PACKAGE LEAFLET

This is a SELF-MEDICATION medicine that can be used to treat
mild and transient disorders 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 adverse effects.

For further information and advice, consult your pharmacist
Consult a doctor if the condition does not resolve after a short period of treatment

IDRASTIL 0.15% eye drops, solution
Sodium Hyaluronate
What it is
IDRASTIL is an artificial tear formulation based on sodium hyaluronate, a natural, ultra-pure molecule obtained through a biotechnological process. Due to its viscosity, sodium hyaluronate protects the ocular surface and stabilizes the tear film.
Why it is used
IDRASTIL is used for the symptomatic treatment of dry eye syndrome.
When it must not be used
Hypersensitivity to the active substance or to any of the excipients.
Due to the presence of benzalkonium chloride, the use of the multi-dose eye drop is contraindicated in wearers of soft contact lenses.
Precautions for use
Avoid concomitant use of IDRASTIL and other ocular cleansing or disinfecting solutions.
Which medicines or foods can affect the medicine’s action
Inform your doctor or pharmacist if you have recently taken any other medicines, including those not requiring a prescription.
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
In case of concomitant use with ocular disinfectants or cleansers, use IDRASTIL only after consulting a doctor.
Pregnancy and breastfeeding (see section "What to do during pregnancy and breastfeeding").
What to do during pregnancy and breastfeeding
During pregnancy and breastfeeding, IDRASTIL should only be used after consulting a doctor and evaluating with him the individual risk/benefit ratio.
Consult your doctor if you suspect you are pregnant or wish to plan a pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
Effects on ability to drive vehicles and use machinery
IDRASTIL does not impair the ability to drive vehicles or operate machinery.
How to use this medicine
Dosage
Apply 1 drop of eye drops into the eye up to 6 times daily.
Caution: do not exceed the recommended doses without medical advice.
When and for how long
Caution: use only for short-term treatment.
Consult a doctor if symptoms recur repeatedly or if you have noticed any recent changes in their characteristics.
The product must not be used for treatment periods longer than one month.
How to use
Instill into the conjunctival sac.
Instructions for opening:
Unscrew the cap, turn the bottle upside down and instill by applying gentle pressure to the bottle.
Close the bottle by screwing the cap tightly.
( any figures )
What to do if you have taken an excessive dose
In case of accidental ingestion/overdose of IDRASTIL, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of IDRASTIL, consult your doctor or pharmacist.
Adverse effects
Like all medicines, IDRASTIL can cause adverse effects, although not everybody experiences them.
Allergic-type reactions such as eyelid or conjunctival inflammation, itching, burning, redness, increased tearing, or superficial keratitis may occur during treatment. These adverse effects are usually transient. However, if they occur, it is advisable to consult your doctor or pharmacist.
Following the instructions in this leaflet reduces the risk of adverse effects. If any of the listed adverse effects worsens, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Expiry date and storage
Unopened packaging: 24 months.
The eye drops must not be used more than 28 days after first opening.
Store at a temperature not exceeding 25°C.
Avoid exposure to light and heat sources.
Caution: do not use the medicine after the expiry date stated on the
packaging.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help
protect the environment.
Keep the medicine out of the reach and sight of children.
It is important to always keep the medicine information available; therefore,
retain both the carton and the package leaflet.
COMPOSITION
100 ml contains:
Active substance: Sodium hyaluronate 0.150 g.
Excipients: Disodium phosphate dodecahydrate – Monobasic sodium phosphate – Sodium chloride –
Benzalkonium chloride – Purified water.
Presentation
5 ml of ophthalmic eye drops solution.
10 ml of ophthalmic eye drops solution.
Marketing Authorization Holder
SIFI S.p.A. - Via Ercole Patti, 36 - 95020 Lavinaio - Aci S. Antonio (CT)
Manufacturer and Final Controller
SIFI S.p.A. - Via Ercole Patti, 36 - 95020 Lavinaio - Aci S. Antonio (CT)
November 2009
BEFORE USE
READ CAREFULLY ALL INFORMATION CONTAINED IN THE

PATIENT LEAFLET

This is a SELF-MEDICATION product that can be used to treat
mild and transient disorders that are easily recognizable and manageable without medical
advice.
It can therefore be purchased without a prescription, but must be used correctly to ensure
its effectiveness and reduce the risk of adverse effects.

For further information and advice, consult your pharmacist
Consult a doctor if the condition does not resolve after a short period of treatment

IDRASTIL 0.15% eye drops, solution
Sodium Hyaluronate
What it is
IDRASTIL is an artificial tear formulation based on sodium hyaluronate, a natural, ultra-pure molecule obtained through a biotechnological process. Due to its viscosity, sodium hyaluronate protects the ocular surface and stabilizes the tear film.
Why it is used
IDRASTIL is used for the symptomatic treatment of dry eye syndrome.
When it must not be used
Hypersensitivity to the active substance or to any of the excipients.
Precautions for use
Avoid simultaneous use of IDRASTIL and other ocular cleansing or disinfecting solutions.
Which medicines or foods can affect the action of this medicine
Inform your doctor or pharmacist if you have recently taken any other medicine, including those available without a prescription.
It is important to know that
Sodium hyaluronate may precipitate in the presence of quaternary ammonium salts. Therefore, simultaneous use of solutions containing such substances should be avoided.
When it should only be used after consulting a doctor
If you are using ocular disinfectants or cleansers concurrently, use IDRASTIL only after consulting your doctor.
Pregnancy and breastfeeding (see section "What to do during pregnancy and breastfeeding").
What to do during pregnancy and breastfeeding
During pregnancy and breastfeeding, IDRASTIL should only be used after consulting a doctor and evaluating with them the benefit-risk ratio in your individual case.
Consult your doctor if you suspect you are pregnant or if you plan to become pregnant.
Effects on the ability to drive vehicles and use machinery
IDRASTIL does not impair the ability to drive vehicles or operate machinery.
How to use this medicine
Dosage
Instill 1 drop of eye drops into the eye up to 6 times daily.
Caution: Do not exceed the recommended doses without medical advice.
When and for how long
Caution: Use only for short treatment periods.
Consult your doctor if symptoms recur frequently or if you notice any recent changes in their characteristics.
How to use
Instill into the conjunctival sac.
The single-dose container must be used immediately after opening. Any remaining solution must not be reused.
Instructions for opening:
Before use, ensure the single-dose container is intact.
Detach the single-dose container from the strip.
Open by twisting the top part without pulling.
Avoid contact between the tip of the container and the eye or any other surface. (figures if applicable )
What to do if you have used too much medicine
In case of accidental ingestion/overdose of IDRASTIL, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of IDRASTIL, consult your doctor or pharmacist.
Undesirable effects
Like all medicines, IDRASTIL can cause undesirable effects, although not everyone experiences them.
Allergic-type reactions such as inflammation of the eyelids or conjunctiva, itching, burning, redness, increased tearing, or superficial keratitis may occur during treatment. These adverse effects are generally transient. However, if they occur, it is advisable to consult your doctor or pharmacist.
Following the instructions in this leaflet reduces the risk of adverse effects. If any of the listed adverse effects worsens, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Expiry and storage
Unopened packaging: 24 months.
No special storage precautions required.
Avoid exposure to light and heat sources.
The single-dose container must be used immediately after opening. Any remaining solution must not be reused.
Caution: Do not use this medicine after the expiry date stated on the
packaging.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of 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 medicine information available; therefore,
keep both the outer box and the patient leaflet.
COMPOSITION
100 ml contains:
Active substance: Sodium hyaluronate 0.150 g.
Excipients: Disodium phosphate dodecahydrate - Monobasic sodium phosphate - Sodium chloride – Purified water.
Presentation
20 single-dose containers of 0.3 ml eye drops
40 single-dose containers of 0.3 ml eye drops
Marketing Authorization Holder
SIFI S.p.A. - Via Ercole Patti, 36 - 95020 Lavinaio - Aci S. Antonio (CT)
Manufacturer and Final Controller
SIFI S.p.A. - Via Ercole Patti, 36 - 95020 Lavinaio - Aci S. Antonio (CT)
November 2009