Package Insert: Information for the User

Posiforlid 20 mg/gOphthalmic Ointment

Bibrocatol

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3. How to use Posiforlid 20 mg/g

4. Possible adverse effects

5. Storage of Posiforlid 20 mg/g

6. Contents of the package and additional information

Posiforlid 20 mg/g is an ocular ointment that is a disinfectant, astringent and a secretion inhibitor.

This medication is used for chronic (prolonged) inflammation of the eyelid margin not caused by bacteria.

You should consult a doctor if it worsens or does not improve after seven days.

Do not usePosiforlid 20 mg/g

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to usePosiforlid 20 mg/g.

This medication may cause local skin reactions (such as contact dermatitis) because it contains lanolin.

Do not wear contact lenses during the use of this medication.

Children and adolescents

This medication is recommended for adolescents and children aged 6 years and above.

Other medications andPosiforlid 20 mg/g

No interactions have been studied.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those obtained without a prescription.

Note: If you are applying other eye drops or ointments, leave a gap of approximately 1 hour between the two applications. Eye ointments should always be applied last.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

No data are available on the use of bibrocatol in pregnant women. This medication should not be used during pregnancy unless clearly necessary.

It is also unknown whether bibrocatol is excreted in breast milk. A risk to the infant cannot be ruled out. Your doctor will decide whether you should stop breastfeeding or discontinue treatment with Posiforlid 20 mg/g ointment.

Driving and operating machinery

After applying Posiforlid 20 mg/g, the ointment will form a fatty film on the surface of the eye, temporarily affecting vision. Therefore, your ability to drive and operate machinery will be affected. Do not drive or use machinery until your vision is clear.

Posiforlid 20 mg/g contains lanolin

This medication may cause local skin reactions (such as contact dermatitis) because it contains lanolin.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

The recommended dose in adults is a portion of approximately 0.5 cm in the conjunctival sac of the affected eye 3 to 5 times a day.

Use in children and adolescents

The recommended dose in childrenfrom 6 years oldis to apply a portion of approximately 0.5 cm in the conjunctival sac of the affected eye 3 times a day for a maximum of 10 days.

Usage instructions:

• Wash your hands
• Remove the cap
• Avoid touching the eye or skin with the tip of the tube.
• Remove the cap.
• Tilt your head slightly back, gently pull down your lower eyelid and apply a small portion of ophthalmic ointment to the conjunctival sac by pressing the tube gently.
• Closure of the eyes slowly.
• Close the tube after use.

The ophthalmic ointment can be applied easily by pressing the tube gently without bending or rolling it.

Apply the ophthalmic ointment at regular intervals during the day.

This medication can be used until the symptoms disappear.

If discomfort persists or symptoms worsen after 7 days, consult your doctor.

In case of chronic eye irritation, always consult an ophthalmologist. You should avoid chronic use without control.

Consult your doctor if you think the effect of this medication is too strong or too weak.

If you use morePosiforlid 20 mg/g than you should

No specific measures are necessary. A short-term overdose of this medication does not cause known adverse effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to usePosiforlid 20 mg/g

Do not use a double dose to compensate for the missed doses. Apply the next dose as soon as possible and then continue with the same dose and intervals described above or prescribed by your doctor.

If you interrupt treatment with Posiforlid 20 mg/g

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following convention has been used to classify adverse reactions in terms of frequency:

Very frequent: (≥ 1/10)

Frequent:(≥ 1/100 to <1)

Infrequent:(≥ 1/1,000 to <1)

Rare:(≥ 1/10,000 to <1)

Very rare:(<1)

Frequency unknown: (cannot be estimated from available data).

Eye Disorders

Immune System Disorders

Skin and Subcutaneous Tissue Disorders

Additional Adverse Effects in Children and Adolescents

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Once opened:Do not use more than 4 weeks after the first opening.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Posiforlid 20 mg/g

The active principle is biberiden 20 mg/g.

The other components are white vaseline, liquid paraffin, and lanolin.

Appearance of the product and contents of the packaging

Posiforlid 20 mg/g is a yellowish-brown ointment packaged in aluminum tubes with a screw cap.

Each box contains a tube with 5 g of eye ointment.

Marketing Authorization Holder

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Responsible for manufacturing

URSAPHARM Arzneimittel GmbH

Industriestraße 35

66129 Saarbrücken

GERMANY

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Bibrocathol-POS 2 % Eye Ointment

Belgium:Bibrocathol-POS 20 mg/g eye ointment

Czech Republic:Posiforlid

Spain: Posiforlid 20 mg/g eye ointment

France:Posiforlid 20 mg/g eye ointment

Germany:Posiforlid 20 mg/g Eye Ointment

Luxembourg:Bibrocathol-POS 20 mg/g eye ointment

Malta:Posiforlid 20 mg/g, eye ointment

Poland:Posiforlid

Netherlands:Posiforlid 20 mg/g, eye ointment

Slovak Republic:Posiforlid 20 mg/g, Eye Ointment

Last reviewed date of this leaflet:September 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/