Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fentanyl citrate
Kyowa Kirin International UK NewCo Ltd
N02AB03
Fentanyl citrate
800microgram
Sublingual tablet
Sublingual
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5038903000464
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ABSTRAL 100 MICROGRAM SUBLINGUAL TABLETS ABSTRAL 200 MICROGRAM SUBLINGUAL TABLETS ABSTRAL 300 MICROGRAM SUBLINGUAL TABLETS ABSTRAL 400 MICROGRAM SUBLINGUAL TABLETS ABSTRAL 600 MICROGRAM SUBLINGUAL TABLETS ABSTRAL 800 MICROGRAM SUBLINGUAL TABLETS Fentanyl READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Abstral is and what it is used for 2. What you need to know before you take Abstral 3. How to take Abstral 4. Possible side effects 5. How to store Abstral 6. Contents of the pack and other information 1. WHAT ABSTRAL IS AND WHAT IT IS USED FOR Abstral _ _ is a treatment for adults WHO MUST ALREADY REGULARLY BE TAKING STRONG PAIN-RELIEVING MEDICINE (OPIOIDS) for their persistent cancer pain, but require treatment for their breakthrough pain. If you are not sure, talk to your doctor. Breakthrough pain is pain which occurs suddenly, even though you have taken or used your usual opioid pain-relieving medicine. The active substance in Abstral sublingual tablets is fentanyl. Fentanyl belongs to a group of strong pain-relieving medicines called opioids. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ABSTRAL DO NOT TAKE ABSTRAL if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6) if you have severe breathing problems 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 Olvassa el a teljes dokumentumot
OBJECT 1 ABSTRAL SUBLINGUAL TABLETS Summary of Product Characteristics Updated 03-Apr-2018 | Kyowa Kirin Ltd 1. Name of the medicinal product Abstral 100 microgram, 200 microgram, 300 microgram, 400 microgram, 600 microgram, 800 microgram sublingual tablets 2. Qualitative and quantitative composition Each sublingual tablet contains: 100 micrograms fentanyl (as citrate) 200 micrograms fentanyl (as citrate) 300 micrograms fentanyl (as citrate) 400 micrograms fentanyl (as citrate) 600 micrograms fentanyl (as citrate) 800 micrograms fentanyl (as citrate) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Sublingual tablet 100 microgram sublingual tablet is a white round tablet 200 microgram sublingual tablet is a white oval-shaped tablet 300 microgram sublingual tablet is a white triangle-shaped tablet 400 microgram sublingual tablet is a white diamond-shaped tablet 600 microgram sublingual tablet is a white “D”-shaped tablet 800 microgram sublingual tablet is a white capsule-shaped tablet 4. Clinical particulars 4.1 Therapeutic indications Management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain. Breakthrough pain is a transient exacerbation of otherwise controlled chronic background pain. 4.2 Posology and method of administration Abstral should only be administered to patients who are considered tolerant to their opioid therapy for persistent cancer pain. Patients can be considered opioid tolerant if they take 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. Method of administration: Abstral sublingual tablets should be administered directly under the tongue at the deepest part. Abstral sublingual tablets should not be swallowed, but allowed to completely dissolve in the sublingual cavity without chewing or sucking. Patients should be advised not to eat or drink anyt Olvassa el a teljes dokumentumot