CELLUFRESH 5 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the User

Cellufresh5 mg/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.

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

• Keep this package leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the package leaflet

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

1. What is Cellufresh and what is it used for

Cellufresh is a tear substitute and contains a lubricant called sodium carmelose. This medicine is used for the symptomatic relief of irritation and dryness of the eyes.

You should consult a doctor if it worsens or does not improve after 3 days (see section 2).

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

Do not useCellufresh

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

Warnings and precautions

If irritation, pain, redness, or changes in vision occur, or if you think your condition is worsening, stop using this medicine and consult your doctor or pharmacist.

UsingCellufreshwith other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine can be used during pregnancy and breastfeeding.

Driving and using machines

This medicine may cause temporary blurred vision, usually lasting 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 Cellufresh

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

Cellufresh is used by ophthalmic route(applied to the eye).

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

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

Make sure the single-dose container is intact before use. The solution should be used immediately after opening. To avoid possible contamination of the dropper tip and the solution, the dropper should not come into contact with the eye or any other surface.

Wash your hands before use.

To administer correctly, follow these instructions:

1. Remove a single-dose container from the strip.
2. Check that the single-dose container is not damaged.
3. Hold the single-dose container between the index finger and thumb of one hand.

With the index finger and thumb of the other hand, turn the winged piece located at the end of the monodose two full turns.

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

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

If more than one medicine is used by ophthalmic route, the applications of the different medicines should be spaced at least 5 minutes apart.

If you use moreCellufreshthan you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medicine and the amount administered or ingested.

If you forget to useCellufresh

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

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

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people) are: eye irritation (including stinging and burning), eye pain, itching in the eye/eyelid, visual disturbances.

The following side effects may occur, although their frequency cannot be determined:

Blurred vision and increased tearing.

Side effects observed after marketing (whose frequency cannot be determined from the available data) are: allergic reactions (including ocular), sticky eye sensation, redness of the eye/eyelid, ocular surface injury due to the dropper tip coming into contact with the eye surface.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect 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 Cellufresh

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 stated on the container after "EXP". The expiry date is the last day of the month shown.

Store the single-dose containers in the original packaging.

Discard the opened single-dose container after use (do not reuse the container once opened for subsequent doses).

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 your pharmacy. If in doubt, 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 Cellufresh

• The active ingredient is sodium carmelose. Each ml of solution contains 5 mg of sodium carmelose.
• The other ingredients are sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydroxide, hydrochloric acid, and purified water.

Appearance and packaging of the product

Cellufresh is presented in single-dose containers of 0.4 ml of sterile solution. Each carton contains 10 or 30 single-dose containers.

Only certain pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

AbbVie Spain, S.L.U.

Avenida de Burgos 91

28050, Madrid

Spain

Manufacturer:

Allergan Pharmaceuticals Ireland

Westport,

County Mayo,

Ireland

Date of last revision of this package leaflet:February 2014

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