Rebrikel 10 micrograms/hour transdermal patches

• These patches contain a strong pain killer
• Ensure that old patches are removed before applying a new one
• Patches must not be cut
• Do not expose the patches to a heat source (such as a hot water bottle)
• Do not soak in a hot bath or take a hot shower whilst wearing a patch
• If you develop a fever tell your doctor immediately
• Follow the dosage instructions carefully and only change your patch on the same day and at the same time 7 days later
• If your breathing becomes shallow and weak take the patch off and seek medical help

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Rebrikel patches are and what they are used for
2. What you need to know before you use Rebrikel patches
3. How to use Rebrikel patches
4. Possible side effects
5. How to store Rebrikel patches
6. Content of the pack and other information

• if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6);
• if you have breathing problems;
• if you are addicted to drugs;
• if you 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;
• if you suffer from myasthenia gravis (a condition in which the muscles become weak);
• if you 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.

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.

Using this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

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 taking 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 taking 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. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

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.

If you have recently had an operation, please speak to your doctor before using these patches.

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 taken high doses for a long time.

Do not give this medicine to children below 18 years.

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 taking Rebrikel patches without first talking to your doctor, especially:

• Anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, 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 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.

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.

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.

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 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:
  • The medicine has been prescribed to treat a medical or dental problem; and
  • 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).

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

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

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.

Rebrikel patches should not be used in patients below the age of 18 years.

In patients with kidney disease, no change in dose is necessary.

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.

• 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.

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.

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).

• 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.

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.

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.

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.

Do not suddenly stop taking this medicine. If you want to stop taking 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 taking 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 notice any of the following signs whilst using Rebrikel patches, it could be a sign that you have become addicted.

• You need to take 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 taking the medicine you feel unwell, and you feel better once taking 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 heart beat.
• 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 take 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.

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.

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 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-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5)

Adhesive matrix (without buprenorphine): Poly[(2-ethylhexyl)acrylate-co-glycidylmethacrylate-co- (2-hydroxyethyl)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

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

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:

Manufacturer: