Reparil 20 mg Tablet

Reparil 20 mg coated tablets are round biconvex white, glossy coated tablets of 7 mm in diameter.
Active ingredient: amorphous aescin.
The active substance is aescin. 1 enteric coated tablet contains 20 mg amorphous aescin.
Aescin is derived from horse chestnut (Aesculus hippocastanum).
Excipients/Inactive Ingredients: lactose-monohydrate, povidone, magnesium stearate, sucrose, talc, acacia, titanium dioxide (E 171), colloidal anhydrous silica, poly(ethyl acrylate, methacrylic acid), macrogol 8000, sodium hydroxide, carmellose sodium, triethyl citrate, simethicone emulsion, Carnauba wax and white beeswax.

Pharmacotherapeutic group: Capillary-stabilising agents. ATC code: C05CA.
Pharmacology: Pharmacodynamics: The target site of amorphous aescin is the vascular wall. In pathologically raised permeability, amorphous 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, amorphous aescin raises capillary resistance, inhibits inflammatory processes and improves microcirculation.
Pharmacokinetics: The metabolism of orally administered amorphous aescin was studied in rats and mice. After oral administration of tritium-marked amorphous aescin, the administered activity absorbed from the gastrointestinal tract averaged 12%-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 amorphous aescin is insignificant in the excretion organs, liver and kidneys, compared to the increased blood level.
Toxicology: Acute Toxicity: Humans: The acute IV toxicity of aescin varies among species between 2.0 and 15.2 mg/kg. Toxicity due to acute nephrotic conditions can precipitate the clinical picture of fatal uraemia within 24 to 48 hours.
Chronic Toxicity: Humans: Late toxicity has never been observed. β-aescin is tolerated very well by humans. The differences in toxicity between aescin and total horse chestnut extracts are of minor importance. The therapeutic window cannot be increased by freedom from saponins.

Reparil coated tablets have decongestant effect in case of injuries.
Reparil enteric coated tablets are indicated for reduction of localised swelling following injuries.

Always use Reparil enteric coated tablets exactly as the doctor has instructed. The patient should check with a doctor or pharmacist if unsure.
Method of Administration: oral use.
If not otherwise prescribed: 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.
Treatment should be continued for two to three months.

Cases of overdose have not been reported.
Toxicologic properties: After 24 to 48 hours, an overdosage with aescin leads to excitation and anxiety, diarrhoea and vomiting, mydriasis, delirium and death due to respiratory paralysis, especially in children.
Countermeasures: Elimination of poison (gastric lavage with KMnO₄ solution, medicinal charcoal), correction of the water and electrolyte balance, monitoring of renal function, administration of anticonvulsants and antispasmodics.

Do not take Reparil enteric coated tablets if: with known hypersensitivity against aescin or any of the excipients; with renal insufficiency/renal failure or kidney diseases.

Patients suffering from rare hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption, fructose intolerance or saccharase-isomaltase deficiency should not take Reparil enteric coated tablets because of its contents of lactose and sucrose.
Driving and using machines: No restrictions.
Use in Children: Reparil enteric coated tablets are not indicated for children under 7 years of age.

Pregnancy: Reparil enteric coated tablets should not be taken during pregnancy, because animal studies are insufficient with respect to effects on pregnancy and/or embryonal/fetal development. Experience with the administration in pregnant women is not documented.
Breast-feeding: Since it is unknown to which extent the active ingredient is passed into breast milk, breast-feeding should not be done during the treatment.

Like all medicines, Reparil enteric coated tablets can have side effects.
For the evaluation of undesirable effects, the following terms of frequency are used: very common: more than 1 of 10 patients; common: less than 1 of 10 patients, but more than 1 of 100 patients; uncommon: less than 1 of 100 patients, but more than 1 of 1,000 patients; rare: less than 1 of 1,000 patients, but more than 1 of 10,000 patients; very rare: less than 1 of 10,000 patients, including isolated reports.
In very rare cases, hypersensitivity reactions, like urticaria, can occur. Disorders of the gastrointestinal tract are uncommon.
Countermeasure: In case hypersensitivity reactions occur, intake of Reparil enteric coated tablets should be discontinued.
If the patient notice any side effects not mentioned in this monograph, inform the doctor or pharmacist.

The effects of anticoagulants may be enhanced by aescin.
The concomitant administration of antibiotics of the aminoglycoside type (e.g. gentamicin) should be avoided, since it can not totally be ruled out that the 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 previously should therefore not be administered concomitantly to Reparil enteric coated tablets.

Avoid storing product in direct sunlight. Store below 30 degrees Celsius.

Phlebitis & Varicose Preparations

C05B - ANTIVARICOSE THERAPY ; Used in antivaricose therapy.

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