Bibrocathol Pos

Patient leaflet: information for the patient

Bibrocathol POS, 20 mg/g, eye ointment

Active substance: Bibrocathol

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.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Table of contents of the leaflet

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

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

Bibrocathol POS is a disinfecting, drying, and secretion-inhibiting eye ointment.
Bibrocathol POS is used in chronic (long-term) blepharitis that is not caused by bacteria.
If there is no improvement or the patient feels worse after seven days, consult a doctor.

2. Important information before using Bibrocathol POS

When not to use Bibrocathol POS

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

Warnings and precautions

Before starting to use Bibrocathol POS, discuss it with your doctor.
Lanolin may cause local skin reactions (e.g., contact dermatitis).
Do not wear contact lenses while using the medicinal product Bibrocathol POS.

Children and adolescents

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

Bibrocathol POS and other medicines

No interaction studies have been performed.
Edition 06/2024

• 1.3.1 SmPC, packaging labeling and patient leaflet

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Inform your doctor if you are using, have recently used, or plan to use other medicines.
Note: When using other eye drops or eye ointments at the same time, keep an interval of at least 1 hour between administering the two products. Eye ointments should always be administered last.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
There are no adequate studies on pregnancy and breastfeeding. The eye ointment Bibrocathol POS should not be used during pregnancy unless absolutely necessary.
It is also not known whether bibrocathol passes into breast milk. A risk to the breastfed child cannot be excluded. The doctor will decide whether to stop breastfeeding or use the eye ointment Bibrocathol POS.

Driving and using machines

After applying the eye ointment Bibrocathol POS, a greasy film forms on the surface of the eye, which temporarily impairs vision.
Therefore, the ability to drive and use machines will be impaired. Do not drive or use machines until you have clear vision.

Bibrocathol POS contains lanolin (wool fat).

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

3. How to use Bibrocathol POS

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
The recommended dose for adults is 3 to 5 times a day, applying a strip of about 0.5 cm of ointment to the conjunctival sac of the affected eye for a maximum of 14 days.

Use in children and adolescents

The recommended dose for children aged 6 and older is 3 times a day, applying about 0.5 cm of ointment to the conjunctival sac of the affected eye for a maximum of 10 days.
Instructions for use:

• Wash your hands
• Open the tube
• Do not let the tip of the tube touch the eye or skin.
• Remove the cap.
• Tilt your head back slightly, pull the lower eyelid down, and gently squeeze a small strip of ointment into the conjunctival sac.
• Slowly close your eyes.
• After use, close the tube carefully.

The eye ointment can be easily applied by gently squeezing the tube without pinching or twisting it.
Apply the eye ointment at regular intervals throughout the day.
Edition 06/2024

• 1.3.1 SmPC, packaging labeling and patient leaflet

Bibrocathol POS can be used until symptoms disappear.
If symptoms persist or worsen within seven days, consult a doctor immediately.
In case of chronic eye irritation, always consult an ophthalmologist. Avoid long-term use without control.
If you feel that the effect of Bibrocathol POS is too strong or too weak, consult your doctor.

Using more than the recommended dose of Bibrocathol POS

No special measures are required. There are no known side effects associated with short-term overdose.

Missing a dose of Bibrocathol POS

Do not use a double dose to make up for a missed dose, but use the next dose as soon as possible, and then continue treatment with the same dose and at the same intervals as described above or as advised by your doctor.

Stopping treatment with Bibrocathol POS

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following convention has been used for the classification of frequencies:
Very common:
more than 1 in 10 treated patients
Common:
between 1 and 10 in 100 treated patients
Uncommon:
between 1 and 10 in 1,000 treated patients
Rare:
between 1 and 10 in 10,000 treated patients
Very rare:
less than 1 in 10,000 treated patients
Not known:
frequency cannot be estimated from the available data
Eye disorders
Immune system disorders
Skin and subcutaneous tissue disorders

Additional side effects in children and adolescents

The same side effects that may occur in adults can also occur in children and adolescents.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, see below for contact information.
Edition 06/2024

• 1.3.1 SmPC, packaging labeling and patient leaflet

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 side effects, you can help provide more information on the safety of this medicine.

5. How to store Bibrocathol POS

Keep this medicine out of the 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 month.
Do not store above 30°C.
Shelf-life after first opening the tube: 4 weeks
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 Bibrocathol POS contains

The active substance is bibrocathol 20 mg/g.
The other ingredients are white petrolatum, liquid paraffin, and lanolin.

What Bibrocathol POS looks like and contents of the pack

Bibrocathol POS is a yellow ointment in aluminum tubes with a screw cap.
Each pack contains one tube with 5 g of eye ointment.

Marketing authorization holder and manufacturer

Marketing authorization 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

• 1.3.1 SmPC, packaging labeling and patient leaflet

This medicinal product is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: 11/2024

Edition 06/2024