Siccafluid 2,5 mg/g gel oftalmico

Prospecto: information for the user

SICCAFLUID 2.5 mg/g EYE GEL

Carbomer 974 P

Read the entire prospect carefully because it contains important information for you.

This medication can be purchased without a prescription. Nevertheless, to achieve the best results, it must be used properly.

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

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

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

-If you consider that any of the adverse effects you are experiencing is severe or if you notice anyadverse effect not mentioned in this prospect, inform your doctor or pharmacist.

1. What is Siccafluid and for what it is used

2. Before using Siccafluid

3. How to use Siccafluid

4. Possible adverse effects

5. Conservation 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 eyes(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 ingredients of Siccafluid listed in section 6, “What Siccafluid contains”.

Be especially careful with Siccafluid

•If you wear soft contact lenses:you must remove them before using Siccafluid. After using Siccafluid, wait at least 30 minutes before reinserting them. See also section 2, “Siccafluid contains benzalkonium chloride”.

•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 on the basis of clinical experience, but there are no clinical studies available.

Use of other medicines

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Siccafluid contains benzalkonium chloride

This medicine contains0.0015 mgof benzalkonium chloride in each drop equivalent to 0.06 mg/g.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the lenses. Remove the contact lenses before using this medicine and wait 30 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medicine.

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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.

Theusual doseis 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:

Do not usethe bottle if the tamper-evident seal on the capis brokenbefore the first opening.

Wash your hands before opening the bottle. Tilt your head back and look up.

1. Push slightly downward on the lower eyelid of the affected eye until a small "pouch" forms.
2. Turn the bottle 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 you also need to treat it.

To help prevent infection, do not touch the eye, the surrounding area, or any other part with the

dropper from the bottle.

Close the bottle after use.

Storethe bottle in an upright position, with thecap facing down, to facilitate the formation of drops for the next time you use Siccafluid.

Onceopened, the bottleshould not be used for more than 28 days; also see section 5, "Storage of Siccafluid".

If you use more Siccafluid than you should

Using more drops of Siccafluid than you should causes no 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 forget to use Siccafluid

Do not use a double dose to make up for the missed 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.

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 eye gel after the expiration date that appears on the label of the bottle 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 the bottle in the outer packaging to protect it from light.

Storethe bottle in an upright position, with thecap facing downwards, to facilitate the formation of drops for the next time you use Siccafluid.

Dispose of the bottle after 28 days after the first opening, even if there are some drops left in it.

Medicines should not be thrown away through the drains or in the trash. Deposit the containers and medicines that you do not need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help to protect the environment.

Composition of Siccafluid

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

Appearance of the product and contents of the package

Siccafluid is an opalescent, slightly yellowish gel packaged in plastic bottles with a screw cap.

Each bottle contains 10 g of gel.

Each box contains one bottle.

Holder of the marketing authorization

Laboratorios Thea S.A.

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

Responsible for manufacturing

Ursapharm, Arzneimittel GmbH

Industriestrasse

66129 Saarbrücken, Germany

or

Farmila-Thea Farmaceutici S.p.A.

Via Enrico Fermi, 50

20019 Settimo Milanese

Italy

This prospectus was approved in March 2025

The 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/