Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fentanyl
Pfizer Ltd
N02AB03
Fentanyl
50microgram/1hour
Transdermal patch
Transdermal
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5013457011036
Page 1 of 16 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OPIODUR 12 MICROGRAMS/HOUR TRANSDERMAL PATCH 25 MICROGRAMS/HOUR TRANSDERMAL PATCH 50 MICROGRAMS/HOUR TRANSDERMAL PATCH 75 MICROGRAMS/HOUR TRANSDERMAL PATCH 100 MICROGRAMS/HOUR TRANSDERMAL PATCH Fentanyl • These patches contain a strong painkiller. • Ensure that old patches are removed before applying a new one. • Patches must not be cut. • Do not expose the patches to a heat source (such as a hot water bottle). • If you develop a fever tell your doctor immediately. • Follow the dosage instructions carefully and only change your patch every 72 hours. • If your breathing becomes shallow and weak take the patch off and seek medical help. 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 or pharmacist. - This medicine has been prescribed for you. 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, or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Opiodur is and what it is used for 2. What you need to know before you use Opiodur 3. How to use Opiodur 4. Possible side effects 5. How to store Opiodur 6. Contents of the pack and other information 1. WHAT OPIODUR IS AND WHAT IT IS USED FOR Fentanyl is one of a group of strong painkillers called opioids. The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body. ADULTS Opiodur is used for treatment of severe and long-lasting pain that can only adequately be managed with strong pain relievers (opioids). CHILDREN Long term management of severe chronic pain in children receiving opioid therapy from 2 years of age. Page 2 of 16 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPIODUR DO NOT USE OPIODUR: - if you are allergic to fentanyl or any of Baca dokumen lengkap
OPIODUR 50 MICROGRAMS/HOUR TRANSDERMAL PATCH Summary of Product Characteristics Updated 03-Aug-2016 | Pfizer Limited 1. Name of the medicinal product Opiodur 50 micrograms/hour transdermal patch 2. Qualitative and quantitative composition Each Opiodur 50 micrograms/ hour transdermal patch contains 5.5 mg of fentanyl in a patch size of 20cm 2 , releasing 50 micrograms of fentanyl per hour. Excipients(s) with known effect: For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal Patch Opiodur transdermal patch is a rectangular, tan coloured patch placed between two oversized, transparent protective layers which must be removed prior to the patch application. The patches will be imprinted: Fentanyl 50 μg/h in red ink 4. Clinical particulars 4.1 Therapeutic indications ADULTS This product is indicated in severe chronic pain which can be adequately managed only with opioid analgesics. CHILDREN Long term management of severe chronic pain in children receiving opioid therapy from 2 years of age. 4.2 Posology and method of administration It is not possible to ensure the interchangeability of different fentanyl containing transdermal patch product in individual patients. Therefore, it should be emphasised that patients should not be changed from one fentanyl containing product to another without specific counselling on the change from their healthcare professionals. Initial dose selection The appropriate initiating dose of fentanyl should be based on the patient's current opioid use. It is recommended that fentanyl be used in patients who have demonstrated opioid tolerance. Other factors to be considered are the current general condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance. ADULTS Opioid-tolerant patients To convert opioid-tolerant patients from oral or parenteral opioids to fentanyl refer to _Equianalgesic _ _potency conversion_ below. The dosage may subsequently be titrated upwards or downwards, if Baca dokumen lengkap