VISCOFRESH 10 mg/ml EYE DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the User

Viscofresh10 mg/ml eye drops, solution in single-dose container

sodium carmelose

Read the entire package leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Viscofresh and what is it used for

Viscofresh is a tear substitute and contains the lubricant sodium carmelose. It is used to treat the symptoms of dry eye (such as pain, itching, irritation, or dryness) caused by not producing enough tears to keep the eye moist.

2. What you need to know before you start using Viscofresh

Do not use Viscofresh:

• If you are allergic to sodium carmelose or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• If you wear contact lenses, they should be removed before using Viscofresh. Lenses can be put back 15 minutes after application.
• If irritation, pain, redness, or changes in vision occur, or if your condition worsens, stop using this medicine and consult your doctor or pharmacist.
• To avoid contamination or possible eye injuries, do not let the open end of the single-dose container come into contact with the eye or any other surface.

Other medicines and Viscofresh

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

If you are using other eye drops, wait at least 15 minutes between administration of the other drops and Viscofresh.

Pregnancy and breastfeeding

Viscofresh can be used during pregnancy and breastfeeding.

Driving and using machines

Viscofresh may cause temporary blurred vision, usually for 1 to 15 minutes. If you experience temporary blurred vision, do not drive or use machines until your vision is clear.

3. How to use Viscofresh

Viscofresh is for ophthalmic use (applied to the eye).

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is 1-2 drops of Viscofresh in the affected eyes, as needed.

Make sure the single-dose container is intact before use. The solution should be used immediately after opening. Wash your hands before use.

1. Separate one of the single-dose containers from the strip of several containers.

1. Hold the single-dose container in a vertical position (with the cap upwards) and twist the cap.

1. Gently pull down the lower eyelid to form a pouch. Turn the single-dose container upside down and squeeze it to apply one drop to each eye. Blink a few times.

Do not reuse the single-dose container even if some solution remains. It is very important that you discard it and do not keep it.

If you use more Viscofresh than you should

It will not cause you any harm. If you are concerned, talk to your doctor or pharmacist.

If you forget to use Viscofresh

Apply the next dose as needed or following the usual routine indicated by your doctor or pharmacist. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The adverse reactions or medically relevant effects mentioned below have been identified during clinical trials:

Common(may affect up to 1 in 10 people):

• eye irritation (including itching and discomfort)
• eye pain
• eye itching
• visual disturbances

Post-marketing experience

The adverse reactions or medically relevant effects mentioned below have been reported during post-marketing experience:

Uncommon(may affect up to 1 in 100 people):

• allergic reaction (including ocular or eyelid inflammation)
• blurred vision
• increased tear production (also known as lacrimation)
• sticky eye
• crust on the eyelid and/or residue of the medicine
• feeling of having something in the eye
• ocular/eyelid redness
• worsening of vision
• injury to the surface of the eye due to the dropper coming into contact with the eye during administration of the eye drops.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Viscofresh

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the single-dose container, on the aluminum bag, and on the carton after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C.

Keep the single-dose containers in the bag and put the bag back in the box. The bag is necessary to prevent loss of moisture.

Do not use if the container shows signs of tampering. Do not use this medicine if you notice the solution changes color or becomes cloudy.

Medicines should not be disposed of via wastewater or household waste. Dispose of the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Viscofresh

• The active substance is sodium carmelose, 10 mg/ml.

• The other ingredients are: sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, and purified water.

The components used in Viscofresh 10 mg/ml were chosen to match those found in naturally produced tears.

Appearance and pack contents

Viscofresh is a clear, colorless to slightly yellowish solution in a small, transparent container (bubble type) known as a single-dose container. The single-dose container has a twist-off cap. Each single-dose container contains 0.4 ml of solution.

Each box contains 10, 20, 30, 40, 60, or 90 single-dose containers in an aluminum bag.

Each aluminum bag contains 10 single-dose containers.

Not all pack sizes may be marketed.

Marketing authorization holder:

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid

Spain

Manufacturer:

Allergan Pharmaceuticals Ireland.

Westport, Co. Mayo,

Ireland

Date of last revision of this package leaflet:March 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es