Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine
Dr Reddy's Laboratories (UK) Ltd
N02AE01
Buprenorphine
20microgram/1hour
Transdermal patch
Transdermal
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04070200; GTIN: 05036072006492
WHAT IS IN THIS LEAFLET: 1. WHAT PANITAZ IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PANITAZ 3. HOW TO USE PANITAZ 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PANITAZ 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT PANITAZ IS AND WHAT IT IS USED FOR Panitaz 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. Panitaz patches should not be used to relieve acute pain. Panitaz 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 PANITAZ DO NOT USE PANITAZ: • 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 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 (a condition in which the muscles become weak) • if you have previously suffered from WITHDRAWAL SYMPTOMS such as agitation, anxiety, shaking or sweating UPON STOPPING TAKING ALCOHOL. Panitaz MUST NOT be used to treat symptoms associated with DRUG WITHDRAWAL. WARNINGS AND PRECAUTIONS Talk to your doctor before using Panitaz: • if you suffer from SEIZURES, FITS OR CONVULSIONS • if you have a SEVERE HEADACHE or FEEL SICK DUE TO A HEAD INJURY or increased pressure in your skull (for instance due to brain disease). This is because the patches may make symptoms worse or hide the extent of a head injury • if you are feeling LIGHT-HEADED or FAINT • if you have severe LIVER PROBLEMS • if you have ever been ADDICTED TO DRUGS • if you have a HIGH TEMPERATU Pročitajte cijeli dokument
OBJECT 1 PANITAZ 20 MICROGRAMS/H TRANSDERMAL PATCHES Summary of Product Characteristics Updated 08-Aug-2016 | Dr. Reddy's Laboratories (UK) Ltd 1. Name of the medicinal product Panitaz 20 micrograms/h Transdermal Patches 2. Qualitative and quantitative composition Each transdermal patch contains 20 mg buprenorphine. Area containing active substance: 25 cm 2 . Nominal release rate: 20 micrograms per hour (over a period of 7 days). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal patch Rectangular patch with rounded edges, a beige coloured web backing layer imprinted with Buprenorphin and 20 μg/h in blue colour, a transparent adhesive matrix laminated with a central placed transparent matrix and a transparent release liner with a cut to facilitate the application. 4. Clinical particulars 4.1 Therapeutic indications Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. Panitaz is not suitable for the treatment of acute pain. 4.2 Posology and method of administration Posology Panitaz should be administered every 7 th day. _Patients aged 18 years and over:_ The lowest Panitaz dose (Panitaz 5 micrograms/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 Panitaz, patients should use the usual recommended doses of short- acting supplemental analgesics (see section 4.5) as needed until analgesic efficacy with Panitaz 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 patch Pročitajte cijeli dokument