Optium Special Precautions

Dosage should be reduced in case of severe renal insufficiency requiring dialysis.
In very rare cases (0.32/1,000,000 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 eg, 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 any sign of infection must immediately be reported to the physician. In that case, it is essential to control without delay the blood formula and leucogram and to discontinue the treatment.
Use in pregnancy & lactation: Pregnancy Category C: Studies in pregnant women or animals are not available. As it is not known whether calcium dobesilate crosses the placental barrier in humans, it should only be administered if the potential benefit justifies the potential risk to the foetus.
Calcium dobesilate enters the maternal milk in very low quantities (0.4 mcg/mL after intake of three 500-mg capsules. As a precaution, either the treatment or the breastfeeding should be stopped.