SICCAFLUID 2.5 mg/g OPHTHALMIC GEL SINGLE-DOSE

Introduction

Package Leaflet: Information for the User

SICCAFLUID 2.5 mg/g OPHTHALMIC GEL IN UNIT DOSE

Carbomer 974 P

Read this package leaflet carefully because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If your symptoms worsen or persist, you should consult your doctor.
• If you think any of the side effects that you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet

1. What is Siccafluid and what is it used for
2. Before using Siccafluid
3. How to use Siccafluid
4. Possible side effects
5. Storage of Siccafluid
6. Further information

1. What is Siccafluid and what is it used for

Siccafluid is a tear substitute and contains a lubricant called Carbomer 974P.

It is an ophthalmic gel used for the relief of symptoms of dry eyes (such as inflammation, burning, irritation, or dryness) caused when the eyes do not produce enough tears.

2. Before using SICCAFLUID

Do not use Siccafluid

•If you are allergic (hypersensitive) to carbomer or any of the other components of Siccafluid listed in section 6, "What contains Siccafluid".

Be careful with Siccafluid

•If your condition worsens or does not improveafter starting treatment with Siccafluid, contact your doctor.

•DO NOT INJECT, DO NOT INGEST.

Children and adolescents up to 18 years of age

The safety and efficacy of SICCAFLUID in children and adolescents at the recommended posology for adults have been established based on clinical experience, but no clinical studies are available.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

If you need to use any other ophthalmic medication during treatment with Siccafluid: first use the other ophthalmic medication and wait 15 minutes before using Siccafluid.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, contact your doctor to consult before starting the use of Siccafluid.

He or she will decide if you can use Siccafluid.

Driving and using machines

Your vision may become blurry for a short time after using Siccafluid.

You should not drive or use machinery until your vision returns to normal.

3. How to use Siccafluid

If you have been recommended Siccafluid for use, follow exactly the administration instructions indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The doseusuallyis 1 drop administered in the affected eye or eyesup to4 times a day.

Children and adolescents up to 18 years of age

The safety and efficacy of SICCAFLUID in children and adolescents at the recommended posology for adults have been established based on clinical experience, but no clinical studies are available.

How to use:

Wash your hands before opening the unit dose container.

Check that the gel is at the tip of the container. To open the container, turn until the tab on the top breaks.

Tilt your head back and look up.

1. Gently pull down the lower eyelid of the affected eye until a small "pouch" forms.
2. Turn the container upside down. Press until a drop falls into the "pouch".
3. Release the lower eyelid and blink several times.
4. Repeat steps 1 to 3 in the other eye if it also needs to be treated.

To help prevent infection, do not touch the eye, surrounding areas, or any other area with the tip of the container.

Discard the unit dose container after use. Do not save it for later use.

If you use more Siccafluid than you should

Using more drops of Siccafluid than you should does not cause any harm.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to use Siccafluid

Do not use a double dose to make up for the forgotten dose. Apply the next dose according to the frequency you have established.

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

4. Possible side effects

Like all medications, Siccafluid can cause side effects, although not everyone gets them.

Contactyour doctor if:

•Your symptoms worsen or do not improve after starting treatment with Siccafluid.

If you experience any of the following side effects after applying the ophthalmic gel to the eye, talk to your doctor if it concerns you:

•Transient blurred vision

•Mild itching or burning sensation in the eye.

The side effects mentioned may occur, but the number of people likely to be affected may vary.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Siccafluid

Keep out of the reach and sight of children.

Do not use Siccafluid 2.5 mg/g ophthalmic gel after the expiration date that appears on the container and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C. Keep the unit dose containers in the original packaging to protect them from light.

Discard the unit dose container with the remaining solution immediately after use.

Do not save for later use.

Medications should not be thrown away through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.In this way, you will help protect the environment.

6. Further information

Composition of Siccafluid

• The active ingredient is Carbomer 974 P 2.5mg/g.
• The other ingredients are sorbitol, lysine monohydrate, sodium acetate trihydrate, polyvinyl alcohol, and water for injection.

Appearance of the product and container contents

Siccafluid is a slightly yellowish opalescent gel in unit dose containers.

Each unit dose container contains 0.5 g of gel.

Each box contains 10, 20, 30, or 60 unit dose containers (not all presentations may be marketed).

Marketing authorization holder

LABORATORIOS THEA S.A.

C/ Enric Granados, nº 86-88, 2ª planta, 08008 Barcelona

Manufacturer

LABORATOIRES UNITHER

1 RUE DE L’ARQUERIE 50200 COUTANCES

FRANCE

OR

LABORATOIRES UNITHER

INDUSTRIAL AREA NORTH

151, RUE ANDRÉ DUROUCHEZ – BP 28028

80084 AMIENS CEDEX-2

FRANCE

This medication is authorized in the member states of the European Economic Area under the following names:

France, Spain, Italy, and Portugal: ……………………………….. SICCAFLUID

Netherlands …………………………………………………… SICCAFLUID UNIDOSE

Iceland and Norway …………………………………………….. OFTAGEL

This package leaflet was approved in March 2015

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