Package leaflet: Information for the patient

Posterisan H
387.1 mg + 5 mg, suppositories
Standardized suspension of Escherichia coli bacterial culture + Hydrocortisone
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Posterisan H is and what it is used for
Important information before using Posterisan H
How to use Posterisan H
Possible side effects
How to store Posterisan H
Contents of the pack and other information

1. What Posterisan H is and what it is used for

Posterisan H stimulates the body's immune system and supports the natural defense response against infections. This action helps relieve itching and burning. Due to the presence of hydrocortisone, Posterisan H additionally reduces itching and inflammatory processes.
Posterisan H suppositories are used in particularly severe cases of itching and inflammation around the anus caused by hemorrhoidal nodules.

2. Important information before using Posterisan H

When not to use Posterisan H:

if the patient is allergic to standardized bacterial suspension, hydrocortisone, or any of the other ingredients of this medicine (listed in section 6).
if the patient has specific skin conditions (e.g. tuberculosis, syphilis, gonorrhea) in the treated area, chickenpox, post-vaccination reactions, fungal infections, perioral dermatitis, or rosacea.

Warnings and precautions
Before starting to use Posterisan H, discuss it with your doctor or pharmacist.
In case of fungal infections, concomitant use of topical antifungal medications is required.
Children
Posterisan H suppositories must not be used in infants and children under 12 years of age.
Posterisan H and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of Posterisan H suppositories and systemic glucocorticoids (in the form of tablets, drops, or injections) may increase the occurrence of adverse effects associated with Posterisan H and those associated with glucocorticoids.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
There are insufficient data on the use of this medicine in pregnant women.
Therefore, the medicine should be used during pregnancy only when absolutely necessary and after careful assessment of the benefit-risk ratio.
Breastfeeding
Hydrocortisone passes into breast milk. Breastfeeding should be avoided during continuous or high-dose administration of hydrocortisone.
Driving and operating machinery
Posterisan H has no effect on the ability to drive or operate machinery.
Posterisan H contains macrogol glycerol hydroxystearate
This medicine may cause skin reactions.
Important information for patients with hemorrhoids

What are hemorrhoids?
Proper closure of the anus is ensured by soft, widely distributed, and richly vascularized vascular cushions located in the terminal part of the rectum, above the anal sphincter, beneath the mucous membrane.
Symptoms occur when these cushions become enlarged due to blood congestion, forming nodular thickenings. These are known as hemorrhoids (also called anal varices or piles). Contributing factors include improper diet low in dietary fiber, chronic constipation, excessive straining during defecation, frequent use of laxatives, sedentary work, and sometimes connective tissue weakness.
Patients typically complain of a sensation of pressure, or bleeding during or after defecation. Bleeding results from abrasions of the mucosa around the hemorrhoids or from rupture of a hemorrhoidal node. As the condition progresses, troublesome and sometimes painful itching, stabbing pain, burning, and discharge around the anus may occur, associated with inflammation and skin rash.
In advanced stages, hemorrhoidal nodes may intermittently or permanently prolapse from the anus.

Course of treatment
After thorough examination, your doctor will provide treatment recommendations. Ointments and suppositories help relieve acute symptoms such as itching, stabbing pain, burning, discharge, and pain at the onset of the disease, as well as before and after surgical procedures. Continuing therapy is very important, even if symptoms improve, because otherwise symptoms may recur within a few days.
However, this treatment does not eliminate enlarged hemorrhoidal nodes. In advanced stages, enlarged hemorrhoids require surgical treatment.

Prevention
Prevention primarily involves regulating bowel movements and maintaining anal hygiene.
Hard stools promote the development of hemorrhoids, so it is important to ensure regular passage (not necessarily daily) of soft stools.
However, excessively soft stools induced by laxatives, which irritate and weaken the anal region, should be avoided. Stool consistency should be regulated through an appropriate diet rich in dietary fiber (fruits, non-gassy vegetables, wholemeal bread and porridge), dairy products, and adequate fluid intake. Spicy foods, alcohol, and constipating foods should be avoided. Body weight should be monitored and excess weight reduced.

Additionally, regular physical activity—such as walking, cycling, or swimming—should be maintained, especially for those with sedentary jobs. Avoid sitting on cold surfaces.

Regular and thorough hygiene of the anal area is also important. After each bowel movement, use soft toilet paper and wash the anal area with lukewarm water and a soft cloth, without soap or disinfectants. Do not rub! Commercially available moist hygiene wipes may be effective. The anal area should be thoroughly cleaned at least once daily, preferably in the evening. Careful and gentle drying with soft toilet paper or cotton wool may help prevent infection (by bacteria, fungi, or yeasts).

Blood congestion in hemorrhoidal nodes can be prevented by performing exercises to improve circulation—tightening and relaxing the anal sphincter every 2 seconds, for a total of 3 minutes daily. Sitz baths or rinsing the anus with cool water under the shower improve circulation and provide relief from itching and burning.

What must be strictly observed?
In case of bloody stools or frequent or prolonged symptoms, consult a doctor immediately, as serious underlying diseases may be concealed behind these symptoms. If your doctor prescribes medication, carefully read the package leaflet and follow the instructions for use and dosing recommendations provided by your doctor.

For your own safety, regular preventive examinations of the rectum should be performed—even in the absence of acute symptoms.

3. How to use Posterisan H

This medicine should always be used as directed by a physician. In case of doubts, consult your
doctor or pharmacist.
Recommended dose
The usual dose is to use suppositories twice daily, in the morning and evening, preferably after
defecation, inserting the suppository deeply into the rectum.
Posterisan H suppositories should be used only until acute symptoms subside.
To remove a suppository, tear or stretch the aluminum foil along the package.
Suppositories should not be used for longer than 10 consecutive days. If symptoms recur, Posterisan H
suppositories may be used again.
Use in children
Posterisan H suppositories must not be used in infants and children under 12 years of age.
Use of a higher than recommended dose of Posterisan H
There are no known cases of overdose or poisoning.
In case of accidental oral ingestion of the suppositories, gastrointestinal symptoms such as
abdominal pain and nausea may occur.
Missed dose of Posterisan H
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common (may affect fewer than 1 in 10 people):
Local hypersensitivity reactions (e.g. itching and burning)

Uncommon (may affect fewer than 1 in 100 people):
Allergic contact dermatitis (e.g. due to hypersensitivity to the preservative phenol)

Prolonged use of high doses of the medicine may cause skin atrophy (gradual reduction in skin volume), telangiectasia (presence of dilated small blood vessels, commonly known as spider veins), striae (stretch marks) and steroid acne.

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl.

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Posterisan H

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
"Expiry date". The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect the
environment.

6. Contents of the package and other information

What Posterisan H contains

The active substances in Posterisan H are a standardized bacterial culture suspension of Escherichia coli and hydrocortisone. Each suppository contains 387.1 mg of standardized bacterial culture suspension of Escherichia coli (killed with 6.6 mg of liquid phenol) and 5 mg of hydrocortisone. The suspension consists of cellular components and metabolic products derived from 1 billion Escherichia coli bacteria, killed and preserved with phenol.
Other ingredients: hard fat, macrogolglycerol hydroxystearate, acetylcysteine, disodium edetate, all-rac-α- tocopherol.

What Posterisan H looks like and contents of the pack
Posterisan H is white or yellowish, homogeneous suppositories.
The blister pack contains 10 suppositories.
Marketing Authorisation Holder and Manufacturer
DR. KADE Pharmazeutische Fabrik GmbH
Rigistrasse 2
12277 Berlin
Germany
For further information, please contact the representative of the Marketing Authorisation Holder:
Kadefarm Sp. z o.o.
Sierosław, Gipsowa 18
62-080 Tarnowo Podgórne, Poland
Tel.: +48 61 862 99 43
e-mail: [email protected]