Country: Malta
Language: English
Source: Medicines Authority
TAPENTADOL
Grunenthal GmbH Zieglerstrasse 6, 52078 Aachen, Germany
N02AX06
TAPENTADOL 200 mg
PROLONGED-RELEASE TABLET
TAPENTADOL 200 mg
POM
ANALGESICS
Withdrawn
2011-01-18
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PALEXIA RETARD 50 MG PROLONGED-RELEASE TABLETS PALEXIA RETARD 100 MG PROLONGED-RELEASE TABLETS PALEXIA RETARD 150 MG PROLONGED-RELEASE TABLETS PALEXIA RETARD 200 MG PROLONGED-RELEASE TABLETS PALEXIA RETARD 250 MG PROLONGED-RELEASE TABLETS Tapentadol 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 PALEXIA Retard is and what it is used for 2. What you need to know before you take PALEXIA Retard 3. How to take PALEXIA Retard 4. Possible side effects 5. How to store PALEXIA Retard 6. Contents of the pack and other information 1. WHAT PALEXIA RETARD IS AND WHAT IT IS USED FOR Tapentadol - the active substance in PALEXIA Retard - is a strong painkiller which belongs to the class of opioids. PALEXIA Retard is used for the treatment of severe chronic pain in adults that can only be adequately managed with an opioid painkiller. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PALEXIA RETARD DO NOT TAKE PALEXIA RETARD: If you are allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6) If you have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia) If you have paralysis of the gut If you have acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions) (see “Other medicines and PALEXIA Retard”) WARNINGS AND PRECAUTIONS 2 Talk to your doctor or pharmacist before taking PALEXIA Retard if yo Read the complete document
1. NAME OF THE MEDICINAL PRODUCT PALEXIA Retard 25 mg prolonged-release tablets PALEXIA Retard 50 mg prolonged-release tablets PALEXIA Retard 100 mg prolonged-release tablets PALEXIA Retard 150 mg prolonged-release tablets PALEXIA Retard 200 mg prolonged-release tablets PALEXIA Retard 250 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 25 mg tapentadol (as hydrochloride). Each prolonged-release tablet contains 50 mg tapentadol (as hydrochloride). Each prolonged-release tablet contains 100 mg tapentadol (as hydrochloride). Each prolonged-release tablet contains 150 mg tapentadol (as hydrochloride). Each prolonged-release tablet contains 200 mg tapentadol (as hydrochloride). Each prolonged-release tablet contains 250 mg tapentadol (as hydrochloride). Excipient(s) with known effect: PALEXIA Retard 25 mg contains 1.330 mg lactose. PALEXIA Retard 50 mg contains 3.026 mg lactose. PALEXIA Retard 100 mg contains 3.026 mg lactose. PALEXIA Retard 150 mg contains 3.026 mg lactose. PALEXIA Retard 200 mg contains 3.026 mg lactose. PALEXIA Retard 250 mg contains 3.026 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet [25 mg]: Slightly brownish-orange film-coated oblong shaped tablets (5.5 mm x 10 mm) marked with Grünenthal logo on one side and “H9” on the other side. [50 mg]: White film-coated oblong shaped tablets (6.5 mm x 15 mm) marked with Grünenthal logo on one side and “H1” on the other side. [100 mg]: Pale yellow film-coated oblong shaped tablets (6.5 mm x 15 mm) marked with Grünenthal logo on one side and “H2” on the other side. [150 mg]: Pale pink film-coated oblong shaped tablets (6.5 mm x 15 mm) marked with Grünenthal logo on one side and “H3” on the other side. [200 mg]: Pale orange film-coated oblong shaped tablets (7 mm x 17 mm) marked with Grünenthal logo on one side and “H4” on the other side. [250 mg]: Brownish red film-coated oblong shaped tablets (7 mm x 17 mm) Read the complete document