Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fentanyl
Zentiva Pharma UK Ltd
N02AB03
Fentanyl
50microgram/1hour
Transdermal patch
Transdermal
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5000283653042
PACKAGE LEAFLET: INFORMATION FOR THE USER OSMANIL 25, 50, 75 AND 100 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 25, 50, 75 and 100 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 PAT Izlasiet visu dokumentu
OBJECT 1 OSMANIL 50MCG/HR TRANSDERMAL PATCHES Summary of Product Characteristics Updated 06-Nov-2014 | Zentiva 1. Name of the medicinal product Osmanil 50 micrograms/h transdermal patch 2. Qualitative and quantitative composition Each patch releases 50 micrograms fentanyl per hour. Each patch of 15cm 2 contains 8.25 mg fentanyl. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal patch Transparent and colourless patch with blue imprint on the backing foil: fentanyl 50 µg/h. 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 _POSOLOGY_ Initial dose selection The appropriate initiating dose of Osmanil transdermal patch should be based on the patient's current opioid use. It is recommended that Osmanil transdermal patch 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 Osmanil transdermal patch refer to _Equianalgesic potency conversion_ below. The dosage may subsequently be titrated upwards or downwards, if required, in increments of either 12.5 or 25 micrograms/hr to achieve the lowest appropriate dose of Osmanil transdermal patch depending on response and supplementary analgesic requirements. Opioid-naïve patients In strong opioid-naive patients, the normal initial Osmanil transdermal patch dosage should not exceed 25 micrograms/h. Clinical experience with Osmanil transdermal patch is limited in opioid-naive patients. In the circumstances in which therapy with Osmanil transdermal patch Izlasiet visu dokumentu