Instructions for Use: NovaTears® Lubricating Eye Drops 3mL

Eye drops containing Perfluorohexyloctane (EyeSolTM; 100 % v/v)

What is NovaTears® and what is it used for?

NovaTears® is a water-free, preservative-free eye drops liquid and does not contain phosphate. Each clear, round 5 mL polypropylene bottle is filled with 1 mL or 3 mL NovaTears®.

NovaTears® contains Perfluorohexyloctane (EyeSol™) as sole ingredient. NovaTears® can be used by vegans.

NovaTears® ophthalmic solution eye drops relieve the symptoms associated with dry eye by lubricating and protecting the corneal surface, stabilizing the lipid layer of the tear film, and reducing the evaporation of the underlying water phase of the tear film.

NovaTears® drops are intended for topical use in the eye only.

What you need to consider before applying NovaTears®?

Do not use NovaTears® if you are hypersensitive (allergic) to Perfluorohexyloctane.

NovaTears® is supplied as a sterile liquid. Do not use NovaTears® if the bottle or the tamper evident seal ring is damaged. Do not use NovaTears® after its expiration date or beyond 6 months from the initial opening.

Take special care with the use of NovaTears® if you are concurrently using other eye medication. Please keep a time distance of at least 15 minutes between the applications.

NovaTears® must not be used if you wear contact lenses due to the lack of data concerning the compatibility of NovaTears® with the contact lens materials.

NovaTears® drops are intended for topical use in the eye only. Do not drink the liquid.

Children:

NovaTears® should not be used in children under 18 years.

Pregnant and breast-feeding women:

NovaTears® is not recommended for use in pregnant or breast-feeding women due to a lack of data on safety.

How to use NovaTears®?

Unless your physician recommends otherwise, administer 1 drop up to 4 times daily in the lower eyelid.

Read and follow these instructions carefully.

1. Wash your hands well with soap and water.

2. Unscrew the cap of the bottle.

3. Prior to the first administration of NovaTears® you must separate the cap from the safety seal ring below the cap and remove it.

4. Avoid any contact of the dropper with the skin, eye, and eyelashes, after removing the cap.

5. To avoid loss of solution please read steps 6 to 8 carefully before applying the eye drops.

6. Hold the opened bottle with the dropper pointing upwards and gently press the bottle between thumb and index finger.

7. Keep the bottle under slight pressure and turn the bottle until the dropper points downwards.

8. With the dropper pointing downwards reduce the pressure on the bottle to allow some air to flow into the bottle.

9. Lean your head back slightly and carefully pull down your lower eyelid. Look upwards.

10. Hold the opened bottle with the dropper pointing downwards above your eye. Apply gentle pressure on the bottle and administer 1 drop per eye.

Note: Due to the special properties of NovaTears® you may not feel the drop falling into your eye. We recommend application in front of a mirror.

11. Do not touch the dropper with your eye or lashes.

12. For an even distribution, close your eyes after applying NovaTears®. Do not blink or rub your eyes.

13. Put the screw cap back on after administration

14. Wash your hands again with soap and water to remove any residue.

Discard NovaTears® 6 months after first opening the bottle.

Possible side effects of NovaTears®

Signs of temporary ocular irritation (like a burning or itching sensation in the eyes or eye redness) and temporary blurred vision have been reported after the application of NovaTears®. If you experience these effects stop the treatment and seek advice at your doctor or pharmacist.

If too much NovaTears® is used

You should only use NovaTears® as directed. Immediately contact your doctor, pharmacist, or phone the Poisons Information Centre in Australia (13 11 26) or the National

Poisons Information Centre in New Zealand (0800 POISON or 0800 764 766) or go to the Emergency department at your nearest hospital, if you think that you may have used too much, or if anyone else has taken any NovaTears® by mistake. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Take the pack of NovaTears® with you, if you can.

Keep the telephone numbers for these places handy.

How to store NovaTears®?

Store below 25 °C

NovaTears® can be used for up to 6 months after first opening.

Keep out of the reach and sight of children.

If you want to know more

If you have any questions regarding this product talk to your doctor, pharmacist, ophthalmologist, optometrist, or other health professionals.

Distributed by:

Australia:

AFT Pharmaceuticals Pty Ltd, 113 Wicks Road, North Ryde, Sydney NSW 2113

New Zealand:

AFT Pharmaceuticals Ltd, Auckland

Manufacture by:

Novaliq GmbH

Im Neuenheimer Feld 515, 69120 Heidelberg, Germany

These instructions for use were updated in November 2023.