DROPYAL

Package leaflet: Information for the user

DROPYAL 0.015% eye drops, solution

Sodium hyaluronate
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What DROPYAL is and what it is used for

DROPYAL, containing the active substance sodium hyaluronate, is a hydrating ophthalmic solution.
This medicinal product is indicated for the treatment of conditions characterized by insufficient tear production
(dry eye syndromes), as it hydrates and lubricates the cornea and conjunctiva. In addition, DROPYAL is a valuable aid for contact lens wearers.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using DROPYAL

Do not use DROPYAL

• if you are allergic to sodium hyaluronate 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 DROPYAL.

To avoid contamination, take care that the microcontainer and the capsule, once separated, do not come into contact with the eyes or with other non-sterile surfaces.

Other medicines and DROPYAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
DROPYAL may be used during pregnancy and breastfeeding.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use DROPYAL

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For correct use of the medicine, carefully follow these instructions:

• detach a single-dose vial from the strip (Figure A);
• shake the nozzle gently to clear it of liquid;
• open the single-dose vial by twisting the tab and pulling it at the same time (Figure B);
• turn the vial upside down and apply slight pressure to dispense the medicine drop by drop;
• to avoid contamination, take care that the cap and the microvial do not come into contact with the eyes or other non-sterile surfaces;
• reseal the vial by pressing the cap, located under the tab, onto the neck of the vial;
• any remaining solution may be used within 6 hours after opening, provided the microvial is properly sealed and stored in suitable conditions (see section “How to store DROPYAL”).

Figure A Figure B
The recommended dose is 1–2 drops to be instilled into the eye (conjunctival sac), 4 or more times a day, according to the doctor’s judgment.
The duration of treatment depends on the severity of the condition. Consult your doctor if prolonged treatment is needed.
If you use more DROPYAL than you should
Cases of overdose are not known.
If you accidentally ingest or take an excessive amount of this medicine, contact your doctor or the nearest hospital immediately.
If you forget to use DROPYAL
Do not use a double dose to make up for the missed dose.
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 can cause side effects, although not everybody will experience them.
The following adverse reactions may occur:
Frequency not known (frequency cannot be estimated from the available data)

• Transient eye burning immediately after instillation.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the following website: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DROPYAL

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 packaging after "Exp".
The expiry date refers to the last day of that month and to the product in its original intact packaging,
properly stored.
Store the medicine at a temperature not exceeding 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DROPYAL contains

• The active substance is sodium hyaluronate. 100 ml of solution contain 0.015 g of sodium hyaluronate.
• The other components are: carbopolymethylene, glycerol, purified water.

Description of the appearance of DROPYAL eye drops and package contents
Single-dose microcontainers contained in aluminum pouches and packaged in a printed cardboard box.
20 single-dose containers of 0.65 ml.
Marketing Authorization Holder
Bruschettini S.r.l. - Via Isonzo, 6 – 16147 Genoa – Italy
Manufacturer
Excelvision - Rue de la Lombardière – 07100 Annonay - France