Proktosedon

Proktosedon

5 mg + 5 mg + 10 mg + 10 mg, suppositories
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 directed by a 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 consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 3-6 days there is no improvement or the patient feels worse, they should contact their 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 an anti-inflammatory effect, cinchocaine has a local anesthetic effect. Neomycin is a broad-spectrum antibiotic that prevents secondary infections and treats 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 suppositories are indicated for the treatment of external and internal hemorrhoids, chronic and acute anal conditions, anal fissures, and anal itching. They can be used pre- and post-operatively.

2. Important information before using Proktosedon

When not to use Proktosedon:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has diabetes, tuberculosis, glaucoma, osteoporosis, acute psychosis, fungal or viral infections, or venous thrombosis.

Warnings and precautions

Before starting to use Proktosedon, you should discuss it with your doctor or pharmacist.

If the patient has any of the following conditions, they should discuss it with their doctor before starting to use Proktosedon.

The patient should be particularly careful when using Proktosedon if:

• they have a concurrent infection, allergy, or other symptoms - they should then receive appropriate causal treatment;
• they are undergoing vaccinations or immunization treatment - they should not use the medicine then;
• they experience symptoms of irritation - they should then stop using the medicine;
• they use the medicine for a long time - there is a small probability that systemic changes characteristic of corticosteroids may occur;
• they experience rectal bleeding - they should then immediately consult a doctor;
• they have previously used hydrocortisone - they should tell their doctor about it.
• If the patient experiences blurred vision or other vision disturbances, they should contact their doctor. If the treatment is not effective, they should consult a doctor.

Children

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

Proktosedon and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as medicines they plan to take, including those that are available without a prescription.

Particular caution should be exercised when using Proktosedon with any of the following medicines.

Non-steroidal anti-inflammatory drugs or acetylsalicylic acid. This may cause stomach and duodenal ulcers, erosion, or bleeding from the gastrointestinal tract.
In patients with hypoprothrombinemia, caution is recommended when using corticosteroids with acetylsalicylic acid.
Phenytoin - the therapeutic effect of corticosteroids may be reduced due to increased metabolism and decreased 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 decreased antibody levels or lack of response to vaccination.
Some medicines may enhance the effect of Proktosedon, and the doctor may want to carefully monitor the condition of the patient taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Animal studies have shown the teratogenic and embryotoxic effects of hydrocortisone. There are unconfirmed data indicating the 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 directed by a doctor. In case of doubt, the patient should consult their doctor or pharmacist.
Adults usually use one suppository in the morning, one in the evening, and after each bowel movement.
Use for three to six days, until the inflammation subsides. If after this time there is no improvement or the patient feels worse, they should consult their doctor.

Method of administration

Open the suppository packaging, remove the suppository, and gently insert it into the anus with the pointed end.

Using more than the recommended dose of Proktosedon

No cases of poisoning have been reported. In case of accidental ingestion of suppositories, gastric lavage is recommended.
In case of taking a higher dose of the medicine than recommended or accidental ingestion of suppositories, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Occasionally, anal burning may occur, especially if the mucous membrane is significantly damaged.
During long-term use, side effects may occur due to the systemic effect of hydrocortisone.
Side effects with unknown frequency: blurred vision.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 at a temperature below 30°C.
Do not use the medicine after the expiry date stated on the packaging. The expiry date (EXP) means the last day of the given month.

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.

One suppository contains:

active substances:
5 mg hydrocortisone in the form of acetate (Hydrocortisonum)
5 mg cinchocaine hydrochloride (Cinchocaini hydrochloridum)
10 mg neomycin sulfate (Neomycini sulfas)
10 mg esculin in the form of a hemihydrate (Esculinum)
excipient:
hard fat (Witepsol)

What Proktosedon looks like and contents of the pack

A cardboard box containing 12 suppositories in 2 blisters of 6 pieces each.

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

Fulton Medicinali S.p.A., Via Marconi 28/9, Arese (MI), Italy

Date of last revision of the leaflet: