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Manufacturer
Teva Pharmaceuticals Polska Sp. z o.o.
ATC Code
C05CX
Source
URPL
- Pharmacotherapeutic group: venoactive drug, antivaricose agent. ATC code: C05CX
The active substance is aescin alfa, obtained from the fruits of horse chestnut (Aesculus hippocastanum).
Mechanism of action
The exact mechanism of action is not known, but from preclinical and clinical pharmacological studies, an effect on venous tone and capillary filtration is evident.
Clinical efficacy
Based on systematic reviews (meta-analyses) of 17 clinical studies, it can be concluded that horse chestnut seed extract (standardised to aescin) significantly reduces symptoms of chronic venous insufficiency, such as oedema, pain, and pruritus compared to placebo.
Leg pain was assessed in seven placebo-controlled studies. Six studies (n=543) showed a statistically significant reduction (P<0.05) in leg pain on various measurement scales in subjects treated with aescin compared to placebo, while others still showed improvement compared to pre-treatment values.
Oedema was assessed in six placebo-controlled studies. In four studies (n=461), a statistically significant reduction in oedema was reported in subjects treated with aescin compared to placebo. Additionally, one study indicated improvement compared to pre-treatment values. Corresponding data from one study are available showing results in favour of aescin.
Pruritus was assessed in eight placebo-controlled studies. Four studies (n=407) showed a statistically significant reduction in pruritus in subjects treated with aescin compared to placebo (P<0.05). Two studies indicated a statistically significant difference in favour of aescin compared to pre-treatment values (P<0.05). Another study comparing aescin with the reference product oxerutin (O-beta-hydroxyethyl-rutoside), which did not include a placebo group, confirmed these findings.
Leg volume (oedema) was assessed in seven placebo-controlled studies. All of these studies used plethysmometry to measure outcomes. A meta-analysis of six studies (n=502) demonstrated a reduction in leg volume in favour of aescin compared to placebo. Results of one study suggest that aescin was equivalent to oxerutin (O-beta-hydroxyethyl-rutoside), and another study (n=194) suggests that it may be a treatment as effective as compression stockings.
Significant beneficial effects on chronic venous insufficiency were reported in studies in which patients received standardised aescin at doses of 100 to 150 mg daily. Three studies in which 100 mg of aescin was administered daily reported a statistically significant reduction in leg volume (oedema) after two weeks of treatment compared to placebo (P<0.01). In one study, the persistence of treatment effects was monitored. At the end of the follow-up period (six weeks), leg volume (oedema) was similar to that at the end of treatment.
⚠️ Warnings
In the event of the following symptoms: dermatitis, thrombophlebitis or subcutaneous induration, severe pain, occurrence of ulcers, sudden swelling of one or both legs, cardiac or renal insufficiency, a physician must be contacted immediately, as these may be signs of a serious condition.
In case of concomitant use of anticoagulants, frequent monitoring of blood coagulation parameters is required.
Due to insufficient safety data, Aescin Teva is not suitable for children and adolescents under 18 years of age.
It is essential to combine the use of this product with other non-invasive measures prescribed by the physician, such as bandaging of the lower extremities, wearing compression stockings, or using cold water.
The use of Aescin Teva does not replace other preventive measures or treatments, such as the use of cold water or wearing compression stockings.
This product contains lactose monohydrate
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this product.
This product contains the azo dye aluminium lake of sunset yellow (E 110)
It may cause allergic reactions.