FELIBEN 35 micrograms/HOUR TRANSDERMAL PATCHES

Introduction

Package Leaflet: Information for the User

Feliben 35 micrograms/hour transdermal patches

Buprenorphine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet, you may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of thepackage leaflet

1. What is Feliben and what is it used for
2. What you need to know before you use Feliben
3. How to use Feliben
4. Possible side effects
5. Storage of Feliben
6. Contents of the pack and further information.

1. What is Feliben and what is it used for

Feliben is a pain reliever (medication to relieve pain) indicated for the relief of moderate to severe oncological pain and severe pain that does not respond to other types of pain relievers.

Feliben acts through the skin. When the transdermal patch is applied to the skin, the active substance buprenorphine passes through the skin into the blood.

Buprenorphine is an opioid (relieves strong pain), which reduces pain by acting on the central nervous system (in specific nerve cells in the spinal cord and brain). The effect of the transdermal patch lasts for up to three days. Feliben is not suitable for the treatment of acute (short-term) pain.

2. What you need to know before you use Feliben

Do not 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 strong pain relievers (opioids).
• If you have a disease in which you have great difficulty breathing or in which this may occur.
• If you are taking MAO inhibitors (certain medications for the treatment of depression) or have taken them in the last two weeks (see "Other medications and Feliben").
• In case of severe myasthenia (a type of severe muscle weakness).
• In case of delirium tremens (confusion and tremors after abstaining from alcohol) or occurs during a episode of high alcohol consumption.
• If you are pregnant.

Feliben should not be used to treat withdrawal syndrome in drug addicts.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Feliben if

• You have recently drunk a lot of alcohol;
• You have epileptic seizures or convulsions (attacks);
• You have altered consciousness (feeling of dizziness or fainting) for some unknown reason;
• You are in a state of shock (a sign could be cold sweat);
• You have increased intracranial pressure (e.g., after head trauma or brain disease), without the possibility of artificial respiration;
• You have difficulty breathing or are taking other medication that may 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 that are treated with antidepressants. The use of these medications along with Feliben may cause serotonin syndrome, a potentially life-threatening disease (see "Use of Feliben with other medications").

Also, note the following precautions:

• Fever and ambient temperature can lead to higher than normal amounts of buprenorphine in the blood. Also, ambient temperature can prevent the patch from sticking properly. Therefore, consult your doctor if you have a fever and avoid exposure to heat sources (e.g., sauna, infrared lamps, electric blankets, or hot water bottles).

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, this is known as tolerance). Repeated use of Feliben can also cause dependence, abuse, and addiction, which can lead to a potentially life-threatening overdose. The risk of side 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 higher risk of becoming dependent or addicted to Feliben if:

• You or a family member have a history of abuse or dependence on alcohol, prescription medications, or illicit substances ("addiction").
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental illnesses.

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 longer than recommended by your doctor.
• You need to take more doses than recommended.
• You may feel like you need to keep taking your medication, even when 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 attempts to stop or control the use of the medication without success.
• 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 appropriate therapeutic strategy in your case, including when it is appropriate to stop taking it and how to do so safely (see section 3 "If you stop treatment with Feliben").

Athletes should be aware that this medication may cause a positive reaction to doping tests.

Respiratory disorders related to sleep

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

Children and adolescents

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

Use of Feliben with other medications:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

Some medications can increase the side effects of Feliben and may occasionally cause very serious reactions. Do not take any other medication while taking Feliben without first consulting your doctor, especially:

• Feliben should not be taken with MAO inhibitors (certain medications for the treatment of depression) or if you have taken this type of medication during the last two weeks.
• Feliben may cause drowsiness, vomiting, dizziness, or slow and weak breathing in some patients. These side effects may be intensified if you take other medications that can produce the same effects. These other medications include other strong pain relievers (opioids), some sleep aids, tranquilizers, anesthetics, antidepressants, and antipsychotics (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, breathing difficulties (respiratory depression), coma, and can be life-threatening. Due to this, 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 must limit the dose and duration of concomitant treatment.

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

• If Feliben is used with other medications that block the breakdown of buprenorphine, the effect of the patch may be intensified. These medications include, for example, certain anti-infectives/antifungals (e.g., those containing erythromycin or ketoconazole) or HIV medications (e.g., those containing ritonavir).
• If Feliben is used with other medications that increase its breakdown, the effect of the patch may be reduced. These medications include, for example, dexamethasone, certain products for the treatment of epilepsy (e.g., those containing carbamazepine or phenytoin) or antituberculars (e.g., those containing rifampicin).

• Antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medications may interact with Feliben, and you may experience symptoms such as involuntary muscle contractions, including muscles 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 suffer from these symptoms.

• Gabapentin or pregabalin used to treat epilepsy or pain due to nerve problems (neuropathic pain).
• Medications for the treatment of depression;
• Medications used for the treatment of allergies and for the treatment of vomiting or nausea during travel (antihistamines or antiemetics).
• Medications for the treatment of psychiatric disorders (antipsychotics or neuroleptics).
• Muscle relaxants
• Medications for the treatment of Parkinson's disease

Use of Feliben with food, drinks, and alcohol

You should avoid drinking alcohol while being treated with Feliben. Alcohol may increase certain effects of the transdermal patches, and you may not feel well. If you drink grapefruit juice, it may intensify the effects of Feliben.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.

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

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

Driving and using machines

Feliben may make you feel dizzy or drowsy or have blurred or double vision and alter your reflexes so that you do not react adequately or quickly enough in case of sudden or unexpected situations.

This applies especially:

• at the beginning of treatment
• when changing the dose
• when changing from another medication to this one
• if you are also taking other medications that act on the brain
• if you drink alcohol

If this happens to you, do not drive or operate machinery while using 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 soybean oil. If you are allergic to peanuts or soy, do not use this medication.

3. How to use Feliben

Always use this medication exactly as your doctor has indicated. Consult your doctor or pharmacist if you are unsure.

Before starting treatment and periodically during treatment, your doctor will discuss with you what you can expect from using 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 stop treatment with Feliben").

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in 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. Always use Feliben as your doctor indicates. 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 indicated that you should take other painkillers in addition to the transdermal patch, strictly follow your doctor's instructions; otherwise, you will not fully benefit 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 in this age group to date.

Elderly

No dose adjustment is required in the elderly.

Patients with renal impairment / patients on dialysis

In patients with renal impairment and on dialysis, no dose adjustment is needed.

Patients with hepatic impairment

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

Instructions for opening the child-resistant pouch:

1. Make an incision at the dotted marks on each side
2. Tear both marks along the heat-sealed area
3. Open the pouch 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 collarbone 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!
• Avoid areas of skin that are red, irritated, or have any other type of spots, such as large scars.
• The area of skin you choose must be dry and clean. If necessary, wash it with cold or lukewarm 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 pouch. Do not open the pouch until you are ready to use the patch.
2. Start by separating the protective liner that covers the silver part.
3. Carefully peel off half of the liner. 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 liner.
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.

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

While wearing the patch:

You can wear the patch for up to 3 days. If you have applied the patch correctly, the risk of it coming off is low. You can shower, bathe, or swim while wearing it. However, do not expose the patch to extreme heat (e.g., sauna, infrared lamps, electric blankets, hot water bottle).

In the unlikely event that your 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 inward.
• Throw it away with caution, out of sight and reach of children.
• Apply a new patch to a suitable area of skin (as described above). At least 1 week should pass before you can apply a new patch to the same area again.

Duration of treatment:

Your doctor will indicate the duration of your treatment with Feliben. Do not stop treatment before this, as the pain may return and you may feel unwell (see also "Effects when stopping treatment with Feliben").

If you think the effect of Feliben 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 an overdose of buprenorphine. An overdose can intensify the adverse effects of buprenorphine, such as drowsiness, nausea, and vomiting. You may have pinpoint pupils, 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 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 make up for the one you forgot.

If you stop treatment with Feliben

If you stop or finish 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 whether other medications can be administered.

Some people may experience effects after using powerful painkillers for a long time and stopping them. The risk of having effects after stopping Feliben is very low. However, if you feel agitated, anxious, nervous, or shaky, if you are overactive, have difficulty sleeping, or have digestive problems, consult your doctor.

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone will 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

Psychiatric disorders

Uncommon: confusion, sleep disorders, restlessness

Rare: hallucinations, anxiety, and nightmares, decreased sexual desire

Very rare: drug dependence, mood changes

Nervous system disorders

Common: dizziness, headache

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

Very rare: muscle contraction, taste disorders

Eye disorders

Rare: vision changes, blurred vision, eyelid swelling

Very rare: small 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

Respiratory, thoracic, and mediastinal disorders

Common: shortness of breath

Rare: breathing difficulties (respiratory depression)

Very rare: increased ventilation, hiccups

Gastrointestinal disorders

Very common: nausea (feeling of discomfort)

Common: vomiting, constipation

Uncommon: dry mouth

Rare: stomach acid

Very rare: retching

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

Very common: redness, itching

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

Uncommon: rash

Rare: hives

Very rare: pustules, vesicles

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

Urinary disorders

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

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), administration site reactions

Very rare: chest pain

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

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

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

Some people may experience withdrawal symptoms when they have used powerful painkillers for a long time and stop them. Feliben has a low risk of dependence, and it is unlikely that withdrawal symptoms will appear after treatment with Feliben. However, if you feel agitated, anxious, nervous, or shaky, if you are overactive, have difficulty breathing, or have gastrointestinal disorders, consult your doctor.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Feliben

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

Storage conditions:

Do not store above 25°C.

Do not freeze.

Keep this medication in a safe and protected place, where others cannot access it. It can cause serious harm and be fatal if taken accidentally or intentionally by people who have not been prescribed it.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Feliben 35 micrograms/hour transdermal patches:

The active ingredient is: Buprenorphine.

Feliben 35 micrograms/hour transdermal patch: Each transdermal patch contains 20 mg of buprenorphine and releases approximately 35 micrograms per hour of buprenorphine. The contact area of the transdermal patch with the active ingredient is 25 cm2

The other ingredients are:

Adhesive matrix (with buprenorphine):

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

Polyethylene-pigmented separating layer, thermoplastic resin, and polyester coated with aluminum vapor, blue printing ink.

Protective release layer (to be removed before application): polyester layer, siliconized on one side.

Appearance ofFelibenand package contents

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 pouch.

Feliben is available in individually sealed pouches in packages containing 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 manufacturer

Marketing authorization holder

Laboratorios Gebro Pharma, S.A.

Avda. Tibidabo, 29 – 08022 Barcelona (Spain)

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 medication is authorized in the Member States of the European Economic Area under 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

Date of the last revision of thisleaflet:November 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/