Limitations
for use
Contraindications
Hypersensitivity towards calcium dobesilate and/or sulfites.
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 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.
Pregnancy
and 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, the
drug 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 µg/ml after intake of 1500 mg).
As a precaution, either the treatment or the breast-feeding
should be stopped. |
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