Buprenorphine Teva 52.5 micrograms/hour transdermal patch EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Buprenorphine Teva 52.5 micrograms/hour transdermal patch EFG

Buprenorphine

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 Teva is and what it is used for
2. What you need to know before using Buprenorphine Teva
3. How to use Buprenorphine Teva
4. Possible adverse effects
5. How to store Buprenorphine Teva
6. Contents of the pack and other information

1. What Buprenorphine Teva is and what it is used for

The active substance in Buprenorphine Teva is buprenorphine.

Buprenorphine Teva is an analgesic (a medicine for pain relief) indicated for the relief of moderate to severe cancer pain and severe pain that does not respond to other types of analgesics. Buprenorphine Teva 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 (a medicine for the relief of severe 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 Teva is not suitable for the treatment of acute pain (short-term pain).

2. What you need to know before using Buprenorphine Teva

Do not use Buprenorphine Teva

• if you are allergic to buprenorphine or any of the other components of this medicine (listed in section 6),
• if you are addicted to strong painkillers (opioids),
• if you have a condition 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 before starting treatment with Buprenorphine Teva (see “Other medicines and Buprenorphine Teva”),
• in case of myasthenia gravis (a type of severe muscle weakness),
• in case of delirium tremens (confusion and tremors caused by alcohol withdrawal after habitual excessive alcohol intake or during an episode of high alcohol consumption),
• in case of pregnancy.

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

Warnings and precautions

Talk to your doctor or pharmacist before using Buprenorphine Teva

• 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 trauma or brain disease), without the possibility of artificial ventilation,
• if you have difficulty breathing or are taking other medicines that may cause slower or weaker breathing (see “Other medicines and Buprenorphine Teva”),
• if you have depression or other conditions treated with antidepressants.

Using these medicines together with Buprenorphine Teva may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Buprenorphine Teva”),

• if you have liver problems,
• if you have a tendency to abuse medicines or drugs.

Also consider the following precautions:

• Some people may become dependent on strong painkillers such as Buprenorphine Teva when used for long periods. These patients may experience effects after stopping treatment (see “If you stop using Buprenorphine Teva”).

• 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 sources of heat (e.g. sauna, infrared lamps, electric blankets, or hot water bottles).

• Sleep-related breathing disorders: Buprenorphine Teva 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, 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 the dose.

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

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, known as tolerance). Repeated use of Buprenorphine Teva may also cause dependence, abuse, and addiction, which may lead to 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 or how often you take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to Buprenorphine Teva 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 ever had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses.

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

• You need to take the medicine longer than recommended by your doctor.
• You need to take higher doses than recommended.
• You feel that you need to continue using the medicine even when it no longer helps relieve your pain.
• You are using the medicine for reasons other than prescribed, for example, “to calm down” or “to help you sleep”.
• You have made repeated unsuccessful attempts to stop or control your medicine use.
• You feel unwell when you stop taking the medicine and feel better when you resume it (“withdrawal symptoms”).

If you notice any of these signs, talk to your doctor to discuss the most appropriate treatment strategy for your case, including when and how to safely stop taking the medicine (see section 3 “If you stop using Buprenorphine Teva”).

Children and adolescents

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

Other medicines and Buprenorphine Teva

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

• Buprenorphine Teva 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 Teva may cause drowsiness, vomiting, dizziness, or slow or weak breathing in some patients. These adverse effects may be intensified if taken together with 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 such as tranquilizers, antidepressants, and neuroleptics.

Concomitant use of Buprenorphine Teva and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all sedative medicines you are taking and closely follow the dose recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Concomitant use of Buprenorphine Teva and gabapentinoids such as gabapentin or pregabalin, used to treat epilepsy or nerve-related pain (neuropathic pain), may cause breathing difficulties (respiratory depression), low blood pressure, profound drowsiness, coma, and may be potentially fatal.

• If Buprenorphine Teva is used together with anticholinergic medicines or medicines with anticholinergic activity, such as medicines used to treat depression, medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics), medicines used to treat psychiatric disorders (antipsychotics or neuroleptics), muscle relaxants, or medicines used to treat Parkinson’s disease, anticholinergic side effects may increase.

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

• Some medicines may increase the side effects of Buprenorphine Teva and, in some cases, may cause very serious reactions. Do not take any other medicine while using Buprenorphine Teva 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 Teva and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

Use of Buprenorphine Teva with food, drinks, and alcohol

You must not drink alcohol while using Buprenorphine Teva. Alcohol may intensify certain adverse effects of the transdermal patch and you may feel unwell. If you drink grapefruit juice, it may enhance the effects of Buprenorphine Teva.

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 Teva in pregnant women. Therefore, do not use Buprenorphine Teva during pregnancy.

Buprenorphine, the active ingredient in the transdermal patch, inhibits milk production and passes into breast milk. Therefore, do not use Buprenorphine Teva during breastfeeding.

Driving and using machines

Buprenorphine Teva may cause dizziness, drowsiness, double or blurred vision, and may impair 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 Teva,
• 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 Teva. This also applies at the end of treatment with Buprenorphine Teva. 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 Teva

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

Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from using this medicine, 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 Buprenorphine Teva”).

This medicine is available in three doses: Buprenorphine Teva 35 micrograms/hour transdermal patch EFG, Buprenorphine Teva 52.5 micrograms/hour transdermal patch EFG, and Buprenorphine Teva 70 micrograms/hour transdermal patch EFG.

Your doctor has selected this buprenorphine patch as the most suitable one for you. During treatment, your doctor may switch you from one transdermal patch to another with a lower or higher dose if necessary.

The recommended dose is:

Adults

Follow these instructions unless your doctor has given you different ones. Apply the buprenorphine patch (as detailed below) and change it after four days at the latest. To make it easier to use, 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 calendar printed on the 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 will not fully benefit from treatment with buprenorphine.

Children and adolescents

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

Elderly patients

No dose adjustment is required in elderly patients.

Patients with renal impairment / patients undergoing dialysis

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

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.

Method of administration

Before applying a transdermal patch

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

• If the selected area is hairy, trim the hair with scissors. Do not shave!
• Avoid areas of skin that are red, irritated, or have any other type of markings, 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 along the sealed edge with scissors. Be careful not to damage the transdermal patch. Take out the transdermal patch.
Step 2: The adhesive side of the transdermal patch is covered by a clear protective liner. Carefully peel off half of the liner. Avoid touching the adhesive side of the transdermal patch.
Step 3: Apply the transdermal patch to the chosen skin area and remove the remaining part of the liner.
Step 4: Press the transdermal patch firmly against your skin with the palm of your hand and count slowly to 30. 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 correctly applied, 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 patch (see “Changing the transdermal patch” below).

Changing the transdermal patch

• Carefully remove the old patch.
• Fold it in half with the adhesive side inwards.
• Dispose of it carefully, out of sight and reach of children.
• 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 this medicine. Do not stop treatment with buprenorphine on your own, as pain may return and you may feel unwell (see also “If you stop treatment with Buprenorfina Teva”).

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

If you use more Buprenorfina Teva than you should

If this happens, there may be signs of buprenorphine overdose. An overdose may intensify the adverse effects of buprenorphine, such as drowsiness, nausea, and vomiting. You may have pinpoint pupils, and breathing may become slow and weak. You could also experience cardiovascular collapse.

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Buprenorfina Teva

If you miss an application, apply 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 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 patch too late, your 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 treatment with Buprenorfina Teva

If you interrupt or stop treatment with this medicine too early, your pain will 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 you can be treated with other medicines.

Some people may experience withdrawal symptoms after using strong painkillers for a long time, when stopping them. The risk of experiencing such effects after stopping buprenorphine patches is very low. However, if you feel agitated, anxious, nervous, or shaky, if you are hyperactive, have difficulty sleeping, or have 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 but serious 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, loss of consciousness due to low blood pressure)
• dry mouth
• rashes
• urinary retention (less urine than normal), urinary disturbances
• weakness (lassitude)

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

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

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

• severe allergic reactions
• dependence, mood changes
• muscle twitching, taste disturbances
• pinpoint pupils
• ear pain
• hyperventilation, hiccups
• retching
• pustules, vesicles
• chest pain

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

• contact dermatitis (skin rash with inflammation that may include 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 Teva 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 Teva, 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 it is a possible adverse effect 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 Teva

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

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

This medicine does not require any special storage conditions.

Store this medicine in a safe and secure place, out of reach of other people. It may cause serious harm or be fatal to individuals who take it accidentally or intentionally without being prescribed it.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their packaging should be handed over to the SIGRE Point at your pharmacy. If you have any doubts, 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 Teva

The active substance is buprenorphine.

Each 37.5 cm² transdermal patch contains 30 mg of buprenorphine and releases 52.5 micrograms of buprenorphine per hour.

The other components are:

• Adhesive matrix (with buprenorphine): povidone K90, levulinic acid, oleyl 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)
• Separator film between the adhesive matrices with and without buprenorphine: poly(ethylene terephthalate) film
• Coating layer: polyester
• Release liner (on the front covering the adhesive matrix containing buprenorphine): silicone-coated poly(ethylene terephthalate) film
• Blue printing ink

Appearance of Buprenorphine Teva and contents of the pack

Rectangular patch with rounded edges, beige in colour, printed with “Buprenorphine” and “52.5 μg/h”.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Teva Pharma S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Manufacturer

Labtec GmbH

Heykenaukamp 10, Hamburg

21147 Germany

or

Merckle GmbH

Ludwig-Merckle-Straße 3, Blaubeuren

89143 Germany

or

Teva Operations Poland Sp.z.o.o

ul. Mogilska 80, Krakow

31-546 Poland

This medicinal product is authorised in Member States under the following names:

Germany:	Buprenorphine ratiopharm 52.5 micrograms/hour Transdermal Patch
Austria:	Buprenorphine ratiopharm 52.5 micrograms/h transdermal patch
Belgium:	Buprenorphine Teva 52.5 microgram/h transdermal patch for transdermal use Buprenorphine Teva 52.5 micrograms/h transdermal system Buprenorphine Teva 52.5 micrograms/h transdermal patch
Spain:	Buprenorphine Teva 52.5 micrograms/hour transdermal patch EFG
Finland:	Buprenorphine ratiopharm 52.5 micrograms/hour depot patch
Croatia:	Laribon 52.5 micrograms/h transdermal patch
Netherlands:	Buprenorphine Teva 52.5 micrograms/hour patch for transdermal use
Portugal:	Buprenorphine ratiopharm
United Kingdom:	Timpron 52.5 micrograms/h Transdermal patch

Date of the most recent review of this leaflet: October 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80610/P_80610.html

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