Posiforlid 20 mg/g ophthalmic ointment
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Posiforlid 20 mg/g is and what it is used for
- 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. Package contents and additional information
Patient Information Leaflet
Introduction
Patient Information Leaflet
Posiforlid 20 mg/g ophthalmic ointment
Bibrocatol
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only; do 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 the effects are not listed in this leaflet. See section 4.
Leaflet Contents
- What Posiforlid 20 mg/g is and what it is used for
- What you need to know before using Posiforlid 20 mg/g
- How to use Posiforlid 20 mg/g
- Possible side effects
- How to store Posiforlid 20 mg/g
- Contents of the pack 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.
This medicine is used for chronic (long-lasting) inflammation of the eyelid margin not caused by bacteria.
You should consult a doctor if the condition worsens or does not improve after seven days.
2. What you need to know before starting to use Posiforlid 20 mg/g
Do not use Posiforlid 20 mg/g
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Posiforlid 20 mg/g.
This medicine may cause local skin reactions (such as contact dermatitis) because it contains lanolin.
You should not wear contact lenses during treatment with this medicine.
Children and adolescents
This medicine is recommended for adolescents and children from 6 years of age.
Other medicines and Posiforlid 20 mg/g
No interaction studies have been conducted.
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Note: If you are using other eye drops or ophthalmic ointments, leave an interval of approximately 1 hour between each application. Ophthalmic ointments should always be applied last.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There are no data on the use of bibrocatol in pregnant women. This medicine 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 ruled out. Your doctor will decide whether to discontinue breastfeeding or treatment with Posiforlid 20 mg/g ophthalmic ointment.
Driving and using machines
After applying Posiforlid 20 mg/g, the ophthalmic ointment will form a greasy film on the eye surface, which will temporarily affect your vision. Therefore, your ability to drive and use machinery will be impaired. Do not drive or operate machinery until your vision is clear.
Posiforlid 20 mg/g contains lanolin
This medicine may cause local skin reactions (such as contact dermatitis) because it contains lanolin.
3. How to use Posiforlid 20 mg/g
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.
The recommended dose in adults is a portion of approximately 0.5 cm applied into the conjunctival sac of the affected eye 3 to 5 times daily.
Use in children and adolescents
The recommended dose in children aged 6 years and older is to apply a portion of approximately 0.5 cm into the conjunctival sac of the affected eye 3 times daily for a maximum of 10 days.
Instructions for use:
- Wash your hands.
- Unscrew the cap.
- Avoid touching the eye or skin with the tip of the tube.
- Remove the cap.
- Tilt your head slightly backward, gently pull down the lower eyelid of the eye, and apply a small amount of ophthalmic ointment into the conjunctival sac by gently squeezing the tube.
- Close your eyes slowly.
- Close the tube after use.
The ophthalmic ointment can be easily applied by gently pressing the tube without bending or rolling it.
Apply the ophthalmic ointment at regular intervals throughout the day.
This medicine may be used until symptoms disappear.
If discomfort persists or symptoms worsen after 7 days, consult your doctor.
In case of chronic eye irritation, an ophthalmologist should always be consulted. Chronic use without medical supervision should be avoided.
Consult your doctor if you think that the effect of this medicine is too strong or too weak.
If you use more Posiforlid 20 mg/g than you should
No specific measures are necessary. Short-term overdose of this medicine does not cause any known adverse effects.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Posiforlid 20 mg/g
Do not use a double dose to make up for forgotten doses. Apply the next dose as soon as possible, then continue with the same dose and intervals as described above or as prescribed by your doctor.
If you stop using Posiforlid 20 mg/g
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following convention has been used to classify adverse reactions according to frequency:
Very common: (≥ 1/10)
Common: (≥ 1/100 to < 1/10)
Uncommon: (≥ 1/1,000 to < 1/100)
Rare: (≥ 1/10,000 to < 1/1,000)
Very rare: (< 1/10,000)
Frequency not known: (cannot be estimated from available data).
Eye disorders
Rare | The following ocular and eyelid irritation symptoms have been reported: eye pruritus, eye swelling, eye pain, ocular hyperemia, burning sensation, lacrimation |
Disorders of the immune system
Rare | Hypersensitivity, allergy (e.g. facial swelling, facial flushing) to bibrocatecol |
Disorders of the skin and subcutaneous tissue
Rare | erythema, pruritus, rash |
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 not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of 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 packaging after “EXP”. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
After opening: Do not use more than 4 weeks after first opening.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Package contents and additional information
Composition of Posiforlid 20 mg/g
The active substance is bibrocathol 20 mg/g.
The other components are white soft paraffin, liquid paraffin, and lanolin.
Appearance of the product and contents of the packaging
Posiforlid 20 mg/g is an ochre-colored ointment packed in aluminum tubes with screw caps.
Each box contains one tube with 5 g of ophthalmic ointment.
Marketing Authorization Holder
BRILL PHARMA, S.L.
C/ Munner, 8
08022 Barcelona
Spain
Manufacturer responsible for manufacturing
URSAPHARM Arzneimittel GmbH
Industriestraße 35
66129 Saarbrücken
GERMANY
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Bibrocathol-POS 2 % Augensalbe
Belgium: Bibrocathol-POS 20 mg/g pommade ophtalmique
Czech Republic: Posiforlid
Spain: Posiforlid 20 mg/g pomada oftálmica
France: Posiforlid 20 mg/g pommade ophtalmique
Germany: Posiforlid 20 mg/g Augensalbe
Luxembourg: Bibrocathol-POS 20 mg/g pommade ophtalmique
Malta: Posiforlid 20 mg/g, eye ointment
Poland: Posiforlid
Netherlands: Posiforlid 20 mg/g, oogzalf
Slovak Republic: Posiforlid 20 mg/g, Ocná mast
Date of the most recent review of this leaflet: September 2021
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/