Država: Malta
Jezik: engleski
Izvor: Medicines Authority
TRAMADOL HYDROCHLORIDE
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
N02AX02
TRAMADOL HYDROCHLORIDE 100 mg
PROLONGED-RELEASE TABLET
TRAMADOL HYDROCHLORIDE 100 mg
POM
ANALGESICS
Authorised
2011-03-14
_ _ Page 1 of 14 PACKAGE LEAFLET: INFORMATION FOR THE USER MABRON RETARD 100 MG PROLONGED-RELEASE TABLETS MABRON RETARD 150 MG PROLONGED-RELEASE TABLETS MABRON RETARD 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 signs of illness 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. WHAT IS IN THIS LEAFLET 1. What Mabron Retard is and what it is used for 2. What you need to know before you take Mabron Retard 3. How to take Mabron Retard 4. Possible side effects 5. How to store Mabron Retard 6. Contents of the pack and other information 1. WHAT MABRON RETARD IS AND WHAT IT IS USED FOR Tramadol – the active substance in Mabron Retard is a pain killer belonging to the class of opiods that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the brain and spinal cord. Mabron Retard is used for the treatment of moderate to severe pain. _ _ Page 2 of 14 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MABRON RETARD DO NOT TAKE MABRON RETARD: ▪ If you are allergic to tramadol hydrochloride 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 Mabron Retard (see “Other medicines and Mabron Retard”). ▪ If you are an epileptic and your fits are not adequately controlled by treatment ▪ As a substitut Pročitajte cijeli dokument
_ _ Page 1 of 16 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Mabron Retard 100 mg prolonged-release tablets Mabron Retard 150 mg prolonged-release tablets Mabron Retard 200 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-release tablet contains 100 mg tramadol hydrochloride. One prolonged-release tablet contains 150 mg tramadol hydrochloride. One prolonged-release tablet contains 200 mg tramadol hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet. Mabron Retard 100 mg prolonged-release tablets are off white, round biconvex tablets, 9.1 mm diameter Mabron Retard 150 mg prolonged-release tablets are off white, capsule shaped tablets, 14.3 mm long Mabron Retard 200 mg prolonged-release tablets are off white, capsule shaped tablets 17.1 mm long 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of moderate to severe pain. _ _ Page 2 of 16 _ _ 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. Unless otherwise prescribed, Mabron Retard prolonged-release tablets should be given as follows: _Adults and adolescents older than 12 years:_ The usual initial dose is 50 - 100mg 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. For doses not practicable with this strength, other strengths of this medicinal product are available. Mabron Retard prolonged-release tablets should be swallowed completely, without breaking or chewing, independent of meals, with sufficient liquid. Daily doses of 400 mg of active substance should not be exceeded, except in special clinical circumstances. Under no circumstances should Mabron Retard be used for longer than absolutely necessary. If long-term pain treatme Pročitajte cijeli dokument