Description
Medical device with mechanical action, specific protective properties, and a coadjuvant to the natural healing process of the rectal mucosa.
Proctilor rectal cream adheres to the rectal mucosa, creating a protective layer and isolating damaged, erythematous, or ulcerated areas. Proctilor rectal cream reduces painful symptoms with a rapid reduction in burning and pain, and promotes the natural healing process of lesions of the anal canal epithelium and rectal mucosa, improving the mucosa's resistance to irritating agents.
It is indicated for actinic proctitis from radiotherapy treatment of the pelvic region and for proctitis during chemotherapy or combined treatments (radio and chemotherapy). It is indicated for all conditions involving lesions of the an-rectal mucosa, such as:
- acute and chronic anal fissures;
- fistulas;
- anal and peri-anal abscesses;
- isolated rectal ulcers;
- various types of proctitis;
- hemorrhoidal varicose syndrome (external and internal hemorrhoids);
- post recto-colonoscopy treatment.
Nickel tested.

Instructions for use
Prevention: apply twice a day.
Treatment: apply three times a day, for no more than 3 consecutive weeks or until symptoms disappear. Consult your doctor for longer use if no improvement in clinical status is observed.
Immediately before using the product, with the bowel free of faeces, cleanse the anus and surrounding area with specific or pH-neutral cleansers. Wash your hands before handling the cannula. Open the product tube to be applied. Screw the cannula onto the open tube. Remove the cap from the end of the endorectal cannula. Squeeze the tube until the cannula is filled, expelling a small amount of product to lubricate the cannula itself. Lubricate the previously cleansed perianal areas with a small amount of gel. Gently insert the cannula into the rectum. Squeeze the tube again until the correct amount of product is dispensed. Remove the cannula from the anal cavity. Spread any excess gel that has come out of the anus around the perianal area.
Cannula cleaning
After each application, the cannula must be thoroughly cleaned according to the following procedure:
1. after use, clean the outside of the cannula with a clean paper towel;
2. clean the inside of the cannula with a clean cotton swab;
3. clean the outside again with a clean paper towel;
4. rinse the inside and outside of the cannula with warm water (40 °C) for about 1 minute;
5. dry the outside of the cannula with a clean paper towel;
6. replace the protective cap;
7. store the cannula in its box.
After the procedure, visually inspect the cannula, and if any residue is visible, repeat the procedure from point 4. Repeat the cleaning procedure before use from point 4 if the cannula is not used daily, making sure to remove the protective cap.

For prevention, it is recommended to apply Proctilor Rectal Cream twice a day.
For treatment, it is recommended to apply Proctilor Rectal Cream three times a day.
Treatment duration: use for no more than 3 consecutive weeks or until symptoms disappear. Consult your doctor for longer use if no improvement in clinical status is observed.

Components
Zinc-L-carnosine, aqua, paraffinum liquidum, glyceryl stearate (and) PEG-100 stearate, cetearyl alcohol, behenyl alcohol, glycerin, C12-20 acid PEG-8 ester, tocopheryl acetate, Aloe barbadensis leaf juice, microcrystalline cellulose (and) cellulose gum, phenoxyethanol, propylene glycol, methylparaben, propylparaben, ethylparaben, butylparaben.

Does not contain cortisone.

Warnings
No contraindications or side effects associated with the use of the medical device are known. It is recommended not to use in case of known hypersensitivity to any of the components. As complete data are not available, it is advisable to consult a doctor for use during pregnancy and in children under 14 years of age.
- Do not use in case of known hypersensitivity to any of the components.
- In case of rectal bleeding, consult a doctor before using any treatment.
- Consult a doctor if irritation, pain, or discomfort occurs after application.
- Consult a doctor if the use of the product does not lead to an improvement in symptoms.
- The device is not intended for pediatric use; keep out of reach and sight of children.
- Interaction with other drugs or medical devices has not been evaluated; seek medical advice before concomitant use with other pharmaceutical products.
- Device for internal use. Do not ingest.
- Do not use beyond the expiry date. Do not use if the packaging is damaged.
- Perform instillation under hygienic conditions. Close tightly after use.

Storage
Store in a cool, dry place, at room temperature, away from direct light and heat sources.

Format
30 ml tube + 1 applicator cannula.

Cod. 01A