One enteric coated tablet contains 20 mg Aescin as active ingredient.
Excipients/Inactive Ingredients: Lactose monohydrate, povidone, magnesium stearate, sucrose, talc, acacia, titanium dioxide, colloidal anhydrous silica, copolymer (ethyl acrylate, methacrylic acid), macrogol 8000, sodium hydroxide, carmellose sodium, triethyl citrate, simethicone emulsion, white beeswax, carnauba wax.
Pharmacotherapeutic group: Capillary-stabilising agents. ATC code: C05AC07.
Pharmacology: Pharmacodynamics: The target site of Aescin is the vascular wall. In pathologically raised permeability, Aescin inhibits exudation by reducing the extravasation of fluid into the tissue and accelerating the subsidence of oedema. The mode of action is based on changes in the permeability of the affected capillary walls. In addition, Aescin raises capillary resistance, inhibits inflammatory processes and improves microcirculation.
Pharmacokinetics: The metabolism of oral administered Aescin was studied in rats and mice. After oral administration of tritium-marked Aescin, the administered activity absorbed from the gastrointestinal tract averaged 12% to 16%. Excretion occurs by both, bile and urine. The rate of metabolisation is bigger following oral administration than with intravenous application. The organ distribution of Aescin is insignificant in the excretion organs liver and kidneys, compared to the increased blood level.
Toxicology: Preclinical Safety Data: Aescin has not been studied sufficiently in animal experiments. In the existing studies, however, it proved medium to highly toxic. Especially significant were nephrotoxic changes. The complete mutagenicity studies yielded no hint at mutagenic effects. Studies on carcinogenicity have not been performed. Aescin has not been studied sufficiently with respect to reproduction toxicity. In mice and rabbits, following oral Aescin administration, embryotoxic effects (reduced fetal weight, retarded ossification of the skeleton, embryo mortality with higher doses) occurred during the phase of organogenesis. Effects on the vitality of prenatally exposed young animals were not discovered.
Localised swelling following injury, varicose veins, haemorrhoids.
As an initial dose, adults and adolescents over 14 years should take 2 tablets 3 times daily after meals with some fluid. In milder cases, or as a maintenance dose, they should take 1 tablet 3 times daily.
Children between 7 and 14 years of age should take 1 tablet 2 or 3 times daily after meals with some fluid.
For children under 7 years of age, Reparil-Dragees are not indicated.
Cases of overdose have not been reported.
Reparil-Dragees must not be taken: in cases of known hypersensitivity against Aescin or any of the excipients, with renal insufficiency/renal failure or renal diseases.
Patients suffering from hereditary galactose intolerance, fructose intolerance, lactase deficiency, saccharase-isomaltase deficiency or glucose-galactose malabsorption should not take Reparil-Dragees.
Effects on Ability to Drive and Use Machines: Not relevant.
There are no adequate data from the use of Aescin in pregnant women. Animal studies are insufficient with respect to effects on pregnancy or fetal/embryonal development. Reparil-Dragees should not be used during pregnancy.
As it is unknown to which extent Aescin passes into breast milk, Reparil-Dragees should not be taken during lactation.
For the evaluation of undesirable effects the following terms of frequency are used (MedDRA frequency convention): very common: more than 1 of 10 patients; common: more than 1 of 100 patients; uncommon: more than 1 of 1,000 patients; rare: more than 1 of 10,000 patients; very rare: 1 or less than 1 of 10,000 patients, including isolated reports.
For Reparil-Dragees the following undesirable effects have been reported:
Immune system disorders: Very rare: Hypersensitivity reactions, e.g. urticaria.
Gastrointestinal disorders: Uncommon: Disorders of the gastrointestinal tract.
If hypersensitivity reactions occur, the administration of Reparil-Dragees should be discontinued.
Other possible adverse effects: Headache, vertigo, pruritus (The frequency is unknown).
Concern have been raised that horse chestnut lowers blood glucose, but the evidence is limited.
Reparil-Dragees may enhance the effects of anticoagulants.
The concomitant administration of antibiotics of the aminoglycoside type (e.g. gentamicin) should be avoided, since it can not totally be ruled out that their nephrotoxicity may be enhanced.
The binding of Aescin to plasma proteins may be affected by antibiotics. Cephalotin and ampicillin, e.g., cause a rise in the concentration of free serum Aescin.
The substances mentioned should therefore not be given concomitantly with Reparil-Dragees.
Incompatibilities: Not applicable.
Store below 30°C, in tightly closed container.
Shelf Life: 5 years.
C05CX - Other capillary stabilizing agents ; Used as capillary stabilizing agents.
Reparil-Dragees EC tab 20 mg
10 × 10's
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