PROCTOSOLL RECTAL CREAM 30G TUBE AND DISPENSING CANNULA

Name
Proctosoll rectal cream
Benzocaine, Hydrocortisone acetate, Sodium heparin


What is it and what is it for?
Proctosoll is a cream indicated for the symptomatic treatment of uncomplicated external hemorrhoids.
It is applied locally to hemorrhoids and contains 3 active ingredients:
• Benzocaine which has the function of relieving local pain (local anesthetic);
• Hydrocortisone acetate which serves to reduce inflammation and itching;
• Sodium heparin which reduces blood clotting (anticoagulant).

The action of these active ingredients produces a reduction in the symptoms of hemorrhoids, especially in the acute phase.


What you need to know before taking the medicine
DO NOT use Proctosoll
• if you are allergic to benzocaine, hydrocortisone acetate and sodium heparin or any of the other ingredients of this medicine (listed in section 6);
• if you have skin lesions due to forms of tuberculosis;
• in case of simultaneous viral infections.


Warnings and precautions
• This medicine should not be used for long-term treatments. After a short period of treatment without noticeable results, consult your doctor.
• Use the minimum amount of cream to achieve the desired effect, applying Proctosoll with caution, especially in case of severe lesions or inflammation of the rectal mucosa, as excessive use can cause high absorption of the active ingredients.
• Excessive or prolonged application of cortisone-based drugs can alter absorption by the body.
• High absorption of benzocaine can cause serious reactions especially in children and elderly patients.
• Stop treatment and consult your doctor if allergic reactions occur after prolonged use of the medicine.
• During treatment with medicines containing benzocaine, a condition known as methemoglobinemia may occur, characterized by the inability of hemoglobin to transport oxygen efficiently. The risk is greater with prolonged use, high doses, and in individuals with low body weight, such as children. If you experience symptoms such as bluish discoloration of the skin or lips (cyanosis), headache, dizziness, shortness of breath, tiredness, or a rapid heartbeat (tachycardia) after using Proctosoll, seek medical attention immediately. Methemoglobinemia is a serious condition and prompt treatment is essential.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur locally:
• burning sensation or pain
• irritation
• dry skin
• inflammation of the hair follicles (folliculitis)
• acne-like skin rash (acne rash)
• excessive hair growth (hypertrichosis)
• skin hyperpigmentation (alteration of skin color)
• thinning of the skin (cutaneous atrophy)

The side effects listed above are generally transient. It is advisable to discontinue treatment and consult your doctor if you experience any of the local reactions listed above, typical of cortisone-based therapies.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.