Active ingredients: Escin
Reparilexin 40mg coated tablets
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
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01.0 NAME OF THE MEDICINAL PRODUCT
REPARILEXIN 40 MG COATED TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
Active ingredient: aescin 40 mg.
Excipients with known effects: lactose, sucrose, castor oil.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Coated tablets for oral use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptoms attributable to venous insufficiency; states of capillary fragility.
04.2 Posology and method of administration
For oral administration in adults, which is used for attack therapy, the doses are 1 coated tablet of 40 mg, three times a day. For a further maintenance period or in milder morbid forms or in the treatment of adolescents, the doses are 1 coated tablet of 40 mg once a day, after meals, with a little liquid, unless otherwise prescribed.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Haemolytic affections, generalized edema of cardiac, renal and dyscrasic origin. Renal failure, renal shock, previous kidney disease.
Thrombotic risk patients; women who use oral contraceptives.
04.4 Special warnings and appropriate precautions for use
There are no known cases of addiction or dependence.
REPARILEXIN must not be used in patients with renal emunctory insufficiency. Therefore, when REPARILEXIN is used in conditions that can complicate with reduced renal function (eg. Trauma from massive crushing, extensive burns) it must be carefully monitored from the beginning and if it appears to be altered, treatment with REPARILEXIN must be stopped immediately.
This medicine contains lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
This medicine contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
The concomitant administration of aminoglycosides (eg gentamicin) should be avoided as escin could increase the nephrotoxicity of these antibiotics.
Aescin may enhance the action of anticoagulants administered simultaneously. In this case, the doses must be appropriately modified according to the results of the clinical analyzes (for example prothrombin time).
Plasma protein binding of aescin may be modified by some antibiotics (eg cephalothin may increase the concentration of free aescin in serum). With ampicillin this effect is very modest.
04.6 Pregnancy and breastfeeding
In the pregnancy state there are no manifest contraindications, however it is considered appropriate to exclude the use of the drug in the first three months of pregnancy and during breastfeeding.
04.7 Effects on ability to drive and use machines
REPARILEXIN does not affect the ability to drive or use machines.
04.8 Undesirable effects
Rare cases of digestive disorders have been reported. In some cases, acute allergic reactions (hives) may appear.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
No cases of overdose have been reported, nor are specific antidotes known.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: vasoprotectors - capillary protective substances.
ATC code: C05CX.
The escin obtained from horse chestnut was isolated in a state of purity from the other natural components of the extract and thus made suitable for intravenous and oral use. It carries out a detumefying, anti-edema and anti-inflammatory action at the level of localized edemas which are found in a very wide range of conditions.
05.2 Pharmacokinetic properties
After intravenous administration, aescin is rapidly eliminated from the blood 2/3 by the biliary route and 1/3 by the renal route. The rapid elimination from the circulation excludes accumulation phenomena. After oral administration, good absorption is observed.
05.3 Preclinical safety data
Orally, escin exhibits such acute toxicity as to ensure safety in clinical use; Medium and long-term administrations do not affect general tolerability even at doses higher than those used in therapy. Even the haemolytic activity, typical of saponins, is not evident for aescin except at dosages much higher than the maximum achievable in therapy. At therapeutic doses, aescin does not cause negative phenomena affecting the intimate venous or gastric mucosa. REPARILEXIN is devoid of teratogenic or embryotoxic effects and has no action on spermatogenesis.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Hesperidin, lactose, polyethylene glycol (Carbowax 1500), polyethylene glycol (Carbowax 6000), gum arabic, magnesium stearate, acrylic polymer (Eudragit L), castor oil, silicic acid, sucrose, talc, titanium dioxide, Kepal lacquer.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
No special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Box containing 30 coated tablets of 40 mg in blister packs
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Madaus GmbH
51101 Cologne (Germany)
08.0 MARKETING AUTHORIZATION NUMBER
REPARILEXIN 40 mg coated tablets - 30 tablets AIC n. 020762035
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: June 2010
10.0 DATE OF REVISION OF THE TEXT
July 2015
