Calcium dobesilate

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 3x500mg). As a precaution, either the treatment or the breastfeeding should be stopped.

Calcium dobesilate has no effect upon driving capacity and managing of machines.

Calcium dobesilate has no effect upon driving capacity and managing of machines.The side effects are classified according to the MedDRA convention by system organ class and by frequency as follows:

Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1 000 to <1/100)
Rare (≥1/10 000 to <1/1 000)
Very rare (<1/10 000)
Not known (cannot be estimated from the available data)

Gastrointestinal disorders

Rare: nausea, diarrhoea, vomiting.

Skin and subcutaneous tissue disorders

Rare: pruritus,rash.

General disorders and administration site conditions

Rare: fever,chills.

Musculoskeletal disorders

Rare: arthralgia.

Cardiac disorders

Uncommon: tachycardia.

Blood and lymphatic system disorders

Isolated cases of agranulocytosis have been reported mainly in elderly patients and in combination with other drugs.

These reactions are generally reversible when stopping treatment course.

In case of gastrointestinal disorders, the dosage should be reduced or the treatment temporarily withdrawn.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 hypersensitivity reactions.