Active ingredients: Hyaluronic acid (Hyaluronic acid sodium salt)
HYALISTIL 0.2% eye drops, solution
Why is Hyalistil used? What is it for?
What is it
Artificial tears.
Why is it used
Hyalistil is used for the symptomatic treatment of dry eye syndrome.
Contraindications When Hyalistil should not be used
Hypersensitivity to components or other closely related substances from a chemical point of view.
Hypersensitivity to any component of the preparation.
Precautions for use What you need to know before taking Hyalistil
In case of administration of ophthalmic solutions for curative purposes, suspend the instillation of the product.
The use, especially if prolonged, can give rise to sensitization phenomena, in this case stop the treatment and consult the doctor to institute suitable therapy. In case of persistence or worsening of symptoms, suspend use and consult your doctor.
Interactions Which drugs or foods can modify the effect of Hyalistil
No phenomena of interactions of HYALISTIL with other drugs are known to date. It is however recommended to avoid the simultaneous use of other detergent or disinfectant solutions.
If you are using other medicines ask your doctor or pharmacist for advice.
Warnings It is important to know that:
Hyaluronic acid sodium salt can precipitate in the presence of quaternary ammonium salts.
The simultaneous use of solutions containing these substances should therefore be avoided.
Pregnancy and breastfeeding (see What to do during pregnancy and breastfeeding).
What to do during pregnancy and breastfeeding
In pregnancy and lactation HYALISTIL should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
Consult your doctor if you suspect pregnancy or wish to plan a maternity leave.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
HYALISTIL does not interfere with the ability to drive and use of machines.
Important information about some of the ingredients of Hyalistil
This medicinal product contains thiomersal as a preservative and, therefore, allergic reactions may occur.
Dose, Method and Time of Administration How to use Hyalistil: Posology
How many
Two drops of eye drops 3 or more times a day.
Warning: do not exceed the indicated doses.
When and for how long
Warning: use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Like
Instill into the conjunctival sac.
HYALISTIL in single-dose container should only be used immediately after opening. Any residue should not be reused.
Instructions for Use
HYALISTIL in 5 ml and 10 ml vials
Remove the protective cap and unscrew the cap. (Pictogram)
Turn the bottle upside down and instill the eye drops by exerting light pressure on the bottle itself.
Close the bottle by screwing the cap.
HYALISTIL in single-dose container
Before use, make sure that the single-dose container is intact.
Detach the single-dose container from the strip. (Pictogram)
Open by turning the top without pulling. (Pictogram)
Avoid letting the tip of the container come into contact with the eye or any other surface
Overdose What to do if you have taken an overdose of Hyalistil
In case of accidental ingestion / intake of an excessive dose of Hyalistil, notify your doctor immediately or go to the nearest hospital.
If you have any further questions on the use of Hyalistil, ask your doctor or pharmacist.
Side Effects What are the side effects of Hyalistil
Like all medicines, Hyalistil can cause side effects, although not everybody gets them.
Compliance with the instructions contained in the package insert reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Neither local nor systemic adverse drug reactions are known.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Store below 25 ° C.
Avoid exposure to light and heat sources.
HYALISTIL 0.2% in 5 ml and 10 ml bottle: The shelf life after first opening the bottle is 28 days.
HYALISTIL 0.2% in single-dose container:
The single-dose package should only be used immediately after opening. Do not reuse.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children
It is important to always have the information on the medicine available, so always keep both the box and the package leaflet.
COMPOSITION
HYALISTIL 0.2% in bottle of 5 ml and 10 ml 1 ml of eye drops, solution contains:
Active ingredient: Hyaluronic acid sodium salt 2 mg
Excipients: Sodium chloride - Potassium chloride - Monobasic sodium phosphate monohydrate - Disodium phosphate dodecahydrate - Thiomersal - Purified water.
HYALISTIL 0.2% in single-dose container
Each single-dose container contains
0.25 ml of eye drops, solution. 1 ml of eye drops, solution contains:
Active ingredient: Hyaluronic acid sodium salt 2 mg
Excipients: Sodium chloride - Potassium chloride - Monobasic sodium phosphate monohydrate - Disodium phosphate dodecahydrate - Purified water.
How it looks
HYALISTIL 0.2% comes in the form of eye drops, solution.
The contents of the package are:
HYALISTIL 0.2% eye drops, solution: bottle of 5 ml.
HYALISTIL 0.2% eye drops, solution: bottle of 10 ml.
HYALISTIL 0.2% eye drops, solution: 20 single-dose containers of 0.25 ml.
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
HYALISTIL 0.2% EYE DROPS, SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
HYALISTIL 0.2% in 5 ml and 10 ml bottle
1 ml of eye drops, solution contains:
Active ingredient: Hyaluronic acid sodium salt 2 mg
Excipients: thiomersal
For the full list of excipients, see section 6.1.
HYALISTIL 0.2% in 0.25 ml single-dose container
1 ml of eye drops, solution contains:
Active ingredient: Hyaluronic acid sodium salt 2 mg
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Eye drops, solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of dry eye syndrome.
04.2 Posology and method of administration
Instill in the conjunctival sac two drops of eye drops 3 or more times a day.
Before use, make sure that the single-dose container is intact.
HYALISTIL in single-dose container should only be used immediately after opening. Any residue should not be reused.
By applying the drops, prevent the end of the container from coming into contact with the eye or any other surface.
04.3 Contraindications
Hypersensitivity to components or other closely related substances from a chemical point of view.
Hypersensitivity to any component of the preparation.
04.4 Special warnings and appropriate precautions for use
In case of administration of ophthalmic solutions for curative purposes, suspend the instillation of the product.
The use, especially if prolonged, can give rise to sensitization phenomena, in this case stop the treatment and consult the doctor to institute suitable therapy. In case of persistence or worsening of symptoms, suspend use and consult your doctor.
Keep out of the reach and sight of children.
Instructions for Use
HYALISTIL 0.2% in 5 ml and 10 ml bottle
Remove the protective cap and unscrew the cap.
Turn the bottle upside down and instill the eye drops by exerting light pressure on the bottle itself.
Close the bottle by screwing the cap.
HYALISTIL 0.2% in single-dose container
Detach the single dose from the strip.
Open by turning the top without pulling.
04.5 Interactions with other medicinal products and other forms of interaction
No phenomena of interactions of HYALISTIL with other drugs are known to date. It is however recommended to avoid the simultaneous use of other detergent or disinfectant solutions (for example solutions containing quaternary ammonium salts see p. 6.2).
04.6 Pregnancy and lactation
There are no adequate and well-controlled studies on the use of the drug in pregnancy or lactation. Therefore the medicine should only be used if the expected benefit to the mother outweighs the risk to the fetus.
04.7 Effects on ability to drive and use machines
HYALISTIL does not interfere with the ability to drive and use of machines.
04.8 Undesirable effects
Neither local nor systemic adverse drug reactions are known.
This medicinal product contains thiomersal (an organomercurial compound) as a preservative and, therefore, sensitization reactions may occur (see section 4.3).
04.9 Overdose
No cases of overdose have ever been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals.
ATC code: S01XA
Hyaluronic acid sodium salt, active ingredient of HYALISTIL eye drops, is a natural, ultra-pure biopolymer obtained through an original molecular filtration method. The pseudoplasticity, viscoelasticity, adhesiveness to the mucous layer of the tear film, the ability to incorporate molecules of water by Hyaluronic acid sodium salt are the basis of the stabilizing and / or restorative action of the tear film exerted by HYALISTIL eye drops.
The hydration and lubrication of the cornea and conjunctiva make HYALISTIL eye drops a valid tool to be used to improve the tolerability of contact lenses and, more generally, in the symptomatic treatment of dry eye syndrome.
05.2 "Pharmacokinetic properties
Hyaluronic acid, introduced into the baboon's eye as a substitute for the aqueous or vitreous, is rapidly eliminated; introduced into the anterior chamber it follows the normal outflow pathways of the aqueous humor and is subsequently metabolized.
It has already been shown in animals (rabbit and mouse) that exogenous hyaluronic acid administered intravenously disappears rapidly from the bloodstream with a half-life of 2.5-4.5 minutes corresponding to a "clearance" of HA of about 10 mg / kg / day.
Metabolization occurs essentially in the liver where, probably, the Kupffer cells are responsible for the pinocytosis and degradation of the polymer by the lysosomal enzymes that metabolize it to simple saccharide fragments that enter the common pathways of hexoses, the same ones used by the "organism. to metabolize the endogenous hyaluronic acid, widely present in the vitreous body, as well as in the aqueous humor.
05.3 Preclinical safety data
Studies of acute, subacute and chronic toxicity, embryotoxicity, fertility, peri- and postnatal toxicity, mutagenesis and immunogenicity, in the various animal species treated, have shown the absolute lack of toxicity of Hyaluronic acid. sodium.
As far as local tolerability is concerned, following the administration of hyaluronic acid sodium salt in the animal's eye, no intolerance phenomenon has occurred.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
HYALISTIL 0.2% in 5 ml and 10 ml bottle
Sodium chloride - Potassium chloride - Monobasic sodium phosphate monohydrate - Disodium phosphate dodecahydrate - Thiomersal - Purified water.
HYALISTIL 0.2% in single-dose container
Sodium chloride - Potassium chloride - Monobasic sodium phosphate monohydrate - Disodium phosphate dodecahydrate - Purified water.
06.2 Incompatibility
Hyaluronic acid sodium salt can precipitate in the presence of quaternary ammonium salts. The simultaneous use of solutions containing these substances should therefore be avoided. Up to now phenomena of incompatibility of HYALISTIL with other drugs are not known.
06.3 Period of validity
HYALISTIL 0.2% in 5 ml and 10 ml bottle:
3 years.
The shelf life after first opening the bottle is 28 days.
HYALISTIL 0.2% in single-dose container:
3 years.
The single-dose package should only be used immediately after opening. Do not reuse.
06.4 Special precautions for storage
Store below 25 ° C.
Avoid exposure to light and heat sources.
06.5 Nature of the immediate packaging and contents of the package
HYALISTIL 0.2% in 5 ml and 10 ml bottle
Low density polyethylene bottle with a capacity of 5 ml and 10 ml
HYALISTIL 0.2% in single-dose container
20 single-dose containers in low density polyethylene of 0.25 ml of solution.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
S.I.F.I. S.p.A. - Via Ercole Patti, 36 - 95020 Lavinaio - Aci S. Antonio (CT)
08.0 MARKETING AUTHORIZATION NUMBER
HYALISTIL 0.2% eye drops, solution - 5 ml bottle: A.I.C. 032072062
HYALISTIL 0.2% eye drops, solution - 10 ml bottle: A.I.C. 032072074
HYALISTIL 0.2% eye drops, solution - single-dose container: A.I.C. 032072050
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: November 1995
Date of last renewal: November 2010
10.0 DATE OF REVISION OF THE TEXT
January 2012
