País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Paracetamol; Tramadol hydrochloride
KRKA, d.d., Novo mesto
N02AJ; N02AJ13
Paracetamol; Tramadol hydrochloride
37.5 mg/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
Marketed
2015-01-23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRAMADOL/PARACETAMOL KRKA 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tramadol/Paracetamol Krka is and what it is used for 2. What you need to know before you take Tramadol/Paracetamol Krka 3. How to take Tramadol/Paracetamol Krka 4. Possible side effects 5. How to store Tramadol/Paracetamol Krka 6. Contents of the pack and other information 1. WHAT TRAMADOL/PARACETAMOL KRKA IS AND WHAT IT IS USED FOR Tramadol/Paracetamol Krka is a combination of two analgesics (pain killers) tramadol and paracetamol, which act together to relieve your pain. Tramadol/Paracetamol Krka is intended for use in the treatment of moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed. Tramadol/Paracetamol Krka should only be taken by adults and adolescents over 12 years. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL/PARACETAMOL KRKA DO NOT TAKE TRAMADOL/PARACETAMOL KRKA IF YOU - are allergic to tramadol hydrochloride, paracetamol or any of the other ingredients of this medicine (listed in section 6) - are in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions) - are also taking MAO inhibitors (certain medicines used for treatment of depression or Parkinson’s disease) or have taken them in the last 14 days before treatment with Tramadol/Paracetamol Krka - Leer el documento completo
Health Products Regulatory Authority 22 August 2023 CRN00DJ30 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tramadol/Paracetamol Krka 37.5mg/325mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 37.5 mg tramadol hydrochloride equivalent to 32.94 mg tramadol and 325 mg paracetamol. Excipient with known effect Each film-coated tablet contains 1.25 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Tablets are yellow-brown, oval, slightly biconvex. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tramadol/Paracetamol Krka tablets are indicated for the symptomatic treatment of moderate to severe pain. The use of Tramadol/Paracetamol Krka 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 Tramadol/Paracetamol Krka 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 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 and 2 600 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 Tramadol/Paracetamol Krka is recommended. Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol) per day. The dosing interval should not be less than six hours. Tramadol/Paracetamol Krka 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 Krka is required as a result of the nat Leer el documento completo