Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Tramadol hydrochloride
Grunenthal Pharma Ltd
N02AX; N02AX02
Tramadol hydrochloride
200 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Other opioids; tramadol
Marketed
1997-02-21
Date: January 2022 1 PACKAGE LEAFLET: INFORMATION FOR THE USER ZYDOL SR 100 MG, 150 MG, AND 200 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 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 (section 4) IN THIS LEAFLET: 1. What ZYDOL SR is and what it is used for 2. What you need to know before you take ZYDOL SR 3. How to take ZYDOL SR 4. Possible side effects 5. How to store ZYDOL SR 6. Contents of the pack and other information 1. WHAT ZYDOL IS AND WHAT IT IS USED FOR The full name of your medicine is ‘ZYDOL SR 100 mg, 150 mg or 200mg prolonged-release tablets’. It is referred to as ‘ZYDOL SR’ in the rest of this leaflet. Tramadol - the active substance in ZYDOL SR - is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain. ZYDOL SR is used for the treatment of moderate to severe pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYDOL SR DO NOT TAKE ZYDOL SR, - if you are allergic to tramadol 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 medicines (medicines that affect mood and emotions); - if you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with ZYDOL SR (see "Other medicines and ZYDOL SR"); - if you are an epileptic and your fits are not adequately controlled by treatment; - as a substitute in drug withdrawal. WARNINGS Read the complete document
Health Products Regulatory Authority 18 February 2022 CRN00CJN6 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ZYDOL SR 200 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 200 mg tramadol hydrochloride. Excipient: Each prolonged-release tablet contains 2.5 mg lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablets Slightly brownish orange coloured, round biconvex film-coated tablets marked with manufacturer’s logo on one side and T3 on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 400 mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances. Unless otherwise prescribed, ZYDOL 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 (see section 5.1). Children ZYDOL SR is not suitable for children below the age of 12 years. Older 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 interval should be carefully considered according to the Read the complete document