Active ingredients: Tetracaine, Ruscogenine
RUSCOROID 25 mg + 25 mg suppositories
RUSCOROID 1% + 1% cream
Why is Ruscoroid used? What is it for?
Vasoprotectors, anti-haemorrhoids for topical use, products based on local anesthetics: ruscogenins have a "vasoprotective action while tetracaine is an anesthetic."
Why is it used
Treatment of symptoms associated with hemorrhoids, anal fissures and proctitis such as: itching, pain and a sense of weight.
Contraindications When Ruscoroid should not be used
Hypersensitivity to components or other closely related substances from a chemical point of view.
When it can only be used after consulting your doctor
- age under 12 (see "It is important to know that")
- pregnancy and breastfeeding (see "What to do during pregnancy and" breastfeeding ")
What to do during pregnancy and breastfeeding
During pregnancy and breastfeeding, RUSCOROID can only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
Consult your doctor if you suspect a pregnancy or wish to plan a maternity leave.
Precautions for use What you need to know before you take Ruscoroid
Clinical use has not highlighted the need for special precautions for use.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena with a worsening of symptoms or the appearance of skin redness and generalized itching: if this happens, it is necessary to interrupt the treatment and consult the doctor to adopt suitable therapeutic measures.
Interactions Which drugs or foods may change the effect of Ruscoroid
No phenomena referable to interactions with other substances have ever been reported.
However, if you are using other medicines, ask your doctor or pharmacist for advice.
Warnings It is important to know that:
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena (local irritation); in this case it is necessary to interrupt the treatment and consult the doctor for appropriate treatment.
Do not use for prolonged treatments. After a short period of treatment without appreciable results and in case of prolonged use, consult your doctor.
It is not recommended to use under 12 years of age, unless under direct medical supervision.
In the case of patients under the age of 12, it is necessary to consult a doctor.
Dose, Method and Time of Administration How to use Ruscoroid: Posology
- How many
Adults
Suppositories: 1-2 suppositories a day.
Cream: 1-2 applications per day
Age under 12: exclusively according to medical prescription.
Warning: do not exceed the indicated doses without the advice of the doctor.
- When and for how long
Warning: use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
- Like
Suppositories: gently introduce the suppository into the rectum.
Cream: apply directly or using the special applicator that is screwed onto the tube
Overdose What to do if you have taken too much Ruscoroid
There are no known cases of overdose.
In case of ingestion / intake of an excessive dose of RUSCOROID, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Ruscoroid
Rare cases of sensitization, such as local and generalized erythema associated with itching.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
These side effects are usually transient. However, when they arise, it is advisable to consult the doctor or pharmacist.
It is important to inform the doctor or pharmacist of the appearance of undesirable effects not described in the package leaflet.
Request and fill in the undesirable effects report form available at the pharmacy (form B)
Expiry and Retention
RUSCOROID suppositories: store at a temperature not exceeding 30 ° C.
RUSCOROID cream: store at a temperature not exceeding 25 ° C.
the shelf life after first opening is 6 months
Warning: do not use the medicine after the expiry date indicated on the package.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH OF CHILDREN.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Composition
Suppositories
Each suppository contains: active ingredients: ruscogenine 25 mg; tetracaine hydrochloride 25 mg.
Excipients: polysorbate 60, medium chain saturated triglycerides, corn starch, anhydrous colloidal silica, solid semisynthetic glycerides.
Cream
100 g of cream contain: active ingredients: ruscogenine 1g; tetracaine hydrochloride 1g.
Excipients: cetyl alcohol, polysorbate 80, Macrogol 400, Macrogol 4000, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl phydroxybenzoate, Rosemary perfume 7144, purified water.
How it looks
Ruscoroid comes as suppositories for rectal use or as a cream for external use.
The contents of the pack of RUSCOROID suppositories is 10 units.
The contents of the pack of RUSCOROID cream is a tube of 40 g.
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
RUSCOROID
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUPPOSITORIES
Each 1,550g suppository contains:
Active principles:
Ruscogenine 25 mg
Tetracaine hydrochloride 25 mg
CREAM
100 g of cream contain:
Active principles:
Ruscogenine 1 g
Tetracaine hydrochloride 1 g
For excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
10 suppositories for rectal use dosed at 25 mg of each active ingredient.
40 g cream with 1% of each active ingredient for external use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of symptoms associated with hemorrhoids, anal fissures and proctitis, such as: itching, pain and a sense of weight.
04.2 Posology and method of administration
Suppositories: 1-2 suppositories per day.
Cream: 1-2 applications per day (directly or using the special applicator).
Do not exceed the recommended dose.
04.3 Contraindications
Hypersensitivity to the components of the product and to other closely related substances from a chemical point of view.
04.4 Special warnings and appropriate precautions for use
Do not use for prolonged treatments. After a short period of treatment without appreciable results and in case of prolonged use, consult your doctor.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena; if this happens, the treatment must be interrupted and the doctor must be consulted to adopt suitable therapeutic measures.
Clinical use has not highlighted the need for special precautions for the use of RUSCOROID.
It is not recommended for use under 12 years of age, unless under direct medical supervision.
04.5 Interactions with other medicinal products and other forms of interaction
No phenomena referable to interaction with other substances have ever been reported.
04.6 Pregnancy and lactation
The product should be used in cases of real need under direct medical supervision.
04.7 Effects on ability to drive and use machines
There are no restrictions.
04.8 Undesirable effects
Rare cases of sensitization, such as local and generalized erythema associated with itching.
04.9 Overdose
There are no known cases of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
RUSCOROID contains ruscogenine as active ingredients, with anti-inflammatory-decongestant and vasoconstrictive activity, and tetracaine hydrochloride, with local anesthetic action.
The anti-inflammatory-decongestant activity has been documented against carrageenan and brewer's yeast edema in the rat's paw, while in the rabbit it has been shown that ruscogenins are able to decrease capillary permeability and induce vasoconstrictive effects on the blood vessels. "isolated ear.
In men, it has also been shown that ruscogenins antagonize the spasm of the anal sphincter thus contributing also to a rapid resolution of painful symptoms.
05.2 Pharmacokinetic properties
After rectal administration in the baboon an absorption of about 3 per cent of the administered product was calculated; in the same primate, after topical application of cream containing marked ruscogenins, it was not possible to detect their presence in the plasma.
05.3 Preclinical safety data
RUSCOROID in the two pharmaceutical forms, cream and suppositories, is well tolerated both systemically and locally and does not give rise to histological changes of the tissues involved even after prolonged treatment and with doses many times higher than those achievable in clinical practice.
RUSCOROID administered epicutaneously in rats and rectally in rabbits during pregnancy did not induce harmful effects on embryo-fetal development.
The active ingredients of RUSCOROID both individually and in combination, in the ratios in which they are contained in the specialty, do not induce mutagenic effects.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
SUPPOSITORIES: polysorbate 60, medium chain saturated triglycerides, corn starch, colloidal anhydrous silica, solid semisynthetic glycerides.
CREAM: cetyl alcohol, polysorbate 80, Macrogol 400, Macrogol 4000, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, Rosemary 7144 perfume, purified water.
06.2 Incompatibility
None known.
06.3 Period of validity
RUSCOROID cream: 24 months
the shelf life after first opening is 6 months.
RUSCOROID suppositories: 5 years.
06.4 Special precautions for storage
Keep RUSCOROID cream at a temperature not exceeding 25 ° C.
Keep RUSCOROID suppositories at a temperature not exceeding 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
Suppositories: non-toxic PVC valve, external cardboard box. Pack of 10 suppositories
Cream: aluminum tube internally coated with epoxy resins, special applicator in low density polyethylene, external cardboard box. Pack of 40 g of cream.
06.6 Instructions for use and handling
Not relevant
07.0 MARKETING AUTHORIZATION HOLDER
Sanofi S.p.A: - Viale L. Bodio, 37 / b - IT-20158 Milan
08.0 MARKETING AUTHORIZATION NUMBER
Suppositories: AIC 025825011
Cream: AIC 025825023
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Suppositories: March 9, 1987 / June 1, 2010
Crema: March 9, 1987 / June 1, 2010
10.0 DATE OF REVISION OF THE TEXT
October 2014
