Pajjiż: Peru
Lingwa: Spanjol
Sors: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)
DICLOFENACO DE SODIO;
INSTITUTO QUIMIOTERAPICO S.A.
M01AB05
DICLOFENAC SODIUM;
TABLETA DE LIBERACION PROLONGADA
POR TABLETA
ORAL
Caja de cartón dúplex x 2, 5, 10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 100, 200, 500 y 1000 Tabletas de Liberación Prolongada en
Con receta médica
INSTITUTO QUIMIOTERAPICO S.A.; PERU
DICLOFENACO
Presentación: Caja de cartón dúplex x 2, 5, 10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 100, 200, 500 y 1000 Tabletas de Liberación Prolongada en envase blíster de PVC/PVDC ámbar -Aluminio y envase blíster de PVC/PVDC incoloro-Aluminio .
VIGENTE
2026-07-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dicloflex Retard 100 mg Fenactol Retard 100mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diclofenac sodium 100 mg Excipients(s) with known effect For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. Pink, round, biconvex tablet, marked "DICL100" on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS AND ELDERLY Relief of all grades of pain and inflammation in a wide range of conditions, including: (i) arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, (ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis, (iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery. CHILDREN Diclofenac Sodium 100mg prolonged-release tablets are not suitable for children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 000014 000047 Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). _ADULTS:_ One 100 mg diclofenac sodium prolonged-release tablet daily. If necessary, the daily dosage can be increased to 150 mg by supplementation with the conventional dosage forms containing diclofenac sodium 25 mg or 50 mg. The recommended maximum daily dose of diclofenac sodium is 150mg. _SPECIAL POPULATIONS _ _ELDERLY:_ Although the pharmacokinetics of Diclofenac sodium are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also precautions) and the patient should be monitored for GI bleeding during NSAID therapy. Aqra d-dokument sħiħ