PROCTOSOLL*RECTAL CREAM 30G OTC

Proctosoll rectal cream
Benzocaine, Hydrocortisone acetate, Heparin sodium

What it is and what it is used 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 relieves local pain (local anesthetic);
• Hydrocortisone acetate which reduces inflammation and itching;
• Heparin sodium which reduces blood clotting (anticoagulant).

The action of these active ingredients reduces 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 heparin sodium or any of the other ingredients of this medicine (listed in paragraph 6);
• if you have skin lesions due to forms of tuberculosis;
• in case of concomitant viral infections.

Warnings and precautions
• This medicine should not be used for prolonged treatments; if there are no appreciable results after a short period of treatment, consult your doctor.
• Use the minimum amount of cream to achieve the desired effect, applying Proctosoll with caution especially in cases 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 severe 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 efficiently transport oxygen. The risk is higher with prolonged use, high dosages, 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, fatigue, or rapid heartbeat (tachycardia) after using Proctosoll, consult a doctor immediately, as methemoglobinemia is a serious condition, and timely 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 at the hair follicles (folliculitis)
• acne-like rash (acneiform eruption)
• excessive hair growth (hirsutism)
• skin hyperpigmentation (skin discoloration)
• thinning of the skin (skin atrophy)

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.