Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
- 1. What the Transtec patch is and what it is used for
- 2. Before you use Transtec patches
- 3. How to use Transtec patches
- 4. Possible side effects
- 5. Storing Transtec patches
Transtec 35 µg/h, 52.5 µg/h, 70 µg/h
Transdermal patch
Buprenorphine
- The active substance contained in Transtec patches is buprenorphine.
Three sizes are available:
Transtec patch 35 µg/h
- contains 20 mg buprenorphine and releases about 35 micrograms of buprenorphine per hour. The area of the patch containing the active substance is 25 cm2.
Transtec patch 52.5 µg/h
- contains 30 mg buprenorphine and releases about 52.5 micrograms of buprenorphine per hour. The area of the patch containing the active substance is 37.5 cm2.
Transtec patch 70 µg/h
- contains 40 mg buprenorphine and releases about 70 micrograms of buprenorphine per hour. The area of the patch containing the active substance is 50 cm2.
- The other ingredients are: [(Z)-octadec-9-en-1-yl] oleate; povidone K90; 4-oxopentanic acid; poly[acrylic acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5), cross-linked; poly(ethyleneterephthalate) foil; poly(ethyleneterephthalate) tissue.
- Each patch lasts for up to 4 days (96 hours).
Marketing Authorisation Holder and Manufacturer
For further information contact:
What The Transtec Patch Is And What It Is Used For
Transtec transdermal patches act through the skin. After application, the active substance buprenorphine passes through the skin into the blood. Buprenorphine is an opioid (strong pain reliever), which acts on the central nervous system (specific nerve cells in the spinal cord and in the brain). It is intended to relieve moderate or severe, long-lasting pain that has not responded to other painkillers.
Transtec patches come in cartons containing four individually sealed patches.
Before You Use Transtec Patches
Do not use Transtec patches
- if you are allergic to the active substance buprenorphine or any of the other substances contained in the patch;
- if you are pregnant;
- if you are dependent on strong pain relievers;
- if you suffer from a disease which means you have great difficulty breathing;
- if you are taking monoamine oxidase inhibitors (drugs used to treat depression), or you have taken this type of medicine in the last two weeks;
- if you have severe muscle weakness;
- if you have severe confusion due to alcohol.
Transtec patches must not be used to treat withdrawal symptoms in drug-dependent persons.
Take special care with Transtec patches
- if you have alcohol poisoning;
- if you suffer from seizures or convulsions (fits);
- if your consciousness is disturbed (feeling light-headed or faint);
- if you are in a state of shock (cold sweat might be a sign of it);
- if the pressure in your skull is increased (for instance after head injury or in brain disease);
- if you have difficulty breathing or are taking other medication that may make you breathe more slowly or weakly (see "Taking other medicines");
- if your liver does not work properly;
- if you are inclined to abuse medicines or drugs.
Please consult your doctor if any of these statements apply to you or were applicable to you at any time in the past.
Also, please be aware of the following precautions:
- Some people may become dependent on strong pain relievers such as Transtec patches when they use them over a long period of time. They may have side effects when they stop using them (see Effects when Transtec patch is stopped).
- Fever and external heat may lead to larger quantities of buprenorphine in the blood than normal. Also, external heat may prevent the patch from sticking properly. Therefore, consult your doctor if you have fever and do not expose yourself to external heat (e.g. electric blanket, hot water bottle).
Transtec patches should not be used in persons below the age of 18 years, because no experience has so far been gained in this age group.
Using Transtec patches with alcohol
Alcohol may intensify certain side effects of the patch and you may feel unwell if you drink alcohol while wearing Transtec patches.
Pregnancy and breast-feeding
Transtec patches should not be used if you are pregnant or breast-feeding.
Driving and using machines
Do not drive or use machines while using Transtec patches, or for 24 hours after removing the patch. Transtec 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.
Please note that this applies particularly
- at the beginning of treatment;
- when you switch from another preparation;
- if you also use other medicines that act on the brain;
- if you drink alcohol.
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Transtec patches must not be used together with monoamine oxidase inhibitors (certain medicines for the treatment of depression).
Transtec patches 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 certain sleeping pills, tranquillizers, anaesthetics, anti-depressants and neuroleptics (medicines to treat certain psychological diseases).- If you take some medicines such as cimetidine (for ulcers), erythromycin (for infections) or ketoconazole (for infections caused by fungi), the effects of Transtec patches may be increased.
- If you take some medicines such as carbamazepine (for epilepsy and certain pain conditions) or rifampicin (for tuberculosis), the effects of Transtec patches may be reduced.
How To Use Transtec Patches
The choice of which Transtec patch will suit you best will be made by your doctor. During treatment, your doctor may change which patch you use to a smaller or larger one if necessary.
Always use the Transtec patch exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Adults and elderly patients
Unless your doctor has told you differently, attach one Transtec patch (as described in detail below) and change it every 3 - 4 days (96 hours at the latest). To make it easy, you can change your patch twice each week on the same days, e.g. always on Mondays and Thursdays. To help you remember when to change your patch, you should make a note on the outer pack. If your doctor has advised you to take other pain relievers in addition to the patch, strictly follow the doctor's instructions, otherwise you will not fully benefit from treatment with the Transtec patch.
Patients under 18 years of age
Transtec patches should not be used in persons below the age of 18 years, because no experience has so far been gained in this age group.
Patients with kidney disease/dialysis patients
In patients with kidney disease, no dosage adjustment is necessary.
Patients with liver disease
In patients with liver disease, the intensity and duration of action of the Transtec patch may be affected. If you belong to this patient group, your doctor will check on you more closely.
Before you stick a patch on
- Choose an area of skin that is flat and hairless on your upper body, preferably on the chest below the collar-bone or on the upper part of the back (see adjacent illustrations). Call for assistance if you cannot apply the patch yourself.
- If the chosen area has hairs, cut them 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 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.
Sticking the patch on
Step 1:
- Each patch is sealed in a pouch. Just before use, open the pouch by tearing where indicated. Take out the patch.
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 onto 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
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 (e.g. electric blanket, hot water bottle).
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
- Take the old patch off.
- Fold it in half with the sticky side inwards. Put the used patch into its original pouch. Now put the pouch in the bin you use for your household rubbish. Even used patches contain some active medicine that may harm children or animals, so make sure your used patches are always kept well away from them.
Throw it away carefully, out of the reach and sight of children.
- Stick a new patch on a different appropriate skin site (as described above). Wait at least one week before using the same site again.
Duration of treatment
Your doctor will tell you how long you should be treated with the Transtec patch. Do not stop treatment on your own account, because pain may return and you may feel unwell (see also "Effects when treatment with Transtec patches is stopped" below).
If you have the impression that the effect of the Transtec patch is too weak or too strong, talk to your doctor or pharmacist.
If you use more Transtec patches than you should
If this happens there may be signs of an overdose of the substance buprenorphine. An overdose may intensify the side-effects of buprenorphine such as drowsiness, nausea and vomiting. You may get pin-point pupils and your breathing may become slow and weak. You may also get cardiovascular collapse where your heart stops pumping blood.
As soon as you discover that you have used more patches than you should, remove the excess patches and talk to a doctor or pharmacist.
If you forget to apply the Transtec patch
If you forget an application, stick a new patch on as soon as you remember and make a note of the day. You will then need to change your routine, e.g. if you usually apply your patches on Mondays and Thursdays, but you forget and don't stick on a new patch until Wednesday, you will need to change your patches on Wednesdays and Saturdays from then on. If you are very late changing your patch, pain may return. In this case, please contact your doctor.
Never apply twice the number of patches to make up for the forgotten application!
Effects when treatment with Transtec patches is stopped
If you interrupt or finish treatment with Transtec patches too soon, pain may return. If you wish to stop treatment because of unpleasant side effects, please consult your doctor. He/she will tell you what can be done and whether you can be treated with other medicines.
Some people may have side effects when they have used strong pain relievers for a long time and stop using them. The risk of having effects after stopping Transtec patches is very low. However, if you feel agitated, anxious, nervous or shaky, if you are overactive, have difficulty sleeping or digestion problems, tell your doctor.
Possible Side Effects
Like all medicines, Transtec patches can have side effects. Side effects are usually classified as follows: very common (at least 10% of patients), common (1 to 10%), uncommon (0.1 to 1%), rare (0.01 to 0.1%) and very rare (under 0.01% including isolated cases).
In patients treated with Transtec patches, the following side effects have been reported:
Very common
Feeling sick, redness, or itching.
Common
Dizziness, headache, vomiting, constipation, skin eruptions, sweating, shortness of breath, swelling, or tiredness.
Uncommon
Sedation (calmness), drowsiness, dry mouth, rash, confusion, sleep disorder, restlessness, low blood pressure or, rarely, failure of circulation, problems with passing water, or weariness.
Rare
Difficulties with concentration, speech or balance. Numbness and pricking or burning sensation of the skin. Local allergic reactions with signs of swelling (in such cases treatment should be stopped). Difficulty breathing, loss of appetite, hallucinations, anxiety, nightmares, decreased sexual drive, disturbed vision (e.g. blurring), swelling of the eyelid, hot flushes, heartburn, decreased erection, or withdrawal symptoms.
Very rare
Muscle twitching, bad taste in mouth, trying to vomit, swelling containing pus, blisters, hyperventilation, hiccups, dependence (reliance on the medicine), mood swings, constriction of pupils, ear pain, or chest pain.
Although extremely rare, serious allergic reactions can occur. Symptoms may include swelling of the face, neck, eyes or throat, wheezing or difficulty in breathing, a rash, redness or itching covering most of your body, collapsing or feeling faint.
If you develop any of these symptoms, remove the patch immediately and contact your doctor.
Rarely allergic reactions which are localised to the area of skin covered by the patch may develop. If this occurs, talk to your doctor.
If you experience any of the side effects listed above, tell your doctor as soon as possible. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Storing Transtec Patches
Do not use Transtec patches after the expiry date stated on the carton and on the pouch. After the expiry date, take any unused patches you have left to a pharmacy.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Date this leaflet was written
May 2005
The NAPP device (logo) and Transtec are Registered Trade Marks
© Napp Pharmaceuticals Ltd. 2005
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