Posterisan

Package Leaflet: Information for the Patient

Posterisan, 166.7 mg, Ointment

Standardized suspension of bacterial culture Escherichia coli

Read the 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 as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Posterisan and what is it used for

Posterisan stimulates the body's immune system and supports the natural defense reaction to infections. This action leads to the alleviation of itching and burning. Posterisan ointment is used for itching, discharge, and burning in the anal area caused by hemorrhoids, anal fissures, and anal tears, as well as eczema.

2. Important information before using Posterisan

When not to use Posterisan:

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

Warnings and precautions

Before starting to use Posterisan, the patient should discuss it with their doctor or pharmacist. In the case of fungal infections, concurrent use of locally acting antifungal medicines is required. During treatment with Posterisan ointment, the tear resistance of condoms may be reduced due to the content of yellow soft paraffin. This may affect the safety of using these products.

Posterisan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

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. There are no known contraindications to the use of Posterisan ointment during pregnancy and breastfeeding.

Driving and using machines

Posterisan does not affect the ability to drive and use machines.

Posterisan contains lanolin

The medicine may cause local skin reactions (e.g., contact dermatitis).

Important information for patients with hemorrhoids

What are hemorrhoids?
The exact closure of the anus is enabled by soft, widely spread, and strongly vascularized cushions located at the end of the rectum above the anal sphincter, under the mucous membrane.
Discomfort occurs when these cushions become enlarged due to blood stasis and form nodular thickenings. This is referred to as hemorrhoids (anal varices, piles). The causes of these discomforts are: improper diet, low in plant fibers, chronic constipation, too strong straining during bowel movements, frequent use of laxatives, sedentary work, and sometimes connective tissue weakness.
Patient complaints usually include a feeling of pressure or bleeding during or after bowel movements.
These bleedings occur through injuries to the mucous membrane around the hemorrhoids or rupture of the hemorrhoid. In the further course of the disease, annoying and sometimes painful stabbing, itching, burning, and discharge in the anal area may occur, accompanied by inflammation and rash.
In advanced stages, there may be temporary or permanent prolapse of hemorrhoids from the anus.
Course of therapy
After a thorough examination, the doctor will provide guidance on treatment. The use of ointments and suppositories alleviates acute discomfort, such as itching, stabbing, burning, discharge, and pain at the beginning of the disease, as well as before and after surgical procedures. It is very important to continue therapy, even if improvement occurs, because otherwise, the discomfort may return after a few days.
This therapy, however, does not remove enlarged hemorrhoids. In advanced stages, enlarged hemorrhoids should be treated surgically.
Prevention
Prevention mainly involves regulating bowel movements and anal hygiene.
Too hard stools contribute to the formation of hemorrhoids, so it is essential to take care of regular, soft stools (not necessarily every day).
However, this does not mean forcing too soft stools with the use of laxatives, which irritate and weaken the anus. Stools should be regulated through a suitable diet rich in plant fibers (fruits, non-gas-forming vegetables, wholemeal bread, and bran), dairy products, and sufficient fluids. Highly seasoned dishes, alcohol, and foods that cause constipation should be avoided. Body weight should be controlled, and excess weight reduced.
Furthermore, especially with sedentary work, regular exercise, such as walking, cycling, or swimming, should be practiced. Cold places to sit should be avoided.
Regular and thorough anal hygiene is also crucial. After each bowel movement, soft toilet paper and lukewarm water with a soft cloth should be used, without soap and disinfectants. Do not rub! Moistened hygiene wipes available for sale are effective. The anal area should be thoroughly cleaned in this way, at least in the evening. Careful and gentle drying with soft toilet paper or a cotton ball can prevent infection (by bacteria, fungi, or yeast).
Stasis of blood in hemorrhoids can be prevented by performing daily exercises that improve blood circulation, consisting of contracting and relaxing the anal sphincter every 2 seconds for a total of 3 minutes. A sitz bath or rinsing the anus with cool water in the shower also improves blood circulation and provides relief from itching and burning.
What must be strictly observed?
In the case of bloody stools or frequent or prolonged discomfort, it is essential to consult a doctor, as these discomforts may sometimes hide serious diseases. If the doctor prescribes medicines, the patient should carefully read the enclosed leaflet and follow the doctor's instructions regarding dosage.
Furthermore, for their own safety, patients should regularly (even without acute discomfort) undergo preventive examination of the rectum.

3. How to use Posterisan

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose

Posterisan ointment should be applied twice a day, in the morning and evening, after bowel movements.
A thin layer of ointment (about 2.5 g) should be rubbed into the skin and mucous membranes requiring treatment.
For easier application, it is recommended to store the ointment at room temperature (around 18°C to 20°C).
Treatment with Posterisan ointment to prevent relapses should be continued for a longer period. Even when the annoying symptoms of the inflammatory condition and discomfort such as acute itching, discharge, and burning have subsided, it is recommended to continue treatment for several days.
To apply the ointment in the anal canal, the applicator provided with the packaging should be used.
Using the applicator
The applicator is screwed onto the tube with the ointment, and its top part is removed. After pressing the tube, the ointment enters the applicator and appears in its side openings. Then, the applicator is carefully inserted into the anus.
Moistening the applicator with ointment may facilitate its insertion into the anus. Repeatedly pressing the tube causes the ointment to enter the anal canal. Careful rotation of the tube leads to the proper distribution of the ointment. After application, the applicator should be cleaned by expressing a small amount of ointment through the side openings, wiping the surface with absorbent paper, and then reattaching the top part of the applicator. This protects the ointment from drying out.
Concomitant use of ointment and suppositories is recommended.
Warning:
Using the ointment in the anal area may cause soiling of underwear; it is recommended to use pads, panty liners, etc.

Using a higher dose of Posterisan than recommended

No cases of overdose or poisoning have been reported.
In the event of accidental oral ingestion of the ointment, gastrointestinal disorders, such as abdominal pain and nausea, may occur.

Missing a dose of Posterisan

A double dose should not be used to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Posterisan can cause side effects, although not everybody gets them.
Phenol is used as a preservative in Posterisan. Rarely, in case of hypersensitivity, skin allergic reactions may occur, causing, for example, redness and itching.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 side effects will allow for more information to be collected on the safety of the medicine.

5. How to store Posterisan

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the tube and carton after "Expiry date". The expiry date refers to the last day of the month stated.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Posterisan contains

• The active substance is standardized suspension of bacterial culture Escherichia coli. 1 gram of ointment contains 166.7 mg of standardized suspension of bacterial culture Escherichia coli (killed with 3.3 mg of liquid phenol). The suspension consists of cellular components and metabolic products from 330 million Escherichia coli bacteria killed and preserved with phenol.
• The other ingredients are: lanolin, yellow soft paraffin.

What Posterisan looks like and contents of the pack

Posterisan is a white or almost white, homogeneous ointment.
Aluminum tube with a plastic applicator in a cardboard box.
The pack contains 25 g of ointment.

Marketing authorization holder and manufacturer

DR. KADE Pharmazeutische Fabrik GmbH
Rigistrasse 2
12277 Berlin
Germany
For more detailed information, please contact the representative of the marketing authorization holder:
Kadefarm Sp. z o.o.
Sierosław, ul. Gipsowa 18
62-080 Tarnowo Podgórne, Poland
Tel.: +48 61 862 99 43
e-mail: [email protected]

Date of last revision of the leaflet: