Ország: Hollandia
Nyelv: holland
Forrás: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
FENTANYLDIWATERSTOFCITRAAT 628 µg/stuk SAMENSTELLING overeenkomend met ; FENTANYL 400 µg/stuk
FENTANYLDIWATERSTOFCITRAAT 628 µg/stuk SAMENSTELLING overeenkomend met ; FENTANYL 400 µg/stuk
Tablet voor sublinguaal gebruik
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; SILICIUMDIOXIDE (E 551), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; SILICIUMDIOXIDE (E 551)
Sublinguaal gebruik
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SUBMENA 100 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK SUBMENA 200 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK SUBMENA 300 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK SUBMENA 400 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK SUBMENA 600 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK SUBMENA 800 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL GEBRUIK 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 Subema is and what it is used for 2. What you need to know before you take Subema 3. How to take Subema 4. Possible side effects 5. How to store Subema 6. Contents of the pack and other information 1. WHAT SUBEMA IS AND WHAT IT IS USED FOR Subema 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 Submena 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 SUBEMA _ _ DO NOT TAKE SUBEMA - 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, mor Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Submena 100 microgram, tabletten voor sublinguaal gebruik Submena 200 microgram, tabletten voor sublinguaal gebruik Submena 300 microgram, tabletten voor sublinguaal gebruik Submena 400 microgram, tabletten voor sublinguaal gebruik Submena 600 microgram, tabletten voor sublinguaal gebruik Submena 800 microgram, tabletten voor sublinguaal gebruik 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sublingual tablet contains: 157 micrograms of fentanyl citrate equivalent to 100 micrograms of fentanyl 314 micrograms of fentanyl citrate equivalent to 200 micrograms of fentanyl 471 micrograms of fentanyl citrate equivalent to 300 micrograms of fentanyl 628 micrograms of fentanyl citrate equivalent to 400 micrograms of fentanyl 943 micrograms of fentanyl citrate equivalent to 600 micrograms of fentanyl 1275 micrograms of fentanyl citrate equivalent to 800 micrograms of fentanyl For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sublingual tablet 100 microgram sublingual tablet is a 6 mm white round tablet 200 microgram sublingual tablet is a 7 x 5 mm white oval-shaped tablet 300 microgram sublingual tablet is a 6 x 6 mm white triangle-shaped tablet 400 microgram sublingual tablet is a 9 x 7 mm white diamond-shaped tablet 600 microgram sublingual tablet is a 9 x 6 mm white “D”-shaped tablet 800 microgram sublingual tablet is a 10 x 6 mm 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 Submena 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 Olvassa el a teljes dokumentumot