Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Naproxen
Atnahs Pharma UK Limited
M01AE; M01AE02
Naproxen
500 milligram(s)
Gastro-resistant tablet
oral use
blisters of 56 tablets
Product subject to prescription which may be renewed (B)
Anti-inflammatory and antirheumatic products, non- steroids
Propionic acid derivatives; naproxen
Naprosyn EC is indicated in adults and adolescents (16 years and above) for the treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute gout, acute musculo-skeletal disorders (such as sprains and strains, direct trauma, lumbosacral pain, cervical spondylitis, tenosynovitis and fibrositis) and dysmenorrhoea.
Marketed
1990-07-04
BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ● Keep this 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 1. What Naprosyn EC is and what it is used for 2. What you need to know before you take Naprosyn EC 3. How to take Naprosyn EC 4. Possible side effects 5. How to store Naprosyn EC 6. Contents of the pack and other information 1. WHAT NAPROSYN EC IS AND WHAT IT IS USED FOR Naprosyn EC contains a medicine called naproxen. This is a ‘Non Steroidal Anti Drug’ or NSAID. Naprosyn EC can lessen pain, swelling, redness and heat and is used to: ● relieve problems with your muscles, joints and tendons, e.g. strains, back pain, ankylosing spondylitis (pain and stiffness in the neck and back), gout, rheumatoid arthritis or osteoarthrosis. ● relieve period pain in women. Naprosyn EC tablets are used to treat adults and adolescents (16 years and above). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAPROSYN EC DO NOT TAKE NAPROSYN EC IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO: ● Naproxen, naproxen sodium or any of the other ingredients of Naprosyn EC (listed in section 6). ● Aspirin, other NSAIDs or any other pain relief medicines (such as ibuprofen or diclofenac). DO NOT TAKE NAPROSYN EC IF: ● you have now or have ever had any problems with your stomach or gut (intestine) e.g. an ulcer or bleeding. ● you have previously experienced bleeding or perforation in your stomach while taking NSAIDs. ● you have SEVERE problems with your kidneys, liver or heart. ● you are in the last three months of pregnancy. Do not take Naprosyn EC if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Naprosyn EC. WA Đọc toàn bộ tài liệu
Health Products Regulatory Authority 01 October 2018 CRN008MFY Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Naprosyn EC 500mg Gastro-resistant Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg Naproxen. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablets. Capsule-shaped, white film-coated tablet marked ‘NPR EC 500’ in black ink on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Naprosyn EC is indicated in adults and adolescents (16 years and above) for the treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute gout, acute musculo-skeletal 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 For oral administration Naprosyn EC tablets should be swallowed whole and not broken or crushed. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). _ADULTS:_ _RHEUMATOID ARTHRITIS, OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS:_ The usual dose is 500mg to 1g daily taken in two doses at 12-hour intervals. Where 1g per day is needed one 500mg tablet twice daily or two 500mg tablets in a single administration (morning or evening) is recommended. _ACUTE GOUT:_ Health Products Regulatory Authority 01 October 2018 CRN008MFY Page 2 of 15 The recommended dosage is 750mg initially, then 250mg every eight hours until the attack has passed. _ACUTE MUSCULO-SKELETAL DISORDERS AND DYSMENORRHOEA:_ The recommended dose is 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 naproxen is unchanged, the unbound plasma fraction of naproxen is increased in older people. The implication of this findi Đọc toàn bộ tài liệu