Felibén 35 micrograms/hour transdermal patches

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Feliben 35 micrograms/hour transdermal patches

Buprenorphine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Feliben is and what it is used for

Feliben is an analgesic (a medicine used to relieve pain) indicated for the relief of moderate to severe cancer-related pain and severe pain that does not respond to other types of analgesics.

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

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). The effect of the transdermal patch lasts up to three days. Feliben is not suitable for the treatment of acute pain (short-term).

2. What you need to know before using Feliben

Do not use Feliben

• If you are allergic to buprenorphine, soy, peanuts, or any of the other components of this medicine (listed in section 6).
• If you are addicted to strong painkillers (opioids).
• If you suffer from a disease in which you have great difficulty breathing, or in which this may occur.
• If you are taking MAO inhibitors (certain medicines used to treat depression), or have taken them within the last two weeks (see "Other medicines and Feliben").
• In case of myasthenia gravis (a type of severe muscle weakness).
• In case of delirium tremens (confusion and tremors after abstaining from alcohol) or during an episode of heavy alcohol consumption.
• If you are pregnant.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Feliben if:

• You have recently consumed large amounts of alcohol;
• You have epileptic seizures or convulsions (fits);
• You have altered consciousness (dizziness or fainting) for an unknown reason;
• You are in shock (a sign could be cold sweating);
• You have increased intracranial pressure (e.g., after head injury or brain disease), without the possibility of artificial respiration;
• You have difficulty breathing, or you are taking other medicines that may cause slower or weaker breathing (see "Other medicines and Feliben");
• You have liver problems;
• You have a tendency to abuse medicines or drugs;
• You have depression or other conditions treated with antidepressants. Using these medicines together with Feliben may cause serotonin syndrome, a potentially life-threatening condition (see "Use of Feliben with other medicines").

Also consider the following precautions:

• Fever and high ambient temperature may lead to higher than normal levels of buprenorphine in the blood. High ambient temperature may also prevent the patch from adhering 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 medicine contains buprenorphine, an opioid substance. Repeated use of opioids may reduce the effectiveness of the medicine (your body becomes accustomed to the medicine—this is known as tolerance). Repeated use of Feliben may also lead to dependence, abuse, and addiction, which may result in potentially fatal overdose. The risk of adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over how much medicine you need to take or how often.

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

• You or a family member has a history of alcohol, prescription medicine, or illicit substance abuse or dependence ("addiction").
• You are a smoker.
• You have previously had mood disorders (depression, anxiety, or a personality disorder), or have received treatment from a psychiatrist for other mental illnesses.

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

• You need to take the medicine for longer than recommended by your doctor.
• You need higher doses than recommended.
• You feel you need to continue taking the medicine even when it is not helping relieve your pain.
• You are using the medicine for reasons other than prescribed, e.g., "to calm down" or "to help you sleep."
• You have made repeated unsuccessful attempts to stop or control your use of the medicine.
• You feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal symptoms").

If you notice any of these signs, speak with your doctor to determine the most appropriate treatment strategy for your case, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3 "If you stop using Feliben").

Athletes should be aware that this medicine may lead to a positive result in sports doping control tests.

Sleep-related breathing disorders

Feliben may cause sleep-related breathing 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, 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 reducing your dose.

Children and adolescents

• Feliben must not be used in individuals under 18 years of age, as there is no experience with its use in this age group.

Use of Feliben with other medicines:

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

Some medicines may increase the side effects of Feliben and, in some cases, cause very serious reactions. Do not take any other medicine while using Feliben without first consulting your doctor, especially:

• Feliben must not be taken together with MAO inhibitors (certain medicines used to treat depression), or if you have taken such medicines within the last two weeks.
• Feliben may cause drowsiness, vomiting, dizziness, or slower or weaker breathing in some patients. These adverse effects may be intensified if taken together with other medicines that cause similar effects. These include other strong painkillers (opioids), certain sleeping medicines, tranquilizers, anesthetics, antidepressants, and neuroleptics (medicines used to treat certain psychological conditions).
• Concomitant use of Feliben and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.

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

Please inform your doctor about all sedative medicines you are taking and closely follow your doctor’s dosing recommendations. It may be helpful to inform friends or family members to be alert for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.

• If Feliben is used together with other medicines that inhibit the breakdown of buprenorphine, the effect of the patch may be intensified. These medicines include, for example, certain anti-infectives/antifungals (e.g., containing erythromycin or ketoconazole) or medicines for HIV (e.g., containing ritonavir).

• If Feliben is used together with other medicines that increase its breakdown, the effect of the patch may be reduced. These medicines include, for example, dexamethasone, certain medicines used to treat epilepsy (e.g., containing carbamazepine or phenytoin), or antituberculosis medicines (e.g., containing rifampicin).

• Antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with Feliben, and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

• Gabapentin or pregabalin, used to treat epilepsy or nerve-related pain (neuropathic pain).

• Medicines used to treat depression;

• Medicines used to treat allergies and travel-related nausea or vomiting (antihistamines or antiemetics).

• Medicines used to treat psychiatric disorders (antipsychotics or neuroleptics).

• Muscle relaxants;

• Medicines used to treat Parkinson’s disease.

Use of Feliben with food, beverages, and alcohol

You should avoid drinking alcohol while being treated with Feliben. Alcohol may enhance certain effects of transdermal patches, and you may feel unwell. 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is insufficient experience with the use of Feliben in pregnant women. Therefore, Feliben must not be used if you are pregnant.

Buprenorphine, the active substance 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 cause dizziness, drowsiness, blurred or double vision, and may impair your reflexes so that you do not react appropriately or quickly enough in sudden or unexpected situations.

This is especially relevant:

• At the beginning of treatment;
• When changing dose;
• When switching from another medicine to this one;
• If you are also taking other medicines that act on the brain;
• If you drink alcohol.

If this happens, you must not drive or operate machinery while using Feliben. This also applies at the end of treatment with Feliben. Do not drive or operate machinery for at least 24 hours after the patch has been removed.

If in doubt, consult your doctor or pharmacist.

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

3. How to use Feliben

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

Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from using Feliben, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also “If you stop treatment with Feliben”).

Follow exactly the administration instructions for this medicine given 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 selected this Feliben patch as the most suitable one for you. During treatment, your doctor may switch you to a higher-dose patch if necessary. Always use Feliben exactly as directed by your doctor. 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 when to change it, note the date on the outer carton. If your doctor has instructed you to take other analgesics in addition to the transdermal patch, follow your doctor’s instructions strictly; otherwise, you may not fully benefit from Feliben treatment.

Use in children and adolescents

Feliben must not be used in individuals under 18 years of age, as there is currently no experience with its use in this age group.

Elderly

No dose adjustment is required in elderly patients.

Patients with renal impairment / patients on dialysis

No dose adjustment is needed in patients with renal impairment or those undergoing dialysis.

Patients with hepatic impairment

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

Instructions for opening the child-resistant pouch:

1. Cut along the dotted marks on each side
2. Tear along both marks at the heat-sealed area
3. Open the pouch and remove the patch

Method of administration

Before applying the patch:

• Choose a clean, smooth, hair-free area of skin on the upper part of your body, preferably below the clavicle on the chest or upper back. Ask for help if you cannot apply the patch yourself.
• If the chosen area is hairy, trim the hair with scissors. Do not shave!
• Avoid areas of red, irritated skin or skin with any other type of lesion, such as large scars.
• The skin area you choose should 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, as this could prevent the patch from adhering 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. Begin by peeling back the protective liner covering the silver side.

3. Carefully peel off half of the liner. Try not to touch the adhesive side of the patch.

4. Apply the patch to the chosen skin area and remove the rest of the liner.

5. Press the patch firmly onto 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 may wear the patch for up to 3 days. If applied correctly, the risk of the patch detaching is low. You may shower, bathe, or swim while wearing the patch. However, do not expose the patch to extreme heat (e.g., sauna, infrared lamps, electric blankets, hot water bottles).

In the unlikely event that your patch falls off before it needs to be changed, do not reuse the same patch. Immediately apply a new one (see “Changing the patch”).

Changing the patch:

• Carefully remove the old transdermal patch.
• Fold it in half with the adhesive side inward.
• Dispose of it carefully in the trash, out of sight and reach of children.
• Apply a new patch to a suitable skin area (as described above). At least 1 week should pass before applying a new patch to the same area again.

Duration of treatment:

Your doctor will determine the duration of your treatment with Feliben. Do not stop treatment prematurely, as pain may return and you may feel unwell (see also “Effects when stopping treatment with Feliben”).

If you feel that the effect of Feliben is too strong or too weak, inform your doctor or pharmacist.

If you use more Feliben patches than you should:

If this happens, signs of buprenorphine overdose may occur. Overdose can intensify the adverse effects of buprenorphine, such as drowsiness, nausea, and vomiting. You may develop pinpoint pupils, and your breathing may become slow and weak. Cardiovascular collapse may occur.

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 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, your pain may return. In this case, consult your doctor.

Never apply double the number of transdermal patches to make up for a missed application.

If you stop treatment with Feliben:

If you stop or end treatment with Feliben too early, your pain may return.

If you wish to discontinue treatment due to unpleasant adverse effects, consult your doctor. Your doctor will advise you on what to do and whether other medications may be given.

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone will experience them.

Adverse reactions are classified as follows:

Very common: May affect more than 1 in 10 people	Common: May affect up to 1 in 10 people
Uncommon: May affect up to 1 in 100 people	Rare: May affect up to 1 in 1,000 people
Very rare: May affect up to 1 in 10,000 people	Frequency not known: Cannot be estimated from the available data

The following adverse effects have been reported:

Immune system disorders

Very rare: severe allergic reactions (see below)

Metabolism and nutrition disorders

Rare: loss of appetite

Psychiatric disorders

Uncommon: confusion, sleep disorders, restlessness

Rare: illusions such as 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 numbness, difficulty concentrating, speech disorders, numbness, impaired balance, paresthesia (numbness, sensation of heat or tingling in the skin)

Very rare: muscle spasms, taste disturbances

Eye disorders

Rare: vision disturbances, blurred vision, eyelid swelling

Very rare: small pupils (miosis)

Ear disorders

Very rare: ear pain

Heart and blood circulation disorders

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

Rare: hot flushes

Chest and lung disorders

Common: shortness of breath

Rare: difficulty breathing (respiratory depression)

Very rare: increased ventilation, hiccups

Gastrointestinal disorders

Very common: nausea (feeling unwell)

Common: vomiting, constipation

Uncommon: dry mouth

Rare: stomach acid reflux

Very rare: retching

Skin 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 burning sensation), skin discoloration

Urinary system disorders

Uncommon: urinary retention (less urine than normal), urinary disturbances

Reproductive system disorders

Rare: decreased erection

General disorders

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

Uncommon: weakness

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

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 occur. In such cases, discontinue treatment with Feliben after consulting your doctor.

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

Some individuals may experience withdrawal symptoms when they have used strong painkillers for prolonged periods and then stop treatment. Feliben has a low risk of dependence, and withdrawal symptoms after treatment with Feliben are unlikely. However, if you feel agitation, anxiety, nervousness, restlessness, have difficulty breathing, or gastrointestinal disturbances, consult your doctor.

Reporting of adverse reactions:

If you experience any type of adverse reaction, talk to your doctor or pharmacist, even if these adverse reactions are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Feliben

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the container and on the sachet after EXP. The expiry date refers to the last day of the month indicated.

Storage conditions:

Do not store above 25°C.

Do not freeze.

Keep this medicine in a safe and secure place, out of reach of others. It may cause serious harm or be fatal to individuals who take it accidentally or intentionally when it has not been prescribed for them.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and empty containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Feliben 35 micrograms/hour transdermal patches:

The active substance is: Buprenorphine.

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

The other components are:

Adhesive matrix (containing buprenorphine):

styrene-butadiene-styrene (SBS) and styrene-butadiene copolymer groups, colophonium resins, antioxidants (2,4-bis(1,1-dimethylethyl)phenyl phosphite (3:1), tris(2,4-di-tert-butylphenyl) phosphate), leaf extract oil of aloe vera (also contains refined soybean oil and alpha-tocopherol acetate).

Polyethylene-pigmented release liner, thermoplastic resin and aluminium vapour-coated polyester, blue printing ink.

Protective release liner (to be removed before application): silicone-coated polyester layer.

Appearance of Feliben and contents of the pack

The patches are brown, rectangular in shape with four sides and rounded corners, marked with "Buprenorphin 35 µg/h".

Each patch is individually sealed in a pouch.

Feliben is available in individually sealed pouches within packages containing 2, 3, 4, 5, 8, 10, 12, 16, 18, 20, 24, 25 and 30 transdermal patches.

Only certain pack 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 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 medicinal product is authorized in the European Economic Area member states 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 most recent review of this package leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/