MEDORIL Capsule Ref.[28132] Active ingredients: Calcium dobesilate

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 infections. 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.

Medoril contains carmoisine, which may cause allergic reactions.

None known.

The safety of the drug during pregnancy or lactation has not been established. Therefore its use is not recommended.

None known effect.

Rare (≥1/10,000 to <1/1,000): gastrointestinal disorders including nausea and diarrhoea, skin reactions and fever have been reported.

In case of gastrointestinal disorders, the dosage should be reduced or the treatment should be temporarily withdrawn. In case of skin reactions and fever, the treatment must be stopped and the treating physician informed as this may constitute an allergic reaction.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

None known.