Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
TRAMADOL HYDROCHLORIDE, PARACETAMOL
Teva Pharma B.V.
N02AJ13
TRAMADOL HYDROCHLORIDE, PARACETAMOL
37.5/325 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
opiods in combination with non-opiod analgesics
Authorised
2010-11-19
PACKAGE LEAFLET: INFORMATION FOR THE USER TRAMADOL/PARACETAMOL TEVA 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. Do not pass it on to others. It may harm them, even if their symptoms 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. 1. WHAT TRAMADOL/PARACETAMOL TEVA IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL/PARACETAMOL TEVA 3. HOW TO TAKE TRAMADOL/PARACETAMOL TEVA 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TRAMADOL/PARACETAMOL TEVA 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT TRAMADOL/PARACETAMOL TEVA IS AND WHAT IT IS USED FOR Tramadol/Paracetamol Teva is a combination of two analgesics, tramadol and paracetamol, which act together to relieve your pain. Tramadol/Paracetamol Teva 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 Teva should only be taken by adults and adolescents over 12 years. 2. BEFORE YOU TAKE TRAMADOL/PARACETAMOL TEVA DO NOT TAKE TRAMADOL/PARACETAMOL TEVA • if you are allergic to tramadol or 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 medicin Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tramadol/Paracetamol Teva 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. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film - coated tablet Peach, capsule shaped, film - coated tablet engraved with T37.5 on one side and A325 on the other side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tramadol/Paracetamol Teva 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 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 the 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 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 assess whether continuation of the treatment is necessary. _Paediatric population_ The effective and safe use of tramadol/paracetamol has not been established in children below the age of 12 years. Treatm Soma hati kamili