Find similar products:
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: PL08553/0566.
Panitaz 5 micrograms/h, 10 micrograms/h, 20 micrograms/h Transdermal Patches
Panitaz 5 micrograms/h, 10 micrograms/h, 20 micrograms/h Transdermal Patches
Buprenorphine
1. What Panitaz is and what it is used for
2. What you need to know before you use Panitaz
3. How to use Panitaz
4. Possible side effects
5. How to store Panitaz
6. Contents of the pack and other information
This medicine has been prescribed for you to relieve moderate, long-lasting pain that requires the use of a strong painkiller. It contains 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.
Panitaz patches should not be used to relieve acute pain.
Panitaz patches act through the skin. After application, buprenorphine passes through the skin into the blood. Each patch lasts for seven days.
Panitaz must not be used to treat symptoms associated with drug withdrawal.
Talk to your doctor, pharmacist or nurse before using Panitaz:
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 Panitaz 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.
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 Panitaz if:
If you notice any of the following signs whilst taking [product name], it could be a sign that you have become dependent or addicted:
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 Panitaz).
Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else.
Panitaz 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 Panitaz patches are removed. More serious allergic reactions may occur such as blisters with discharge, which may spread outside the application site and may not resolve rapidly after Panitaz removal. Chronic allergic reactions may lead to open wounds, bleeding, ulcers, skin discoloration 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 medicine may be necessary.
If you have recently had an operation, please speak to your doctor before using these patches.
Similar to other opioids, Panitaz 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 long period of 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.
Some medicines may increase the side effects of Panitaz patches and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Panitaz patches without first talking to your doctor, especially:
Alcohol may make some of the side effects worse and you may feel unwell if you drink alcohol whilst wearing Panitaz patches. Drinking alcohol whilst using Panitaz patches may also affect your reaction time.
Do not use Panitaz patches if you are pregnant or think you may 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 Panitaz patches during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not use Panitaz while you are breastfeeding as buprenorphine passes into breast milk and will affect your baby.
Ask your doctor or pharmacist for advice before taking this medicine.
Panitaz 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 Panitaz 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.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
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 Panitaz, 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 Panitaz).
Different strengths of Panitaz patches are available. Your doctor will decide which strength of Panitaz patch will suit you best.
When people first start using Panitaz 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 Panitaz 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, 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.
Unless your doctor has told you differently, attach one Panitaz 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 Panitaz 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.
Panitaz 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 Panitaz patch may be affected and your doctor will therefore check on you more closely.
Step 1: Each transdermal patch is sealed in a sachet. Just before use, cut the sachet along the sealed edge with scissors. Take out the transdermal patch. Do not use the patch if the sachet seal is broken.
Step 2: The sticky side of the transdermal patch is covered with a transparent protective foil. Carefully peel off one part of the foil. Try not to touch the sticky part of the transdermal patch.
Step 3: Stick the transdermal patch on to the area of skin you have chosen and remove the remaining foil.
Step 4: Press the transdermal patch against your skin with the palm of your hand and count slowly to 30. Make sure that the whole transdermal 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 Panitaz patches (see “Warnings and precautions” 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 transdermal patch” below).
Your doctor will tell you how long you should be treated with the Panitaz 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 Panitaz” below).
If you feel that the effect of the Panitaz 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 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 taking this medicine.
If you stop using Panitaz patches too soon or you interrupt your treatment your pain may return.
The pain relieving effect of Panitaz 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects that may be associated with Panitaz patches are similar to those seen with other strong painkillers and include difficulty in breathing and low blood pressure.
Drug Withdrawal
When you stop using Panitaz, 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.
If you notice any of the following signs whilst using Panitaz, it could be a sign that you have become addicted
If you notice any of these signs, it is important to talk to your prescriber.
In patients treated with Panitaz patches, the following other side effects have been reported:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
If you need to have blood tests remind your doctor that you are using Panitaz patches. This is important because Panitaz 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)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
If you get any side effects, talk to your doctor, 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.
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.
Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not use the patch if the sachet 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.
The active substance is buprenorphine.
Each 5 micrograms/h 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).
Each 10 micrograms/h 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).
Each 20 micrograms/h 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 polyacrylate, povidone K90, levulinic acid, oleyl oleate, PET film, polyester web, blue printing ink.
Transdermal patch.
Three sizes are available.
Each 5 micrograms/h transdermal patch is beige coloured with rounded corners and is imprinted with “Buprenorphin” and “5 μg/h”.
Each 10 micrograms/h transdermal patch is beige coloured with rounded corners and is imprinted with “Buprenorphin” and “10 μg/h”.
Each 20 micrograms/h transdermal patch is beige coloured with rounded corners and is imprinted with “Buprenorphin” and “20 μg/h”.
One transdermal patch is sealed in one child-resistant sachet. The patches are available in cartons containing 4 transdermal patches.
Not all pack sizes may be marketed.
This leaflet was last revised in 08/2024