Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
TRAMADOL HYDROCHLORIDE PARACETAMOL PARACETAMOL
Paladin Labs Europe Limited
TRAMADOL HYDROCHLORIDE PARACETAMOL PARACETAMOL
75/650 Milligram
Tablet Prolonged Release
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-09-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER75MG/650 MG PROLONGED-RELEASE TABLETS Tramadol hydrochloride/Paracetamol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Lesen Sie das vollständige Dokumentis and what it is used for 2. Before you take 3. How to take 4. Possible side effects 5. How to store 6. Further information 1. WHAT IS AND WHAT IT IS USED FOR is a combination of two analgesics, tramadol and paracetamol, which act together to relieve your pain. 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. should only be taken by adults and adolescents over 12 years. 2. BEFORE YOU TAKE DO NOT TAKE - If you have had an allergic reaction_ _(for instance skin rash, swelling of the face, wheezing or difficulty breathing) after taking tramadol or paracetamol or any of the other ingredients in ; - In acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions); - If you are also taking MAO inhibitors (certain medicines used for treatment of depression or Parkinson’s disease) or
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tramadol / Paracetamol 75 mg / 650 mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-release tablet contains 75 mg tramadol hydrochloride and 650 mg paracetamol. Excipients: Each tablet contains 0.09 mg sunset yellow (E110). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM PROLONGED-RELEASE TABLET. Bi-layered biconvex oval shaped film-coated tablets, consisting of an immediate-release layer (light peach) and a prolonged-release layer (white to off-white). The tablets are embossed “DDS 082” on the face of light peach layer. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DDS-06C tablets are indicated for the symptomatic treatment of moderate to severe pain in adults and adolescents over the age of 12 years. The use of DDS-06C should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ Adults and adolescents (12 years and older) The use of DDS-06C 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. An initial dose of one or two tablets of DDS-06C (equivalent to 75 mg or 150 mg of tramadol hydrochloride and 650 mg or 1300 mg of paracetamol) is recommended. Additional doses can be taken as needed, not exceeding four tablets (equivalent to 300 mg tramadol and 2600 mg paracetamol) per day. The dosing interval should not be less than twelve hours. DDS-06C should under no circumstances be administered for longer than is strictly ne Lesen Sie das vollständige Dokument