البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Buprenorphine
Imbat Limited
N02AE; N02AE01
Buprenorphine
20 Microgram per hour
Transdermal patch
Product subject to prescription which may not be renewed (A)
Oripavine derivatives; buprenorphine
Authorised
2013-03-15
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER BUTRANS _®_ _ _20 MICROGRAMS/HOUR TRANDSDERMAL PATCH (buprenorphine) Your medicine is available using the name BuTrans 10 micrograms/hour Transdermal Patch but will be referred to as BuTrans patches throughout this leaflet. 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 any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT BUTRANS_ _PATCHES ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU USE BUTRANS_ _PATCHES 3. HOW TO USE BUTRANS_ _PATCHES 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE BUTRANS_ _PATCHES 6. FURTHER 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. BEFORE YOU USE BUTRANS PATCHES DO NOT USE BUTRANS_ _PATCHES: • if you are allergic (hypersensitive) to buprenorphine or any of the other ingredients of BuTrans patches; • 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 tranylcypromide, phenelzine, isocarboxazid, moclobamide and linezolid), or you have taken this type of medicine in the last two weeks; • if you suffer from myasthenia gravis اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BuTrans 20 micrograms/hour transdermal patch. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 20 µg/h transdermal patch contains: 20 mg buprenorphine. Area containing active substance: 25 cm 2 . Nominal release rate: 20 micrograms of buprenorphine per hour (over a period of 7 days). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. _Product imported from: UK_ Square, beige coloured patch with rounded corners marked: BuTrans 20 mg 20 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION BuTrans should be administered every 7th day. _Patients aged 18 years and over:_ The lowest BuTrans dose (BuTrans 5 µg/h 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 and titration with BuTrans, patients should use the usual recommended doses of short-acting supplemental analgesics_ (see section 4.5)_ as needed until analgesic efficacy with BuTrans is attained. The dose should not be increased before 3 days, when the maximum effect of a given dose is established. 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 applied at the same time, regardless of the patch strength. A new patch should not be applied to the same skin site for the subsequent 3-4 weeks_ (see section 5.2)._ اقرأ الوثيقة كاملة