Active ingredients: Escin, Tetracaine (Tetracaine hydrochloride)
RectoReparil 4.5% + 0.5% CREAM - 40 G TUBE + 1 APPLICATOR
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
RECTO-REPARIL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Each suppository contains:
Active ingredients: escin 5 mg, Tetracaine hydrochloride 45 mg.
100 g of ointment contain:
Active ingredients: escin 0.5 g, Tetracaine hydrochloride 4.5 g.
03.0 PHARMACEUTICAL FORM -
Suppositories, ointment
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Anorectal varicose syndrome, external and internal hemorrhoids; complications of hemorrhoids: anal congestion, anal itching. Proctiti. Anal fissures.
04.2 Posology and method of administration -
Suppositories:
One suppository in the morning, one suppository in the evening.
It is recommended to carry out the application of the suppository after defecation.
For greater ease of use, it is recommended to put the suppositories in the refrigerator or in ice water for a few minutes before use.
Ointment:
One application in the morning and one in the evening (a 2 cm long strip of ointment).
The package is equipped with a cannula for intra-rectal applications.
It is recommended to carry out the endo-rectal application of the ointment after defecation.
04.3 Contraindications -
Known individual hypersensitivity to one or more components.
04.4 Special warnings and appropriate precautions for use -
The recommended dosage should not be exceeded as the use of high doses for prolonged periods may result in systemic absorption of the active ingredients.
Warnings:
The use, especially prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy. Keep out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction -
No drug interactions have been reported.
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.
04.7 Effects on ability to drive and use machines -
No effects on ability to drive or use machines have been reported with Recto-Reparil.
04.8 Undesirable effects -
They were not reported.
04.9 Overdose -
No cases of overdosing have been reported.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
The Recto-Reparil medicinal product consists of the combination of an anti-inflammatory-anti-edema (escin), and a local anesthetic (tetracaine).
Aescin has a strong local anti-inflammatory and anti-edematous activity, it also has a phlebotonic and protective action on the capillary endothelium and is therefore able to perform a decongestant and detumefying effect.
The anti-hemorrhoidal action of escin is completed in Recto-Reparil by the presence of tetracaine, a substance that has a well-known local anesthetic effect.
05.2 "Pharmacokinetic properties -
Topical administration of the product at adequate doses generally results in limited absorption. For aescin, studies carried out with the labeled product have shown the presence of minimal quantities, however rapidly decreasing over time, in the internal organs, in the bile and in the urine.
05.3 Preclinical safety data -
The toxicological tests in laboratory animals have shown for Recto-Reparil favorable data of acute toxicity and an excellent chronic tolerability without any modification of the functionality of the main organs and systems.
Recto-Reparil is also devoid of teratogenic and foetotoxic effects.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
- 40g ointment tube:
Polyglycolic cotenside of fatty acids g 2.0, polyglycolic ester of fatty acids g 21, polyglycol ester of saturated fatty alcohols g 3, partial glyceride of fatty acids g 7, methyl-p-hydroxybenzonate g 0.1, ethyl ester of the acid linol-linoleic 20 g, anoxid SBN 0.5 g, deionized water 41.4 g.
- 10 suppositories:
Polysorbitan monostearate 500 mg, titanium dioxide 30 mg, ethyl ester of linol-linolenic acid 250 mg, anoxid SBN 15 mg, zinc oxide 100 mg, semisynthetic glycerides 2055 mg.
06.2 Incompatibility "-
They are not known.
06.3 Period of validity "-
Ointment and suppositories: 3 years.
06.4 Special precautions for storage -
No particular precautions.
06.5 Nature of the immediate packaging and contents of the package -
Box of 10 suppositories; 40 g ointment tube.
06.6 Instructions for use and handling -
See information in the section "Posology and method of administration".
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
MADAUS A.G.
Ostmerheimerstrasse, 198 - Cologne (Germany)
08.0 MARKETING AUTHORIZATION NUMBER -
Recto-Reparil suppositories AIC n. 023470053
Recto-Reparil ointment AIC n. 023470065
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Renewal: June 2000
10.0 DATE OF REVISION OF THE TEXT -
June 2000
