HYALISTIL

BEFORE USE, READ CAREFULLY ALL THE INFORMATION
CONTAINED IN THIS LEAFLET
This is a self-medication product intended for the treatment of mild and transient conditions that are easily recognizable and resolvable without medical advice.
It may therefore be purchased without a prescription, but must be used correctly to ensure its effectiveness and reduce the risk of unwanted side effects.

• For further information and advice, consult your pharmacist.
• Consult a doctor if symptoms do not resolve after a short period of treatment.

HYALISTIL 0.2% eye drops, solution
Sodium hyaluronate
What it is
Artificial tears.
Why it is used
Hyalistil is used for the symptomatic treatment of dry eye syndrome.
When it must not be used
Hypersensitivity to the components or to other substances closely related from a chemical standpoint.
Hypersensitivity to any component of the formulation.
Precautions for use
If other ophthalmic solutions are administered for therapeutic purposes, discontinue instillation of this product.
Prolonged use, especially, may lead to sensitization phenomena; in such cases, discontinue treatment and consult a doctor to establish appropriate therapy. If symptoms persist or worsen, discontinue use and consult a doctor.
Which medicines or foods can alter the effect of this medicine
To date, no interactions between HYALISTIL and other drugs are known. However, it is advisable to avoid concomitant use of other cleaning or disinfectant solutions.
If you are using other medicines, consult your doctor or pharmacist.
It is important to know that
Sodium hyaluronate may precipitate in the presence of quaternary ammonium salts.
Therefore, concomitant use of solutions containing such substances should be avoided.
When it should only be used after consulting a doctor
Pregnancy and breastfeeding (see What to do during pregnancy and breastfeeding).
What to do during pregnancy and breastfeeding
During pregnancy and breastfeeding, HYALISTIL should be used only after consulting a doctor and evaluating with him the risk-benefit ratio in your specific case.
Consult your doctor if you suspect you are pregnant or plan to become pregnant.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
HYALISTIL does not interfere with the ability to drive or use machinery.
Important information about some excipients in Hyalistil
This medicinal product contains thiomersal as a preservative, and therefore allergic reactions may occur.
How to use this medicine
Dosage
Two drops of eye drops 3 or more times daily.
Caution: do not exceed the recommended doses.
When and for how long
Caution: use only for short treatment periods.
Consult a doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.
How to use
Instill into the conjunctival sac.
HYALISTIL in single-dose containers must be used immediately after opening. Any remaining solution must not be reused.
Instructions for use

HYALISTIL in 5 ml and 10 ml bottles

Remove the protective cap and unscrew the cap. (Pictogram)
Turn the bottle upside down and instill the eye drops by gently squeezing the bottle.
Close the bottle by screwing the cap back on.
HYALISTIL in single-dose containers
Before use, ensure the single-dose container is intact.
Detach the single-dose container from the strip. (Pictogram)
Open by twisting the top part without pulling. (Pictogram)
Avoid letting the tip of the container touch the eye or any other surface.
What to do if you have taken an excessive dose
In case of accidental ingestion/overdose of Hyalistil, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Hyalistil, consult your doctor or pharmacist.
Undesirable effects
Like all medicines, Hyalistil can cause side effects, although not everyone experiences them.
Following the instructions in this leaflet reduces the risk of side effects.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
No adverse reactions, either local or systemic, are known.
Expiry and storage
Expiry date: see the date on the packaging.
The expiry date refers to the product in unopened packaging, stored correctly.
Caution: do not use the medicine after the expiry date stated on the packaging.
Store below 25°C.
Avoid exposure to light and heat sources.
HYALISTIL 0.2% in 5 ml and 10 ml bottles: The shelf life after first opening is 28 days.
HYALISTIL 0.2% in single-dose containers:
Single-dose containers must be used immediately after opening. Do not reuse.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This helps protect the environment.
Keep the medicine out of the reach and sight of children.
It is important to always have medicine information available; therefore, always keep both the packaging and the leaflet.
COMPOSITION
HYALISTIL 0.2% in 5 ml and 10 ml bottles
Each 1 ml of eye drops, solution contains:
Active substance: Sodium hyaluronate 2 mg
Excipients: Sodium chloride - Potassium chloride - Monobasic monohydrate sodium phosphate - Dodecahydrate disodium phosphate - Thiomersal - Purified water.
HYALISTIL 0.2% in single-dose containers
Each single-dose container contains 0.25 ml of eye drops, solution.
Each 1 ml of eye drops, solution contains:
Active substance: Sodium hyaluronate 2 mg
Excipients: Sodium chloride - Potassium chloride - Monobasic monohydrate sodium phosphate - Dodecahydrate disodium phosphate - Purified water.
Presentation
HYALISTIL 0.2% is available as eye drops, solution.
Pack contents:
HYALISTIL 0.2% eye drops, solution: 5 ml bottle.
HYALISTIL 0.2% eye drops, solution: 10 ml bottle.
HYALISTIL 0.2% eye drops, solution: 20 single-dose containers of 0.25 ml.
Marketing Authorization Holder
S.I.F.I. S.p.A. - Registered office: Via Ercole Patti, 36 - 95020 Lavinaio - Aci S. Antonio (CT)
Manufacturer
S.I.F.I. S.p.A. – Via Ercole Patti, 36 – 95020 Lavinaio - Aci S. Antonio (CT)
January 2012