Localised swelling following injury

 Posology

Adults and adolescents aged 14 years and above initially take 2 tablets 3 times daily, as maintenance dose and in milder cases 1 tablet unchewed with some liquid after meals 3 times daily.

Paediatric population

Children aged 7 to 14 years take 1 tablet unchewed with some liquid after meals 2 to 3 times daily.

Reparil coated tablets are not indicated in children under the age of 7 years.

Method of administration

The tablets are taken unchewed with some liquid after meals.

 Patients with rare hereditary (deficiency) problems of galactose intolerance, lactase deficiency, glucose-galactose malabsorption, fructose intolerance or sucrase isomaltase deficiency should not use Reparil coated tablets.

Information on some of the excipients

This medicine contains less than 1 mmol sodium (23 mg) per coated tablet, that is to say essentially 'sodium-free'.

Paediatric population

Reparil coated tablets are not indicated in children under the age of 7 years.

Administration of aescin can enhance the effect of anticoagulant medicinal products.

Concurrent use of aminoglycosides (e.g. gentamicin) should be avoided because an increase in the nephrotoxicity of aminoglycosides cannot be completely excluded.

The plasma protein binding of aescin can be inhibited by antibiotics. Cephalotin and ampicillin, for instance, raise the concentration of free aescin in the serum.

Therefore, concurrent administration of these medicinal products with Reparil coated tablets is not recommended.

 Reparil coated tablets should not be used during pregnancy because the product has only inadequately been tested in animal studies and no experience with pregnant women has been documented. Breast-feeding during treatment is not recommended, because it is not known to which extent the active substance passes into breast milk.

 Not applicable.

The following convention has been used for the classification of side effects in terms of frequency:

Very common: ≥ 1/10

Common: ≥ 1/100 to < 1/10

Uncommon: ≥ 1/1,000 to < 1/100

Rare: ≥ 1/10,000 to < 1/1,000

Very rare: < 1/10,000

Not known: Frequency cannot be estimated from the available data.

The following side effects are known for Reparil coated tablets:

Immune system disorders:

Very rare: hypersensitivity reactions (e.g. urticaria)

Gastro-intestinal disorders:

Uncommon: gastro-intestinal tract disorders

If hypersensitivity reactions occur, use of Reparil coated tablets should be discontinued.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the following:

To report side effect(s):

Saudi Arabia:

The National Pharmacovigilance Centre (NPC):

Fax: +966-11-205-7662

SFDA Call Center: 19999

E-mail:npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa/

Other Countries:

Please contact the relevant competent authority.

No cases of overdose have been reported.

Pharmacotherapeutic group: Capillary stabilizing agents ATC Code: C05CA07

The site of action of aescin is the vascular wall. In case of abnormally raised permeability, aescin inhibits exsudation by reducing extravasation of fluid into the tissue and accelerating re-absorption of the existing oedema. The mechanism of action is based on a change in the permeability of the capillary openings involved. Furthermore, aescin promotes capillary resistance, inhibits inflammatory processes and improves microcirculation.

After oral administration of tritium-labelled aescin, a mean 12 – 16% of the applied activity was absorbed from the intestinal tract in mice and rats. Excretion occurs via the bile as well as the urine. The metabolisation rate is higher after oral administration than after intravenous injection. Organ distribution is negligibly low in the excretory organs liver and kidneys in comparison to the higher values in the blood.

Aescin was only inadequately tested in animal experiments. In these experiments it proved to be moderately to highly toxic. Nephrotoxic changes were particularly significant. Complete testing for mutagenicity produced no evidence of mutagenic effects. No carcinogenicity studies have been carried out.

Aescin was inadequately tested for reproductive toxicity. After oral administration of aescin in mice and rabbits during organogenesis embryotoxic effects occurred (reduced foetal weights, delayed skeleton ossification, in higher doses embryo lethality). No effects on the viability of offspring with prenatal exposure were found.

 Lactose monohydrate, Povidone (K29-32), Magnesium stearate (Ph. Eur.), Sucrose (sugar), Talc, Gum arabic, Titanium dioxide E 171, Colloidal anhydrous silica, Poly(ethyl acrylate, methacyrylic acid), Macrogol 8000, Sodium hydroxide, Carmellose sodium, Triethyl citrate, Simeticone emulsion, Bleached wax, Carnauba wax.

 Not applicable.

 Store below 30°C, in a dry place.

PVC and printed aluminium blister packs in strips of 10 coated tablets Packs of 40 coated tablets

 No special requirements.