Consumer Medicine Information
This leaflet answers some common questions about NORSPAN Transdermal Drug Delivery System ("patches").
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
NORSPAN patches contain buprenorphine. Buprenorphine belongs to a group of medicines called opioid analgesics.
NORSPAN patches are used to relieve moderate to severe pain.
Opioid analgesics such as buprenorphine have been used to treat pain for many years. Your doctor, however, may prescribe it for another purpose.
Ask your doctor if you have any questions about why it has been prescribed for you.
NORSPAN patches act through the skin. After application, buprenorphine passes through the skin into the blood. Each patch can be worn for seven days. They should not be used for acute pain.
As with all strong painkillers, your body may become used to you using buprenorphine patches. Using them may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop using buprenorphine suddenly, so it is important to use it exactly as directed by your doctor.
This medicine is only available with a doctor's prescription.
Do not use NORSPAN patches if you:
Do not use NORSPAN patches if you are allergic to buprenorphine, opioid analgesics or any of the ingredients listed at the end of this leaflet.
Do not use this medicine after the expiry date (EXP) printed on the pack. If you use it after the expiry date has passed, it may not work very well.
Do not use it if the packaging is torn or shows signs of tampering.
Do not use this medicine if you are pregnant or plan to become pregnant whilst using this medicine. Like most medicines of this kind, NORSPAN patches should not be used during pregnancy. Your doctor can discuss with you the risks of using it if you are pregnant.
Do not give this medicine to a child younger than eighteen years of age. Safety and effectiveness in children younger than eighteen years have not been established.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any medical conditions, especially the following:
Tell your doctor whether you have used an opioid before.
Tell your doctor if you are breastfeeding or planning to breastfeed. NORSPAN patches should not be used by breastfeeding women as buprenorphine can pass into the breastmilk and can affect the baby.
If you have not told your doctor about any of the above, tell them before you start using NORSPAN patches.
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and alcohol may interfere with NORSPAN patches. These include:
These medicines and alcohol may be affected by NORSPAN patches, may affect how well the patches work or may increase side effects. You may need to use different amounts of your medicines, or take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking this medicine.
NORSPAN patches are available in three different strengths. Your doctor will decide which patch, or combination of patches, is suitable to control your pain. During treatment, your doctor may change the patch you use to a different strength if necessary.
You should not apply more than two patches at the same time, regardless of the patch strength.
Follow the instructions your doctor or pharmacist gives you exactly.
Each patch is applied onto the skin and lasts for seven days.
After seven days, remove the patch and apply a new patch to a different site.
The first NORSPAN patch you use may take up to three days to reach its full effect. This is because buprenorphine needs to be absorbed through the skin and then into the blood before you start to feel the effects. Your doctor may prescribe additional medicines to control the pain during this time.
You should wear the patch continuously for 7 days. Bathing, showering or swimming should not affect the patch. However, it is a good idea to keep the patch dry whenever possible.
Do not expose the patch to heat sources such as heating pads, hot water bottles, electric blankets, heat lamps, saunas, hot tubs or heated water beds etc. and avoid intensive sunbathing. Heat may cause more medicine than normal to be absorbed and lead to an increase in side effects. External heat may also prevent the patch from sticking properly.
In the unlikely event that your patch falls off before it needs changing, do not use the same patch again. Apply a new patch to a different site straight away.
If you feel that the effect of the patch is too weak or too strong, talk to your doctor.
Change your patch on the same day at the same time each week.
For example, if you start using your patch at 9 am Monday morning, change your patch the following Monday morning at 9 am.
A new patch should not be applied to the same skin site for three to four weeks.
Remove the old patch and apply a new patch as soon as you remember. Also make a note of the day as your usual day of changing the patch may now be different. If you are late changing your patch, your pain may return. In this case, contact your doctor.
Do not apply twice the number of patches to make up for the patch that you forgot to change on time. Using extra patches will increase the chance of unwanted side effects.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering the day and time to change your patch, ask your pharmacist for some hints.
Continue using the patches for as long as your doctor tells you.
If you stop using NORSPAN patches suddenly, your pain may worsen and you may experience withdrawal symptoms such as:
If you have received an overdose, remove all patches and immediately telephone your doctor or the Poisons Information Centre (Australia: telephone 13 11 26, New Zealand: telephone 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital. This also applies if someone else has used your patches.
Keep telephone numbers for these places handy.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If someone has overdosed they may experience difficulties in breathing, become drowsy and tired, feel sick, vomit, have constricted pupils, have very low blood pressure or slow heart rate, and possibly may even become unconscious or die.
When seeking medical attention, take this leaflet and the used patch or any remaining patches with you to show the doctor. Also tell them about any other medicines or alcohol which have been taken.
Use NORSPAN patches exactly as your doctor has prescribed.
Before you start on a new medicine, remind your doctor and pharmacist that you are using NORSPAN patches.
Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.
If you are going to have surgery, tell the surgeon and anaesthetist that you are using this medicine. It may affect other medicines used during surgery.
Tell your doctor if you develop a high fever. At high body temperatures, the amount of buprenorphine absorbed into the skin may increase.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all your doctor's appointments so that your progress can be checked.
Tell your doctor if your pain is getting worse, or if you are having frequent breakthrough pain. This may be due to you developing tolerance to buprenorphine which means that the effect of the medicine may decrease.
Keep enough NORSPAN patches with you to last over weekends and holidays.
Do not use NORSPAN patches to treat any other complaint unless your doctor tells you to.
Do not give your medicine to anyone else, even if you think they may have the same condition as you.
Do not expose the patch to direct heat sources, or wear it in saunas or hot tubs and avoid intensive sunbathing.
Do not stop using your medicine or change the dosage without checking with your doctor. Over time your body may become used to you having buprenorphine so if you stop using it suddenly, your pain may worsen and you may have unwanted withdrawal symptoms. This is called physical dependence.
If you need to stop using this medicine, your doctor will gradually reduce the amount you use each day, if possible, before stopping the medicine completely.
The pain-relieving effect of the NORSPAN patch is maintained for some time after removal of the patch. You should not start another opioid analgesic (strong pain medicine) within 24 hours after removal of the patch.
Do not apply more than two patches at any one time.
Tell your doctor if you find that you cannot concentrate or that you feel more sleepy than normal when you start having this medicine or when the dose is increased. This feeling should wear off after a few days.
Do not drive or operate machinery until you know how NORSPAN patches affect you. NORSPAN patches may cause drowsiness, dizziness or may affect alertness whilst being worn or for at least 24 hours after the patch is removed. Discuss these aspects and any impact on your driving or operating machinery with your doctor.
Be careful when drinking alcohol while you are taking this medicine. Alcohol use could increase serious side-effects of buprenorphine, such as sleepiness, drowsiness, slow and shallow breathing.
Be careful if you are elderly, unwell or taking other medicines. Some people may experience side effects such as unsteadiness, dizziness, drowsiness or confusion which may increase the risk of a fall.
Tell your doctor if you suffer from nausea or vomiting when using NORSPAN patches. Your doctor may prescribe some medicine to help.
Tell your doctor if using NORSPAN patches causes constipation. Your doctor can advise you about your diet, the proper use of laxatives and suitable exercise you can do to help manage this.
There is potential for abuse of buprenorphine and the development of addiction to buprenorphine. It is important to discuss this issue with your doctor.
All medicines may have some unwanted side effects. Sometimes they are serious, most of the time they are not. Side effects from using NORSPAN patches tend to reduce over time except for constipation. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.
Do not be alarmed by this list of possible side effects. Not everybody experiences them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using NORSPAN patches. This medicine helps most people with pain, but it may have unwanted side effects in some people. Other side effects not listed here may also occur.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
Tell your doctor as soon as possible if you notice any of the following and they worry you:
If any of the following happen, remove the NORSPAN patch and go to Accident and Emergency at your nearest hospital:
The previous list includes very serious side effects. You may need urgent medical attention or hospitalisation.
When seeking medical attention, take this leaflet and the used patch or any remaining patches with you to show the doctor.
Keep your patches in the pouch until it is time to use them. If you take the patch out of the pouch they may not keep as well.
Keep your patches in a cool dry place where the temperature stays below 25°C.
Do not store it or any other medicine in the bathroom, near a sink or on a window sill.
Do not leave it in the car. Heat and damp can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist how to dispose of medicines no longer required. After removing the used patch, fold it over on itself and dispose of it safely where children cannot reach it.
NORSPAN® patches are either rectangular or square with rounded corners. They are beige in colour. Each NORSPAN® patch is printed with the trade name and the strength in blue ink. Each strength is a different size. The higher the strength, the larger the size.
NORSPAN® patches are supplied in cartons containing two individually packaged patches.
NORSPAN® patches contain buprenorphine base as the active ingredient and are available in three different strengths:
The patches also contain:
NORSPAN® patches are supplied in Australia by:
Mundipharma Pty Limited
ABN 87 081 322 509
50 Bridge Street
Sydney NSW 2000
Phone: 1800 188 009
NORSPAN® patches are supplied in New Zealand by:
Mundipharma New Zealand Limited
C/- Pharmaco (N.Z.) Ltd
PO BOX 4079
Toll Free (Medical enquiries): 0800 773 310
®: NORSPAN is a Registered Trademark
This leaflet was prepared in July 2012.
Australian Registration numbers for NORSPAN® patches are:
5 micrograms/hr AUST R 116647
10 micrograms/hr AUST R 116648
20 micrograms/hr AUST R 116650.
Orbis RA-0028 Dec12
Published by MIMS March 2013