VISCOFRESH 5 mg/ml EYE DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the User

VISCOFRESH 5mg/ml eye drops, solution in single-dose container

Sodium carmelose

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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
   1. Storage of Viscofresh

1. 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. This is used for the treatment of symptoms of dry eye (such as pain, burning, irritation or dryness).

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

Consult your doctor or pharmacist before you start using Viscofresh.

• If irritation, pain and changes in vision occur or if the symptoms worsen, or if you think your situation is getting worse, stop using this medicine and consult your doctor or pharmacist.

Other medicines and Viscofresh

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

If you are using any other eye product, you should administer it 5 minutes before applying Viscofresh.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Viscofresh can be used during pregnancy and breast-feeding.

Driving and using machines

Viscofresh may cause temporary blurred vision, do not drive or operate hazardous machinery until your vision is clear.

3. How to use Viscofresh

Follow exactly the administration instructions of the medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Viscofresh is for ophthalmic use.

The recommended dose is one or two drops in the affected eye(s) as often as needed or as indicated by your specialist.

It is not necessary to remove contact lenses before using Viscofresh.

To use the product properly:

• Separate one of the single-dose vials from the strip formed by several.
• Before applying the solution to the eye, check that the single-dose container is not broken.
• Open the container by exerting pressure on the top part.
• Apply one or two drops to the affected eye(s) immediately after opening the container and discard the rest of it.

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

1. Separate one of the single-dose containers from the strip formed by several containers.
2. Hold the single-dose container in a vertical position (with the cap upwards) and turn the cap.
3. 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 couple of times.

Do not reuse the single-dose container even if there is remaining solution.

If you use more Viscofresh than you should

If you accidentally use too much Viscofresh or in case of accidental ingestion, contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

2. If you forget to use Viscofresh
3. Apply one drop to the eye(s) that need treatment as soon as you remember, and then return to your usual routine. Do not use a double dose to make up for forgotten doses.
5. If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Common side effects (occur in 1 to 10 patients out of 100): Eye irritation (including burning and stinging), eye pain, itching in the eye/eyelid, visual disturbances.

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

Side effects observed after marketing (whose frequency cannot be determined) are: allergic reactions (including ocular), blurred vision and increased tearing, sticky eye sensation, eye redness, injury to the ocular surface due to the dropper coming into contact during the application of the eye drops.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist or nurse, even if it is possible side effects not listed in this package leaflet. You can also report them 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 store above 25°C.

Do not use this medicine after the expiry date which is stated on the container after “CAD”. The expiry date is the last day of the month shown.

Do not use Viscofresh if the container shows signs of tampering.

Viscofresh is a colorless or slightly yellowish solution. Do not use the container if a change in color or clouding of its contents is observed.

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the SIGRE collection point at your pharmacy. If you have any further questions, 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 ingredient is sodium carmelose.
• The other ingredients are: sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, hydrochloric acid or sodium hydroxide for pH adjustment and purified water.

Appearance of the product and contents of the container

Viscofresh is presented as a sterile solution eye drops in single-dose container. Each single-dose container contains 0.4 ml of solution.

The single-dose container has a cap that opens by twisting the tab.

It is presented in a format of 10 single-dose vials or 30 single-dose vials in a sealed aluminum bag. One aluminum bag contains 10 single-dose vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid,

Spain

Manufacturer:

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

County Mayo

Ireland

Date of the last revision of this package leaflet:

11/2017

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