Prospecto: information for the user

Feliben 35 micrograms/hour transdermal patches

Buprenorphine

Content of theprospect

1.What Feliben is 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 the relief of 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 where you have great difficulty breathing or where this can occur.

• 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 disorder).

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

• 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 of dizziness or fainting) 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 in a 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”).

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 may reduce the effectiveness of the medication (your body gets used to the medication, which is known as tolerance). Repeated use of Feliben may also cause dependence, abuse, and addiction, which may 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 may 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 like you need to continue taking your medication, even if it no longer helps with pain relief.

- 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 your medication use.

- 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 may 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 disorders).

• 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 aware of 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 HIV medications (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 epilepsy treatments (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 to treat allergies and for vomiting or nausea during travel (antihistamines or antiemetics).

• Medications for the treatment of psychological 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 transdermal 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, sleepy, or have blurred or double vision, and alter your reflexes in such a way that you may not react quickly or adequately in sudden or 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 to 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. Consult with your doctor or pharmacist if you are unsure.

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 as 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 has told 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 of age because there is no experience with this age group so far.

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 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 safety package:

1. Make a cut in the marked points on each side
2. Rip both marks along the thermosellable area
3. Open the package 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 of use of the patch.

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

3.Carefully remove the 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 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). At least 1 week must pass before you can apply 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, there may be 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 Toxicological Information Service, phone 91 562 04 20.

If you forget to use Feliben:

If you forget an application, apply a new patch 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 you can do and if other medications can be administered.

Some people may experience effects after using potent analgesics for a long time and 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 the use of this medication, ask your doctor or pharmacist.

Like all medications,this medication may have adverse effects, although not all people may experience them.

Adverse reactions are classified as follows:

The following adverse effects have been reported:

Immune system disorders

Very rare: severe allergic reactions (see below)

Metabolic and nutritional disorders

Rare: loss of appetite

Mental disorders

Uncommon: confusion, sleep disorders, restlessness

Rare: illusions such as hallucinations, anxiety, and nightmares, decreased libido

Very rare: medication dependence, mood changes

Nervous system disorders

Common: dizziness, headache

Uncommon: sedation, ranging from drowsiness to numbness, difficulty concentrating, speech disorders, numbness, alteration of balance, paresthesia (numbness, sensation of heat or tingling in the skin)

Very rare: muscle contraction, alterations of taste

Eye disorders

Rare: vision disturbances, blurred vision, eyelid swelling

Very rare: constricted pupils (miosis)

Auditory disorders

Very rare: ear pain

Cardiovascular and circulatory disorders

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

Rare: hot flashes

Chest and lung disorders

Common: shortness of breath

Rare: difficulty breathing (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 disorders (usually at the application site)

Very common: redness, itching

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), skin discoloration.

Urinary system disorders

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

Reproductive system disorders

Rare: decreased erection

General disorders

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 above-mentioned side effects, inform your doctor as soon as possible.

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

If you experience swelling of the hands, feet, ankles, face, lips, mouth, or throat with difficulty swallowing and breathing, urticaria, dizziness, 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 very severe and rare 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 adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse 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 other people 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 of 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 35 micrograms/hour transdermal patches:

The active ingredient is: Buprenorphin.

Feliben 35 micrograms/hour transdermal patch: Each transdermal patch contains 20 mg of buprenorphin and releases 35 micrograms per hour of buprenorphin. The contact area of the transdermal patch with the active ingredient is 25 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).

Separating layer of pigmented polyethylene, thermoplastic resin, and aluminum vapor-coated polyester, blue printing ink.

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

Appearance ofFelibenand contents of the package:

The patches are brown, rectangular with four edges and rounded corners, marked with Buprenorphin 35 µg/h.

Each patch is packaged in an individually sealed envelope.

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

Only some package sizes may be marketed.

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-Street, 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 Transdermal Pflaster

Acinorphin 52,5 Mikrogramm/Stunde Transdermal Pflaster

Acinorphin 70 Mikrogramm/Stunde Transdermal 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 thisleaflet: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/