Relevtec 52.5 microgram/hour transdermal patch – patient leaflet, side effects, dosage

What Relevtec is and what it is used for

Relevtec contains the active substance buprenorphine which is a strong painkiller and belongs to a group of medicines called opioids. It acts on specific nerve cells in the spinal cord and in the brain.

Relevtec is used to treat

• moderate to severe cancer pain and severe pain that

  has not responded to other types of painkillers.

This medicine is not suitable for treating short-lasting pain.

What you need to know before you use Relevtec

first talking to your doctor especially anti-depressants such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with Relevtec 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.

• Relevtec may make some people feel drowsy, sick, or faint or make them breathe more slowly or weakly. These side effects may be intensified if other medicines that may produce the same effects are taken at the same time. These other medicines include other strong pain relievers (opioids), certain sleeping pills, anaesthetics, and medicines used to treat certain psychological diseases such as tranquillizers, anti-depressants, and neuroleptics.

Do not use Relevtec if you:

• are allergic to buprenorphine or any of the other

  ingredients of this medicine (listed in section 6)

• are dependent on opioids

  Relevtec must not be used to treat withdrawal symptoms of

  drug-dependent persons.

• have serious breathing problems

• are being treated or have been treated during the last

  2 weeks with medicines known as monoamine oxidase (MAO) inhibitors

  These types of medicines are used to treat depression or

  Parkinson’s disease.

• have myasthenia gravis (a certain type of severe muscle

  weakness)

• have delirium tremens (confusion and trembling caused

  by abstinence from alcohol following habitual excessive drinking or occurring during an episode of heavy alcohol consumption)

• if you are pregnant

Do not use Relevtec for acute post-operative pain because of the increased risk of dependency 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 taking Relevtec. Your doctor may adjust your dose.

• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
• Medicines to treat Parkinson’s disease
• other medicines to treat depression
• medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics)

• medicines which calm and/or induce sleep Concomitant use of Relevtec and sedative medicines such as benzodiazepines or related medicines increases 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 Relevtec together with sedative medicines the dose and the 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

• anaesthetics
• medicines to treat mental or anxiety disorders, with sedative effects
• medicines to treat psychiatric disorders (antipsychotics or neuroleptics)
• muscle relaxants

Warnings and precautions

Talk to your doctor or pharmacist before using Relevtec if you:

• have recently drunk a lot of alcohol
• have seizures or convulsive disorders (fits)

• have unexplained loss of consciousness (feeling

  light-headed or faint)

• are in a state of shock (cold sweat might be a sign of it)

• have increased pressure inside the skull such as after head

  injury or in brain disease, and artificial respiration is not possible

• have difficulty breathing or are taking other medicines that

  may make you breathe more slowly or weakly (see “Other medicines and Relevtec”)

  • other strong painkillers (opioids)
  • certain medicines to treat bacterial infections, such as erythromycin
  • certain medicines to treat fungal infections, such as ketoconazole
  • certain medicines to treat HIV infections, such as ritonavir, indinavir, saquinavir
  • dexamethasone, a medicine to treat many conditions including inflammation
  • certain medicines to treat epilepsy or certain pain conditions, such as carbamazepine or phenytoin
  • rifampicin, a medicine to treat tuberculosis or certain other infections

• have depression or other conditions that are treated with

  antidepressants

  The use of these medicines together with Relevtec can

  lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Relevtec”).

• have reduced liver function

  Patients with reduced liver function require careful

  monitoring by the doctor during treatment.

  Relevtec with food, drink and alcohol

  Avoid alcohol and products containing grapefruit while using Relevtec as they may intensify effects of buprenorphine.

  Pregnancy, breast-feeding and fertility

  If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• have fever or exposure to external heat. Fever and external

  heat increase skin permeability, which may cause a higher buprenorphine blood level. Therefore, consult your doctor if you have fever. External heat - such as sauna, infrared lamp, electric blanket, hot water bottle - may prevent the transdermal patch from sticking properly. Do not expose yourself to external heat.

• are inclined to abuse medicines or drugs. Please see “Do

  not use Relevtec”.

• are an athlete. This medicine may cause positive results in

  sports doping control tests.

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 Relevtec 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.

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.

There is not sufficient experience regarding the use of Relevtec in pregnant women. Therefore do not use Relevtec if you are pregnant.

Buprenorphine, the active substance contained in the transdermal patch, inhibits milk formation and passes into the breast milk. Therefore, do not use Relevtec if you are breast-feeding.

Driving and using machines

Relevtec may make you feel dizzy or drowsy or experience blurred or double vision and 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,
• when your dosage is changed,
• when you switch to Relevtec from another pain reliever,
• if you also use other medicines that act on the brain,
• if you drink alcohol.

If you are affected, you should not drive or operate machinery whilst using Relevtec. This applies also at the end of treatment with Relevtec. Do not drive or operate machinery for at least 24 hours after the patch has been removed.

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 Relevtec 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 Relevtec, 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’

  Do not drive or use machines:

  • if you feel dizzy, drowsy, experience blurred or double vision, or other effects that affect your reactions
  • for at least 24 hours after the transdermal patch has been removed

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking 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 taken it according to the instructions given by the prescriber and in the information provided with the medicine

• 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 Relevtec).

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

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Sleep-related breathing disorders

Relevtec 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.

Some people may become dependent on strong painkillers such as Relevtec when using them over a long period. They may have withdrawal effects when they stop using them. See section 3, “If you stop using Relevtec”.

Children and adolescents

Relevtec should not be used in children and adolescents below the age of 18 years, because no experience has so far been gained in this age group.

Other medicines and Relevtec

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

The following medicines can affect or be affected by Relevtec:

• certain medicines used to treat depression or Parkinson’s

  disease known as monoamine oxidase (MAO) inhibitors Do not use Relevtec if you are being treated, or have

  been treated in the last 2 weeks, with monoamine oxidase inhibitors

• Some medicines may increase the side effects of Relevtec

  and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Relevtec without

  Consult your doctor or pharmacist if you are unsure about anything.

How to use Relevtec

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Relevtec, 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 Relevtec).

Your doctor chooses the appropriate strength of Relevtec for you and decides upon any changes to this, where necessary. The lowest possible dose providing adequate pain relief will be given.

The recommended dose is:

• one transdermal patch every 3 to 4 days (maximum

  96 hours)

For convenience of use you can change your transdermal patch twice weekly - always on the same days - such as always on Monday mornings and Thursday evenings. Please make a note on the outer pack to help you remember when to change your patch.

Should your doctor advise you to use any additional painkiller, follow the doctor’s instructions strictly. Otherwise you will not benefit fully from treatment with Relevtec.

This dose applies to all adults regardless of age, including patients with kidney diseases.

Patients with liver disease require close monitoring by the doctor.

Contact your doctor or pharmacist if you think that the effect of Relevtec is too weak or too strong.

Method of administration

Transdermal use.

After application, the active substance passes through the skin into the blood.

Before using a transdermal patch

• Choose an area of skin on your upper body that is flat,

  clean and hairless. Preferably, use the chest below the collar-bone, or the upper part of the back. See pictures 1a) and 1b). Ask for assistance if you cannot apply the transdermal patch yourself.

1a) 1b)

chest back

• If the chosen area has hair, cut it off with a pair of scissors.

  Do not shave it 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 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 transdermal patch from sticking properly.

Sticking on the transdermal patch

Each patch is marked with “Buprenorphinum 35 µg/h”, “Buprenorphinum 52.5 µg/h” or “Buprenorphinum 70 µg/h”.

1. 2. Just before use, tear open the sachet where indicated, as

seen in the picture. Remove the transdermal patch.3. The sticky side of the patch is protected with a transparent

foil. Carefully peel off half the foil. Try not to touch the sticky part of the patch.4. Stick the patch onto the area of skin you have chosen in

step 1 and remove the remaining foil.5. Press the patch against your skin with the palm of your

hand. Ensure that the whole patch is in contact with your skin, especially the edges.Wearing the transdermal patch

Provided that you have applied the patch correctly, there is little risk of it coming off. You may shower, bathe or swim while wearing it.

However, do not expose the patch to extreme heat, such as sauna, infrared lamp, electric blanket or hot water bottle.

In the unlikely event that your patch falls off before it needs changing, do not reuse it. Stick a new one on straight away.

Changing the transdermal patch

Take the old transdermal patch off and fold it in half with the sticky side inwards. Dispose of the used patch carefully.

Always use a new appropriate site for a new patch, following steps 1 to 5 above. Wait at least one week before using the same site again.

Duration of use

This will be decided by your doctor. See also under “If you stop using Relevtec”.

If you use more Relevtec than you should

Remove the excess patches and consult a doctor immediately.

Signs of overdose are:

• drowsiness
• nausea, vomiting
• pinpoint pupils
• reduced breathing
• blood circulation collapse

If you forget to use Relevtec

Stick a new transdermal patch on as soon as you remember and make a note of the day. Amend your patch change routine. For example, if you usually change your patch on Mondays and Thursdays, but you forget and don’t renew your patch until Wednesday. In this case, change your patches on Wednesdays and Saturdays from then on.

If you are very late changing your transdermal patch, pain may return. Contact your doctor if this occurs.

Never apply extra patches to make up for a forgotten application.

If you stop using Relevtec

If you interrupt or finish treatment too soon, pain may return and you may feel unwell. Contact your doctor who will decide upon the necessary steps should you wish to stop treatment.

The risk of side effects after ending Relevtec transdermal patches use is very low. Consult your doctor if you feel excited, anxious, nervous, shaky, overactive, or have sleeping difficulties or digestion problems.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious allergic reactions (very rare, may affect up to 1 in 10,000 people)

Remove the transdermal patch and contact your doctor

immediately if you develop any allergic reaction symptoms such as:

• swelling of the face, lips, mouth, neck, eyes or throat
• wheezing or difficulty in swallowing or breathing
• skin rash, redness or itching covering most of the body
• yellowing of the skin and eyes
• collapse, feeling faint

In some cases delayed allergic reactions occur with signs of inflammation. In such a case, remove the transdermal patch and contact your doctor.

If you experience swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing, hives, fainting, yellowing of the skin and eyes (also called jaundice), remove the transdermal patch and call your doctor immediately or seek help at the casualty department of the nearest hospital. These can be symptoms of a very rare serious allergic reaction.

Some people may have withdrawal symptoms when they have used strong pain relievers for a long time and stop using them. The risk of having withdrawal effects when you stop using Relevtec is low. However, if you feel agitated, anxious, nervous or shaky, if you are overactive, have difficulty sleeping or digestion problems, tell your doctor.

Other side effects can occur with the following frequencies: Very common, may affect more than 1 in 10 people

• nausea
• skin reddening, itching

Common, may affect up to 1 in 10 people

• dizziness
• headache
• shortness of breath
• vomiting, constipation
• skin changes
• sweating
• tissue swelling caused by excess fluid (oedema)
• tiredness

Uncommon, may affect up to 1 in 100 people

• confusion
• sleep disorder, restlessness
• various degrees of sedation (calmness), ranging from tiredness to muzziness, sleepiness
• blood circulation disorders such as low blood pressure and, rarely, fainting or even circulatory collapse
• dry mouth
• rash
• difficulties in passing urine, urine retention
• weariness

Rare, may affect up to 1 in 1,000 people

• loss of appetite
• hallucinations, anxiety, nightmares
• decreased sexual drive
• reduced concentration
• speech or balance disorder
• muzziness
• drowsiness
• abnormal skin sensation such as numbness, prickling, tingling or burning
• visual disturbance such as blurred vision
• swelling of the eyelid
• hot flushes
• breathing difficulties (respiratory depression)
• heartburn
• nettle rash
• decreased erection
• withdrawal symptoms
• administration site reactions

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

• dependence on the medicine
• mood swings
• muscle twitching
• taste disturbance
• pinpoint pupils
• ear or chest pain
• breathing faster than normal
• hiccups, retching
• pustules, small blisters

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

• dermatitis contact (skin rash with inflammation which may include burning sensation)
• skin discolouration

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (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 Relevtec

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.

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

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

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Used transdermal patches should be folded with the adhesive surfaces inwards. 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 Relevtec contains

The active substance is buprenorphine.

Relevtec 35 microgram/hour transdermal patch: Each transdermal patch contains 20 mg of buprenorphine in a patch size of 25 cm² releasing 35 micrograms of buprenorphine per hour.

Relevtec 52.5 microgram/hour transdermal patch: Each transdermal patch contains 30 mg of buprenorphine in a patch size of 37.5 cm² releasing 52.5 micrograms of buprenorphine per hour.

Relevtec 70 microgram/hour transdermal patch: Each transdermal patch contains 40 mg of buprenorphine in a patch size of 50 cm² releasing 70 micrograms of buprenorphine per hour.

The other ingredients are:

Release liner (to be removed before applying the patch): poly(ethylene terephthalate) foil, siliconized

Adhesive matrix (containing buprenorphine): levulinic acid, oleyl oleate, povidone K90, poly[acrylic acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5) Separating film (between the adhesive matrices with and without buprenorphine): poly(ethylene terephthalate) foil Adhesive matrix (without buprenorphine): acrylate adhesive Backing layer (printed): polyurethane backing foil, printing ink

What Relevtec looks like and contents of the pack

Relevtec is a pale yellowish-brown, rectangular transdermal patch with rounded edges, containing the following imprint: Buprenorphinum 35 µg/h

Buprenorphinum 52.5 µg/h

Buprenorphinum 70 µg/h

Each transdermal patch is individually packed in a child resistant sachet.

Carton containing 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 16, 18, 19, 20, 21 or 24 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Limited

Maxis 1 Western Road

Bracknell

United Kingdom

RG12 1RF

Manufacturer

Hexal AG

Industriestraße 25,

83607 Holzkirchen,

Germany

This leaflet was last revised in 04/2026.

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