Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Rebrikel 5 micrograms/hour transdermal patches

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Buprenorphine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Buprenorphine

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

FOR This medicine has been prescribed for you for the relief of moderate, long-lasting pain that requires the use of a strong painkiller. It contains the active ingredient buprenorphine which belongs to a class of medicines called opioids, which are 'pain relievers'. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop using it suddenly. Your prescriber should have explained how long you will use it for, when it is appropriate to stop, and how to do this safely. Rebrikel patches should not be used to relieve acute pain. Rebrikel patches act through the skin. After application, buprenorphine passes through the skin into the blood. Each patch lasts for seven days.

What you need to know before you take it

E REBRIKEL PATCHES Do not use Rebrikel patches if you:

  • are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6);
  • have breathing problems;
  • are addicted to drugs;
  • are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks;
  • suffer from myasthenia gravis (a condition in which the muscles become weak);
  • have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking alcohol. Rebrikel patches must not be used to treat symptoms associated with drug withdrawal. Warning and precautions Talk to your doctor, pharmacist or nurse before using Rebrikel patches if you:
  • are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs;
  • have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs;
  • feel you need to use more Rebrikel patches to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever;
  • are treated with antidepressants. The use of these medicines together with Rebrikel patches can lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Rebrikel patches");
  • suffer from seizures, fits or convulsions;
  • suffer from breathing related sleep disorder (sleep apnoea);
  • have a severe headache or feel sick due to a head injury or increased pressure in your skull (for instance due to brain disease). This is because the patches may make symptoms worse or hide the extent of a head injury;
  • are feeling light-headed or faint;
  • have severe liver problems;
  • are a smoker;
  • have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illness;
  • have a high temperature, as this may lead to larger quantities of the active ingredient being absorbed into the blood than normal;
  • suffer from constipation. Tolerance, dependence, and addiction This medicine contains buprenorphine which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Rebrikel patches can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use. Your prescriber should have explained how long you will be using this medicine for, when it is appropriate to stop, and how to do this safely. Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it. The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Rebrikel patches if:
  • You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction").
  • You are a smoker.
  • You have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses. If you notice any of the following signs whilst taking Rebrikel patches, it could be a sign that you have become dependent or addicted:
  • You need to take the medicine for longer than advised by your doctor.
  • You need to take more than the recommended dose.
  • You might feel that you need to carry on taking your medicine, even when it doesn't help to relieve your pain.
  • You are using the medicine for reasons other than prescribed, for instance, 'to stay calm' or 'help you sleep'.
  • You have made repeated, unsuccessful attempts to quit or control the use of the medicine.
  • When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again ('withdrawal effects'). If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (see section 3, "If you stop taking Rebrikel patches"). Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment. Addiction can cause withdrawal symptoms when you stop using this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop using the medicine suddenly as you will be more likely to experience withdrawal symptoms. Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Using higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death. Sleep-related breathing disorders Buprenorphine can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor. This medicine may cause application site reactions which are usually presented by a mild or moderate skin inflammation, and their typical appearance may include redness, swelling, itching rash, small blisters, and painful/burning sensation at the application site. Most commonly the cause is skin irritation, and these reactions stop after the Rebrikel patches are removed. Chronic allergic reactions may lead to open wounds, bleeding, ulcers, skin discolouration and infections. If you notice any of the above skin reactions, please contact your doctor. This medicine may increase your sensitivity to pain particularly at high doses. Tell your doctor if this happens. A reduction in your dose or a change in your medication may be necessary. Do not use if you have pain which lasts only for a short period or pain after having an operation because of the increased risk of dependence and developing serious breathing problems. If you are going to have an operation, or have just had an operation, please tell the doctor at the hospital if you are currently treated with Rebrikel patches to discuss your pain management. Similar to other opioids, Rebrikel patches may affect the normal production of hormones in the body, such as cortisol or sex hormones, particularly if you have used high doses for a long time.

Children and adolescents Do not give this medicine to children below 18 years. Other medicines and Rebrikel patches Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Rebrikel patches may sometimes cause very serious reactions. Do not take any other medicines whilst using Rebrikel patches without first talking to your doctor, especially:

  • Anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with Rebrikel patches and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
  • Rebrikel patches must not be used together with a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid), or if you have taken this type of medicine in the last two weeks.
  • If you take some medicines such as phenobarbital or phenytoin (medicines commonly used to treat seizures, fits or convulsions), carbamazepine (a medicine to treat seizures, fits or convulsions and certain pain conditions), or rifampicin (a medicine to treat tuberculosis) the effects of Rebrikel patches may be reduced.
  • Rebrikel patches may make some people feel drowsy, sick or faint or make them breathe more slowly or weakly. These side effects may be made worse if other medicines that produce the same effects are taken at the same time. These include certain medicines to treat pain, depression, anxiety, psychiatric or mental disorders, medicines to help you sleep, medicines to treat high blood pressure such as clonidine, other opioids (which may be found in painkillers or certain cough mixtures e.g. morphine, dextropropoxyphene, codeine, dextromethorphan, noscapine), antihistamines (medicines used to treat allergies) which make you drowsy, or anaesthetics such as halothane.
  • Concomitant use of Rebrikel patches and sedative medicines such as benzodiazepines or related drugs may increase the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Rebrikel patches together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor's dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
  • Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
  • Medicines used to treat travel sickness or nausea (antiemetics).
  • Medicines to treat psychiatric disorders (antipsychotics or neuroleptics).
  • Muscle relaxants.
  • Medicines to treat Parkinson's disease. Using Rebrikel patches with food, drink and alcohol Alcohol may make some of the side effects worse and you may feel unwell if you drink alcohol whilst wearing Rebrikel patches. Drinking alcohol whilst using Rebrikel patches may also affect your reaction time. Pregnancy, breast-feeding and fertility Do not use Rebrikel patches if you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, unless otherwise instructed by your doctor having carefully considered the benefits and risk to both mother and child. If you use Rebrikel patches during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated. Do not use Rebrikel patches while you are breast-feeding as buprenorphine passes into breast milk and will affect your baby. Ask your doctor or pharmacist for advice before using this medicine. Driving and using machines Rebrikel patches may affect your reactions to such an extent that you may not react adequately or quickly enough in the event of unexpected or sudden occurrences. This applies particularly:
  • at the beginning of treatment;
  • if you are taking medicines to treat anxiety or help you sleep;
  • if your dose is increased. If you are affected (e.g. feel dizzy, drowsy or have blurred vision), you should not drive or operate machinery whilst using Rebrikel patches, or for 24 hours after removing the patch. The medicine can affect your ability to drive as it may make you sleepy or dizzy.
  • Do not drive while using this medicine until you know how it affects you.
  • It is an offence to drive while you have this medicine in your body over a specified limit unless you have a defence (called the 'statutory defence').
  • This defence applies when: o The medicine has been prescribed to treat a medical or dental problem; and o You have used it according to the instructions given by the prescriber and in the information provided with the medicine.
  • Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected). Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while using this medicine. Details regarding the driving offence concerning driving after drugs have been taken/used in the UK may be found here: https://www.gov.uk/drug-driving-law

How to take it

REBRIKEL PATCHES Always use Rebrikel patches exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Different strengths of Rebrikel patches are available. Your doctor will decide which strength of Rebrikel patch will suit you best. When people first start using Rebrikel patches, they often experience some nausea and vomiting (see section 4). This usually passes after the first week of treatment. It's a good idea to book a follow-up appointment with your doctor a week or two after you first start using Rebrikel patches to ensure that you are using the correct dose and to manage any side effects. During treatment, your doctor may change the patch you use to a smaller or larger one if necessary or tell you to use a combination of up to two patches. Do not cut or divide the patch or use a higher dose than recommended. You should not apply more than two patches at the same time, up to a maximum total dose of 40 micrograms/hour. Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Rebrikel patches, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also, "If you stop taking Rebrikel patches"). Adults and elderly patients Unless your doctor has told you differently, attach one Rebrikel patch (as described in detail below) and change it every seventh day, preferably at the same time of day. Your doctor may wish to adjust the dose after 3-7 days until the correct level of pain control has been found. If your doctor has advised you to take other painkillers in addition to the patch, strictly follow the doctor's instructions, otherwise you will not fully benefit from treatment with the Rebrikel patch. The patch should be worn for 3 full days before increasing the dose, this is when the maximum effect of a given dose is established. Patients under 18 years of age Rebrikel patches should not be used in patients below the age of 18 years. Patients with kidney disease/dialysis patients In patients with kidney disease, no change in dose is necessary. Patients with liver disease In patients with liver disease, the effects and period of action of the Rebrikel patch may be affected and your doctor will therefore check on you more closely. Before applying the Rebrikel patch

  • Choose an area of non-irritated, intact skin on your upper arm, outer arm, upper chest, upper back or side of the chest. (See illustrations below). Ask for assistance if you cannot apply the patch yourself.
  • The Rebrikel patch should be applied to a relatively hairless or nearly hairless skin site. If no suitable hair free sites are available the hairs should be cut off with a pair of scissors. Do not shave them off.
  • Avoid skin which is red, irritated or has any other blemishes, for instance large scars.
  • The area of skin you choose must be dry and clean. If necessary, wash it with cold or lukewarm water. Do not use soap, alcohol, oil, lotions or other detergents. After a hot bath or shower, wait until your skin is completely dry and cool. Do not apply lotion, cream or ointment to the chosen area. This might prevent your patch from sticking properly. Applying the patch Step 1: Each 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 with the scissors. Take out the patch. Do not use the patch if the pouch seal is broken. Step 2: The sticky side of the patch is covered with a silvery protective foil. Carefully peel off half the foil. Try not to touch the sticky part of the patch. Step 3: Stick the patch on to the area of skin you have chosen and remove the remaining foil. Step 4: Press the patch against your skin with the palm of your hand and count slowly to 30. Make sure that the whole patch is in contact with your skin, especially at the edges.

Wearing the patch You should wear the patch for seven days. Provided that you have applied the patch correctly, there is little risk of it coming off. If the edges of the patch begin to peel off, they may be taped down with a suitable skin tape. You may shower, bathe or swim whilst wearing it. Do not expose the patch to extreme heat (e.g. heating pads, electric blanket, heat lamps, sauna, hot tubs, heated water beds, hot water bottle, etc) as this may lead to larger quantities of the active ingredient being absorbed into the blood than normal. External heat may also prevent the patch from sticking properly. If you have a high temperature this may alter the effects of Rebrikel patches (see "Take special care" section above). In the unlikely event that your patch falls off before it needs changing, do not use the same patch again. Stick a new one on straight away (see "Changing the patch" below). Changing the patch

  • Take the old patch off.
  • Fold it in half with the sticky side inwards.
  • Open and take out a new patch. Use the empty pouch to dispose of the old patch. Now discard the pouch safely.
  • Even used patches contain some active ingredient that may harm children or animals, so make sure your used patches are always kept out of the sight and reach of them.
  • Stick a new patch on a different appropriate skin site (as described above). You should not apply a new patch to the same site for 3-4 weeks.
  • Remember to change your patch at the same time of day. It is important that you make a note of the time of day. Duration of treatment Your doctor will tell you how long you should be treated with the Rebrikel patch. Do not stop treatment without consulting a doctor, because your pain may return and you may feel unwell (see also "If you stop using Rebrikel patches" below). If you feel that the effect of the Rebrikel patch is too weak or too strong, talk to your doctor or pharmacist. If you use more Rebrikel patches than you should As soon as you discover that you have used more patches than you should, remove all patches and call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy and sick. They may also have breathing difficulties or lose consciousness and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining patches with you to show to the doctor. If you forget to apply the Rebrikel patch Stick a new patch on as soon as you remember. Also make a note of the date, as your usual day of changing may now be different. If you are very late changing your patch, your pain may return. In this case, please contact your doctor. Do not apply additional patches to make up for the forgotten application. If you stop using Rebrikel patches Do not suddenly stop using this medicine. If you want to stop using this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop using this medicine. If you stop using Rebrikel patches too soon or you interrupt your treatment your pain may return. If you wish to stop treatment please consult your doctor. They will tell you what can be done and whether you can be treated with other medicines. The pain relieving effect of Rebrikel patch is maintained for some time after removal of the patch. You should not start another opioid analgesic (strong painkiller) within 24 hours after removal of the patch. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Rebrikel patches can cause side effects, although not everybody gets them. Serious side effects that may be associated with Rebrikel patches are similar to those seen with other strong painkillers and include difficulty in breathing and low blood pressure. This medicine can cause allergic reactions, although serious allergic reactions are rare. Remove the patch and tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body. Drug Withdrawal When you stop using Rebrikel patches, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating. How do I know if I am addicted? If you notice any of the following signs whilst using Rebrikel patches, it could be a sign that you have become addicted.

  • You need to use the medicine for longer than advised by the prescriber.
  • You feel you need to use more than the recommended dose.
  • You are using the medicine for reasons other than prescribed.
  • When you stop using the medicine you feel unwell, and you feel better once using the medicine again. If you notice any of these signs, it is important you talk to your prescriber. In patients treated with Rebrikel patches, the following other side effects have been reported: Very common (may affect more than 1 in 10 people)
  • Headache, dizziness, drowsiness.
  • Constipation, feeling or actually being sick.
  • Itchy skin.
  • Rash, redness, itching, inflammation or swelling of the skin at application site. Common (may affect up to 1 in 10 people)
  • Loss of appetite.
  • Confusion, depression, anxiety, difficulty in sleeping, nervousness, shaking (tremors).
  • Shortness of breath.
  • Abdominal pain or discomfort, diarrhoea, indigestion, dry mouth.
  • Sweating, rash, skin eruptions.
  • Tiredness, a feeling of unusual weakness, muscle weakness, swelling of hands, ankles or feet. Uncommon (may affect up to 1 in 100 people)
  • Restlessness, agitation, a feeling of extreme happiness, hallucinations, nightmares, decreased sexual drive, aggression.
  • Changes in taste, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness.
  • Loss of memory, migraine, fainting, problems with concentration or co-ordination.
  • Dry eyes, blurred vision.
  • A ringing or buzzing sound in the ears, a feeling of dizziness or spinning.
  • High or low blood pressure, chest pain fast or irregular heartbeat.
  • Cough, hiccups, wheezing.
  • Wind.
  • Weight loss.
  • Dry skin.
  • Spasms, aches and pains.
  • Difficulty in beginning the flow of urine.
  • Fever.
  • An increase in accidental injuries (e.g. falls).
  • Withdrawal symptoms such as agitation, anxiousness, sweating or shaking upon stopping using Rebrikel patches (see section 'Drug withdrawal'). If you need to have blood tests remind your doctor that you are using Rebrikel patches. This is important because Rebrikel patches may change the way your liver works and this could affect the results of some blood tests. Rare (may affect up to 1 in 1,000 people )
  • Angina (severe chest pain associated with heart disease).
  • Mental disorder.
  • Difficulties with balance.
  • Swelling of the eyelids or face, a reduction in size of the pupils in the eye.
  • Difficulty in breathing, worsening of asthma, over breathing.
  • A feeling of faintness, especially on standing up.
  • Difficulty in swallowing.
  • Local allergic reaction with marked signs of swelling (in such cases treatment should be stopped).
  • Swelling and irritation inside the nose.
  • Decreased erection, sexual dysfunction.
  • A flu like illness.
  • Flushing of the skin.
  • Dehydration. Very rare (may affect up to 1 in 10,000 people)
  • Muscle twitching.
  • Mood swings.
  • Ear pain.
  • Blisters. Not known (frequency cannot be estimated from the available data)
  • Problems with breathing during sleep (sleep apnoea syndrome), see section 2 'Warnings and precautions.'
  • Seizures, fits or convulsions.
  • Inflammation of the bowel wall. Symptoms may include fever, vomiting and stomach pain or discomfort.
  • An increased sensitivity to pain.
  • Colicky abdominal pain or discomfort.
  • Feeling detached from oneself.
  • Withdrawal symptoms in babies born to mothers who have been given Rebrikel patches in pregnancy may include high-pitched crying, irritability and restlessness, shaking (tremor), feeding difficulties, sweating and not putting on weight.
  • A need to use increasingly higher doses of this medicine to obtain the same level of pain relief (tolerance).
  • Dermatitis contact (skin rash with inflammation which may include burning sensation), skin discolouration.
  • Dependence and addiction (see section "How do I know if I am addicted?").
  • Joint pain. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

REBRIKEL PATCHES Keep this medicine out of the sight and reach of children. Store this medicine in a safe and secure place, where other people cannot access it. It can cause serious harm and be fatal to people who may take this medicine by accident, or intentionally when it has not been prescribed for them. Rebrikel 5 μg/h, 10 μg/h and 15 μg/h transdermal patch: Do not store Rebrikel patches above 25°C. Rebrikel 20 μg/h transdermal patch: This medicine does not require any special storage conditions. Do not use the patch if the pouch seal is broken. Used patches must be folded over on themselves with the adhesive layer inwards, and discarded safely out of sight and reach of children. Do not use Rebrikel patches after the expiry date which is stated on the carton and on the pouch. The expiry date refers to the last day of that month. After the expiry date, take any unused patches to a pharmacy. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Rebrikel patches contain The active ingredient is buprenorphine. Rebrikel 5 micrograms/hour transdermal patch Each transdermal patch contains 5 mg of buprenorphine in a patch size of 6.25 cm2 and releases about 5 micrograms of buprenorphine per hour (over a period of 7 days). Rebrikel 10 micrograms/hour transdermal patch Each transdermal patch contains 10 mg of buprenorphine in a patch size of 12.5 cm2 and releases about 10 micrograms of buprenorphine per hour (over a period of 7 days). Rebrikel 15 micrograms/hour transdermal patch Each transdermal patch contains 15 mg of buprenorphine in a patch size of 18.75 cm2 and releases about 15 micrograms of buprenorphine per hour (over a period of 7 days). Rebrikel 20 micrograms/hour transdermal patch Each transdermal patch contains 20 mg of buprenorphine in a patch size of 25 cm2 and releases about 20 micrograms of buprenorphine per hour (over a period of 7 days). The other ingredients are: Adhesive matrix (containing buprenorphine): povidone K90, levulinic acid, oleyl oleate, Poly[acrylic acid-cobutylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5) Adhesive matrix (without buprenorphine): Poly[(2-ethylhexyl)acrylate-co-glycidylmethacrylate-co-(2hydroxyethyl)acrylate-co-vinylacetate] (68:0,15:5:27), Separating foil between adhesive matrices with and without buprenorphine: Polyethylene terephthalate film, Backing foil: polyester, Release liner: Polyethylene terephthalate film, siliconised Blue printing ink What Rebrikel patches look like and contents of the pack Transdermal patch 5 micrograms/hour: square, beige coloured patch with rounded corners marked Buprenorphin 5 μg/h 10 micrograms/hour: rectangular, beige coloured patch with rounded corners marked Buprenorphin 10 μg/h 15 micrograms/hour: rectangular, beige coloured patch with rounded corners marked Buprenorphin 15 μg/h 20 micrograms/hour: square, beige coloured patch with rounded corners marked Buprenorphin 20 μg/h Rebrikel patches are available in cartons containing 1, 2, 3, 4, 5, 8, 10 or 12 pouches each containing a single patch. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Manufacturer: Labtec GmbH, Heykenaukamp 10, Hamburg, Germany, D-21147 or AdhexPharma, 42/44 rue de Longvic, 21300 Chenôve, France This leaflet was revised in January 2026

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Frequently asked questions about Rebrikel 5 micrograms/hour transdermal patches

How do I take Rebrikel 5 micrograms/hour transdermal patches?

Rebrikel 5 micrograms/hour transdermal patches comes as patch containing 5mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Rebrikel 5 micrograms/hour transdermal patches?

The active substance in Rebrikel 5 micrograms/hour transdermal patches is buprenorphine.

Are there equivalent medicines to Rebrikel 5 micrograms/hour transdermal patches?

Medicines with the same active substance, strength and form include: BuTrans 5 microgram/hour transdermal patch, Bunov 5 microgram/h transdermal patch, Butec 5 microgram/hour transdermal patch. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Rebrikel 5 micrograms/hour transdermal patches, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Rebrikel 5 micrograms/hour transdermal patches without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Buprenorphine (42 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia.

Buprenorphine patches are not suitable for the treatment of acute pain.

Buprenorphine patches are indicated in adults.

4.2. Posology and method of administration

Posology

Buprenorphine patches should be administered every 7th day.

Patients aged 18 years and over

The lowest Buprenorphine patch (5 μg/h transdermal patch) should be used as the initial dose. Consideration should be given to the previous opioid history of the patient (see section 4.5) as well as to the current general condition and medical status of the patient.

Titration

During initiation of treatment with Buprenorphine patches, short-acting supplemental analgesics may be required (see section 4.5) as needed until analgesic efficacy with the Buprenorphine patches is attained.

During the titration process, the dose may be adjusted every 3 days (72 hours). Thereafter, the 7-day dosing interval should be maintained. Subsequent dosage increases may then be titrated based on the need for supplemental pain relief and the patient's analgesic response to the patch.

To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination of patches should be applied in different places to achieve the desired dose. It is recommended that no more than two patches are applied at the same time, up to a maximum total dose of 40 microgram/hour buprenorphine. A new patch should not be applied to the same skin site for the subsequent 3-4 weeks (see section 5.2). Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment.

In the absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4). A Buprenorphine dose reduction or discontinuation of treatment with Buprenorphine patches or treatment review may be indicated.

Conversion from opioids

Buprenorphine patches can be used as an alternative to treatment with other opioids. Such patients should be started on the lowest available dose (Buprenorphine 5 μg/h transdermal patch) and continue taking short-acting supplemental analgesics (see section 4.5) during titration, as required.

Paediatric population

The safety and efficacy of Buprenorphine patches in children below 18 years of age has not been established. No data are available.

Elderly

No dosage adjustment of Buprenorphine patches is required in elderly patients.

Renal impairment

No special dose adjustment of Buprenorphine patches is necessary in patients with renal impairment.

Hepatic impairment

There is no need for dosage adjustment of Buprenorphine patches in patients with mild to moderate hepatic impairment.

Buprenorphine is metabolised in the liver. The intensity and duration of its action may be affected in patients with impaired liver function. Therefore, such patients should be carefully monitored during treatment with Buprenorphine patches.

Patients with severe hepatic impairment may accumulate buprenorphine during Buprenorphine patches treatment. Consideration of alternate therapy should be considered, and Buprenorphine patches should be used with caution, if at all, in such patients.

Method of administration

Route of administration

Transdermal patch to be worn for 7 days. The patch must not be divided or cut into pieces.

Patch application

In order to ensure effective analgesia of buprenorphine and to minimise the potential of skin reactions (see section 4.4), the following directions of use should be followed:

Buprenorphine patches should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest, but not to any parts of the skin with large scars. Buprenorphine patches should be applied to a relatively hairless or nearly hairless skin site. If none are available, the hair at the site should be cut with scissors, not shaven. If the application site must be cleaned, it should be done with clean water only. Soaps, alcohol, oils, lotions or abrasive devices must not be used. The skin must be dry before the patch is applied. The Buprenorphine patch should be applied immediately after removal from the sealed sachet. Following removal of the protective layer, the transdermal patch should be pressed firmly in place with the palm of the hand for approximately 30 seconds, making sure the contact is complete, especially around the edges. If the edges of the patch begin to peel off, the edges may be taped down with suitable skin tape to ensure a 7 day period of wear.

The patch should be worn continuously for 7 days. Bathing, showering, or swimming should not affect the patch. If a patch falls off, a new one should be applied and worn for 7 days.

Treatment goals and discontinuation

Before initiating treatment with Buprenorphine patches, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with Buprenorphine patches it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4).

After removal of the patch, buprenorphine serum concentrations decrease gradually and thus the analgesic effect is maintained for a certain amount of time. This should be considered when therapy with Buprenorphine patches is to be followed by other opioids. As a general rule, a subsequent opioid should not be administered within 24 hours after removal of the patch. At present, only limited information is available on the starting dose of other opioids administered after discontinuation of the transdermal patch (see section 4.5).

Duration of treatment

Buprenorphine patches should not be used for longer than necessary.

If long-term pain treatment with Buprenorphine patches is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.

Patients with fever or exposed to external heat

While wearing the patch, patients should be advised to avoid exposing the application site to external heat sources, such as heating pads, electric blankets, hot water bottles, heat lamps, sauna, hot tubs, and heated water beds, etc, as an increase in absorption of buprenorphine may occur. When treating febrile patients, one should be aware that fever may also increase absorption resulting in increased plasma concentrations of buprenorphine and thereby increased risk of opioid reactions.

4.3. Contraindications

Buprenorphine patches are contraindicated in:

• patients with known hypersensitivity to the active substance buprenorphine or to any of the excipients (see section 6.1),

• opioid dependent patients and for narcotic withdrawal treatment,

• conditions in which the respiratory centre and function are severely impaired or may become so,

• patients who are receiving MAO inhibitors or have taken them within the last two weeks (see section 4.5),

• patients suffering from myasthenia gravis,

• patients suffering from delirium tremens.

4.4. Special warnings and precautions for use

Buprenorphine patches should be used with particular caution in patients with:

• Respiratory depression

• CNS depressants co-administration (see below and section 4.5)

• Serotonergic agents (see below and section 4.5)

• Psychological dependence [addiction], abuse profile and history of substance and/or alcohol abuse (see below)

• Sleep apnoea

• Acute alcohol intoxication

• Head injury, intracranial lesions or increased intracranial pressure, shock, a reduced level of consciousness of uncertain origin

• Severely impaired hepatic function (see section 4.2)

• Constipation

Respiratory depression

Significant respiratory depression has been associated with buprenorphine, particularly by the intravenous route. A number of overdose deaths have occurred when addicts have intravenously abused buprenorphine, usually with benzodiazepines concomitantly. Additional overdose deaths due to ethanol and benzodiazepines in combination with buprenorphine have been reported (see section 4.9). Caution should be exercised when prescribing Buprenorphine patches to patients known to have, or suspected of having, problems with drug or alcohol abuse or serious mental illness.

Concomitant use of opioids such as buprenorphine and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe buprenorphine concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).

Serotonin syndrome

Concomitant administration of Buprenorphine patches and other serotonergic agents, such as MAO inhibitors, selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic antidepressants may result in serotonin syndrome, a potentially life-threatening condition (see section 4.5).

If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.

If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.

Buprenorphine is a µ-opioid agonist, acting as a full agonist with respect to analgesia and as a partial agonist with respect to its respiratory depressant properties (see section 5.1).

Tolerance and opioid use disorder (abuse and dependence)

Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Buprenorphine patches even at therapeutic doses. Repeated use of Buprenorphine patches can lead to OUD. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Buprenorphine patches may result in overdose and/or death. The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders (e.g. major depression, anxiety and personality disorders).

Before initiating treatment with Buprenorphine patches and during the treatment, treatment goals and a discontinuation plan should be agreed with the patient (see section 4.2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician.

Patients will require monitoring for signs of drug-seeking behaviour (e.g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.

A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.

Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient.

Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.

Patients should be closely monitored for signs of misuse, abuse or addiction.

The clinical need for analgesic treatment should be reviewed regularly.

Drug withdrawal syndrome

Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with buprenorphine.

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimize symptoms of withdrawal. Tapering from a high dose may take weeks to months.

The opioid drug withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.

Hyperalgesia

Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain. This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality. Symptoms of hyperalgesia may resolve with a reduction of opioid dose.

Sleep-related breathing disorders

Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.

Skin reactions at application site

To minimise the risk of occurrence of application site skin reactions, it is important to follow the posology instructions (see section 4.2).

Application site reactions with Buprenorphine patches are usually presented by a mild or moderate skin inflammation (contact dermatitis), and their typical appearance may include erythema, oedema, pruritus, rash, small blisters (vesicles), and painful/burning sensation at the application site. Most commonly the cause is skin irritation (irritant contact dermatitis), and these reactions resolve spontaneously after the removal of the Buprenorphine patch.

Patients and caregivers should be instructed accordingly to monitor the application sites for such reactions. If allergic contact dermatitis is suspected, relevant diagnostic procedures should be performed to determine if sensitization has occurred and its actual cause (buprenorphine and/or other ingredients of the patch).

Since CYP3A4 inhibitors may increase concentrations of buprenorphine (see section 4.5), patients already treated with CYP3A4 inhibitors should have their dose of Buprenorphine patches carefully titrated since a reduced dosage might be sufficient in these patients

Buprenorphine is not recommended for analgesia in the immediate post-operative period. Do not use for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI). Buprenorphine patches are also not recommended for analgesia in other situations characterised by a narrow therapeutic index or a rapidly varying analgesic requirement.

Buprenorphine may lower the seizure threshold in patients with a history of seizure disorder.

Severe febrile illness may increase the rate of buprenorphine absorption from the transdermal patches.

Endocrine system

Opioids may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may be manifest from these hormonal changes.

Buprenorphine patches should not be used at higher doses than recommended.

4.5. Interaction with other medicinal products and other forms of interaction

Effect of other active substances on the pharmacokinetics of buprenorphine

Buprenorphine is primarily metabolised by glucuronidation and to a lesser extent (about 30%) by CYP3A4. Concomitant treatment with CYP3A4 inhibitors may lead to elevated plasma concentrations with intensified efficacy of buprenorphine.

Studies with the CYP3A4 inhibitor ketoconazole did not produce clinically relevant increases in mean maximum (Cmax) or total (AUC) buprenorphine exposure following buprenorphine with ketoconazole as compared to buprenorphine alone.

The interaction between buprenorphine and CYP3A4 enzyme inducers has not been studied.

Co-administration of Buprenorphine patches and enzyme inducers (e.g. phenobarbital, carbamazepine, phenytoin and rifampicin) could lead to increased clearance which might result in reduced efficacy.

Reductions in hepatic blood flow induced by some general anaesthetics (e.g. halothane) and other medicinal products may result in a decreased rate of hepatic elimination of buprenorphine.

Pharmacodynamic interactions

Buprenorphine patches must not be used concomitantly with MAOIs or in patients who have received MAOIs within the previous two weeks (see section 4.3).

Buprenorphine patches should be used cautiously when co-administered with:

• Serotonergic medicinal products, such as MAO inhibitors, selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4).

• Other central nervous system depressants: other opioid derivatives (analgesics and antitussives containing e.g. morphine, dextropropoxyphene, codeine, dextromethorphan or noscapine). Certain antidepressants, sedative H1-receptor antagonists, alcohol, anxiolytics, neuroleptics, clonidine and related substances. These combinations increase the CNS depressant activity.

The concomitant use of buprenorphine patches with gabapentinoids (gabapentin and pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or death (see section 4.4).

Sedative medicines such as benzodiazepines or related drugs as concomitant use increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4). Such agents include sedatives or hypnotics, general anesthetics, other opioid analgesics, phenothiazines, centrally acting anti-emetics, benzodiazepines and alcohol.

Concomitant administration of buprenorphine with anticholinergics or medications with anticholinergic activity (e.g. tricyclic antidepressants, antihistamines, antipsychotics, muscle relaxants, anti-Parkinson drugs) may result in increased anticholinergic adverse effects.

At typical analgesic doses buprenorphine is described to function as a pure mu receptor agonist. In buprenorphine clinical studies subjects receiving full mu agonist opioids (up to 90 mg oral morphine or oral morphine equivalents per day) were transferred to buprenorphine. There were no reports of abstinence syndrome or opioid withdrawal during conversion from entry opioid to buprenorphine (see section 4.4).

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amounts of data from the use of Buprenorphine patches in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.

Buprenorphine crosses the placenta and buprenorphine and the active metabolite norbuprenorphine can be detected in newborn serum, urine and meconium following in utero exposure.

Towards the end of pregnancy high doses of buprenorphine may induce respiratory depression in the neonate even after a short period of administration.

Therefore, Buprenorphine patches should not be used during pregnancy and in women of childbearing potential who are not using effective contraception unless the potential benefit justifies the potential risk to the foetus.

Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate.

If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.

Breastfeeding

Administration to nursing women is not recommended as buprenorphine may be secreted in breast milk and may cause respiratory depression in the infant.

Studies in rats have shown that buprenorphine may inhibit lactation. Available pharmacodynamic/ toxicological data in animals has shown excretion of buprenorphine in milk (see section 5.3). A risk to the newborn/infants cannot be excluded. Buprenorphine patches should be used with caution during breast-feeding.

Fertility

No human data on the effect of buprenorphine on fertility are available. In a fertility and early embryonic development study, no effects on reproductive parameters were observed in male or female rats (see section 5.3).

4.7. Effects on ability to drive and use machines

Buprenorphine patches have a major influence on the ability to drive and use machines. Even when used according to instructions, Buprenorphine patches may affect the patient's reactions to such an extent that road safety and the ability to operate machinery may be impaired. This applies particularly in the beginning of treatment and in conjunction with other centrally acting substances including alcohol, tranquilisers, sedatives and hypnotics. An individual recommendation should be given by the physician. A general restriction is not necessary in cases where a stable dose is used.

Patients who are affected and experience side effects (e.g. dizziness, drowsiness, blurred vision) during treatment initiation or titration to a higher dose should not drive or use machines, nor for at least 24 hours after the patch has been removed.

This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

• The medicine is likely to affect your ability to drive.

• Do not drive until you know how the medicine affects you.

• It is an offence to drive while you have this medicine in your body over a specified limit unless you have a defence (called 'statutory defence' ).

• This defence applies when:

o The medicine has been prescribed to treat a medical or dental problem; and

o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine.

• Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).

Details regarding the driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law

4.8. Undesirable effects

Serious adverse reactions that may be associated with Buprenorphine patch therapy in clinical use are similar to those observed with other opioid analgesics, including respiratory depression (especially when used with other CNS depressants) and hypotension (see section 4.4).

The following undesirable effects have occurred:

Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).

System organ class MedDRA

Very common

(≥1/10)

Common

(≥1/100, <1/10)

Uncommon

(≥1/1000, <1/100)

Rare

(≥1/10,000, <1/1000)

Very rare

(<1/10,000)

Not known (cannot be estimated from the available data)

Immune system disorders

Hypersensitivity

Anaphylactic reaction

Anaphylactoid reaction

Metabolic and nutritional disorders

Anorexia

Dehydration

Psychiatric disorders

Confusion

Depression

Insomnia

Nervousness

Anxiety

Affect lability Sleep disorder Restlessness Agitation

Euphoric mood

Hallucinations

Decreased libido Nightmares

Aggression

Psychotic disorder

Mood swings

Drug dependence (see section 4.4)

Depersonalisation

Nervous system disorders

Headache Dizziness Somnolence

Tremor

Sedation Dysgeusia Dysarthria Hypoaesthesia Memory impairment Migraine

Syncope Abnormal coordination Disturbance in attention Paraesthesia

Balance disorder Speech disorder

Involuntary muscle contractions

Seizures Sleep apnoea syndrome Hyperalgesia

Eye disorders

Dry eye Blurred vision

Visual disturbance Eyelid oedema Miosis

Ear and labyrinth disorders

Tinnitus Vertigo

Ear pain

Cardiac disorders

Palpitations Tachycardia

Angina pectoris

Vascular disorders

Hypotension Circulatory collapse Hypertension Flushing

Vasodilatation

Orthostatic hypotension

Respiratory, thoracic and mediastinal disorders

Dyspnoea

Cough

Wheezing

Hiccups

Respiratory depression Respiratory failure Asthma aggravated Hyperventilation Rhinitis

Gastrointestinal disorders

Constipation

Nausea Vomiting

Abdominal pain Diarrhoea Dyspepsia

Dry mouth

Flatulence

Dysphagia Ileus

Diverticulitis

Hepatobiliary disorders

Biliary colic

Skin and subcutaneous tissue disorders

Pruritus Erythema

Rash

Sweating Exanthema

Dry skin

Urticaria

Face oedema

Pustules Vesicles

Dermatitis contact Application skin discolouration

Musculoskeletal and connective tissue disorders

Muscular weakness

Myalgia

Muscle spasms

Arthralgia

Renal and urinary disorders

Urinary incontinence Urinary retention Urinary hesitation

Reproductive system and breast disorders

Erectile dysfunction Sexual dysfunction

General disorders and administration site conditions

Application site reactions1 *

Tiredness Asthenic conditions Peripheral oedema

Fatigue

Pyrexia

Rigors

Oedema

Drug withdrawal syndrome

Chest pain

Influenza like illness

Drug withdrawal syndrome neonatal Drug tolerance

Investigations

Alanine aminotransferase increased

Weight decreased

Injury, poisoning and procedural complications

Accidental injury Fall

1 Includes common signs and symptoms of contact dermatitis (irritative or allergic): erythema, oedema, pruritus, rash, vesicles, painful/burning sensation at the application site.

*In some cases delayed local allergic reactions (allergic contact dermatitis) occurred with marked signs of inflammation. Mechanical injuries during patch removal (e.g. laceration) are also possible in patients with fragile skin. Chronic inflammation may lead to long-lasting sequelae, such as post inflammatory hyper- and hypopigmentation, as well as dry and thick scaly skin lesions, which may closely resemble scars. In such cases treatment with Buprenorphine patches should be terminated (see sections 4.3 and 4.4).

Drug dependence

Repeated use of Buprenorphine patches can lead to drug dependence, even at therapeutic doses. The risk of drug dependence may vary depending on a patient's individual risk factors, dosage, and duration of opioid treatment (see section 4.4).

After discontinuation of Buprenorphine patches, withdrawal symptoms are unlikely. This may be due to the very slow dissociation of buprenorphine from the opioid receptors and to the gradual decrease of buprenorphine plasma concentrations (usually over a period of 30 hours after removal of the last patch).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms

Symptoms similar to those of other centrally acting analgesics are to be expected. These may include respiratory depression, including apnoea, sedation, drowsiness, nausea, vomiting, cardiovascular collapse and marked miosis.

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.

Treatment

Remove any patches from the patient's skin.

Establish and maintain a patent airway, assist or control respiration as indicated and maintain adequate body temperature and fluid balance. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.

A specific opioid antagonist such as naloxone may reverse the effects of buprenorphine, although naloxone may be less effective in reversing the effects of buprenorphine than other µ-opioid agonists. Treatment with continuous intravenous naloxone should begin with the usual doses but high doses may be required.

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