Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Tramadol hydrochloride; Paracetamol
Rowex Ltd
N02AJ; N02AJ13
Tramadol hydrochloride; Paracetamol
37.5mg/325 milligram(s)
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
2016-02-12
PACKAGE LEAFLET: INFORMATION FOR THE USER TRADOL PLUS 37.5 MG/325 MG 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 Tradol Plus is and what it is used for 2. What you need to know before you take Tradol Plus 3. How to take Tradol Plus 4. Possible side effects 5. How to store Tradol Plus 6. Contents of the pack and other information 1. WHAT TRADOL PLUS IS AND WHAT IT IS USED FOR Tradol Plus is a combination of two analgesics (pain killers), tramadol and paracetamol, which act together to relieve pain. Tradol Plus is indicated for the treatment of moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed. Tradol Plus should only be taken by adults and adolescents 12 years and older. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRADOL PLUS DO NOT TAKE TRADOL PLUS if you are allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6) in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions) if you are taking medicines called monoamine oxidase (MAO) inhibitors (certain medicines used to treat depression or Parkinson’s disease) or if you have taken them in the last 14 days before treatment with Tradol Plus if you have a severe liver disease if you have epilepsy that is not adequately controlled on your current medicine. WARNINGS AND PRECAUTIONS Talk to your do Прочитајте комплетан документ
Health Products Regulatory Authority 24 June 2020 CRN008MZD Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tradol Plus 37.5 mg/325 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, scored tablet of oblong shape (15 x 6.5 mm). The score line is not intended for breaking the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tradol Plus tablets are indicated for the symptomatic treatment of moderate to severe pain. The use of Tradol Plus 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 The use of Tradol Plus should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol. The dose should be adjusted to intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total dose of 8 tablets (equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol) per day should not be exceeded. The dosing interval should not be less than six hours. _Adults and adolescents (12 years and older)_ An initial dose of two tablets of Tradol Plus 37.5 mg/325 mg is recommended. Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 300 mg of tramadol and 2600 mg of paracetamol) per day. The dosing interval should not be less than 6 hours. Tramadol/paracetamol should under no circumstances be administered for longer than is strictly necessary (see also section 4.4). 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 asses Прочитајте комплетан документ