Package leaflet: Information for the user

Proctosoll rectal cream

Benzocaine, Hydrocortisone acetate, Sodium heparin
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

What Proctosoll is and what it is used for
What you need to know before using Proctosoll
How to use Proctosoll
Possible side effects
How to store Proctosoll
Contents of the pack and other information

1. What Proctosoll is and what it is used for

Proctosoll is a cream indicated for the symptomatic treatment of uncomplicated external haemorrhoids.
It is applied locally to the haemorrhoids and contains three active substances:

Benzocaine, which acts to relieve local pain (local anaesthetic).
Hydrocortisone acetate, which reduces inflammation and itching.
Sodium heparin, which reduces blood coagulation (anticoagulant).
The combined action of these active substances helps reduce haemorrhoid symptoms, especially during the acute phase.

2. What you need to know before using Proctosoll

DO NOT use Proctosoll

if you are allergic to benzocaine, hydrocortisone acetate, sodium heparin, or any of the other ingredients of this medicine (listed in section 6).
if you have skin lesions due to tuberculosis.
if you currently have viral infections.

Warnings and precautions

This medicine should not be used for prolonged treatments. If after a short period of treatment no noticeable improvement occurs, consult your doctor.
Use the minimum amount of cream necessary to achieve the desired effect. Apply Proctosoll with caution, especially in cases of severe lesions or inflammation of the rectal mucosa, as excessive use may lead to high absorption of the active ingredients.
Prolonged or excessive use of cortisone-based medicines may affect their absorption by the body.
High absorption of benzocaine may cause serious reactions, particularly in children and elderly patients.
Discontinue 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 carry oxygen. The risk is higher with prolonged use, application of 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, fatigue, or rapid heartbeat (tachycardia) after using Proctosoll, seek immediate medical attention, as methemoglobinemia is a serious condition and timely treatment is essential.

Other medicines and Proctosoll
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention if you are being treated simultaneously with other medicines that reduce blood clotting (anticoagulants).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, use Proctosoll only if clearly necessary and only after consulting your doctor and carefully evaluating with them the balance between the expected benefit and the possible risk to the fetus or infant.

Driving and operating machinery
Proctosoll does not impair the ability to drive vehicles or operate machinery.

For those engaged in sports
Using this medicine without medical need constitutes doping and may lead to positive anti-doping test results.

Proctosoll contains propylene glycol
This medicine contains 25 mg of propylene glycol per dose, equivalent to 25 mg/g.

Proctosoll contains butylated hydroxyanisole
It may cause localized skin reactions (e.g., contact dermatitis) or irritation to the eyes and mucous membranes.

Proctosoll contains cetyl stearyl alcohol
It may cause localized skin reactions (e.g., contact dermatitis).

3. How to use Proctosoll

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for acute conditions is 2–3 applications per day, particularly after defecation. Use the provided nozzle screwed onto the tube to apply the cream.
Use the medicine only for short treatment periods and do not exceed the recommended doses without medical advice.
If you use more Proctosoll than you should
Immediately inform your doctor or go to the nearest hospital if you have used an excessive dose of this medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Locally, the following side effects may occur:

burning or pain sensation
irritation
dryness of the skin
inflammation around hair follicles (folliculitis)
acne-like skin rash (acneiform eruption)
excessive hair growth (hypertrichosis)
skin hyperpigmentation (change in skin colour)
thinning of the skin (cutaneous atrophy)

The above-mentioned side effects are generally temporary. You should discontinue treatment and consult your doctor if any of the above local reactions—typical of cortisone-based therapies—occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Proctosoll

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not use this medicine if the packaging is open or damaged.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the carton and the leaflet.

6. Package contents and other information

What Proctosoll contains

The active substances are: Benzocaine, hydrocortisone acetate, sodium heparin. 100 g of cream contain: 5 g of benzocaine, 0.5 g of hydrocortisone acetate, 5,000 I.U. of sodium heparin.
The other components are: cetostearyl alcohol, isopropyl myristate, propylene glycol,

macrogol cetostearyl ether, dimethicone, isothiazolinone, levomenthol, disodium EDTA,
butylhydroxyanisole, purified water.
Description of the appearance of Proctosoll and contents of the pack
Proctosoll is a cream for rectal use.
Each package contains a tube with 20 or 30 grams of cream and an applicator to distribute the
cream.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Alfasigma S.p.A. – Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)
Doppel Farmaceutici S.r.l. Via Martiri delle Foibe n. 1 Cortemaggiore (PC)