Package leaflet: information for the patient

Posterisan, 166.7 mg, ointment
Standardized suspension of Escherichia coli bacterial culture
Please read the entire leaflet carefully 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 according to
the instructions of a doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement or if the patient feels worse, contact a doctor.

Table of contents of the leaflet

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

1. What Posterisan is and what it is used for

Posterisan stimulates the body's immune system and supports the natural defense response against infections. This action helps relieve itching and burning. Posterisan ointment is used for itching, oozing, and burning around the anus caused by hemorrhoids, anal fissures and skin cracks (anal fissures), as well as eczema.

2. Important information before using Posterisan

When not to use Posterisan:

if the patient is allergic to the standardized bacterial culture suspension or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Posterisan, consult your doctor or pharmacist.
In case of fungal infections, concomitant use of topical antifungal agents is required.
When using Posterisan ointment, the tensile strength of condoms may be reduced due to the presence of yellow soft paraffin. This may affect the safety of these products.
Children and adolescents
There is no justified indication for the use of Posterisan in children and adolescents.
Posterisan and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
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.
There is a lack of data on the use of Posterisan in pregnant or breastfeeding women.
Driving and operating machinery
Posterisan has no effect on the ability to drive and operate machinery.
Posterisan contains lanolin
This medicine may cause local skin reactions (e.g. contact dermatitis).
Important information for patients with hemorrhoidal nodules

What are hemorrhoidal nodules?
The anal canal is tightly closed 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 called hemorrhoidal nodules (anal varices, hemorrhoids). Causes of these conditions 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 usually complain of a sensation of pressure or bleeding during or after defecation. Bleeding results from abrasions of the mucosa around the hemorrhoids or rupture of a hemorrhoidal nodule. As the condition progresses, persistent and sometimes painful itching, stabbing pain, burning, and discharge in the anal area may occur, associated with inflammation and skin rash.
In advanced stages, hemorrhoidal nodules may intermittently or permanently prolapse from the anus.

Course of treatment
After a thorough examination, the doctor will provide treatment recommendations. The use of ointments and suppositories relieves acute symptoms such as itching, stabbing pain, burning, discharge, and pain at the beginning of the disease, as well as before and after surgical procedures. Continuing treatment is very important, even if symptoms improve, because otherwise symptoms may recur after a few days.
However, this treatment does not remove the enlarged hemorrhoidal nodules. In advanced stages, enlarged hemorrhoidal nodules 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, this does not mean forcing excessively soft stools with laxatives, which may irritate and weaken the anal region. Stool consistency should be regulated through an appropriate diet rich in dietary fiber (fruits, vegetables that do not cause bloating, wholemeal bread and porridge), dairy products, and adequate fluid intake. Avoid heavily spiced foods, alcohol, and foods that cause constipation. Control body weight and reduce excess weight.

Additionally, especially with sedentary work, regular physical activity such as walking, cycling, or swimming should be maintained. 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 are effective. The anal area should be thoroughly cleaned in this manner at least once daily, preferably in the evening. Careful and gentle drying with soft toilet paper or cotton wool may prevent infection (caused by bacteria, fungi, or yeasts).

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

What must be strictly observed?
In case of bloody stools or frequent or prolonged symptoms, it is essential to see a doctor, as serious diseases may underlie these symptoms. If a doctor prescribes medication, carefully read the package leaflet and follow the doctor's dosage instructions.

Furthermore, for personal safety, regular preventive examinations of the rectum should be performed, even in the absence of acute symptoms.

3. How to use Posterisan

This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Posterisan ointment should be applied twice daily, in the morning and evening, after defecation.
A thin layer of ointment (approximately 2.5 g) should be gently rubbed into the skin and mucous membranes requiring treatment.
For easier application, it is recommended to store the ointment at room temperature (approximately
18°C to 20°C).
The recommended duration of treatment with Posterisan ointment is 2 to 3 weeks.
Treatment with Posterisan ointment for the prevention of recurrences should be continued for a longer period. Even when uncomfortable inflammatory symptoms and distressing complaints such as severe itching, oozing, and burning have already subsided, it is recommended to continue treatment for several more days.
To apply the ointment inside the anal canal, use the applicator provided with the package.
Using the applicator
Screw the applicator onto the tube of ointment and remove its top part. Squeeze the tube so that the ointment fills the applicator and appears through its side openings. Then gently insert the applicator into the anus.
Moistening the applicator with ointment may facilitate insertion into the anus. Squeezing the tube again causes the ointment to enter the anal canal. Gently rotating the tube ensures proper distribution of the ointment. After use, clean the applicator by squeezing a small amount of ointment through the side openings, wipe the surface with absorbent paper, and then screw back the top part of the applicator. This prevents the ointment from drying out.
Note:
Application of the ointment around the anus may cause soiling of underwear; the use of sanitary pads, liners, etc., is recommended.
Use of a higher than recommended dose of Posterisan
There are no known cases of overdose or poisoning.
In case of accidental oral ingestion of the ointment, gastrointestinal symptoms such as abdominal pain and nausea may occur.
Missed dose of Posterisan
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Common side effects (may affect up to 1 in 10 people):
local skin reaction (e.g. itching, burning sensation).
Uncommon side effects (may affect up to 1 in 100 people):
allergic skin inflammation (e.g. due to hypersensitivity to phenol).
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, patients should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. 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.
Reporting of side effects helps to provide more information on the safety of this medicine.

5. How to store Posterisan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Posterisan contains

The active substance in Posterisan is a standardized bacterial culture suspension of Escherichia coli. One gram of ointment contains 66.7 mg of standardized bacterial culture suspension of Escherichia coli (killed with 3.3 mg of liquid phenol). The suspension contains cellular components and metabolic products derived from 330 million phenol-killed and preserved Escherichia coli bacteria.
Other ingredients: lanolin, yellow vaseline.

What Posterisan looks like and contents of the pack
Posterisan is a white or almost white, homogeneous ointment.
Aluminium tube with a plastic applicator in a cardboard box.
The pack contains 25 g of ointment.
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 Street
62-080 Tarnowo Podgórne, Poland
Tel.: +48 61 862 99 43
e-mail: [email protected]