国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TAPENTADOLHYDROCHLORIDE 58,3 mg/stuk SAMENSTELLING overeenkomend met ; TAPENTADOL 50 mg/stuk
TAPENTADOLHYDROCHLORIDE 58,3 mg/stuk SAMENSTELLING overeenkomend met ; TAPENTADOL 50 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL (E 1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
BIJSLUITER: INFORMATIE VOOR DE PATIËNT DOLTEN 50 MG FILMOMHULDE TABLETTEN DOLTEN 75 MG FILMOMHULDE TABLETTEN DOLTEN 100 MG FILMOMHULDE TABLETTEN tapentadol 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 Dolten is and what it is used for 2. What you need to know before you take Dolten 3. How to take Dolten 4. Possible side effects 5. How to store Dolten 6. Contents of the pack and other information 1. WHAT DOLTEN IS AND WHAT IT IS USED FOR Tapentadol, the active substance in Dolten, is a strong painkiller which belongs to the class of opioids. Dolten is used for the treatment of moderate to severe acute pain in adults that can only be adequately managed with an opioid painkiller. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOLTEN DO NOT TAKE DOLTEN - If you are allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6). - If you have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia). - If you have paralysis of the gut. - If you have acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions) (see “Other medicines and Dolten”). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Dolten - If you have slow or shallow breathing. - If you suffer from increased pressure in the brain or disturbed consciousness up to coma. - If you have had a head injury or brain tumors. - If you suffer from a liver or kidney disease (see “H 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Dolten 50 mg filmomhulde tabletten Dolten 75 mg filmomhulde tabletten Dolten 100 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Dolten 50 mg film-coated tablet contains 58.24 mg Tapentadol hydrochloride equivalent to 50 mg Tapentadol. Each Dolten 75 mg film-coated tablet contains 87.36 mg Tapentadol hydrochloride equivalent to 75 mg Tapentadol. Each Dolten 100 mg film-coated tablet contains 116.48 mg Tapentadol hydrochloride equivalent to100 mg Tapentadol. Excipients with known effect: Dolten 50 mg film-coated tablet contains 25.00 mg lactose monohydrate. Dolten 75 mg film-coated tablet contains 37.50 mg lactose monohydrate. Dolten 100 mg film-coated tablet contains 50.00 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Dolten 50 mg appears white, round, convex, film-coated tablets, debossed with “Medochemie logo” on one side and plain on the other side, with diameter 7.0 mm. Dolten 75 mg appears yellow, round, convex, film-coated tablets plain on both sides, with diameter 8.0 mm. Dolten 100 mg appears dark pink, round, convex, film-coated tablets, debossed “MC” on one side and plain on the other side, with diameter 9.0 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dolten is indicated for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosing regimen should be individualised according to the severity of pain being treated, the previous treatment experience and the ability to monitor the patient. Patients should start treatment with single doses of 50 mg tapentadol as film-coated tablet administered every 4 to 6 hours. Higher starting doses may be necessary depending on the pain intensity and the patient’s previous history of analgesic requirements. 1 vs1.0 2 On the first day of dosing, an additional dose may be taken 阅读完整的文件