POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/0876 .
Rebrikel 5 micrograms/hour 10 micrograms/hour 20 micrograms/hour transdermal patches
Package leaflet: Information for the patient
Rebrikel 5 micrograms/hour transdermal patches
Rebrikel 10 micrograms/hour transdermal patches
Rebrikel 20 micrograms/hour transdermal patches
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
This medicine contains buprenorphine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
In this leaflet:
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
5. Possible side effects
6. How to store Rebrikel patches
7. Content of the pack and other information
1. WHAT REBRIKEL PATCHES ARE AND WHAT THEY ARE USED 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 taking it suddenly. 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.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE REBRIKEL PATCHES
Do not use Rebrikel patches:
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:
Taking 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.
If you have recently had an operation, please speak to your doctor before using these patches.
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.
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 think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.
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.
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:
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.
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
3. HOW TO USE REBRIKEL PATCHES
Your prescriber should have discussed with you, how long the course of Rebrikel patches will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
Always use Rebrikel patches exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Three 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 taking 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. 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.
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
Applying the patch
Step 1: Each patch is sealed in a pouch. Just before use, open the pouch by tearing where indicated. 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
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 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 have any further questions on the use of this product, ask your doctor or pharmacist.
4. 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.
As with all strong painkillers, there is a risk that you may become addicted or reliant on Rebrikel patches.
In patients treated with Rebrikel patches, the following other side effects have been reported:
Very common (probably occurring in more than 1 in 10 people)
Common (probably occurring in between 1 and 10 out of every 100 people)
Uncommon (probably occurring in between 1 and 10 out of every 1,000 people)
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 (probably occurring in between 1 and 10 out of every 10,000 people)
Very rare (probably occurring in fewer than 1 out of every 10,000 people)
Not known (frequency cannot be estimated from the available data)
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.
If you notice any of these signs, it is important you talk to your prescriber.
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.
5. HOW TO STORE REBRIKEL PATCHES
Keep this medicine out of the 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.
Rebrikel 5 μg/h and 10 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 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.
6. CONTENT 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 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-(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
What Rebrikel patches look like and contents of the pack
Three sizes are available.
5 micrograms/hour: square, beige coloured patch with rounded corners marked Rebrikel 5 μg/h 10 micrograms/hour: rectangular, beige coloured patch with rounded corners marked Rebrikel 10 μg/h
20 micrograms/hour: square, beige coloured patch with rounded corners marked Rebrikel 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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
This leaflet was last approved in August 2020