Dobelit Capsule

Dobelit capsule is indicated for the treatment of hemorrhoidal syndrome, microcirculation disorders of arteovenous origin, clinical signs of chronic venous insufficiency in the lower limbs (pain, cramps, paresthesia, edema, stasis, dermotosis) and in the particular microangiopathy like diabetic retinopathy. It is also indicated in superficial thrombophlebitis as adjuvant therapy.

Dobelit is a vasoactive drug that presumes effects on endothelial integrity, capillary permeability and blood viscosity. It decreases capillary hyperpermeability, decreases platelet aggregation (clotting - adhesion of platelets) and reduces the serum viscosity, which improves blood circulation and blood supply to tissues and organs.

Calcium Dobesilate is a vasoactive drug that presumes effects on endothelial integrity, capillary permeability and blood viscosity. It decreases capillary hyperpermeability, decreases platelet aggregation (clotting- adhesion of platelets) and reduces the serum viscosity, which improves blood circulation and blood supply to tissues and organs.

One to two 500 mg capsules daily should 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.

Calcium Dobesilate capsule is contraindicated in patients with hypersensitivity to Calcium Dobesilate.Precautions: 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 hyper-sensitivity 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.

Rarely gastrointestinal disorders including nausea and diarrhea, skin reactions, fever, articular pain and in very rare cases, agranulocytosis have been reported. These reactions are generally spontaneously reversible after treatment withdrawal. In case of gastrointestinal disorders, the dosage should be reduced or the treatment temporarily withdrawn. In case of skin reactions, fever, articular pain or change in blood formula, the treatment must be stopped and the treating physician informed as this may constitute allergic reactions.

Studies in pregnant women or animals are not available. As it is not known whether calcium dobesilate crosses the placental barrier in humans, the drug should only be administered if it was estimated that the anticipated therapeutic benefit outweigh the potential risk to the fetus. Calcium dobesilate enters the maternal milk in very low quantities (0.µ4g/ml after intake of 3×500mg). As a precaution either the treatment or the breast-feeding should be stopped.

Dosage should be reduced in case of severe renal insufficiency requiring dialysis. In patient with agranulocytosis, this medication can decrease the number of white blood cells which affect the body’s ability to fight against various infections. If patients experience flu-like symptoms such as cough, sore throat, fever and others, they are advised to seek medical care as soon as possible.

The clinical signs of a possible over dosage are not known.

Vaso Protective

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.