Active ingredients: Sodium heparin
Heparin eye drops 500,000 I.U./100 ml eye drops, solution
Why is Heparin Eye Drops used? What is it for?
The active ingredient in Heparin Eye Drops is sodium heparin, a substance that dissolves accumulations of fibrin (a protein used in blood clotting) (topical profibrinolytic).
This medicine is used in the treatment of the following conditions:
- thermal and chemical burns of the conjunctiva (the mucous membrane that lines the white part of the eye and the inner surface of the eyelids)
- all affections of the anterior part of the eye in which the use of a medicine that dissolves accumulations of fibrin (with topical fibrinolytic action) may be useful.
Contraindications When Heparin Eye Drops should not be used
Do not use Heparin Eye Drops
- if you are allergic to heparin sodium or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Heparin Eye Drops
Talk to your doctor or pharmacist before using Heparin Eye Drops. You should be checked regularly by your doctor during therapy.
Interactions Which medications or foods can change the effect of Heparin Eye Drops
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are no known interactions with other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
There are no clinical data on the safe use of Heparin eye drops in pregnant or lactating women.
Heparin eye drops should only be used during pregnancy if clearly indicated.
Heparin eye drops should not be used while breastfeeding.
Driving and using machines
No adverse effects on ability to drive or use machines have been observed.
Heparin Eye Drops multidose bottle contains parabens
The multidose bottle contains parabens (preservatives) such as methyl parahydroxybenzoate and propyl parahydroxybenzoate which can cause allergic reactions (including delayed).
Eye drops, solution in single-dose containers
This product does not contain preservatives with antimicrobial action to protect it from occasional pollution during use. The product must be used for a single dressing and a single patient and the single-dose container must be disposed of even if not completely used.
Dose, Method and Time of Administration How to use Heparin Eye Drops: Posology
Always use this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
The recommended doses are:
- Thermal and chemical burns of the conjunctiva: after the total elimination by washing and neutralization of corrosive products, instill 1 drop of eye drops every hour for 48 hours.
- Affections of the anterior tract of the eye in which the use of a medicine that dissolves accumulations of fibrin (with fibrinolytic action) may be useful: instill 2 drops in the conjunctival sac, two or more times a day, according to medical prescription.
Instructions for the use of the container:
- Multidose bottle: none in particular.
- Single-dose container:
- Take a single-dose container out of the bag and shake it before opening it to homogenize the solution it contains.
- Open the single-dose container by detaching the cap over the dropper spout.
- By means of moderate pressure on the body of the container, let the medicine drip into the conjunctival sac in the desired quantity.
If you forget to use Heparin Eye Drops
Do not use a double dose to make up for a forgotten previous dose.
If you stop taking Heparin Eye Drops
Do not stop using Heparin Eye Drops unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Heparin Eye Drops
In case of accidental ingestion / intake of an overdose of Heparin Eye Drops, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Heparin Eye Drops
Like all medicines, this medicine can cause side effects, although not everybody gets them.
With local ophthalmic use (instillation in the eyes) undesirable effects on the organism connected with the administration of heparin by other route (intramuscular, intravenous, oral) are not to be expected, also due to the very modest dosages with which the substance is used locally .
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after "EXP". The expiry date refers to the last day of that month. The validity period refers to the product in intact packaging, correctly stored.
Eye drops, solution - multidose bottle: Do not use the product more than 30 days after first opening the container. After this time, discard any residual eye drops.
Eye drops, solution - single-dose containers: The single-dose container does not contain preservatives: use the product immediately after opening the container and throw it away even if only partially used.
After opening the foil pouch, use the single-dose containers within three months; after this period discard the residual containers.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What Heparin Eye Drops contains
Heparin eye drops 500,000 IU / 100 ml - multidose bottle
- The active ingredient is sodium heparin. 100 ml contain 500,000 I.U. of sodium heparin.
- The other ingredients are: dibasic sodium phosphate, monobasic sodium phosphate, sodium chloride, sodium edetate, methyl para-hydroxybenzoate, propyl para-hydroxybenzoate ;, water for injections.
Heparin eye drops 500,000 IU / 100 ml - single-dose containers
- The active ingredient is sodium heparin. 100 ml contain 500,000 I.U. of sodium heparin.
- The other ingredients are: dibasic sodium phosphate, monobasic sodium phosphate, sodium chloride, sodium edetate, water for injections.
What Heparin Eye Drops looks like and contents of the pack
Heparin Eye Drops comes in the form of a solution eye drops.
- 5 ml multidose bottle
- Pack of 10 single-dose containers of 0.5 ml; each strip of 5 containers is placed in an aluminum bag.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
HEPARIN COLLIRIO
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml contain:
active ingredient: sodium heparin 500,000 I.U.
for the complete list of excipients see section 6.1
03.0 PHARMACEUTICAL FORM
Eye drops, solution
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Thermal and chemical burns of the conjunctiva.
All affections of the anterior tract of the eye in which the use of a drug with local fibrinolytic action may be useful.
04.2 Posology and method of administration
Thermal and chemical burns of the conjunctiva: after the total elimination by washing and neutralization of corrosive products, instill one drop of eye drops every hour and for 48 hours.
Subsequently, the instillations can be separated.
All affections of the anterior tract of the eye in which the use of a drug with fibrinolytic action may be useful: 2 drops in the conjunctival sac, 2 or more times a day, according to medical prescription.
04.3 Contraindications
Individual hypersensitivity to one of the components of the product.
04.4 Special warnings and appropriate precautions for use
Eye drops, solution in multidose bottle
The product contains para-hydroxybenzoates, as preservatives, which can cause allergic reactions (even delayed)
Eye drops, solution in single-dose containers
The product does not contain preservatives with antimicrobial action aimed at preserving it from occasional pollution during use. The product must be used for a single dressing and a single patient and the single-dose must be discarded even if not completely used.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
They are not known.
04.6 Pregnancy and breastfeeding
In case of pregnancy or breastfeeding, Heparin has no known contraindications.
04.7 Effects on ability to drive and use machines
No effects are described.
04.8 Undesirable effects
With local ophthalmic use, no systemic undesirable effects connected with the administration by other route (intramuscular, intravenous, oral) of heparin are to be expected, also due to the very modest dosages with which the substance is used locally.
04.9 Overdose
No symptoms of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Heparin is an acidic sulphonated mucop | isaccharide, provided with direct and immediate anticoagulant activity both in vitro and in vivo.
The anticoagulant activity of heparin is the result of its high affinity for antithrombin III.
The interaction induces a conformational change of ATIII and confers activity to the complex as a potent inhibitor of coagulation factors such as factor II (thrombin) and Xa. Furthermore, factors IXa, XIa and XIIa are inhibited by the ATIII-heparin complex.
Among the biological activities of heparin are the anti-inflammatory effects resulting from the inhibition of activated granulocytes, an inhibition that prevents the release of free radicals, proteases and other chemical mediators of inflammation.
Heparin also has a profibrinolytic effect through the stimulation and release of tPA.
The characteristic of favoring the reabsorption of exudates at the conjunctival level and the lysis of protein material in the anterior chamber of the eye (due to a probable indirect activity) is the one that is mostly used in ophthalmology.
Subconjunctival injection in rabbits (and humans) produces improvement of anterior uveitis and a decrease in intraocular tone.
05.2 Pharmacokinetic properties
For systemic administration, heparin is rapidly taken up by endothelial cells and there it has higher rates than plasma ones. It binds very much to plasma proteins. It is degraded to oligosaccharides which are then excreted in the urine.
The topical application of heparin in the rabbit by ocular instillation has shown that, with the eye intact, it does not pass into the anterior chamber when its concentration is 5%. Only at a concentration of 3O% it is found in the aqueous humor, but such concentration produces a partial damage to the corneal epithelium which can only be seen with fluorescein.
In experimental lesions caused by thermal or chemical agents, 5% heparin determines a marked regression of hyperemia, edema and ulcerations (Jaques, 1980).
05.3 Preclinical safety data
In the toxicological studies, no alterations of the haemocoagulative system due to local administration, nor other tissue toxic effects were detected.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Eye drops, solution - multidose bottle
Dibasic sodium phosphate; Monobasic sodium phosphate; Sodium chloride; Sodium edetate; methyl p-hydroxybenzoate; propyl p-hydroxybenzoate; Water for injections.
Eye drops, solution - single-dose containers
Dibasic sodium phosphate; Monobasic sodium phosphate; Sodium chloride; Sodium edetate; Water for injections.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
Eye drops, solution - multidose bottle: 4 years
The product should not be used more than 30 days after first opening the container. After this period, the residual eye drops must be discarded.
Eye drops, solution - single-dose containers: 3 years
The single-dose container does not contain preservatives: the product must be used immediately after opening the container which must be disposed of even if only partially used.
After opening the foil pouch, the single-dose containers must be used within three months, after which time the residual containers must be disposed of.
06.4 Special precautions for storage
No particular storage conditions
06.5 Nature of the immediate packaging and contents of the package
Multidose bottle: Polyethylene dropper bottle containing 5 ml of eye drops.
Single-dose containers: Box of 10 single-dose containers of 0.5 ml enclosed in strips of 5 containers in PE-Al bags.
06.6 Instructions for use and handling
Multidose bottle: None in particular
Single-dose container:
Take a single-dose container out of the bag and shake it before opening it, to homogenize the solution it contains.
Open the single-dose container by removing the cap over the dropper spout.
Using moderate pressure on the body of the container, let the medicine drip into the conjunctival sac in the desired quantity.
In case of administration by subconjunctival or retrobulbar injection, the withdrawal of the medicine using a syringe fitted with a needle is facilitated by the prior removal, by cutting with sterilized scissors, of the dropper nozzle.
07.0 MARKETING AUTHORIZATION HOLDER
FARMIGEA SpA - Via G.B. Olive 6/8, 56121 - Pisa
08.0 MARKETING AUTHORIZATION NUMBER
Heparin eye drops 500,000 I.U / 100 ml eye drops, solution - bottle of 5 ml A.I.C. n. 009956018
Heparin Eye drops 500,000 I.U./100 ml, eye drops, solution - 10 single-dose containers of 0.5 ml - AIC n. 009956020
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
22 April 1955/01 June 2005
10.0 DATE OF REVISION OF THE TEXT
11 January 2008
