Package Insert: Information for the User

SICCAFLUID 2.5 mg/g EYE GEL IN UNITS

Carbomer 974 P

Read this package insert carefully as it contains important information for you.

-Keep this package insert, as you may need to read it again.

-If you need advice or more information, consult your pharmacist.

-If symptoms worsen or persist, you should consult a doctor

-If you consider any of the adverse effects you are experiencing to be severe or if you notice any effect not mentioned in this package insert, inform your doctor or pharmacist.

1. What is Siccafluid and what it is used for

2. Before using Siccafluid

3. How to use Siccafluid

4. Possible adverse effects

5. Storage of Siccafluid

6. Additional information

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

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

Do not use Siccafluid

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

Be especially 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 adult dosage have been established based on clinical experience, but there are no clinical studies available.

Use of other medications

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

If you need to use any other eye medication during treatment with Siccafluid: use the other eye medication first 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 use of Siccafluid.

They will decide if you can use Siccafluid.

Driving and operating machinery

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

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

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 any doubts.

The usual dose is 1 drop administered in the affected eye or eyes up to 4 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 adult dosage have been established based on clinical experience, but there are no clinical studies available.

How to use:

Wash your hands before opening the single-dose container.

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

Incline your head back and look up.

1. Gently pull down on 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, the surrounding areas, or any other surface with the tip of the container.

Dispose of the single-dose container after use. Do not save it for later use.

If you use more Siccafluid than you should

The use of 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 Toxicological Information Service, phone: 91 562 04 20.

If you forgot to use Siccafluid

Do not use a double dose to compensate for the missed dose. Apply the next dose according to the established frequency.

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

Like all medications, Siccafluid may produce adverse effects, although not all people will experience them.

Contact your doctor if:

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

If you experience any of the following adverse effects after applying the eye gel, speak with your doctor if it concerns you:

•Transient blurred vision

•Mild itching or burning sensation in the eye.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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://notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children.

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

Do not store at a temperature above 25°C. Store single-use containers in the original packaging to protect them from light.

Dispose of the single-use container with the remaining solution immediately after use.

Do not store for later use.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point at the 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.

Composition of Siccafluid

• The active principle is Carbomer 974 P at 2.5mg/g.
• The other components are sorbitol, monohydrate of lysine, trihydrate of sodium acetate, polyvinyl alcohol, and water for injections.

Appearance of the product and contents of the package

Siccafluid is an opalescent, slightly yellowish gel in single-dose containers.

Each single-dose container contains 0.5 g of gel.

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

Holder of the marketing authorization

Laboratorios Thea S.A.

C/ Enric Granados, nº 86-88, 2nd floor, 08008 Barcelona

Responsible for manufacturing

UnitHER Laboratories

1 RUE DE L’ARQUERIE50200 COUTANCES

FRANCE

Or

UnitHER Laboratories
ESPACE INDUSTRIEL NORD

151, RUE ANDRÉ DUROUCHEZ– BP 28028

80084 AMIENS CEDEX-2

FRANCE

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

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

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

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

This prospectus was approved in March 2015

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