Posterisan H

Package Leaflet: Information for the Patient

Posterisan H

(166.7 mg + 2.5 mg)/g, ointment
Standardized bacterial culture suspension of Escherichia coli + Hydrocortisone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any 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. Contents of the pack 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 a reduction in itching and burning. Thanks to the content of
hydrocortisone, Posterisan H also reduces itching and inflammatory processes.
Posterisan H ointment is used in particularly severe cases of itching and inflammation of the anal area
caused by hemorrhoids, fissures, anal fissures, and eczema.

2. Important information before using Posterisan H

When not to use Posterisan H:

Escherichia colior hydrocortisone or any of the other ingredients of this medicine (listed in section 6).

Do not use in children under 12 years of age.

Warnings and precautions

Before starting treatment with Posterisan H, discuss it with your doctor or pharmacist.
In case of fungal infections, concurrent use of locally acting antifungal drugs is required.
During treatment with Posterisan H ointment, the tensile strength of condoms may be reduced due to the content of yellow soft paraffin. This may affect the safety of using these products.

Posterisan H and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of Posterisan H ointment and glucocorticosteroids in the form of tablets, drops, or injections may increase the incidence 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, consult your doctor or pharmacist before using this medicine.
Pregnancy
There are insufficient data on the use of this medicine in pregnant women.
In this case, the medicine should only be used during pregnancy when absolutely necessary and after a careful assessment of the benefit-risk ratio.
Breastfeeding
Hydrocortisone passes into breast milk. Breastfeeding should be avoided during continuous administration of hydrocortisone or when administered in high doses.

Driving and using machines

Posterisan H has no effect on the ability to drive or operate machines.

Posterisan H 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 made possible by soft, widely spaced, and highly 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 thickening. This is called hemorrhoids (anal varices, piles). The causes of these discomforts are: poor diet, low in plant fiber, chronic constipation, excessive 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.
Bleeding occurs through scratches 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 transient or permanent prolapse of hemorrhoids from the anus.
Treatment course
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 treatment, even if there is an improvement, because otherwise, the discomfort may return after a few days. However, this treatment does not remove enlarged hemorrhoids. In advanced stages, enlarged hemorrhoids should be treated surgically.
Prevention
Prevention is mainly based on regulating bowel movements and anal area hygiene.
Too hard stools contribute to the formation of hemorrhoids, so it is essential to take care of regular bowel movements (not necessarily every day) of soft stools.
However, this does not mean forcing too soft stools using laxatives, which irritate and weaken the anus. The stool should be regulated using a suitable diet rich in plant fiber (fruits, non-gas-forming vegetables, wholemeal bread, and bran), dairy products, and sufficient fluids. Avoid highly seasoned dishes, alcohol, and foods that cause constipation. It is essential to control body weight and reduce excess weight.
Additionally, regular exercise, such as walking, cycling, or swimming, should be done, especially with sedentary work. Avoid cold places to sit.
Regular and thorough hygiene of the anal area is also crucial. After each bowel movement, use soft toilet paper and wash the anal area with lukewarm water and a soft cloth, without using soap or 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 drying with soft toilet paper or a cotton ball can help prevent infection (by bacteria, fungi, or yeast).
Stagnation of blood in the hemorrhoids can be prevented by performing daily exercises that improve blood circulation, consisting of contracting and relaxing the anal sphincter every 2 seconds for 3 minutes. Sitz baths or rinsing the anus with cool water in the shower also improve blood circulation and provide relief from itching and burning.
What should be strictly followed?
In 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 medication, carefully read the enclosed leaflet and follow the instructions for use and the doctor's recommendations for dosing.
Additionally, for your own safety, regularly perform preventive rectal examinations (even without acute discomfort).

3. How to use Posterisan H

This medicine should always be used as directed by your doctor. In case of doubts, consult your doctor or pharmacist.

Recommended dose

Posterisan H 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.
Posterisan H ointment should not be used for more than 10 days without interruption. The use of Posterisan H ointment should only last until the acute discomfort subsides. In case of relapse, Posterisan H can be used again.
To apply the ointment to the anal canal, use the applicator provided with the packaging.
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 use, clean the applicator 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.
Caution:
Using the ointment in the anal area may cause soiling of underwear; it is recommended to use pads, panty liners, etc.
After the acute discomfort, such as itching, pain, and bleeding, has subsided, treatment can be continued using Posterisan (without hydrocortisone) to prevent relapses.

Use in children

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

Using a higher dose of Posterisan H than recommended

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

Missing a dose of Posterisan H

Do not use a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, consult your 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 period 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 not listed in this leaflet, 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, phone: 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

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 month.
Use within six months of opening.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 H contains

• The active substances of the medicine are standardized bacterial culture suspension of Escherichia coliand hydrocortisone. 1 gram of ointment contains 166.7 mg of standardized bacterial culture suspension of Escherichia coli(killed with 3.3 mg of liquid phenol) and 2.5 mg of hydrocortisone. The suspension consists of cellular components and metabolic products from 500 million Escherichia colibacteria killed and preserved with phenol.
• The other ingredients are: lanolin, yellow soft paraffin.

What Posterisan H looks like and contents of the pack

Posterisan H is a light beige, 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
GermanyKadefarm Sp. z o.o.
Sierosław, ul. Gipsowa 18
62-080 Tarnowo Podgórne, Poland
Phone: +48 61 862 99 43
e-mail: [email protected]

Date of last revision of the leaflet: