Posiforlid

Patient Information Leaflet

Posiforlid 20 mg/g eye ointment

bibrocatolo
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor. See section 4.

Contents of this leaflet:

1. What Posiforlid 20 mg/g is and what it is used for
2. What you need to know before using Posiforlid 20 mg/g
3. How to use Posiforlid 20 mg/g
4. Possible side effects
5. How to store Posiforlid
6. Package contents and other information

1. What Posiforlid 20 mg/g is and what it is used for

Posiforlid 20 mg/g is a disinfectant, astringent, and secretion-inhibiting ophthalmic ointment.
Posiforlid 20 mg/g is used in chronic (long-term) inflammation of the eyelid margin not caused by bacteria.
Consult your doctor if you do not feel better or if you feel worse after seven days.

2. What you need to know before using Posiforlid 20 mg/g

Do not use Posiforlid 20 mg/g
If you are allergic to bibrocatol or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Posiforlid 20 mg/g.
Lanolin may cause local skin reactions (e.g. contact dermatitis).
Do not wear contact lenses during treatment with Posiforlid 20 mg/g.

Children and adolescents
Posiforlid 20 mg/g is recommended for use in adolescents and children aged 6 years and older.

Other medicines and Posiforlid 20 mg/g
No interaction studies have been conducted.
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicines.
Note: If you are using other eye drops or eye ointments, an interval of approximately 1 hour should be maintained between the applications of each medicine. Ophthalmic ointments should always be applied last.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
There are no data available on the use of bibrocatol in pregnant women. Posiforlid 20 mg/g should not be used during pregnancy unless clearly necessary.
It is also unknown whether bibrocatol is excreted in breast milk. A risk to the breastfed infant cannot be excluded. Your doctor will decide whether breastfeeding or treatment with Posiforlid 20 mg/g ophthalmic ointment should be discontinued.

Driving and using machines
After application of Posiforlid 20 mg/g, the ophthalmic ointment will form an oily film on the eye surface, temporarily impairing vision. Therefore, your ability to drive and operate machinery will be affected. Do not drive or operate machinery until your vision has returned to normal.

Posiforlid 20 mg/g contains lanolin
Lanolin may cause local skin reactions (e.g. contact dermatitis).

3. How to use Posiforlid 20 mg/g

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

The recommended dose for adults is one strip of approximately 0.5 cm into the conjunctival sac of the affected eye 3–5 times daily.

Use in children and adolescents
The recommended dose for children ≥ 6 years is one strip of approximately 0.5 cm applied 3 times daily into the conjunctival sac of the affected eye for up to 10 days.

Instructions for use:

• Wash your hands
• Open the tube
• Avoid letting the tip of the tube touch the eye or skin
• Remove the cap
• Tilt your head slightly backward, gently pull down the lower eyelid of the eye, and apply a small strip of ophthalmic ointment into the conjunctival sac by gently pressing the tube
• Close your eyes slowly
• Close the tube tightly after use

The ophthalmic ointment can be easily applied by gently pressing the tube without breaking or rolling it.
Apply the ophthalmic ointment at regular intervals throughout the day.
Posiforlid 20 mg/g may be used until symptoms disappear.
If symptoms persist or no improvement is observed, consult a doctor within seven days.
In case of chronic eye irritation, always consult an ophthalmologist. Avoid chronic, unmonitored use.
Consult your doctor if you feel that the effect of Posiforlid 20 mg/g is too strong or too weak.

If you use more Posiforlid 20 mg/g than you should
No specific measures are required. Short-term overdose of Posiforlid 20 mg/g does not cause known adverse effects.

If you forget to use Posiforlid 20 mg/g
Do not apply a double dose to make up for the missed dose. Instead, apply the next dose as soon as possible and continue taking the same dose at the intervals described above or as prescribed by your doctor.

If you stop using Posiforlid 20 mg/g
If you have any 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.
The following frequencies have been defined for assessing adverse reactions:
Very common – may affect more than 1 in 10 people
Common – may affect up to 1 in 10 people
Uncommon – may affect up to 1 in 100 people
Rare – may affect up to 1 in 1,000 people
Very rare – may affect up to 1 in 10,000 people
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 may also occur in children and adolescents.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You may also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Posiforlid 20 mg/g

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 that month.
Do not store above 30 °C.
Storage duration after opening: do not use for more than 4 weeks after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Posiforlid 20 mg/g contains
The active substance is bibrocathol 20 mg/g.
The other components are white vaseline, liquid paraffin, and lanolin.

Description of the appearance of Posiforlid 20 mg/g and package contents
Posiforlid 20 mg/g is a yellow ointment contained in an aluminum tube with a screw cap.
Each package contains one tube with 5 g of ophthalmic ointment.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
URSAPHARM S.r.l., Via Vittor Pisani 16, 20124 Milano, Italy

Manufacturer
URSAPHARM Arzneimittel GmbH, Industriestraße 35, 66129 Saarbrücken, Germany

This medicinal product is authorized in the European Economic Area countries and in Northern Ireland under the following names:
AT: Bibrocathol-POS 20 mg/g Augensalbe
BE: Bibrocathol-POS 20 mg/g pommade ophtalmique
CZ: Posiforlid 20 mg/g ocní mast
FR: POSIFORLID 20 mg/g, pommade ophtalmique
DE: Posiforlid 20 mg/g Augensalbe
LU: Bibrocathol-POS 20 mg/g pommade ophtalmique
MT: Posiforlid 20 mg/g eye ointment
NL: Posiforlid 20 mg/g, oogzalf
PL: Bibrocathol POS, 20 mg/g, masc do oczu
SK: Posiforlid 20 mg/g ocná mast
ES: Posiforlid 20 mg/g pomada oftalmica
SE: Posilid, 20 mg/g øyensalve
DK: Posiforlid, 20 mg/g øjensalve
FI: Posiforlid, 20 mg/g silmävoide
Northern Ireland: POSIFORLID 20 mg/g eye ointment
IS: Posiforlid 20 mg/g augnsmyrsli
NO: Posiforlid, 20 mg/g øyensalve
PT: Bibrocathol URSAPHARM, 20 mg/g pomada para os olhos
RO: POSIFORLID 20 mg/g unguent oftalmic