DOXIUM导升明胶囊说明书.pdf

MEPPO Full Prescribing Information  DOXIUM 500® OM Pharma 1. Trade name of the medicinal product DOXIUM 500 2. Qualitative and quantitative composition 1 capsule contains: Active principle: Calcium dobesilate monohydrate 500 mg. Colour (E 132), excipients for capsule. 3. Pharmaceutical form Capsules. 4. Clinical particulars 4.1. Therapeutic indications Microangiopathies, in particular diabetic retinopathy. Clinical signs of chronic venous insufficiency in the lower limbs (pain, cramps, paresthesia, oedema, stasis dermatosis), as adjuvant in superficial thrombophlebitis. Haemorrhoidal syndrome, microcirculation disorders of arteriovenous origin. 4.2. Posology and method of administration Generally 500 to 1000 mg – 1 capsule once or twice a day - to be taken with the main meals. Treatment duration, which is generally between a few weeks and several months, depends on the disease and its evolution. Dosage should be adapted individually according to the severity of the case. 4.3. Contra-indications Hypersensitivity towards calcium dobesilate. 4.4. Special warnings and special precautions for use Dosage should be reduced in case of severe renal insufficiency requiring dialysis. In very rare cases (0.32/million patients), incidence estimated on the basis of spontaneous reports, the intake of calcium dobesilate may induce agranulocytosis, probably linked to a hypersensitivity reaction. This condition may be expressed by symptoms such as high fever, oral cavity infections (tonsillitis), sore throat, anogenital inflammation and accompanying symptoms, that are often signs of an infection. The patient should be told that by any sign of infection he/she must immediately inform his/ her physician. In that case, it is essential to control without delay the blood formula and leucogram and to discontinue the treatment. 4.5. Interac