Package Leaflet: Information for the User

Lagroben 5 mg/ml Eye Drops in Single-Use Container

Sodium Carmelose

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

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 3 days.

1.What Lagroben is and what it is used for

2.What you need to know before using Lagroben

3.How to use Lagroben

4.Possible side effects

5.Storage of Lagroben

6.Contents of the pack and additional information

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

You should consult a doctor if it worsens or does not improve after 3 days.

Do not use Lagroben

If you are allergic to sodium caramel 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 is worsening, stop using this medication and consult your doctor or pharmacist.

Use of Lagroben with other medications

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

Pregnancyandlactation

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

Lagroben may be used during pregnancy and lactation.

Driving and operating machines

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

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

Lagroben is used by topical ocular route (applied to the eye).

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

Ensure the single-use container is intact before use. The solution must be used immediately after opening. To avoidapossible contamination of the dropper and the solution, the dropper should not come into contact with the eye or any other surface.

Wash your hands before use.

To ensure correct administration, follow the following instructions:

1.Removeoneunitfromthestripofsingle-usecontainers.

2.Check that the single-use container is not damaged.

3.Hold the single-use container between the index and thumb of one hand.

Withtheindexandthumboftheotherhand,performalightleveronthewingedpiecetoopenit.Donotrotatetobreakit.

4.Removethewingedpiece.

5.Slowly pull the lower eyelid downwards to form a pouch. Turn the single-use container downwards and press it to apply one drop to each eye. Blink a couple of times.

Do not use the single-use container again even if there is solution left.

If you use more than one eye medication, the applications of the different medications should be spaced at least 5 minutes apart.

If you use more Lagroben than you should

You will not be harmed. 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 Toxicological Information Service, Telephone 91 562 04 20, indicating the medication and the amount administered or ingested.

If you forget to use Lagroben

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 the missed doses.

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

Like all medications, Lagroben may produce adverse effects, although not everyone will experience them.

The following adverse effects have been reported, but the number of people who may be affected is unknown:

• Eye irritation, burning sensation, or stinging,
• Blurred vision,
• Increased tear production (also known as tearing).

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 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.

Store single-dose containers in the original packaging.

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

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

Medications should not be thrown down the drains or in the trash.Deposit the containers and medications you no longer need at the Sigre Point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lagroben:

• The active principle is sodium carboxymethylcellulose. Each ml 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 water for injection preparations.

The components of Lagroben have been designed to simulate the natural composition of your tear.

Appearance of the product and contents of the packaging

Lagroben is presented in single-dose vials of 0.4 ml sterile solution. Each cardboard box containsa foil pouch with10 or 30 single-dose vials.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Ed. Albatros B, 1st floor

28108 Alcobendas - Madrid

Responsible for Manufacturing

Neuraxpharm Pharmaceuticals, S.L.Avda. de Barcelona, 69

08970 Sant Joan Despi (Barcelona), Spain

Last review date of this leaflet:February2014

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.gob.es/