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• 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). You should not apply a new patch to the same site for the following 3-4 weeks. • Mark the day and time of application in the calendar on the box. • Remember to change your patch at the same time of day each time. (Therefore it is important that you make a note of the time of day.) Duration of treatment Your doctor will tell you how long you should be treated with the BuTrans patch. Do not stop treatment on your own account, because pain may return and you may feel unwell (see also "Effects when treatment with BuTrans patches is stopped" below). If you feel that the effect of the BuTrans patch is too weak or too strong, talk to your doctor or pharmacist. If you use more BuTrans 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 BuTrans patch If you forget an application, stick a new patch on as soon as you remember. If applicable, mark the new day and time of application in the calendar on the box. Also make a note of the date. This will help you to get into the new "changing rhythm". 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 BuTrans patches is stopped If you interrupt or finish treatment with BuTrans 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 BuTrans 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. 4. POSSIBLE SIDE EFFECTS
Like all medicines BuTrans patches can have side effects. Serious side effects that may be associated with BuTrans patches are similar to those seen with other strong pain relievers and include difficulty in breathing and low blood pressure. In patients treated with BuTrans patches, the following side effects have been reported: Very common (seen in at least 10% of patients) Dizziness, sleepiness, constipation, dry mouth, feeling sick, vomiting, redness or itching, headache. Common (seen in 1 to 10% of patients) Anxiety, confusion, depression, insomnia, nervousness, tingling in the fingers or toes, oedema (swelling), vasodilatation (widening of the blood vessels), shortness of breath, anorexia (reduction or loss of appetite), diarrhoea, indigestion, redness or rash at the application site, sweating, abdominal pain, tiredness, weakness, chest pain, pain. Uncommon (seen in 0.1 to 1% of patients) Sleep disorders, restlessness, sedation (calmness), changes in taste, problems with your circulation such as low blood pressure, difficulty in passing water, weariness. Rare (seen in 0.01 to 0.1% of patients) Difficulties with concentration, speech or balance. Local allergic reactions with signs of swelling (in such cases treatment should be stopped). Difficulty breathing, hallucinations, anxiety, nightmares, decreased sexual drive, decreased erection, heartburn. Difficulty breathing , disturbed vision (e.g. blurring), swelling of the eyelid, hot flushes, numbness or withdrawal symptoms. Very rare (seen in under 0.01% of patients, including isolated cases) Dependence (reliance on the medicine), mood swings, muscle twitching, constriction of the pupils, ear pain, hyperventilation, hiccups, trying to vomit, swelling containing pus, blisters. 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 of 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. 5. STORING BUTRANS PATCHES
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