Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Tramadol hydrochloride
Ethypharm
N02AX; N02AX02
Tramadol hydrochloride
150 milligram(s)
Prolonged-release capsule, hard
Product subject to prescription which may not be renewed (A)
Other opioids; tramadol
Not marketed
2006-10-27
P_REF – P_REVISION (P_APPLICATION_DATE) 1/8 PACKAGE LEAFLET: INFORMATION FOR THE USER BY-MADOL SR 150 MG PROLONGED-RELEASE CAPSULES, HARD 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, pharmacist or nurse. • 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 side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What By-Madol SR is and what it is used for 2. What you need to know before you take By-Madol SR 3. How to take By-Madol SR 4. Possible side effects 5. How to store By-Madol SR 6. Contents of the pack and other information 1. WHAT BY-MADOL SR IS AND WHAT IT IS USED FOR Tramadol hydrochloride – the active substance of By-Madol SR –belongs to a group of medicines known as opioid analgesics or painkillers. Its pain-relieving action is due to its effect on specific nerve cells in the spinal cord and brain. By-Madol SR is used in the treatment of moderate to severe pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BY-MADOL SR DO NOT TAKE BY-MADOL SR: • if you are allergic to tramadol or any of the other ingredients of this medicine (listed in sec- tion 6). • if you are intoxicated with alcohol or with sedative drugs include sleeping pills, other pain- killers or psychotropic medicines (medicines that affect mood and emotions) • if you are taking, or have taken in the last two weeks, certain medicines called “monoamine oxi- dase inhibitors” or MAOIs (used to treat depression). The combination could result in a serious, potentially life threatening interaction (see “Other medicines and By-Madol SR”) • if you have epilepsy that is not controlled with your current Read the complete document
Health Products Regulatory Authority 10 November 2023 CRN00DQ7K Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT By-Madol SR 150 mg prolonged-release capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 prolonged-release capsule contains 150 mg of tramadol hydrochloride equivalent to 131.73 mg tramadol. Excipients with known effects: 16.05mg Sucrose/prolonged-release capsule 10.9 ng benzoic acid/prolonged-release capsule For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard Capsules with opaque yellow cap and body, containing white spherical microgranules 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: 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. Adults and adolescents aged 12 years and over: 150 mg tramadol hydrochloride twice daily (corresponding to 300 mg of tramadol hydrochloride/day), morning and evening administration recommended. The smallest effective analgesic dose should always be used. Daily doses of 400 mg of active substance must not be exceeded, unless exceptional medical reasons require so. A minimum interval of 8 hours must be respected between administrations. _Paediatric population_ By-Madol SR is not suitable for use in children below 25 kg body weight which in general does not allow for individualized dosage in children below 12 years of age. Consequently, a more suitable form of administration should be used. _Geriatric 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 Read the complete document