Posterisan h

Package leaflet: Information for the patient

Posterisan H
(166.7 mg + 2.5 mg)/g, ointment
Standardized suspension of bacterial culture Escherichia coli + Hydrocortisonum
Please read carefully the entire leaflet before use, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Posterisan H is and what it is 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 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 leads to a reduction in itching and burning. Due to the presence of hydrocortisone, Posterisan H additionally reduces itching and inflammatory processes.
Posterisan H ointment is used in particularly severe cases of itching and inflammation around the anus caused by hemorrhoidal nodules, anal fissures, anal cracks (fissures), and eczema.

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 certain skin conditions (e.g. tuberculosis, syphilis, gonorrhea) in the area to be treated, chickenpox, post-vaccination reactions, fungal infections, perioral dermatitis, or rosacea.

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, simultaneous use of topical antifungal medications is required.
During treatment with Posterisan H ointment, the strength of condoms may be reduced due to the presence of yellow soft paraffin. This may affect the safety of these products.
Posterisan H and other medicines
Inform your doctor about all medicines currently used, recently used, or planned to be used.
Concomitant use of Posterisan H ointment and systemic glucocorticosteroids (in tablet, drop, or injectable form) may increase the occurrence of adverse effects associated with Posterisan H and those associated with glucocorticosteroids.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a 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 if absolutely necessary and after 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 operating machinery
Posterisan H has no effect on the ability to drive or operate machinery.
Posterisan H contains lanolin
This medicine may cause local skin reactions (e.g. contact dermatitis).
Important information for patients with hemorrhoidal nodules
What are hemorrhoidal nodules?
Proper closure of the anal canal is ensured by soft, widely distributed, and richly vascularized vascular cushions located at the end 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 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 hemorrhoids or rupture of a hemorrhoidal nodule. As the condition progresses, persistent or intermittent painful stabbing, itching, burning, and discharge around the anus may occur, associated with inflammation and skin rash. In advanced stages, hemorrhoidal nodules may intermittently or permanently prolapse from the anus.
Course of therapy
After thorough examination, the doctor will provide treatment recommendations. The use of ointments and suppositories relieves acute symptoms such as itching, stabbing, 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 return within a few days. However, this treatment does not eliminate 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 overly 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, whole-grain bread and cereals), dairy products, and sufficient fluid intake. Spicy foods, alcohol, and foods that cause constipation should be avoided. Body weight should be monitored and excess weight reduced.
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 anal hygiene 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 this way at least every evening. Careful and gentle drying with soft toilet paper or cotton wool may prevent infection (by bacteria, fungi, or yeasts).
To prevent blood congestion in hemorrhoidal nodules, perform daily exercises to improve circulation by contracting and relaxing the sphincter every 2 seconds for a total of 3 minutes. Sitz baths or rinsing the anus 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 enclosed leaflet and follow the instructions for use and the doctor's dosage recommendations.
For personal 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. If in doubt, consult your doctor or pharmacist.
Recommended dose
Posterisan H ointment should be applied twice daily, in the morning and evening, after bowel movement.
A thin layer of ointment (approximately 2.5 g) should be gently rubbed into the affected skin and mucous membranes.
Posterisan H ointment should not be used continuously for longer than 10 days. Treatment with Posterisan H should continue only until acute symptoms have resolved. In case of recurrence, Posterisan H may be used again.
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. Pressing the tube fills the applicator with ointment, which emerges through its side openings. The applicator is then gently inserted into the anus.
Moistening the applicator with ointment may facilitate insertion. Pressing the tube again delivers the ointment into 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 its surface with absorbent paper, and then replace 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.
After acute symptoms such as itching, pain, and bleeding have subsided, treatment may be continued with Posterisan (which does not contain hydrocortisone) to help prevent recurrence.
Use in children
Posterisan H ointment must not be used in infants and children under 12 years of age.
Use of a higher than recommended dose of Posterisan H
Cases of overdose or poisoning are unknown.
In case of accidental oral ingestion of the ointment, 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 regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.

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 lead to 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 reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions may also be reported to the Marketing Authorisation Holder.

Reporting adverse reactions enables further collection of 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 tube and carton after: "Expiry". The expiry date refers to the last day of the specified month.
Use within six months of opening.
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 in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Posterisan H contains

• The active substances in this medicinal product are standardized bacterial culture suspension of Escherichia coli and hydrocortisone. One 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 contains cellular components and metabolic products derived from 500 million Escherichia coli bacteria, killed and preserved with phenol.
• Other ingredients: lanolin, yellow vaseline.

What Posterisan H looks like and contents of the pack
Posterisan H is a slightly beige, 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, ul. Gipsowa 18
62-080 Tarnowo Podgórne, Poland
Tel.: +48 61 862 99 43
e-mail: [email protected]