Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
fentanyl
Teva B.V.
N02AB03
fentanyl
Analgesics
Pain; Cancer
Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. ,
Revision: 28
Authorised
2008-04-04
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER EFFENTORA 100 MICROGRAMS BUCCAL TABLETS EFFENTORA 200 MICROGRAMS BUCCAL TABLETS EFFENTORA 400 MICROGRAMS BUCCAL TABLETS EFFENTORA 600 MICROGRAMS BUCCAL TABLETS EFFENTORA 800 MICROGRAMS BUCCAL TABLETS Fentanyl 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Effentora is and what it is used for 2. What you need to knowbefore you use Effentora 3. How to use Effentora 4. Possible side effects 5. How to store Effentora 6. Contents of the pack and other information 1. WHAT EFFENTORA IS AND WHAT IT IS USED FOR The active substance of Effentora is fentanyl citrate. Effentora is a pain-relieving medicine known as an opioid, which is used to treat breakthrough pain in adult patients with cancer who are already taking other opioid pain medicines for their persistent (around-the-clock) cancer pain. Breakthrough pain is additional, sudden pain that occurs in spite of you having taken your usual opioid pain-relieving medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EFFENTORA DO NOT USE EFFENTORA: • If you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain. If you have not been using these medicines you MUST NOT use Effentora, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop. • If you are allergic to fentanyl or any of the ot Aqra d-dokument sħiħ
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Effentora 100 micrograms buccal tablets Effentora 200 micrograms buccal tablets Effentora 400 micrograms buccal tablets Effentora 600 micrograms buccal tablets Effentora 800 micrograms buccal tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Effentora 100 micrograms buccal tablets Each buccal tablet contains 100 micrograms fentanyl (as citrate). Excipient with known effect: Each tablet contains 10 mg of sodium. Effentora 200 micrograms buccal tablets Each buccal tablet contains 200 micrograms fentanyl (as citrate). Excipient with known effect: Each tablet contains 20 mg of sodium. Effentora 400 micrograms buccal tablets Each buccal tablet contains 400 micrograms fentanyl (as citrate). Excipient with known effect: Each tablet contains 20 mg of sodium. Effentora 600 micrograms buccal tablets Each buccal tablet contains 600 micrograms fentanyl (as citrate). Excipient with known effect: Each tablet contains 20 mg of sodium. Effentora 800 micrograms buccal tablets Each buccal tablet contains 800 micrograms fentanyl (as citrate). Excipient with known effect: Each tablet contains 20 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Buccal tablet. Effentora 100 micrograms buccal tablets Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “1”. Effentora 200 micrograms buccal tablets Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “2”. Effentora 400 micrograms buccal tablets Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “4”. Effentora 600 micrograms buccal tablets Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “6”. 3 Effentora 800 micrograms buccal tablets Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on Aqra d-dokument sħiħ