Heparin eye drops

Package leaflet: Information for the patient

Heparin Eye Drops 500,000 IU/100 ml eye drops, solution

Sodium heparin
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Heparin Eye Drops is and what it is used for
2. What you need to know before using Heparin Eye Drops
3. How to use Heparin Eye Drops
4. Possible side effects
5. How to store Heparin Eye Drops
6. Contents of the pack and other information

1. What Heparin Eye Drops is and what it is used for

The active substance of Heparin Eye Drops is sodium heparin, a substance that dissolves fibrin deposits (a protein involved in blood coagulation) (topical profibrinolytic agent).
This medicinal product is used in the treatment of the following conditions:
thermal and chemical burns of the conjunctiva (the mucous membrane covering the white part of the eye and the inner surface of the eyelids).
all disorders of the anterior segment of the eye in which the use of a medicinal product with topical fibrinolytic activity (dissolving fibrin deposits) may be beneficial.

2. What you need to know before using Heparin Eye Drops

Do not use Heparin Eye Drops

• if you are allergic to sodium heparin 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 Heparin Eye Drops.
During treatment, you must be regularly monitored by your doctor.
Other medicines and Heparin Eye Drops
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
There are no clinical data available on the safety of Heparin eye drops in pregnant or breastfeeding women.
Heparin eye drops should be administered during pregnancy only if clearly indicated.
Heparin eye drops must not be used during breastfeeding.
Driving and using machines
No negative effects on the ability to drive or operate machinery have been observed.
Heparin Eye Drops contain phosphate buffer
This medicine contains: 0.1893 mg of phosphate buffer per drop, equivalent to 3.80 mg/mL, with a theoretical drop volume of approximately 50 µL.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.
Multi-dose bottle contains parabens
The multi-dose bottle contains parabens (preservatives), namely methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Eye drops, solution in single-dose containers
This product does not contain antimicrobial preservatives to protect against accidental contamination during use. The product is intended for single use in one patient only, and the single-dose container must be discarded even if not completely used.

3. How to use Heparin Eye Drops

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

Recommended doses:

Thermal and chemical burns of the conjunctiva: after complete removal by washing and neutralization of corrosive substances, instill 1 drop of eye drops every hour for 48 hours.
Subsequently, instillations may be spaced out.

• Disorders of the anterior segment of the eye in which the use of a medicine with fibrin-dissolving (fibrinolytic) activity may be beneficial: instill 2 drops into the conjunctival sac two or more times daily, as prescribed by the doctor.

Instructions for use of the container:

Multi-dose bottle: no special instructions.
Single-dose container:

• Remove one single-dose container from the pouch and shake it before opening, in order to homogenize the solution contained within.
• Open the single-dose container by removing the cap covering the dropper tip.
• By applying slight pressure to the body of the container, instill the desired amount of medicine into the conjunctival sac.

If you use more Heparin Eye Drops than you should
If you accidentally swallow or ingest an excessive dose of Heparin Eye Drops, inform your doctor immediately or go to the nearest hospital.

If you forget to use Heparin Eye Drops
Do not use a double dose to make up for the missed dose.

If you stop using Heparin Eye Drops
Do not stop using Heparin Eye Drops unless instructed by your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
When used as an ophthalmic topical application (instillation into the eyes), side effects affecting the body related to administration of heparin by other routes (intramuscular, intravenous, oral) are not expected, especially considering the very low doses used in local treatment.
Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: 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 Heparin Eye Drops

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 that month. The shelf life applies to the product in its original, undamaged packaging and when stored correctly.
Eye drops, solution – multidose container: Do not use the product more than 30 days after first opening the container. After this period, dispose of any remaining eye drops.
Eye drops, solution – single-dose containers: The single-dose container does not contain preservatives: use the product immediately after opening and discard it even if only partially used.
After opening the aluminium pouch, use the single-dose containers within three months; after this period, dispose of any remaining containers.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Heparin Eye Drops contains
Heparin Eye Drops 500,000 IU/100 ml - multidose bottle

• The active substance is sodium heparin. 100 ml contain 500,000 IU of sodium heparin.
• The other components are: dibasic sodium phosphate, monobasic sodium phosphate, sodium chloride, sodium edetate, methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, water for injections.

Heparin Eye Drops 500,000 IU/100 ml - single-dose containers

• The active substance is sodium heparin. 100 ml contain 500,000 IU of sodium heparin.
• The other components are: dibasic sodium phosphate, monobasic sodium phosphate, sodium chloride, sodium edetate, water for injections.

Description of the appearance of Heparin Eye Drops and contents of the pack
Heparin Eye Drops is a solution for eye drops.
Multidose bottle of 5 ml.
Pack containing 10 single-dose units of 0.5 ml; each strip of 5 units is enclosed in an aluminium pouch.

Marketing Authorization Holder
Farmigea S.p.A., Via G.B. Oliva 6/8, 56121 - Pisa
Manufacturer
Farmigea S.p.A., Via G.B. Oliva 8, 56121 - Pisa
Selling Agent
POLIFARMA S.p.A., Viale dell’Arte 69, 00144 - Roma

The following information is intended exclusively for healthcare professionals:

Please read carefully the information contained in sections 1-6 as well.
Instructions for use of the container
When administering by subconjunctival or retrobulbar injection, withdrawal of the medicinal product
using a syringe with a needle is facilitated by prior removal, by cutting with a sterilized scissors,
of the dropper tip.