Leaflet: information for the user

Viscofresh10 mg/ml eye drop solution in single-dose container

Sodium carmelose

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Viscofreshis an artificial tear substitute and contains the lubricant called sodium carboxymethylcellulose. It is used for the treatment of symptoms of dry eye (such as pain, burning, irritation or dryness). You should consult your doctor if it worsens or does not improve.

Do not use Viscofresh:

If you are allergic (hypersensitive) to sodium carboxymethylcellulose or to any of the other components of this medication (listed in section 6).

Warnings and precautions

If you use contact lenses, they must be removed before using Viscofresh. Contact lenses can be reinserted 15 minutes after its application.

Use of Viscofresh with other medications

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medication.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Viscofresh can be used during pregnancy and breastfeeding.

Driving and operating machines

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

Viscofreshis used by ocular route (applied to the eye).

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor, pharmacist or nurse. In case of doubt, ask your doctor, pharmacist or nurse.

The recommended dose is 1-2 drops ofViscofreshin the affected eyes, as needed.

Make sure the single-use container is intact before use. The solution must be used immediately after opening.To avoid contamination or possible eye injury, the dropper should not come into contact with the eye or any other surface.Wash your hands before use.

1. Separate one of the single-use containers from the strip formed by several containers.

1. Hold the single-use container in a vertical position (with the cap facing upwards) and turn the cap.

1. Pull your lower eyelid down to form a pouch. Turn the single-use container downwards and press it toapply one drop to each eye. Blink a couple of times.

Do not use the single-use container again even if there is solution left. It is very important to dispose of it and not keep it.

If irritation, pain, redness or changes in vision occur, or if you consider your condition to worsen, stop using this medication and consult your doctor or pharmacist.

If you use more Viscofreshthan you should

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

If you forgot to use Viscofresh

Apply the next dose as needed, or following the normal schedule indicated by your doctor or pharmacist. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor, pharmacist or nurse.

Like all medications, this medicationmay cause adverse effects, although not all people will experience them.

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

Frequent Adverse Effects(may affect up to 1 in 10 patients):

Eye irritation (including burning and discomfort), eye pain, eye itching, visual disturbances.

Post-Marketing Experience

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

Rare Adverse Effects(may affect up to 1 in 100 patients):

Allergic reaction (including eye or eyelid inflammation), blurred vision, increased tear production (also known as tearing), sticky eye, crust on the eyelid and/or residue of medication, eye redness/palpebral, worsening of vision,corneal abrasion due to the dropper coming into contact with the eye during administration of the eye drops.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the single-dose packaging, in the aluminum bag, and on the carton after EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store the single-dose packaging in the bag and put the bag back in the box. The bag is necessary to prevent moisture loss.Do not use if the packaging is damaged. Do not use this medication if you observe that the solution changes color or becomes turbid.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the Sigre Point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Viscofresh

• The active principle is sodium carboxymethylcellulose, 10 mg/ml.

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

The components ofViscofresh10 mg/mlwere designed to simulate the natural composition of your tear.

Appearance of the product and contents of the package

Viscofreshis presented as an eye drop solution with a transparent appearance, colorless to slightly yellowish in a small transparent package (bubble type) known as a single-dose package. The single-dose package has a flip-top cap. Each single-dose package contains 0.4 ml of solution.

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

Each aluminum bag contains 10 single-dose packages.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid

Spain

Manufacturer responsible:

Allergan Pharmaceuticals Ireland.

Westport, Co.Mayo,

Ireland

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:April 2020

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