מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Tramadol hydrochloride
Rowex Ltd
N02AX; N02AX02
Tramadol hydrochloride
150 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Other opioids; tramadol
Marketed
2005-09-09
PACKAGE LEAFLET: INFORMATION FOR THE USER Tradol SR 150 mg Prolonged release tablets tramadol hydrochloride 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 of the 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 SR is and what it is used for 2. What you need to know before you take Tradol SR 3. How to take Tradol SR 4. Possible side effects 5. How to store Tradol SR 6. Contents of the pack and other information. 1 WHAT TRADOL SR IS AND WHAT IT IS USED FOR Tramadol, the active substance in Tradol SR, is a painkiller (analgesic) of the opioid group. Its pain alleviating effect is due to its influence on specific nerve cells in the spinal cord and in the brain. Tradol SR is used in the treatment of moderate to severe pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRADOL SR DO NOT TAKE TRADOL SR if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6) if you have acute intoxication with alcohol, sleeping agents, painkillers, opioids or other psychotropic agents (medicines which influence mood, emotional status and disposition) if you are taking or have taken in the last two weeks, certain medicines called ‘monoamine oxidase inhibitors’ or MAOIs (used to treat depression). The combination could result in a serious, potentially life-threatening interaction (see “Other medicines and Tradol SR”). if you have epilepsy that is not controlled with your current medicine as a drug substitute for the treatment of drug addiction. WARNINGS AND PRECAUTIONS Talk to your doc קרא את המסמך השלם
Health Products Regulatory Authority 27 October 2021 CRN00CJGZ Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tradol SR 150 mg Prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Prolonged release tablet contains 150 mg of tramadol hydrochloride. Excipients with known effect: Each tablet contains 88.5mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablet. Flat, round, bi-layer tablets. Initial layer white, slow release layer green with one-sided identification mark TR / 150R. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration: Oral The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total daily doses of 400mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances. Unless otherwise prescribed. Tradol SR should be administered as follows: Adults and adolescents above the age of 12 years The usual initial dose is 50-100 mg tramadol hydrochloride twice daily, morning and evening. If pain relief is insufficient, the dose may be titrated upwards to 150 mg or 200 mg tramadol hydrochloride twice daily. Paediatric Population Tradol SR is not suitable for children below the age of 12 years. Elderly patients A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary, the dosage interval is to be extended according to the patient's requirements. Renal insufficiency/dialysis and hepatic impairment In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the קרא את המסמך השלם