Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FENTANYL CITRATE
A. MENARINI SINGAPORE PTE. LTD.
FENTANYL CITRATE
1 x 10's tablet Tablets; 3 x 10'stablet Tablets
Aesica Queenborough Limited
Consumer Medication Information Leaflet (RiMUP) ABSTRAL SUBLINGUAL TABLETS Fentanyl Citrate (100, 200 and 400 microgram) 1 WHAT IS IN THIS LEAFLET 1. What Abstral is used for 2. How Abstral works 3. Before you use Abstral 4. How to use Abstral 5. While you are using it 6. Side effects 7. Storage and Disposal of Abstral 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT ABSTRAL IS USED FOR Abstral is a treatment for adults WHO MUST ALREADY REGULARLY TAKING STRONG PAIN-RELIEVING MEDICINE (OPIODS) 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 HOW ABSTRAL WORKS The active substance in Abstal sublingual tablets is fentanyl. Fentanyl belongs to a group of strong pain- relieving medicines called opioids. Abstral should be used sublingually, which means that the tablet should be placed under the tongue where it is dissolves rapidly in order to allow fentanyl to be absorbed across the lining of the mouth. Once absorbed, fentanyl starts to work to relieve pain. BEFORE YOU USE ABSTRAL - When you must not use it Do not take Abstral if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section Inactive ingredients). if you have severe breathing problems. If you are not regularly using 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 Abstral because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop. If you suffer from short-term pain other than breakthrough pain. if you are being treated with medicines containing sodium oxybate Talk to your doctor or pharmacist b Baca dokumen lengkap
PACKAGE INSERT ABSTRAL® SUBLINGUAL TABLETS FENTANYL (AS CITRATE) 1. NAME OF THE MEDICINAL PRODUCT Abstral 100 microgram sublingual tablets Abstral 200 microgram sublingual tablets Abstral 400 microgram sublingual tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sublingual tablet contains: 100 micrograms fentanyl (as citrate) 200 micrograms fentanyl (as citrate) 400 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 400 microgram sublingual tablet is a white diamond-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 anything until the sublingual tablet is completely dissolved. In patients who have a dry mouth water may be used to moisten the buccal mucosa before taking Abstral. Dose titration: The object of dose titration is to identify an optimal maintenance dose for ongoing treatment of breakthrough pain episodes. This optimal dose should provide adequa Baca dokumen lengkap