Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PARACETAMOL, TRAMADOL HYDROCHLORIDE
Athlone Pharmaceuticals Limited
N02AX52
PARACETAMOL, TRAMADOL HYDROCHLORIDE
37.5/325 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Other opioids
Authorised
2016-06-10
TRAMADOL HYRDOCHLORIDE/ PARACETAMOL – 37.5MG/325MG FILM-COATED TABLETS 1.3 : SMPC, LABELLING AND PACKAGE LEAFLET 1.3.1 : PACKAGE LEAFLET Page : 1/4 PACKAGE LEAFLET: INFORMATION FOR THE USER TRAMADOL HYDROCHLORIDE/PARACETAMOL 37.5MG/325MG FILM-COATED 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. • Ask your pharmacist if you need more information or advice. • 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. • You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Tramadol Hydrochloride/Paracetamol Tablets are and what they are used for 2. What you need to know before you take Tramadol Hydrochloride/Paracetamol Tablets 3. How to take Tramadol Hydrochloride/Paracetamol Tablets 4. Possible side effects 5. How to store Tramadol Hydrochloride/Paracetamol Tablets 6. Contents of the pack and other information 1. WHAT TRAMADOL HYDROCHLORIDE/PARACETAMOL TABLETS ARE AND WHAT THEY ARE USED FOR Tramadol Hydrochloride/Paracetamol tablets are used to treat moderate to severe pain when you doctor recommends that a combination of paracetamol and tramadol hydrochloride is needed. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL HYDROCHLORIDE/PARACETAMOL TABLETS Do not take Tramadol Hydrochloride/Paracetamol film coated tablets: • if you are hypersensitive or have had an allergic reaction (for instance skin rash, swelling of the face, wheezing or difficulty breathing) to tramadol, paracetamol or any of the other ingredients (see section 6) in Tramadol Hydrochloride/Paracetamol tablets. • 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 treatme Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tramadol Hydrochloride/Paracetamol 37.5mg/325mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Pale yellow film-coated tablet, marked with “325” on one side and ’37.5’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tramadol Hydrochloride/Paracetamol tablets are indicated for the symptomatic treatment of moderate to severe pain. The use of Tramadol Hydrochloride/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 Hydrochloride/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. An initial dose of two tablets of Tramadol Hydrochloride/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 Hydrochloride/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 Hydrochloride/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 is necessary. Children The effective and safe use of Tramadol Hydrochloride/Paracetamol has not been esta Read the complete document