Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Tramadol hydrochloride; Paracetamol
Actavis Group PTC ehf
N02AJ; N02AJ13
Tramadol hydrochloride; Paracetamol
37.5/325 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Opioids in combination with non-opioid analgesics; opiods in combination with non-opiod analgesics
Not marketed
2015-01-09
1 PACKAGE LEAFLET: INFORMATION FOR THE USER TRAMADOL/PARACETAMOL 37.5 MG / 325 MG, FILM-COATED TABLETS Tramadol hydrochloride/Paracetamol 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 Tramadol/Paracetamol is and what it is used for 2. What you need to know before you take Tramadol/Paracetamol 3. How to take Tramadol/Paracetamol Possible side effects 4. How to store Tramadol/Paracetamol Contents of the pack and other information. 1. WHAT TRAMADOL/PARACETAMOL IS AND WHAT IS USED FOR Tramadol/Paracetamol is used to treat moderate to severe pain when your doctor recommends that a combination of tramadol hydrochloride and paracetamol is needed. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL/PARACETAMOL DO NOT TAKE TRAMADOL/PARACETAMOL if you are allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in Section 6). in cases of acute alcohol poisoning. if you are taking sleeping pills, pain relievers or medicines that affect mood and emotions. if you are also taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the last 14 days before treatment with Tramadol/Paracetamol. MAOIs are used in the treatment of depression or Parkinson’s disease. if you have a severe liver disorder. if you have epilepsy that is not adequately controlled by your current medicine. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Tramadol/Paracetamol if you: take other medicines containing paracetamol or trama Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 16 August 2019 CRN0098HW Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tramadol/Paracetamol 37.5mg/325mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol Excipient(s) with known effect: one film-coated contains 3.6 mg lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet 6.4 mm x 15.5mm, yellow, oblong, biconvex, film coated tablet with T on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tramadol/Paracetamol tablets are indicated for the symptomatic treatment of moderate to severe pain. The use of Tramadol/Paracetamol should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol (see also section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents (12 years and older)_ The use of Tramadol/Paracetamol should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol. The dose should be individually adjusted according to intensity of pain and response of the patient. The lowest effective dose for analgesia should generally be selected. An initial dose of two tablets of Tramadol/Paracetamol is recommended. Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 300 mg tramadol and 2600 mg paracetamol) per day. The dosing interval should not be less than six hours. Tramadol/Paracetamol should under no circumstances be administered for longer than is strictly necessary (see also section 4.4 – Special warnings and precautions for use). If repeated use or long term treatment with Tramadol/Paracetamol is required as a result of the nature and severity of the illness, then careful, regular monitoring should take place (with breaks in the treatment, where possible), to assess whether continuation of the treatment Olvassa el a teljes dokumentumot