Package Leaflet: Information for the User

Cellufresh5 mg/ml eye drops in single-dose solution

Sodium Carmelose

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• For advice on any aspect of your dose, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. See section 4.
• You must see a doctor if you get worse or do not improve after 3 days.

1. What Cellufresh is and what it is used for

2. What you need to know before using Cellufresh

3. How to use Cellufresh

4. Possible side effects

5. Storage of Cellufresh

6. Contents of the pack and additional information

Cellufresh is an artificial tear substitute and contains a lubricant called sodium carboxymethylcellulose. This medication is used for the symptomatic relief of eye irritation and dryness.

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

Do not useCellufresh

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

Warnings and precautions

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

Use ofCellufreshwith other medications

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

Pregnancy, breastfeeding, and fertility

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

This medication may be used during pregnancy and breastfeeding.

Driving and operating machinery

This medication 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.

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

Cellufreshis used byocular route(applied to the eye).

The recommended dose is one or two drops in the affected eye or eyes as needed or as indicated by your specialist.

No need to remove contact lenses before using Cellufresh.

Make sure the single-use vial is intact before use. The solution must be used immediately after opening. To avoida 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.

For correct administration, follow the following instructions:

1. Remove a single-use vial from the strip.
2. Check that the single-use vial is not damaged.
3. Hold the single-use vial between the index and middle fingers of one hand.

With the index and middle fingers of the other hand, turn two full turns the winged piece located at the end of the single-use vial.

1. Gently pull to remove the winged piece.
2. Gently pull down the lower eyelid to form a pouch. Turn the single-use vial downwards and press it to apply one drop to each eye. Blink a couple of times.

Do not use the single-use vial again even if there is solution remaining.

If more than one medication is used by ocular route, the applications of the different medications should be spaced at least 5 minutes apart.

If you use moreCellufreshthan you should

No harm will be done. If you are concerned, speak with your doctor or pharmacist.

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

If you forgot to useCellufresh

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

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

Like all medications,Cellufreshmay cause adverse effects, although not everyone will experience them.

The frequent adverse effects (may affect between 1 and 10 out of 100 people) are: eye irritation (including burning and stinging), eye pain, eye/eyelid itching, visual disturbances.

The following adverse effects are known to occur, although the frequency cannot be determined:

Blurred vision and increased tearing.

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed 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 about the safety of this medication.

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

Do not store at a temperature above25ºC.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Storesingle-dose containers in the original packaging.

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

Do not use this medication if you observe that the solution changes color or becomes cloudy.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the Sigre Pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Cellufresh

• The active principle is sodium carboxymethylcellulose. Each milliliter of solution contains 5 mg of sodium carboxymethylcellulose.
• The other components are sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydroxide, hydrochloric acid, and purified water.

Appearance of the product and contents of the packaging

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

Only some sizes of containers may be commercially available.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization:

AbbVie Spain, S.L.U.

Avenida de Burgos 91

28050, Madrid

Spain

Manufacturer responsible:

Allergan Pharmaceuticals Ireland

Westport,

CountyMayo,

Ireland

Last review date of this leaflet:February 2014

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