Leaflet:information for the user

Buprenorfina Stada 35 micrograms/hour transdermal patch 96 hours EFG

Buprenorfina Stada 52.5 micrograms/hour transdermal patch 96 hours EFG

Buprenorfina Stada 70 micrograms/hour transdermal patch 96 hours EFG

Read this leaflet carefully before you start using this medicine, because 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 you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isBuprenorfina Stadaand what it is used for

2. What you need to know before starting to useBuprenorfina Stada

3. How to useBuprenorfina Stada

4. Possible side effects

5. Storage ofBuprenorfina Stada

6. Contents of the pack and additional information

The active substance of Buprenorfina Stada is buprenorphine.

Buprenorphine is an analgesic (a 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. Buprenorphine acts through the skin. Buprenorphine is an opioid (a pain-relieving medication for intense pain) that reduces pain by acting on the central nervous system (on specific nerve cells in the spinal cord and the brain). The effect of the transdermal patch lasts for up to a maximum of four days. Buprenorphine is not ideal for the treatment of acute pain (short-term pain).

No use Buprenorfina Stada

• If you are allergic to buprenorphine or any of the other ingredients in this medicine (listed in section 6);
• If you are addicted to strong painkillers (opioids);
• If you have a condition where you have great difficulty breathing or where this could happen;
• If you are taking MAO inhibitors (certain medicines for the treatment of depression) or have taken them in the last two weeks (see “Use of Buprenorfina Stada with other medicines”);
• In the case of myasthenia gravis (a severe type of muscle weakness);
• In the case of delirium tremens (confusion and tremors caused by withdrawal from alcohol after excessive consumption or during an episode of heavy alcohol consumption);
• In the case of pregnancy.

Buprenorphine should not be used to treat withdrawal symptoms in drug-dependent individuals.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Buprenorfina Stada

• If you have recently drunk a lot of alcohol,
• If you have seizures or convulsions (attacks),
• If you have altered consciousness (feeling dizzy or fainting), due to an unknown cause,
• If you are in shock (a sign could be cold sweat),
• If you have high intracranial pressure (for example, after a head injury or in brain disease), without the possibility of artificial respiration,
• If you have difficulty breathing or are taking another medicine that can make you 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 diseases that are treated with antidepressants.

The use of these medicines together with buprenorphine may cause serotonin syndrome, a potentially fatal disease (see “Use of Buprenorfina Stada with other medicines”).

Please also note the following precautions:

?Some people may become dependent on strong painkillers such as buprenorphine when they use them for a long time. These patients may experience effects after they stop using them (see “If you interrupt treatment with Buprenorfina Stada”).

?Fever and heat may cause higher-than-normal levels of buprenorphine in the blood. Heat may also prevent the transdermal patch from sticking properly. Therefore, consult your doctor if you have a fever and do not expose yourself to heat sources (e.g. sauna, infrared lamps, electric blankets or hot water bags).

You should warn athletes that this medicine may give a positive result in doping control tests.

Children and adolescents

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

Respiratory disorders related to sleep

Buprenorphine may cause respiratory disorders related to sleep 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.

Tolerance, dependence and addiction

This medicine contains buprenorphine, which is an opioid. Repeated use of opioids can make the drug less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of buprenorphine can also cause dependence, abuse and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use.

Dependence or addiction may cause a feeling of lack of control over the amount of medicine you should use or the frequency with which you should use it.

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

- You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines or illegal drugs (“addiction”).

- You are a smoker.

- You have had any problems with your mood (depression, anxiety or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

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

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

Other medicines and Buprenorfina Stada

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

Some medicines may increase the side effects of buprenorphine and in some cases may cause severe reactions. Do not take any other medicine while taking 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 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.

?Buprenorphine should not be used together with MAO inhibitors (certain medicines for the treatment of depression), or if you have taken them in the last two weeks.

?Buprenorphine 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 medicines that can cause the same effects. These other medicines include other strong painkillers (opioids), certain sleep medicines, anesthetics and medicines for the treatment of certain psychological diseases (tranquilizers, antidepressants and neuroleptics).

• The concomitant use of buprenorphine with sedatives such as benzodiazepines or related medicines increases the risk of experiencing sedation, respiratory depression, coma or even death. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes buprenorphine together with sedatives, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedatives you are taking and follow your doctor's recommended dosing closely. It may be helpful to inform friends or relatives about the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

• If buprenorphine is used together with some medicines, the action of the transdermal patch may be intensified. These medicines include, for example, certain antibiotics 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 action of the transdermal patch may be reduced. These medicines include, for example, dexamethasone, certain medicines for the treatment of epilepsy (e.g. those containing carbamazepine or phenytoin) or medicines used for the treatment of tuberculosis (e.g. rifampicin).

• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain)
• Medicines for treating allergies, dizziness or nausea (antihistamines or antiemetics)
• Medicines for treating psychiatric disorders (antipsychotics or neuroleptics)
• Muscle relaxants
• Medicines for treating Parkinson's disease

Use of Buprenorfina Stada with food, drinks and alcohol

You should not drink alcohol while using buprenorphine. Alcohol may intensify certain side effects of the transdermal patch and may make you feel unwell.

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 medicine.

There is no experience with the use of buprenorphine to date in pregnant women. Therefore, buprenorphineshould not be used during pregnancy.

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

Driving and operating machines

Buprenorphine may make you feel dizzy, drowsy or have double vision or blurred vision and may alter your reflexes in such a way that you do not react adequately or quickly enough in unexpected situations. This applies especially:

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

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

Consult your doctor or pharmacist if you are unsure.

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

Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of buprenorphine, when and for how long you should use it, when you should contact your doctor and when you should suspend use (see also, If you interrupt treatment with Buprenorfina Stada).

Buprenorfina 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 chosen this buprenorphine patch, as the most suitable for you.

During treatment, your doctor may change the transdermal patch you use to a smaller or larger one if necessary.

Do not cut or divide the patch.

The recommended dose is:

Adults

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

Apply buprenorphine (as detailed below) and change it after four days at most. To make it easier to use, you can change the patch 2 times a week on fixed days, for example: “always on Mondays morning and Thursdays afternoon”. To help you remember when to change the transdermal patch, note it in the packaging. If your doctor has told you to take other painkillers in addition to the transdermal patch, follow your doctor's instructions strictly, or you will not benefit fully from buprenorphine treatment.

Older patients

No dose adjustment is required in elderly patients.

Patients with renal impairment/patients on dialysis

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

Patients with liver impairment

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

Use in children and adolescents

Buprenorphine should not be used in people under 18 years old because there is no experience with this age group.

Administration route

Apply transdermally.

When the transdermal patch is applied to the skin, the active ingredient buprenorphine crosses it to reach the blood.

Administration form

Before applying anew transdermal patch

?If the chosen area has hair, cut it with scissors. Do not shave it!

?Avoid areas of the skin that are red, irritated, or have any other type of marks, for example, 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 transdermal patch from sticking properly.

Applying the transdermal patch:

While wearing the transdermal patch

You can wear the transdermal patch for a maximum of 4 days. If the transdermal patch has been applied correctly, the risk of it falling off is low. You can take a shower, bath, 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 bags).

If the transdermal patch falls off before you need to change it, do not use the same transdermal patch again. Stick a new one immediately (see “Changing the transdermal patch” below).

Changing the transdermal patch

• Remove the old patch carefully.
• Double it over with the adhesive side inwards.
• Dispose of it carefully.
• Stick a new transdermal patch to a different area of skin (as described above). It must be at least 1 week before you can apply a new patch to the same area of skin.

Treatment duration

Your doctor will tell you the duration of your treatment with buprenorphine. Do not stop treatment on your own, as the pain may return and you may feel unwell (see also “If you interrupt treatment with Buprenorfina Stada”).

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

If you use more Buprenorfina Stada than you should

If you have a overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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. You may have pinpoint pupils and your breathing may become slow and weak. You may also experience a cardiovascular collapse.

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

If you forgot to use Buprenorfina Stada

If you forgot an application, stick a new transdermal patch as soon as you remember.

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

Never apply more than one transdermal patch to compensate for the one you forgot!

If you interrupt treatment with Buprenorfina Stada

If you interrupt or stop treatment with buprenorphine 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 painkillers for a long time, when they stop using them. The risk of experiencing effects after stopping buprenorphine application is very low. However, if you feel agitated, anxious, nervous, or tremulous, if you are hyperactive, have difficulty sleeping, or have digestive problems, consult your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience inflammation of the hands, feet, knees, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, hives, fainting, yellowing of the skin and eyes (also known as jaundice), remove the transdermal patch and consult your doctor or go to the nearest hospital immediately. These may be symptoms of a severe allergic reaction, which is very rare.

The following side effects have been reported:

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

• nausea (feeling of dizziness)
• erythema, pruritus

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

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

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

• confusion, sleep disorders, restlessness
• different degrees of sedation (serenity), ranging from fatigue to confusion
• circulatory disorders (such as hypotension or rarely circulatory collapse)
• dry mouth
• eruptions
• urinary retention (less urine than normal), alterations of urination
• weakness

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

• loss of appetite
• illusions as well as hallucinations, anxiety, nightmares, decreased sexual desire
• difficulty concentrating, speech disorders, confusion, balance disorders, abnormal skin sensations (feeling of heat, tingling, or numbness)
• vision changes, blurred vision, swelling of the eyelids
• seizures
• difficulty breathing (respiratory depression)
• stomach acid
• hives
• erection difficulties
• withdrawal symptoms (see below), reactions at the site of administration

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

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

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

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

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

In some cases, late-onset local allergic reactions with marked signs of inflammation occur. In these cases, treatment with buprenorphine should be discontinued after consulting your doctor.

Some people may experience withdrawal symptoms after using potent analgesics 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 disorders, or digestive problems, consult your doctor.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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.

Store this medication in a safe and protected place, to which no one else can access. This medication can cause serious harm and even be fatal to people who may use it by accident or intentionally when it was not prescribed to them.

This medication does not require special storage conditions.

After removing the patch, fold it in half with the adhesive surfaces facing inward and press firmly. Reinsert the patch into the overwrap and dispose of it safely.

Medications should not be thrown away through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Buprenorphin Stada

• The active ingredient is buprenorphin.

Buprenorphin Stada 35 micrograms/hour: each transdermal patch of 25 cm2 contains 20 mg of buprenorphin and releases 35 micrograms of buprenorphin per hour.2

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

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

• The other components are:

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

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

Separator film between the adhesive matrices with and without buprenorphin: poly(ethylene terephthalate) film.

Backing film: polyester.

Removable coating (on the front covering the adhesive matrix containing buprenorphin): siliconized polyethylene terephthalate film.

Blue printing ink.

Appearance of the product and contents of the package

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

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

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

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

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

This medicine is authorized in the member states of the European Economic Area with 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 micrograms/hour transdermal patch 96 hours EFG

Buprenorfina Stada 52.5 micrograms/hour transdermal patch 96 hours EFG

Buprenorfina Stada 70 micrograms/hour transdermal patch 96 hours EFG

Netherlands:Buprenorfine CF 35 micrograms/hour, patch for transdermal use

Buprenorfine CF 52.5 micrograms/hour, patch for transdermal use

Buprenorfine CF 70 micrograms/hour, patch for transdermal use

Portugal:Buprenorfina Ciclum

Last review date of this leaflet:October 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