Dilasal 500 Capsule

فارماتوب لوجو 5

Regulator of capillary functions

Composition

Each Capsule contains

Active principle

Calcium dobesilate monohydrate 500 mg.

Dilasal Properties/Effects

Dilasal acts on the capillary walls by regulating its impaired physiological functions increased permeability and decreased resistance.

It increases erythrocyte flexibility, inhibits platelet hyperaggregation and in diabetic retinopathy, it reduces plasma and blood hyperviscosity, thus improving blood rheological properties and tissue irrigation.

 These effects allow to correct capillary dysfunctions either of functional origin or caused by constitutional or acquired metabolic disorders.

Dilasal  contributes to reduce oedema.

Pharmacokinetics

After oral administration of 500 mg of calcium dobesilate, its blood level is above 6 microgram/ml  between the 3rd and 10th hour, with a maximum (C max) of 8 microgram/ml on the average after 6 hours (t max).

 Twenty four hours after intake blood level is about 3 microgram/ml.

The rate of protein-binding is 20-25 .

 In animals, Calcium dobesilate does not cross the haematoencephalic or the placental barrier, but it is not known whether this is also the case of humans.

 Calcium dobesilate enters the maternal milk in very low quantities (0.4 microgram/ml after intake of 1500 mg as observed in one study).

 Calcium dobesilate does not enter the enterohepatic cycle and is excreted mainly unchanged with only 10  being excreted as metabolites.

 About 50%  of the orally administered dose are eliminated in the first 24-hour and about 50%  in the faeces.

Plasma half-life is around 5 hours.

Kinetics in particular clinical situations

It is not known to what extent renal function disorders influence the Pharmacokinetic properties of calcium dobesilate .

Dilasal Indications and usage

Microangiopathies, in particular diabetic retinopathy.

 Clinical signs of chronic venous insufficiency in the lower limbs (Pain, cramps, paresthesia, oedema stasis dermatosis), as adjuvant in superficial thrombophlebitis.

Haemorrhoidal syndrome, microcirculation disorders of arteriovenous origin.

Dosage

Generally 500 to 1000 mg – 1 capsule once or twice a day – to 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

Contraindications

Hypersensitivity towards 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 Dilasal  may induce agranulocytosis, probably linked to a 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. Pregnancy/Breast-feeding

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 risk to the foetus.

Calcium dobesilate enters the maternal milk in very low quantities (0.4 microgram/ml after intake of 3 x 500 mg). As a precaution either the treatment or the breast – feeding should be stopped.

Adverse effects

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 of change in blood formula, the treatment must be stopped and the treating physician informed as this may constitute allergic reactions.

Dilasal Interactions

No interaction is known up to now.

Overdosage

The clinical signs of a possible overdosage are not known.

PARTICULAR REMARKS

 Incompatibilities

No incompatibility is known up to now.

 Information

At therapeutic doses, calcium dobesilate may interfere with the assay of creatinine (too low values).

Stability

Dilasal 500 should not be used after the expiration date printed on the package after “EXP”.

Storage

Store at a temperature not exceeding 30°C, in a dry place.

Presentation

Carton box containing 5 (AI/colourless PVC) strips of 6 hard gelatin capsules and an inner leaflet.

General information

  1. Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
  2. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sales the medicament
  3. The doctor and the pharmacist are experts in medicine. it’s benefits and risks.
  4. Do not by yourself interrupt the period of treatment prescribed for you.
  5. Do not repeat the same prescription without consulting your doctor.
  6. Keep medicament out of children reach

Manufacturer