Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tapentadol
Grunenthal Ltd
N02AX06
Tapentadol
150mg
Modified-release tablet
Oral
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 4032129029422
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PALEXIA SR 50 MG, 100 MG, 150 MG, 200 MG AND 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 SR is and what it is used for 2. What you need to know before you take PALEXIA SR 3. How to take PALEXIA SR 4. Possible side effects 5. How to store PALEXIA SR 6. Contents of the pack and other information 1. WHAT PALEXIA SR IS AND WHAT IT IS USED FOR The full name of your medicine is ‘PALEXIA SR 50 mg, 100 mg, 150 mg, 200 mg or 250 mg prolonged- release tablets’. It is referred to as ‘PALEXIA SR’ in the rest of this leaflet. Tapentadol - the active substance in PALEXIA SR - is a strong painkiller which belongs to the class of opioids. PALEXIA SR is used in adults for the treatment of severe long-term pain that can only be adequately managed with an opioid painkiller. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PALEXIA SR DO NOT TAKE PALEXIA SR • 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 no bowel movement as shown by severe constipation and bloating which may be accompanied by pain or discomfort in the lower stomach • if you have poisoning with alcohol, sleeping pills, pain relievers or medicines that affect mood and emotions (see ‘Other medicines and PALEXIA SR’) WARNINGS AND PRECAUTIONS Talk to yo Read the complete document
OBJECT 1 PALEXIA SR PROLONGED RELEASE TABLETS Summary of Product Characteristics Updated 03-Jan-2018 | Grunenthal Ltd 1. Name of the medicinal product PALEXIA ® SR 50 mg prolonged-release tablets PALEXIA ® SR 100 mg prolonged-release tablets PALEXIA ® SR 150 mg prolonged-release tablets PALEXIA ® SR 200 mg prolonged-release tablets PALEXIA ® SR 250 mg prolonged-release tablets 2. Qualitative and quantitative composition 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 SR 50 mg contains 3.026 mg lactose. PALEXIA SR 100 mg contains 3.026 mg lactose. PALEXIA SR 150 mg contains 3.026 mg lactose. PALEXIA SR 200 mg contains 3.026 mg lactose. PALEXIA SR 250 mg contains 3.026 mg lactose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged-release tablet 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) marked with Grünenthal logo on one side and “H5” on the other side. 4. Clinical particulars 4.1 Therapeutic indications PALEXIA SR is indicated for the management of severe chronic pain in adults, which can be adequately managed only with op Read the complete document