Buprenorphine Stada 35 micrograms/hour transdermal patch 96 hours EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Buprenorphine Stada 35 micrograms/hour transdermal patch 96 hours EFG

Buprenorphine Stada 52.5 micrograms/hour transdermal patch 96 hours EFG

Buprenorphine Stada 70 micrograms/hour transdermal patch 96 hours EFG

Read the entire leaflet carefully before you start using 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may 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.

Leaflet contents

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

1. What Buprenorfina Stada is and what it is used for

The active substance in Buprenorfina Stada is buprenorphine.

Buprenorphine is an analgesic (a medicine used to relieve pain) indicated for the relief of moderate to severe cancer pain and severe pain that does not respond to other types of analgesics. Buprenorphine acts through the skin. Buprenorphine is an opioid (a medicine for the relief of intense pain) that 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 a maximum of four days. Buprenorphine is not suitable for the treatment of acute pain (short-term pain).

2. What you need to know before using Buprenorfina Stada

Do not use Buprenorfina Stada

• if you are allergic to buprenorphine or to any of the other ingredients of this medicine (listed in section 6);
• if you are addicted to strong painkillers (opioids);
• if you have a disease in which you have great difficulty breathing, or in which this could occur;
• if you are taking MAO inhibitors (certain medicines used to treat depression) or have taken them within the last two weeks (see “Use of Buprenorfina Stada with other medicines”);
• in case of myasthenia gravis (a type of severe muscle weakness);
• in case of delirium tremens (confusion and tremor caused by alcohol withdrawal after habitual excessive alcohol intake or during an episode of high alcohol consumption);
• in case of pregnancy.

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

Warnings and precautions

Talk to your doctor or pharmacist before using Buprenorfina Stada

• if you have recently consumed large amounts of alcohol,
• if you have epileptic seizures or convulsions (fits),
• if you have altered consciousness (dizziness or fainting) of unknown cause,
• if you are in shock (a possible sign could be cold sweating),
• if you have increased intracranial pressure (e.g., after head injury or in brain disease), without the possibility of artificial ventilation,
• if you have difficulty breathing or are taking other medicines that may cause you to breathe more slowly or weakly (see “Use of Buprenorfina Stada with other medicines”),
• if you have liver problems,
• if you have a tendency to abuse medicines or drugs,
• if you have depression or other conditions treated with antidepressants.

Using these medicines together with buprenorphine may cause serotonin syndrome, a potentially life-threatening condition (see “Use of Buprenorfina Stada with other medicines”).

Also consider the following precautions:

? Some people may become dependent on strong painkillers such as buprenorphine when used over a long period. These patients may experience effects after stopping treatment (see “If you stop using Buprenorfina Stada”).

? Fever and high environmental temperature may lead to higher than normal levels of buprenorphine in the blood. Also, high environmental temperature may prevent the transdermal 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).

Athletes should be aware that this medicine may result in a positive doping test.

Children and adolescents

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

Sleep-related breathing disorders

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

Tolerance, dependence, and addiction

This medicine contains buprenorphine, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (the body gets used to it, known as pharmacological tolerance). Repeated use of buprenorphine may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of lack of control over the amount of medicine used or how often it is used.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to buprenorphine may be higher if:

• You or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using buprenorphine, it could be a sign of dependence or addiction:

• You need to use the medicine for longer than prescribed by your doctor.
• You need to use a higher dose than recommended.
• You need to use the medicine even when it does not help relieve pain.
• You are using the medicine for reasons other than prescribed, e.g., “to feel calm” or “to help you sleep”.
• You have made repeated unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine, and feel better once you take it again (“withdrawal effects”).

If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do so safely (see section 3, if you stop using Buprenorfina Stada).

Other medicines and Buprenorfina Stada

Tell 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 buprenorphine and, in some cases, may cause very serious reactions. Do not take any other medicine while using buprenorphine without first consulting your doctor, especially:

? Antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with buprenorphine, 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 tension, body temperature above 38 °C. Contact your doctor if you experience these symptoms.

? Buprenorphine must not be used together with MAO inhibitors (certain medicines used to treat depression), or if you have taken them within the last two weeks.

? Buprenorphine may cause drowsiness, vomiting, dizziness, or slower or weaker breathing in some patients. These adverse effects may be intensified if taken at the same time as other medicines that cause similar effects. These other medicines include other strong painkillers (opioids), certain sleeping medicines, anaesthetics, and medicines used to treat certain psychological conditions (tranquilizers, antidepressants, and neuroleptics).

• Concomitant use of buprenorphine with sedative medicines such as benzodiazepines or related medicines increases the risk of sedation, respiratory depression, coma, or even death. Therefore, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes buprenorphine together with sedatives, the dose and duration of concomitant treatment must be limited by your doctor.

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 relatives about the signs and symptoms listed above. Contact your doctor if you experience such symptoms.

• If buprenorphine is used together with certain medicines, the effect of the transdermal patch may be increased. These medicines include certain anti-infectives and antifungals (e.g., those containing erythromycin or ketoconazole) or medicines for HIV (e.g., those containing ritonavir).

• If buprenorphine is used together with other medicines, the effect of the transdermal patch may be reduced. These medicines include, for example, dexamethasone, certain medicines for epilepsy (e.g., those containing carbamazepine or phenytoin), or medicines used to treat tuberculosis (e.g., rifampicin).

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

• Medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics)

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

• Muscle relaxants

• Medicines used to treat Parkinson’s disease

Use of Buprenorfina Stada with food, drinks, and alcohol

You must not drink alcohol while using buprenorphine. Alcohol may intensify certain adverse effects of the transdermal patch, and you may feel unwell.

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 buprenorphine in pregnant women. Therefore, buprenorphine must not be used during pregnancy.

Buprenorphine, the active substance in the transdermal patch, passes into breast milk and inhibits its production. Therefore, buprenorphine must not be used during breastfeeding.

Driving and using machines

Buprenorphine may cause dizziness, drowsiness, double or blurred vision, and may affect your reflexes so that you do not react adequately or quickly enough in sudden or unexpected situations. This is especially true:

• at the beginning of treatment,
• when changing the dose,
• when switching from another medicine to buprenorphine,
• if you are also taking other medicines that act on the brain,
• if you drink alcohol.

If affected, you should not drive or operate machinery while using buprenorphine. This also applies at the end of treatment with buprenorphine. Do not drive or operate machinery for at least 24 hours after removing the patch.

If in doubt, consult your doctor or pharmacist.

3. How to use Buprenorphine Stada

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you what you can expect from using buprenorphine, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also, If you stop treatment with Buprenorphine Stada).

Buprenorphine Stada is available in three doses: buprenorphine 35 micrograms/hour transdermal patch 96 hours, buprenorphine 52.5 micrograms/hour transdermal patch 96 hours, and buprenorphine 70 micrograms/hour transdermal patch 96 hours.

Your doctor has selected this buprenorphine patch as the most suitable one for you.

During treatment, your doctor may switch the transdermal patch you are using to a lower or higher dose patch, if necessary.

Do not cut or divide the patch.

The recommended dose is:

Adults

Follow these instructions unless your doctor has given you different directions.

Apply buprenorphine (as detailed below) and change it after four days at the latest. To make treatment easier, you may change the patch twice a week on fixed days, e.g., “always on Monday morning and Thursday afternoon”. To help you remember when to change the transdermal patch, write it down on the packaging. If your doctor has instructed you to take other analgesics in addition to the transdermal patch, follow your doctor's instructions strictly; otherwise, you will not fully benefit from treatment with buprenorphine.

Elderly patients

Dose adjustment is not required in elderly patients.

Patients with renal impairment/patients undergoing dialysis

In patients with renal impairment and patients undergoing dialysis, dose adjustment is not required.

Patients with hepatic impairment

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

Use in children and adolescents

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

Route of administration

Apply by transdermal route.

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

Instructions for use

Before applying a transdermal patch

? Choose a smooth, hairless area of skin on your upper body, preferably below the clavicle on the chest or on the upper back (see adjacent figure). Ask for help if you cannot apply the transdermal patch yourself.

? If the selected area is hairy, trim the hair with scissors. Do not shave it!

? Avoid areas of skin that are red, irritated, or have any other type of lesions, such as large scars.

? The skin area you select should be dry and clean. If necessary, wash it with cool 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 selected area, as this could prevent the transdermal patch from adhering properly.

Application of the transdermal patch:

Step 1: Each transdermal patch is sealed in a pouch. Just before use, cut the pouch with scissors along the sealed edge. Take out the transdermal patch.
Step 2: The adhesive side of the transdermal patch is covered by a transparent protective liner. Carefully peel off one part of the liner. Avoid touching the adhesive surface of the transdermal patch.
Step 3: Apply the transdermal patch to the chosen skin area and remove the rest of the liner.
Step 4: Press the transdermal patch firmly against your skin with the palm of your hand for 30 to 60 seconds. Make sure the entire patch is in contact with your skin, especially the edges.
Step 5: Wash your hands after using the transdermal patch. Do not use any cleaning products.

While wearing the transdermal patch

You may wear the transdermal patch for up to 4 days. If the transdermal patch has been applied correctly, the risk of it detaching is low. You may shower, bathe, or swim while wearing it. However, do not expose the transdermal patch to extreme heat (e.g., sauna, infrared lamps, electric blankets, or hot water bottles).

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

Changing the transdermal patch

• Carefully remove the old patch.
• Fold it in half with the adhesive side inward.
• Dispose of it carefully.
• Apply a new transdermal patch to a different area of skin (as described earlier). At least 1 week must pass before applying a new patch to the same skin area.

Duration of treatment

Your doctor will determine how long you should be treated with buprenorphine. Do not stop treatment on your own, as pain may return and you may feel unwell (see also "If you stop using Buprenorphine Stada").

If you think the effect of buprenorphine is too strong or too weak, inform your doctor or pharmacist.

If you use more Buprenorphine Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount taken. It is recommended to bring the medication packaging and leaflet to the healthcare professional.

If this occurs, signs of buprenorphine overdose may appear. An overdose may intensify buprenorphine's adverse effects, such as drowsiness, nausea, and vomiting. You may develop pinpoint pupils, and breathing may become slow and weak. You may also experience cardiovascular collapse.

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

If you forget to use Buprenorphine Stada

If you forget to apply a patch, apply a new transdermal patch as soon as you remember.

This will change your routine; for example, if you normally applied your patch on Mondays and Thursdays, but forgot and did not apply the new patch until Wednesday, from now on you will need to change your patches on Wednesdays and Saturdays. Record the new pair of days on the calendar provided in the packaging. If you change the transdermal patch too late, pain may return. In this case, consult your doctor.

Never apply more than one transdermal patch to make up for a missed dose!

If you stop using Buprenorphine Stada

If you interrupt or stop buprenorphine treatment too early, your pain may return. If you wish to discontinue treatment due to unpleasant side effects, consult your doctor. Your doctor will advise you on what to do and whether other medications can be administered.

Some people may experience effects after using strong painkillers for a long time, when stopping them. The risk of experiencing effects after discontinuing buprenorphine is very low. However, if you feel restless, anxious, nervous, or shaky, 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 cause adverse effects, although not everyone experiences them.

If you experience swelling of the hands, feet, knees, face, lips, mouth or throat, which may cause difficulty swallowing or breathing, hives, fainting, or yellowing of the skin and eyes (also known as jaundice), remove the transdermal patch immediately and consult your doctor or go to the nearest hospital without delay. These may be symptoms of a very rare severe allergic reaction.

The following adverse effects have been reported:

Very common (may affect more than 1 in 10 people):

• nausea (feeling sick)
• erythema, pruritus

Common (may affect up to 1 in 10 people):

• dizziness, headache
• shortness of breath
• vomiting, constipation
• skin changes (rash, usually due to repeated use), increased sweating
• edema (swelling of the legs), fatigue

Uncommon (may affect up to 1 in 100 people):

• confusion, sleep disorders, restlessness
• varying degrees of sedation (calmness), ranging from fatigue to confusion
• circulatory disorders (such as hypotension or, rarely, circulatory collapse)
• dry mouth
• rashes
• urinary retention (less urine than normal), disturbances in urination
• weakness

Rare (may affect up to 1 in 1,000 people):

• loss of appetite
• illusions as well as hallucinations, anxiety, nightmares, decreased sex drive
• difficulty concentrating, speech disorders, confusion, balance disturbances, abnormal skin sensations (feeling of heat, tingling or numbness)
• vision disturbances, blurred vision, eyelid swelling
• hot flushes
• difficulty breathing (respiratory depression)
• stomach acidity
• urticaria
• erection difficulties
• withdrawal symptoms (see below), application site reactions

Very rare (may affect up to 1 in 10,000 people):

• severe allergic reactions (see below)
• dependence, mood changes
• muscle twitching, taste disturbances
• small pupils
• ear pain
• abnormally rapid breathing, hiccups
• retching
• pustules, vesicles
• chest pain

Frequency not known (Frequency cannot be estimated from the available data):

• contact dermatitis (skin rash with inflammation, which may include a burning sensation), skin discoloration.

If you notice any of the adverse effects listed above, consult your doctor as soon as possible.

In some cases, delayed local allergic reactions with marked signs of inflammation may occur. In such cases, treatment with buprenorphine should be discontinued after consulting with your doctor.

Some people may experience withdrawal symptoms after using strong painkillers for a prolonged period and then stopping them. After treatment with buprenorphine, the risk of experiencing withdrawal symptoms is low. However, if you feel agitation, anxiety, nervousness, hyperactivity, sleep disturbances, or digestive problems, consult your doctor.

Reporting of adverse effects

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

5. Storage of Buprenorphine Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and sachet after EXP. The expiry date refers to the last day of the month indicated.

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals who may use it accidentally or intentionally when it has not been prescribed for them.

This medicine does not require any special storage conditions.

After removing the patch, fold it in half with the adhesive surfaces facing inwards and press firmly. Place the patch back into its original sachet and dispose of it safely.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Buprenorphine Stada

• The active substance is buprenorphine.

Buprenorphine Stada 35 micrograms/hour: each 25 cm² transdermal patch contains 20 mg of buprenorphine and releases 35 micrograms of buprenorphine per hour.

Buprenorphine Stada 52.5 micrograms/hour: each 37.5 cm² transdermal patch contains 30 mg of buprenorphine and releases 52.5 micrograms of buprenorphine per hour.

Buprenorphine Stada 70 micrograms/hour: each 50 cm² transdermal patch contains 40 mg of buprenorphine and releases 70 micrograms of buprenorphine per hour.

• The other components are:

Adhesive matrix (containing buprenorphine): povidone K90, levulinic acid, oleoyl oleate, poly[acrylic acid-co-butyl acrylate-co-(2-ethylhexyl)acrylate-co-vinyl acetate] (5:15:75:5).

Adhesive matrix (without buprenorphine): poly[(2-ethylhexyl)acrylate-co-glycidyl methacrylate-co-(2-hydroxyethyl)acrylate-co-vinyl acetate] (68:0.15:5:27).

Interlayer between the adhesive matrices with and without buprenorphine: poly(ethylene terephthalate) film.

Support layer: polyester.

Removable backing (on the front covering the adhesive matrix containing buprenorphine): silicone-coated polyethylene terephthalate film.

Blue printing ink.

Appearance of the product and contents of the pack

Buprenorphine Stada 35 micrograms/hour: the transdermal patches are flesh-coloured with rounded corners and printed with “Buprenorphin” and “35 μg/h”.

Buprenorphine Stada 52.5 micrograms/hour: the transdermal patches are flesh-coloured with rounded corners and printed with “Buprenorphin” and “52.5 μg/h”.

Buprenorphine Stada 70 micrograms/hour: the transdermal patches are flesh-coloured with rounded corners and printed with “Buprenorphin” and “70 μg/h”.

Each transdermal patch is individually sealed in a child-resistant pouch. The patches are packaged in containers containing 3, 4, 5, 6, 8, 10, 12, 16, 18, 20 or 24 transdermal patches.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Labtec GmbH

Heykenaukamp 10

21147 Hamburg

Germany

or

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

or

Laboratori Fundacio Dau

Calle Lletra C De La Zona Franca 12 – 14

Polígono Industrial De La Zona Franca De Barcelona

08040 Barcelona

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany: Buprenorphin AL 35 Mikrogamm/Stunde, Transdermales Pflaster
Buprenorphin AL 52.5 Mikrogamm/Stunde, Transdermales Pflaster
Buprenorphin AL 70 Mikrogamm/Stunde, Transdermales Pflaster

Austria: Buprenorphin STADA 35 Mikrogamm/h, Transdermales Pflaster
Buprenorphin STADA 52.5 Mikrogamm/h, Transdermales Pflaster
Buprenorphin STADA 70 Mikrogamm/h, Transdermales Pflaster

Denmark: Buprenorphin STADA

Spain: Buprenorfina STADA 35 microgramos/hora parche transdérmico 96 horas EFG
Buprenorfina Stada 52.5 microgramos/hora parche transdérmico 96 horas EFG
Buprenorfina Stada 70 microgramos/hora parche transdérmico 96 horas EFG

Netherlands: Buprenorfine CF 35 microgram/uur, pleister voor transdermaal gebruik
Buprenorfine CF 52.5 microgram/uur, pleister voor transdermaal gebruik
Buprenorfine CF 70 microgram/uur, pleister voor transdermaal gebruik

Portugal: Buprenorfina Ciclum

Date of the most recent revision of this leaflet: October 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