patch:

1.Each patch is sealed in a package. Do not open the package until the time to use the patch.

2.Start by separating the protective film that covers the silver part.

3.Carefully remove the top half of the film. Try not to touch the adhesive part of the patch.

4.Stick the patch to the area of skin you have chosen and remove the rest of the film.

5.Press the patch firmly against your skin with the palm of your hand for 30-60 seconds. Make sure the entire patch is in contact with your skin, especially the edges.

6.Wash your hands after applying the transdermal patch. Do not use any cleaning products.

While wearing the patch:

You can wear the patch for a maximum of3days. If the patch has been applied correctly, the risk of it falling off is low. You can bathe, shower, or swim while wearing it. However, do not expose the patch to extreme heat (for example, sauna, infrared lamps, electric blankets, hot water bottle).

If the patch falls off before you need to change it, do not use the same patch again. Apply a new one immediately (see "Changing the patch").

Changing the patch:

• Remove the old transdermal patch carefully.
• Fold it in half with the adhesive side inwards.
• Dispose of it carefully, out of sight and reach of children.
• Stick a new patch to a suitable area of skin (as described above). You should wait at least 1 week before applying a new patch to the same area again.

Duration of treatment:

Your doctor will tell you the duration of your treatment with Feliben. Do not stop treatment prematurely, as the pain may return and you may feel unwell (see also "Effects when treatment with Feliben is interrupted").

If you think Feliben's action is too strong or too weak, tell your doctor or pharmacist.

If you use more Feliben patches than you should::

If this happens, you may experience signs of buprenorphine overdose. An overdose can intensify the adverse effects of buprenorphine, such as drowsiness, nausea, and vomiting. Your pupils may be pinpointed, and your breathing may become slow and weak. You may experience a cardiovascular collapse.

As soon as you realize you have used more Feliben patches than you should, remove the excess patches and consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to use Feliben:

If you forget to apply a patch, apply a new one as soon as you remember. If you change the patch too late, the pain may return. In this case, consult your doctor.

Never apply double the number of transdermal patches to compensate for the one you forgot.

If you interrupt treatment with Feliben:

If you interrupt or stop treatment with Feliben too soon, the pain will return.

If you want to stop treatment due to unpleasant side effects, consult your doctor. Your doctor will tell you what to do and if other medications can be administered.

Some people may experience effects after using potent analgesics for a long time and then stopping them. The risk of experiencing effects after stopping Feliben is very low. However, if you feel agitated, anxious, nervous, or tremulous, if you are hyperactive, have difficulty sleeping, or experience digestive problems, consult your doctor.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications,this medication may have side effects,although not everyone will experience them..

Adverse reactions are classified as follows:

The following side effects have been reported:

Immune system disorders

Very rare: severe allergic reactions (see below)

Metabolic and nutritional disorders

Rare: loss of appetite

Mental health disorders

Uncommon: confusion, sleep disorders, restlessness

Rare: illusions, hallucinations, anxiety, nightmares, decreased libido

Very rare: medication dependence, mood changes

Nervous system disorders

Common: dizziness, headache

Uncommon: sedation, drowsiness to numbness, difficulty concentrating, speech disorders, numbness, altered balance, paresthesia (numbness, tingling, or burning sensation in the skin)

Very rare: muscle contractions, altered taste

Eye disorders

Rare: vision disturbances, blurred vision, eyelid swelling

Very rare: constricted pupils (miosis)

Ear and labyrinth disorders

Very rare: ear pain

Cardiac and vascular disorders

Uncommon: circulatory disorders (such as hypotension or rarely, loss of consciousness due to low blood pressure)

Rare: hot flashes

Chest and respiratory disorders

Common: shortness of breath

Rare: respiratory depression

Very rare: increased ventilation, hiccups

Digestive system disorders

Very common: nausea (feeling unwell)

Common: vomiting, constipation

Uncommon: dry mouth

Rare: acid reflux

Very rare: hiccups

Skin and subcutaneous tissue disorders (usually at the application site)

Very common: redness, pruritus

Common: skin rash (usually due to repeated use), sweating

Uncommon: rash

Rare: urticaria

Very rare: pustules, vesicles

Frequency not known: contact dermatitis (skin rash with inflammation, which may include a burning sensation)

Urinary system disorders

Uncommon: urinary retention (less urine than normal), altered urination

Reproductive system and breast disorders

Rare: decreased erection

General disorders and administration site conditions

Common: edema (e.g., swelling of the legs), fatigue,

Uncommon: weakness

Rare: withdrawal symptoms (see below), reactions at the administration site

Very rare: chest pain

If you notice any of the side effects mentioned above, inform your doctor as soon as possible.

In some cases, delayed adverse reactions with marked signs of inflammation may occur. In these cases, discontinue Feliben treatment after consulting with your doctor.

If you experience swelling of the hands, feet, ankles, face, lips, mouth, or throat with difficulty swallowing and breathing, urticaria, dizziness, or yellowing of the skin and eyes (also known as jaundice), remove the patch and immediately call your doctor or seek help at the nearest hospital.These symptoms may be attributed to a severe and infrequent allergic reaction.

Some people may experience withdrawal symptoms when they have used potent painkillers for a prolonged treatment and then stop using them. Feliben has a low risk of dependence, and it is unlikely that withdrawal symptoms will occur after treatment with Feliben. However, if you feel agitated, anxious, nervous, are very active, have difficulty breathing, or experience gastrointestinal disorders, consult your doctor.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.Do not use this medication after the expiration date that appears on the packaging and on the overwrap after CAD. The expiration date is the last day of the month indicated.

Storage Conditions:

Do not store above25ºC.

Do not freeze.

Store this medication in a safe and protected place, where others cannot access it. It may cause severe harm and be fatal to individuals who take it accidentally or intentionally when not prescribed.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Feliben 52.5 micrograms/hour transdermal patches:

The active ingredient is: Buprenorphin.

Feliben 52.5 micrograms/hour transdermal patch: Each transdermal patch contains 30 mg of buprenorphin and releases 52.5 micrograms per hour of buprenorphin. The contact area of the transdermal patch with the active ingredient is 37.5 cm².

The other components are:

Adhesive matrix (with buprenorphin):

styrene-butadiene-styrene (SBS) and styrene-butadiene copolymer group, colophony resins, antioxidants (2,4-bis (1,1-dimethylethyl)phenyl phosphite (3:1), Tris (2,4-di-tert-butylphenyl) phosphite), aloe vera leaf extract oil (also containing refined soybean oil and alpha-tocopherol acetate).

Pigmented polyethylene separator film, thermoplastic resin, and aluminum vapor-coated polyester, blue printing ink.

Release protective layer (to remove before applying): polyester layer, one side siliconized.

Appearance of Feliben and packaging contents:

The patches are brown, rectangular with four edges and rounded corners, marked with Buprenorphin 52.5 µg/h.

Each patch is packaged in an individually sealed envelope.

Feliben is available in individually sealed envelopes in packaging with 2, 3, 4, 5, 8, 10, 12, 16, 18, 20, 24, 25, and 30 transdermal patches.

Only some packaging sizes may be commercially available.

The following concentrations are available:

Feliben 35 micrograms/hour

Feliben 52.5 micrograms/hour

Feliben 70 micrograms/hour

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Avda. Tibidabo, 29 – 08022 Barcelona (Spain)

Responsible manufacturer:

Luye Pharma AG

Am Windfeld, 35

D-83714 Miesbach (Germany)

or

MERCKLE GMBH

Ludwig-Merckle-Strasse, 3

D-89143 Blaubeuren, Germany

or

ACTAVIS GROUP PTC EHF

Reykjavikurvegi, 76-78

IS-220 Hafnarfjordur, Iceland

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Acinorphin 35 Mikrogramm/Stunde Transdermales Pflaster

Acinorphin 52.5 Mikrogramm/Stunde Transdermales Pflaster

Acinorphin 70 Mikrogramm/Stunde Transdermales Pflaster

United Kingdom:Hapoctasin 35 micrograms/h, transdermal patches

Hapoctasin 52.5 micrograms/h, transdermal patches

Hapoctasin 70 micrograms/h, transdermal patches

Last review date of this prospectus:November 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/