Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Naproxen
Azure Pharmaceuticals Ltd
M01AE02
Naproxen
500 milligram(s)
Gastro-resistant tablet
naproxen
Marketed
2020-04-24
PACKAGE LEAFLET: INFORMATION FOR THE USER NAPROXEN 250 MG GASTRO-RESISTANT TABLETS NAPROXEN 500 MG GASTRO-RESISTANT TABLETS naproxen 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 Naproxen Tablets are and what they are used for 2. What you need to know before you take Naproxen Tablets 3. How to take Naproxen Tablets 4. Possible side effects 5. How to store Naproxen Tablets 6. Contents of the pack and other information 1. WHAT NAPROXEN TABLETS ARE AND WHAT THEY ARE USED FOR Naproxen Tablets contain a medicine called naproxen. This is a ‘Non-Steroidal Anti-Inflammatory Drug’ or NSAID. Naproxen Tablets can lessen pain, swelling, redness and heat (inflammation) and is used to treat adults for: • Problems with your muscles, joints and tendons, like strains, back pain, ankylosing spondylitis (pain and stiffness in the neck and back) or arthritis • Women, while having period pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAPROXEN TABLETS DO NOT TAKE NAPROXEN TABLETS IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO: • Naproxen, naproxen sodium or any of the other ingredients of Naproxen Tablets (listed in section 6). • Aspirin, other NSAIDs or any other pain relief medicines (such as ibuprofen or diclofenac). DO NOT TAKE NAPROXEN TABLETS IF: • You have now or have ever had any problems with your stomach or gut (intestine) like an ulcer or bleeding • You have previously experienced bleeding or perforation in your stomach while taking NSAIDs • You have severe problems with your kidneys, Izlasiet visu dokumentu
Health Products Regulatory Authority 31 July 2023 CRN00DJ4R Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Naproxen 500 mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg naproxen. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant tablets. White colour, capsule shaped biconvex enteric coated tablets debossed with "500" on one side and plain on the other side. Dimension: 16.50 mm x 7.70 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Naproxen Gastro-resistant Tablets are indicated in adults for the treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosingspondylitis, acute musculoskeletal disorders (such as sprains and strains, direct trauma, lumbosacral pain, cervical spondylitis, tenosynovitis and fibrositis) and dysmenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). _ADULTS_ Therapy should be started at the lowest recommended dose, especially in older people. _RHEUMATOID ARTHRITIS, OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS_ The usual dose is 500mg to 1g daily taken in 2 doses at 12-hour intervals. Where 1g per day is needed either one 500mg tablet twice daily or two 500mg tablets in a single administration (morning or evening) is recommended. In the following cases a loading dose of 750mg or 1g per day for the acute phase is recommended: a) In patients reporting severe night-time pain/or morning stiffness. b) In patients being switched to Naproxen from a high dose of another anti-rheumatic compound. c) In osteoarthrosis where pain is the predominant symptom. _ACUTE MUSCULOSKELETAL DISORDERS AND DYSMENORRHOEA_ 500mg initially followed by 250mg at 6 - 8 hour intervals as needed, with a maximum daily dose after the first day of 1250mg. _OLDER PEOPLE_ Studies indicate that although total plasma concentration of n Izlasiet visu dokumentu