Proktosedon

Package Leaflet: Information for the Patient

Proktosedon

5 mg + 5 mg + 10 mg + 10 mg, ointment
Hydrocortisone + Cinchocaine hydrochloride + Esculin + Neomycin sulfate
You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• This medicine should always be used exactly as described in the patient leaflet or as advised by your doctor, pharmacist, or nurse.
• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist or nurse. See section 4.
• If after 3-6 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Proktosedon and what is it used for
• 2. Important information before using Proktosedon
• 3. How to use Proktosedon
• 4. Possible side effects
• 5. How to store Proktosedon
• 6. Contents of the pack and other information

1. What is Proktosedon and what is it used for

Proktosedon is a combination medicine. Hydrocortisone has anti-inflammatory effects, cinchocaine has local anesthetic effects. Neomycin is an antibiotic with a broad spectrum of action, preventing secondary infections and treating local infections caused by staphylococci and sensitive Gram-negative bacteria. Esculin reduces bleeding from vessels and decreases swelling. The medicine reduces symptoms of hemorrhoids, such as inflammation, pain, itching, swelling, and bleeding. Proktosedon ointment is indicated for the treatment of external and internal hemorrhoids, in chronic and acute anal conditions, anal fissures, and anal itching. It can be used pre- and post-operatively.

2. Important information before using Proktosedon

When not to use Proktosedon:

Warnings and precautions

Before starting to use Proktosedon, you should discuss it with your doctor or pharmacist. If you are in any of the situations described below, you should discuss it with your doctor before starting to use Proktosedon.

You should be particularly careful when using Proktosedon if:

• you have an infection, allergy, or other symptoms - you should then use appropriate causal treatment;
• you are being vaccinated or receiving immunization treatment - you should not then use the medicine;
• you experience irritation symptoms - you should then stop using the medicine;
• you use the medicine for a long time - there is a small probability that systemic changes characteristic of corticosteroids may occur;
• you experience rectal bleeding - you should then immediately contact your doctor;
• you have previously used hydrocortisone - you should tell your doctor about it.

If the treatment is not effective, you should contact your doctor.

Children

The use of the medicine in children under 12 years of age is contraindicated.

Proktosedon and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should be particularly careful when using Proktosedon with any of the following medicines. Non-steroidal anti-inflammatory drugs or acetylsalicylic acid may cause stomach and duodenal ulcers, ulceration, or gastrointestinal bleeding. In patients with hypoprothrombinemia, caution is recommended when using corticosteroids with acetylsalicylic acid. Phenytoin may reduce the therapeutic effect of corticosteroids due to increased metabolism and reduced serum concentration. This is caused by the induction of liver microsomal enzymes by phenytoin. In this situation, it may be necessary to increase the dose of corticosteroids;

• Vaccines, live viruses, or other vaccinations. The use of corticosteroids during vaccination is not recommended due to the increased risk of neurological complications after vaccination and possible reduction of antibody levels or lack of response to vaccination.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine. Animal studies have shown teratogenic and embryotoxic effects of hydrocortisone. There are unconfirmed data indicating a risk of cleft palate, intrauterine growth retardation, and suppressive effects on the hypothalamic-pituitary-adrenal axis in fetuses under the influence of hydrocortisone used in pregnant women. Therefore, Proktosedon may be used in pregnant women only if there is an absolute need to use this medicine, after a thorough assessment by the doctor of the risk and benefits. Proktosedon should not be used during breastfeeding due to the risk of growth inhibition in the child by hydrocortisone.

Driving and using machines

The effect of the medicine on the ability to drive and use machines has not been studied.

3. How to use Proktosedon

Proktosedon should always be used exactly as described in the patient leaflet or as advised by your doctor. In case of doubt, you should consult your doctor or pharmacist. In adults, the ointment is usually used for three to six days, until the inflammation subsides. If after this time there is no improvement or you feel worse, you should contact your doctor. Method of use: Using the applicator, apply a small amount of ointment to the anus and outside, in the morning and evening, and after each bowel movement.

Using more than the recommended dose of Proktosedon

No cases of overdose have been reported. If you have taken more than the recommended dose of the medicine, you should contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Proktosedon can cause side effects, although not everybody gets them. Occasionally, anal burning may occur, especially if the skin is significantly damaged. During long-term use, side effects may occur due to the systemic effect of hydrocortisone. The medicine may cause local skin reactions (e.g., contact dermatitis).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Proktosedon

The medicine should be stored out of sight and reach of children. Store in a temperature below 30°C. Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month stated.

6. Contents of the pack and other information

What Proktosedon contains

The active substances of the medicine are: hydrocortisone acetate, cinchocaine hydrochloride, esculin, and neomycin sulfate. 1 g of ointment contains: active substances:5 mg of hydrocortisone as acetate (Hydrocortisonum) 5 mg of cinchocaine hydrochloride (Cinchocaini hydrochloridum) 10 mg of neomycin sulfate (Neomycini sulfas) 10 mg of esculin as hemipentahydrate (Esculinum) excipients:liquid paraffin, white petrolatum, anhydrous lanolin.

What Proktosedon looks like and contents of the pack

Aluminum tubes containing 15 g or 30 g of ointment, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

US Pharmacia Sp. z o.o. ul. Ziębicka 40, 50-507 Wrocław tel. +48 (22) 543 60 00

Manufacturer

Beltapharm S.r.l., Via Stelvio 66, 20095 Cusano MIL (MI), Italy Date of last revision of the leaflet June 2025