Descriptive sheet Proctoial
RECTAL GEL
Description
Medical device containing high molecular weight hyaluronic acid, MSM, and tea tree oil formulated in a fresh gel and intended for application to the rectal mucosa.
It is indicated in ano-rectal repair processes such as in the case of hemorrhoids and anal fissures.
Hyaluronic acid is a polysaccharide consisting of unbranched-chain glycosaminoglycans widely present in connective tissue and which plays an important role in tissue repair, as it accelerates and modulates the re-epithelialization processes following lesions of various origins, restoring tissue tone and elasticity.
MSM is a natural substance present in both plants and physiologically in the human body, with antioxidant properties and capable of enhancing the effects of hyaluronic acid.
Tea tree oil (essential oil of Melaleuca alternifolia) helps protect the product by promoting the effects of hyaluronic acid.
Proctoial was formulated using a hydrocellulose and copolymer matrix to promote high bioadhesion to the rectal mucosa, thus providing an effective protective barrier to the injured and inflamed area. The hyaluronic acid contained in Proctoial also has a lubricating effect, reducing the risk of irritation, itching, burning, and the formation of friction lesions that exacerbate the condition.
How to use
Unscrew the cap, break the safety seal with the back cap, and screw the endorectal cannula, equipped with a protective cap, onto the neck of the tube. Remove the cap and squeeze until the cannula is full, releasing a small amount of product to lubricate the cannula.
Gently insert the cannula into the rectum. Squeeze the tube again until a sufficient amount of product is introduced. Apply Proctoial to the external area as well.
After use, clean the cannula thoroughly and replace the cap.
Apply Proctoial two to three times a day and, when possible, after each bowel movement. Continue application for 1-2 weeks until symptoms resolve.
Components
Aqua, sorbitol, propylene glycol, glycerin, hydroxyethylcellulose, methylsylfonylmethane (MSM), benzyl alcohol, sodium hyaluronate, PVM/MA copolymer, tea tree oil (Melaleuca alternifolia oil), phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, disodium EDTA.
Warnings
Do not use the medical device after the expiry date shown on the packaging.
Do not use the device if the external packaging or safety seal is damaged upon first use.
Use of topical products, especially if prolonged, may cause sensitization. In this case, discontinue treatment and consult your doctor to initiate appropriate therapy.
If bleeding occurs, consult your doctor before using any treatment.
If symptoms persist after treatment, consult your doctor.
Avoid promiscuous use.
The use of the product is permitted only in adults.
Keep out of reach of children.
It is recommended to thoroughly wash the affected areas before application.
After application, it is recommended to avoid bowel movements for at least 20-30 minutes to avoid premature removal of Proctoial. If this is not possible, it is recommended to repeat the application after bowel movements and thoroughly wash the affected areas.
There are currently no known interactions between Proctoial and drugs normally used in the treatment of hemorrhoids or anal fissures.
Contraindicated in cases of known individual hypersensitivity to any of the components present.
Since complete data are not available, the product is not recommended during pregnancy unless clearly necessary and under the direct supervision of a doctor.
Conservation
Store at room temperature.
Shelf life in intact packaging: 36 months.
Shelf life after opening: 3 months.
Format
30 ml tube with disposable rectal applicator
Cod. 7101AVIT