Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fentanyl
Zentiva Pharma UK Ltd
N02AB03
Fentanyl
12microgram/1hour
Transdermal patch
Transdermal
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5000283653790
PACKAGE LEAFLET: INFORMATION FOR THE USER OSMANIL 12 MICROGRAMS/H TRANSDERMAL PATCH (fentanyl) IMPORTANT THINGS YOU NEED TO KNOW ABOUT OSMANIL TRANSDERMAL PATCH • These patches contain a strong pain killer. • 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 3 days (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, nurse or pharmacist. • 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Osmanil transdermal patch is and what it is used for 2. What you need to know before you use Osmanil transdermal patch 3. How to use Osmanil transdermal patch 4. Possible side effects 5. How to store Osmanil transdermal patch 6. Contents of the pack and other information 1. WHAT OSMANIL TRANSDERMAL PATCH_ _IS AND WHAT IT IS USED FOR The name of your medicine is Osmanil 12 micrograms/h transdermal patch. It is called Osmanil transdermal patch or just ‘patch’ in this leaflet. The patches help relieve pain that is very bad and long-lasting. Osmanil transdermal patch contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids. The medicine passes slowly into your body through your skin. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OSMANIL TRANSDERMAL PATCH Osmanil transdermal patches Baca dokumen lengkapnya
OBJECT 1 OSMANIL 12 MICROGRAMS/H TRANSDERMAL PATCH Summary of Product Characteristics Updated 26-Feb-2015 | Zentiva 1. Name of the medicinal product Osmanil 12 micrograms/h transdermal patch 2. Qualitative and quantitative composition Each patch releases 12.5 micrograms fentanyl per hour. Each patch of 3.75 cm 2 contains 2.063 mg fentanyl. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal patch Transparent translucent patch with blue imprint fentanyl 12 µ/h on the protective film. 4. Clinical particulars 4.1 Therapeutic indications Fentanyl transdermal patch is indicated Adults • 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 For transdermal use Osmanil should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arm. In young children, the upper back is the preferred location to apply the patch, to minimise the potential of the child removing the patch. A non-hairy area should be selected. If this is not possible, hair at the application site should be clipped (not shaved) prior to application. If the site of Osmanil application requires to be cleansed prior to application of the patch, this should be done with water. Soaps, oils, lotions or any other agent that might irritate the skin or alter its characteristics should not be used. The skin should be completely dry before the patch is applied. Patches should be inspected prior to use. Patches that are cut, divided, or damaged in any way should not be used. The Osmanil patch should be removed from the protective pouch by first folding the notch (located close to the tip of the arrow on the pouch label) and then carefully tearing the pouch material. If scissors are used to open the pouch, this should be done close to the sealed edge so as not to damage the patch inside. Osmanil should be appli Baca dokumen lengkapnya