Quốc gia: Indonesia
Ngôn ngữ: Tiếng Indonesia
Nguồn: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 40 SACHET @ 600 MG
2022-09-10
PIL_Eng _SDF600_11_20 SPEDIFEN ® IBUPROFEN 600 MG GRANULE CARDIOVASCULAR RISK - NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk - NSAIDs is contraindicated for the treatment of perioperative pain in the setting of coronaryartery bypass graft (CABG) surgery GASTROINTESTINAL RISK - NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomatch or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. COMPOSITIONS Each tablet SPEDIFEN 600 mg granule contains: ACTIVE INGREDIENT: 600 mg Ibuprofen as L-arginine salt, equal to ibuprofen 600 mg. EXCIPIENTS: L-arginine, Sodium hydrogen carbonate, Saccharin sodium, Aspartame, Mint- anise flavour and Sucrose. THERAPEUTIC INDICATIONS : SPEDIFEN is indicated for relieving pain of various etiology: headache, pain after tooth extraction and postoperative pain, as well as for the treatment of primary dysmenorrhea. SPEDIFEN is also indicated for the relief of signs and symptoms of rheumatoid arthritis and _osteoarthritis_, as well as for the musculoskeletal and traumatic alterations implying pain and inflammation PHARMACOLOGICAL PROPERTIES PHARMACOLOGICAL PROPERTIES: PHARMACODYNAMIC PROPERTIES GENERAL PROPERTIES _Pharmacotherapeutic _ _group_: Antiinflammatory and anti-rheumatic products, non-steroids, Propionic acid derivatives. ATC code: M01AE01. Ibuprofen is a synthetic analgesic-antiinflammatory drug with a marked antipyretic action. _Mechanism of action _ Ibuprofen is the first phenylpropionic acid derivative. It is a prostaglandin synthetase inhibitor with analgesic, antipyretic and anti-inflammatory properties. It possesses a non-narcotic anal Đọc toàn bộ tài liệu