Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CALCIUM DOBESILATE
PHARMAFORTE (MALAYSIA) SDN. BHD.
CALCIUM DOBESILATE
30Capsule Capsules; 60Capsule Capsules; 30 Capsules; 60 Capsules
OM PHARMA S.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ DOXIUM ® 500 CAPSULES Calcium dobesilate 500mg Page 1 of 2 WHAT IS IN THIS LEAFLET 1. What DOXIUM is used for 2. How DOXIUM works 3. Before you use DOXIUM 4. How to take DOXIUM 5. While you are using it 6. Side effects 7. Storage and Disposal 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision 12. Serial Number WHAT DOXIUM IS USED FOR DOXIUM 500 is indicated in the following cases: - Microangiopathies, in particular diabetic retinopathy. (Disorders of the small blood vessels of the retina in diabetic patients), - Clinical signs of chronic venous insufficiency in the lower limbs (condition when the veins have problems sending blood from the leg to heart) with pain, cramps, paresthesia (tingling, pricking, chilling, burning or numb sensation on the skin) oedema (swelling), stasis dermatosis (skin inflammation) - As adjuvant in superficial thrombophlebitis (infammatory condition of the veins due to a blood clot just below the surface of the skin) - Haemorrhoids - Micro-circulation disorders of arteriovenous origin (poor blood circulation from arteri and veins) HOW DOXIUM WORKS Calcium dobesilate acts on small blood vessels – the capillaries – to normalise the resistance and permeability of their walls. It improves blood flow in the veins and, in disorders of the venous circulation, helps to reduce swelling of the ankles (oedema) and alleviates the pins and needles, pain and cramps. BEFORE YOU USE DOXIUM _- When you must not take it _ If you are allergic (hypersensitive) to calcium dobesilate or any of the other ingredients of DOXIUM 500. During pregnancy and during breast-feeding. DOXIUM 500 is not indicated for children. _- Before you start to take it _ _ _ If you know or presume that you are pregnant ask your doctor or pharmacist for advice before taking any medicine. If you suffer from kidney problems requiring dialysis, the dose should be reduced in these cases. If you develop high fever, infections of the oral cav Read the complete document
Doxium ®500 Regulator of the capillary functions Product Description Hard gelatin capsule (cap: opaque dark green; body: opaque yellow) with a white powder fill. Composition Active principle: Calcium dobesilate monohydrate 500 mg. Excipients: Maize starch, magnesium stearate. Capsule shell’s composition: gelatin, yellow ferric oxide (E172), titanium dioxide (E171), Indigotin (E132) Properties/Effects Calcium dobesilate acts on the capillary walls by regulating its impaired physiological functions – increased permeability and decreased resistance. It increases erythrocyte flexibility, inhibits platelet hyperaggregation and, in diabetic retinopathy, it r educes plasma and blood hyperviscosity, thus improving blood rheological properties and tissue irrigation. These effects allow to correct capillary dysfunctions either of functional origin or caused by constitutional or acquired metabolic disorders. Calciu m dobesilate contributes to reduce oedema. Pharmacokinetics After oral administration of 500 mg of calcium dobesilate, its blood level is above 6 μg/ml between the 3 rd and 10th hour, with a maximum (Cmax) of 8 μg/ml on the average after 6 hours (tmax). Tw enty four hours after intake blood level is about 3 μg/ml. The rate of protein- binding is 20 - 25%. In animals, calcium dobesilate does not cross the haematoencephalic or the placental barrier, but it is not known whether this is also the case in humans. C alcium dobesilate enters the maternal milk in very low quantities (0.4 μg/ml after intake of 1500 mg as observed in one study). Calcium dobesilate does not enter the enterohepatic cycle and is excreted mainly unchanged with only 10% being excreted as metabolites. About 50% of the orally administered dose are eliminated in the first 24- hour urine and about 50% in the faeces. Plasma half -life is around 5 hours. Kinetics in particular clinical situations Kidney failure The safety and efficacy of calcium dobesilate have not been studied in patients with kidney disorders. As the medication is excreted Read the complete document