Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Buprenorphine
Mundipharma Pharmaceuticals Limited
N02AE; N02AE01
Buprenorphine
10 milligram(s)
Transdermal patch
Product subject to prescription which may not be renewed (A)
Oripavine derivatives; buprenorphine
Marketed
2005-06-24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _BUTRANS_ ® 5 microgram/hour transdermal patches _BUTRANS_ ® 10 microgram/hour transdermal patches _BUTRANS_ ® 15 microgram/hour transdermal patches _BUTRANS_ ® 20 microgram/hour transdermal patches buprenorphine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What _BUTRANS_ patches are and what they are used for 2. What you need to know before you use _BUTRANS_ patches 3. How to use _BUTRANS_ patches 4. Possible side effects 5. How to store _BUTRANS_ patches 6. Contents of the pack and other information 1. WHAT _BUTRANS_ PATCHES ARE AND WHAT THEY ARE USED FOR _BUTRANS_ patches contain the active ingredient buprenorphine which belongs to a group of medicines called strong analgesics or ‘painkillers’. They have been prescribed for you by your doctor to relieve moderate, long-lasting pain that requires the use of a strong painkiller. _BUTRANS_ patches should not be used to relieve acute pain. _BUTRANS _ 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 _BUTRANS_ PATCHES DO NOT USE _BUTRANS_ PATCHES : • if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6); _ _ • if you have breathing problems; _ _ • if you are addicted to drugs; • if you are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromine, phen Pročitajte cijeli dokument
Health Products Regulatory Authority 26 April 2023 CRN00D06Q Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BuTrans 10 micrograms/hour transdermal patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each _BUTRANS_ 10 micrograms/hour transdermal patch contains 10 mg of buprenorphine in a 12.5 cm 2 area releasing a nominal 10 micrograms of buprenorphine per hour over a period of 7 days. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. Beige coloured patch with rounded corners. _BUTRANS_ 10 micrograms/hour transdermal patch is a rectangular patch marked _BUTRANS_ 10 μg/h 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia _BUTRANS _is not suitable for the treatment of acute pain. _BUTRANS_ is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _BUTRANS_ should be administered every 7th day. _Patients aged 18 years and over_ The lowest _BUTRANS_ dose (_BUTRANS_ 5 microgram/hour transdermal patch) should be used as the initial dose. Consideration should be given to the previous opioid history of the patient (see section 4.5) as well as to the current general condition and medical status of the patient. _ _ _Titration_ During initiation of treatment with _BUTRANS_, short‑acting supplemental analgesics may be required (see section 4.5) as needed until analgesic efficacy with _BUTRANS_ is attained. During the titration process, the dose may be adjusted every 3-days (72 hours). Thereafter, the 7-day dosing interval should be maintained. Subsequent dosage increases may then be titrated based on the need for supplemental pain relief and the patient's analgesic response to the patch. To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination of patches should be applied in different places to achieve the desired dose. It is recommended that no more than two patches are a Pročitajte cijeli dokument