Posterisan H

Leaflet attached to the packaging: patient information

Posterisan H

387.1 mg + 5 mg, suppositories
Standardized bacterial culture suspension of Escherichia coli + Hydrocortisone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Posterisan H stimulates the body's immune system and supports the natural defense reaction to
infections. This action leads to the alleviation of itching and burning. Thanks to the content of
hydrocortisone, Posterisan H also reduces itching and inflammatory processes.
Posterisan H suppositories are used in particularly severe cases of itching and inflammation of the
anal area caused by hemorrhoids.

2. Important information before using Posterisan H

When not to use Posterisan H:

• if the patient is allergic to the standardized bacterial culture suspension, hydrocortisone, or any other component of this medicine (listed in section 6).
• if the patient has certain skin pathologies (e.g., tuberculosis, syphilis, gonorrhea) in the treated area, chickenpox, post-vaccination reactions, fungal infections, skin inflammation around the mouth, and rosacea.

Warnings and precautions

Before starting to use Posterisan H, you should discuss it with your doctor or pharmacist.
In the case of fungal infections, it is necessary to use locally acting antifungal medicines at the same time.

Children

Posterisan H suppositories should not be used in infants and children under 12 years of age.

Posterisan H 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.
Taking Posterisan H suppositories and glucocorticosteroids in the form of tablets, drops, or injections at the same time may increase the occurrence of adverse reactions to Posterisan H and glucocorticosteroids.

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.
Pregnancy
There is insufficient data on the use of this medicine in pregnant women.
Therefore, the medicine should only be used during pregnancy if it is absolutely necessary and after a careful assessment of the benefit-to-risk ratio.
Breastfeeding
Hydrocortisone passes into breast milk. You should avoid breastfeeding while continuously taking hydrocortisone or taking it in large doses.

Driving and using machines

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

Posterisan H contains hydroxystearin macrogolglycerin

The medicine may cause skin reactions.

Important information for patients with hemorrhoids

What are hemorrhoids?
The exact closure of the anus is made possible by soft, widely spaced, and highly vascularized cushions located in 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 thickening. This is called hemorrhoids (anal varices, piles). The causes of these discomforts are: improper diet, low in plant fiber, chronic constipation, too intense 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 discomfort, 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 there is an improvement, because otherwise, the discomfort may return after a few days.
This therapy, however, does not remove the 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 necessary to take care of regular, soft stools (not necessarily every day).
However, it is not about forcing too soft stools with the use of laxatives, which irritate and weaken the anus. Stools should be regulated with a suitable diet, rich in plant fiber (fruits, non-gas-forming vegetables, wholemeal bread, and bran), dairy products, and sufficient fluids. You should avoid strongly seasoned dishes, alcohol, and foods that cause constipation. You should control body weight and reduce excess weight.
Additionally, you should - especially with sedentary work - take care of regular exercise, such as walking, cycling, or swimming. Avoid cold places to sit.
Regular and thorough anal hygiene is also important. After each bowel movement, you should use soft toilet paper and wash the anal area with warm water and a soft cloth, without using 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 the hemorrhoids can be prevented by performing exercises that improve blood circulation, consisting of contracting and relaxing the sphincter every 2 seconds for a total of 3 minutes a day. Sitz baths or rinsing the anus with cool water under the shower also improve blood circulation and provide relief from itching and burning.
What should be strictly followed?
In case of bloody stools and frequent or prolonged discomfort, you should necessarily consult a doctor, as serious diseases may sometimes be hidden under these discomforts. If the doctor prescribes medicines, you should carefully read the attached leaflet and follow the instructions for use and the doctor's recommendations for dosing.
Additionally, for your own safety, you should regularly (even without acute discomfort) undergo preventive examination of the rectum.

3. How to use Posterisan H

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.

Recommended dose

Usually, suppositories should be used 2 times a day, in the morning and evening, preferably after bowel movements, inserting the suppository deep into the rectum.
Posterisan H suppositories should only be used until the acute discomfort disappears.
To remove the suppository, tear or cut the aluminum foil along the packaging.
The suppositories should not be used for more than 10 days without interruption. If symptoms recur, Posterisan H suppositories may be used again.

Use in children

Posterisan H suppositories should not be used in infants and children under 12 years of age.

Using a higher dose of Posterisan H than recommended

There are no known cases of overdose or poisoning.
In case of accidental oral ingestion of suppositories, gastrointestinal disorders, such as abdominal pain and nausea, may occur.

Missing a dose of Posterisan H

You should not use a double dose to make up for a missed dose.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)
Local hypersensitivity reactions (e.g., itching and burning)
Uncommon (may affect up to 1 in 100 people)
Allergic contact dermatitis (e.g., due to hypersensitivity to the preservative phenol)
A high dose of the medicine used for a long time may cause skin atrophy (gradual reduction of skin volume), telangiectasias (presence of dilated small blood vessels, commonly referred to as spider veins), stretch marks, and steroid acne.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Posterisan H

The medicine should be stored 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 month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Posterisan H contains

• The active substances of the medicine are standardized bacterial culture suspension of Escherichia coli and hydrocortisone. 1 suppository contains 387.1 mg of standardized bacterial culture suspension of Escherichia coli (killed 6.6 mg liquid phenol) and 5 mg of hydrocortisone. The suspension consists of cellular components and metabolic products from 1 billion bacteria Escherichia coli killed and preserved with phenol.
• Other ingredients are: solid fat, hydroxystearin macrogolglycerin, acetylcysteine, disodium edetate, all-rac-α-tocopherol.

What Posterisan H looks like and what the pack contains

Posterisan H is white or yellowish, uniform suppositories.
The blister pack contains 10 suppositories.

Marketing authorization holder and manufacturer

DR. KADE Pharmazeutische Fabrik GmbH
Rigistrasse 2
12277 Berlin
Germany
To obtain more detailed information, you should 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: