Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
N02AX06
TAPENTADOL 150 mg
PROLONGED-RELEASE TABLET
TAPENTADOL 150 mg
POM
ANALGESICS
Authorised
2023-12-01
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER DOLTEN RETARD 50 MG PROLONGED-RELEASE TABLETS DOLTEN RETARD 100 MG PROLONGED-RELEASE TABLETS DOLTEN RETARD 150 MG PROLONGED-RELEASE TABLETS 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 Retard is and what it is used for 2. What you need to know before you take Dolten Retard 3. How to take Dolten Retard 4. Possible side effects 5. How to store Dolten Retard 6. Contents of the pack and other information 1. WHAT DOLTEN RETARD IS AND WHAT IT IS USED FOR Tapentadol, the active substance in Dolten Retard , is a strong painkiller which belongs to the class of opioids. Dolten Retard is used for the treatment of severe chronic pain in adults that can only be adequately managed with an opioid painkiller. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOLTEN RETARD DO NOT TAKE DOLTEN RETARD - 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 Retard ”) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Dolten Retard if you - have slow or shallow breathing, - suffer from increased pressure in the brain or disturbed consciousness up to coma Belgenin tamamını okuyun
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dolten Retard 50 mg prolonged-release tablets Dolten Retard 100 mg prolonged-release tablets Dolten Retard 150 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 58.24mg tapentadol hydrochloride equivalent to 50 mg tapentadol. Each prolonged-release tablet contains 116.48mg tapentadol hydrochloride equivalent to 100 mg tapentadol. Each prolonged-release tablet contains 174.72mg tapentadol hydrochloride equivalent to 150 mg tapentadol. Excipients with known effect: lactose monohydrate. Each prolonged-release tablet contains 2.825 mg of lactose anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet _50 mg_ : Peach, oval shaped, biconvex, film-coated tablets, debossed “D” on one side and plain on the other side with dimensions 15 x 7mm _100 mg_ : Yellow, oval shaped, biconvex, film-coated tablets debossed ‘C’ on one side and plain on the other side with dimensions 15 x 7mm _150 mg_ : Brown, oval shaped, biconvex, film-coated tablets, debossed “E” on one side and plain on the other side with dimensions 15 x 7mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dolten Retard is indicated for the management of severe chronic 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. Dolten Retard should be taken twice daily, approximately every 12 hours. Page 2 of 13 Dolten Retard is only available as 50 mg, 100 mg and 150 mg prolonged-release tablets. For doses not achievable with these strengths, other tapentadol prolonged-release products are available. _Initiation of therapy _ _Initiation of therapy in patients currently not taking opioid analgesics _ Patients should start trea Belgenin tamamını okuyun