Patient Information Leaflet

Bibrocathol POS, 20 mg/g, eye ointment
Active substance: Bibrocathol
Please read the entire leaflet carefully before using the medicine, as it contains important information for you.

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

Table of Contents

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

1. What is Bibrocathol POS and what is it used for

Bibrocathol POS is a disinfectant, astringent and secretion-inhibiting eye ointment.
Bibrocathol POS is used in chronic (long-term) inflammation of the eyelid margin not caused by bacteria.
If there is no improvement or if symptoms worsen after seven days, consult your doctor.

2. Important information before using Bibrocathol POS

When not to use Bibrocathol POS

if the patient is allergic to boric acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Bibrocathol POS, consult your doctor.
Lanolin may cause local skin reactions (e.g. contact dermatitis).
Do not wear contact lenses during treatment with Bibrocathol POS medicinal product.

Children and adolescents
Bibrocathol POS is recommended for adolescents and children aged 6 years and older.

Bibrocathol POS and other medicines
No interaction studies have been conducted.
Edition 06/2024
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is currently using, has recently used, or plans to use any other medicines.
Note: If other eye drops or eye ointments are used simultaneously, an interval of at least 1 hour should be maintained between administration of the two products. Eye ointments should always be administered last.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
There are no adequate animal studies available on pregnancy and breastfeeding. Bibrocathol POS eye ointment should not be used during pregnancy unless absolutely necessary.
It is also unknown whether boric acid passes into human milk. A risk to the breastfed infant cannot be excluded. The doctor will decide whether breastfeeding should be discontinued or whether Bibrocathol POS eye ointment should be used.

Driving and using machines
After application of Bibrocathol POS eye ointment, an oily film forms on the surface of the eye, which may temporarily impair vision.
Therefore, the ability to drive and operate machinery will be impaired. Do not drive or operate machinery until clear vision is restored.

Bibrocathol POS contains lanolin (wool fat).
Lanolin may cause local skin reactions (e.g. contact dermatitis).

3. How to use Bibrocathol POS

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor.
The recommended dose for adults is a strip of approximately 0.5 cm of ointment applied 3 to 5 times daily into the conjunctival sac of the affected eye for a maximum period of 14 days.
Use in children and adolescents
The recommended dose for children aged 6 years and older is approximately 0.5 cm of ointment applied 3 times daily into the conjunctival sac of the affected eye for a maximum period of 10 days.
Instructions for use:

Wash your hands
Open the tube
Ensure the tip of the tube does not touch the eye or skin.
Remove the cap.
Tilt the head slightly backward, gently pull down the lower eyelid, and carefully squeeze a small amount of ointment from the tube into the conjunctival sac.
Close the eyes slowly.
After use, carefully close the tube.

The eye ointment can be easily applied by gently squeezing the tube without crushing or rolling it.
Apply the eye ointment at regular intervals throughout the day.
Edition 06/2024
Bibrocathol POS may be used until symptoms resolve.
If symptoms persist or there is no improvement within seven days, contact your doctor immediately.
In case of chronic eye irritation, always consult an ophthalmologist. Avoid prolonged use without medical supervision.
If you feel that the effect of Bibrocathol POS is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Bibrocathol POS
No special actions are required. There are no known adverse effects associated with short-term overdose.
Missed dose of Bibrocathol POS
Do not use a double dose to make up for a missed dose. Instead, apply the next dose as soon as possible, then continue treatment using the same dose and at the same intervals as described above or as prescribed by your doctor.
Stopping treatment with Bibrocathol POS
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
The following frequency convention has been used to assess adverse reactions:
Very common: affects more than 1 in 10 patients
Common: affects 1 to 10 in 100 patients
Uncommon: affects 1 to 10 in 1,000 patients
Rare: affects 1 to 10 in 10,000 patients
Very rare: affects less than 1 in 10,000 patients
Not known: frequency cannot be estimated from the available data

Eye disorders

Rarely

Ocular and eyelid irritation has been reported with the following symptoms: eye itching, eye swelling, eye pain, eye hyperemia, burning, lacrimation

Immune system disorders

Rare	Hypersensitivity, allergy to bibrocathol (e.g. facial swelling, facial redness)

Skin and subcutaneous tissue disorders

Rare	erythema, pruritus, rash

Additional adverse reactions in children and adolescents
The same adverse reactions that may occur in adults may also occur in children and
adolescents.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this
leaflet, inform your doctor. Adverse reactions can be reported directly to the
Department of Monitoring Adverse Reactions of Medicinal Products at 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. By reporting adverse reactions, additional information on the safety of the medicinal product can be collected.

5. How to store Bibrocathol POS

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Shelf life after first opening the tube: 4 weeks
Medicines should not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Bibrocathol POS contains
The active substance is bibrocathol 20 mg/g.
The other ingredients are white soft paraffin, liquid paraffin, and lanolin.

What Bibrocathol POS looks like and contents of the pack
Bibrocathol POS is a yellow ointment contained in aluminium tubes with a screw cap.
Each pack contains one tube with 5 g of eye ointment.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
URSAPHARM Poland Sp. z o.o.,
Wybrzeże Gdyńskie 27,
01-531 Warsaw
Tel.: 022 732 07 90
Fax: 022 732 07 99
e-mail: [email protected]

Manufacturer:
Ursapharm Arzneimittel GmbH
Industriestrasse 35
Buebingen
66129 Saarbruecken, Saarland
Germany

Edition 06/2024

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Bibrocathol-POS 2 % Augensalbe
Belgium/Luxembourg: Bibrocathol-POS 20 mg/g pommade ophtalmique
Czech Republic: Posiforlid 20 mg/g ocní mast
France: Posiforlid 20 mg/g pommade ophtalmique
Germany: Posiforlid 20 mg/g Augensalbe
Malta: Posiforlid 20 mg/g eye ointment
Netherlands: Posiforlid 20 mg/g, oogzalf
Slovakia: Posiforlid 20 mg/g, Očná masť
Spain: Posiforlid 20 mg/g pomada oftálmica

Edition 06/2024