Reparil 20 mg Tablet

Reparil 20 mg Tablet

Manufacturer:

Mylan Healthcare

Distributor:

Antah Pharma
Full Prescribing Info
Contents
Amorphous aescin.
Description
Each enteric-coated tablet also contains the following excipients: Lactose monohydrate, povidone, magnesium stearate, sucrose, talc, acacia, titanium dioxide (E171), anhydrous colloidal silica, poly (ethyl acrylate, methacrylic acid), macrogol 8000, sodium hydroxide, sodium carmellose, triethyl citrate, simethicone emulsion, carnauba wax and white beeswax.
Aescin is derived from horse chestnut (Aesculus hippocastanum).
Action
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 activitiy 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 IV application. The organ distribution of amorphous aescin is insignificant in the excretion organs liver and kidneys, compared to the increased blood level.
Toxicology: Humans: Acute Toxicity: The acute IV toxicity of aescin varies among species between 2-15.2 mg/kg. Toxicity due to acute nephrotic conditions can precipitate the clinical picture of fatal uraemia within 24-48 hrs.
Chronic Toxicity: 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.
Indications/Uses
Reduction of localised swelling following injuries. Reparil 20 mg Tablet has decongestant effect in case of injuries.
Dosage/Direction for Use
Initial Dose: Adults and Adolescents >14 years: 2 tab 3 times daily after meals with some fluid.
In milder cases or as a maintenance dose, 1 tab 3 times daily.
Children between 7 and 14 years: 1 tab 2 or 3 times daily after meals with some fluid.
Treatment should be continued for 2-3 months.
Administration: Reparil 20 mg Tablet is taken orally.
Overdosage
Cases of overdosage have not been reported.
Symptoms: After 24-48 hrs, an overdosage with aescin leads to excitation and anxiety, diarrhoea and vomiting, mydriasis, delirium and death due to respiratory paralysis, especially in children.
Treatment: 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.
Contraindications
Known hypersensitivity to aescin or to any of the excipients of Reparil 20 mg Tablet.
Renal insufficiency/renal failure or kidney diseases.
Use in pregnancy & lactation: Reparil 20 mg Tablet 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.
Since it is unknown to which extent the active ingredient is passed into breast milk, breastfeeding should not be done during treatment.
Special Precautions
Patients suffering from rare hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption, fructose intolerance or saccharase-isomaltase deficiency should not take Reparil 20 mg Tablet because of its contents of lactose and sucrose.
Effects on Ability to Drive or Operate Machinery: No restrictions.
Use in children: Reparil 20 mg Tablet is not indicated for children <7 years.
Use In Pregnancy & Lactation
Reparil 20 mg Tablet 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.
Since it is unknown to which extent the active ingredient is passed into breast milk, breastfeeding should not be done during treatment.
Side Effects
Like all medicines, Reparil 20 mg Tablet can have side effects.
For the evaluation of undesirable effects, the following terms of frequency are used: Very common (>1/10 patients), common (<1/10 patients but >1/100 patients), uncommon (<1/100 patients but >1/1000 patients), rare (<1/1000 patients but >1/10,000 patients) and very rare (<1/10,000 patients including isolated reports).
In very rare cases, hypersensitivity reactions eg, urticaria can occur. Disorders of the gastrointestinal tract are uncommon.
Countermeasure: In case hypersensitivity reactions occur, intake of Reparil 20 mg Tablet should be discontinued.
Drug Interactions
The effects of anticoagulants may be enhanced by aescin.
The concomitant administration of antibiotics of the aminoglycoside type (eg, 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 eg, cephalotin and ampicillin which can cause a rise in the concentration of free serum aescin.
The aforementioned substances should therefore not be administered concomitantly to Reparil.
Storage
Store below 25°C. Protect from direct sunlight.
ATC Classification
C05B - ANTIVARICOSE THERAPY ; Used in antivaricose therapy.
Presentation/Packing
EC tab 20 mg (white, glossy, round, biconvex, 7 mm in diameter) x 50's.
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