Siccafluid

Package leaflet: Information for the user

SICCAFLUID 2.5 mg/g, ophthalmic gel

Carbomer 974P
Please read this leaflet carefully because it contains important information for you.
This medicine is available without a prescription. However, you must use
SICCAFLUID carefully to achieve the best results.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, please ask your pharmacist.
• If your symptoms worsen or do not improve, you should contact your doctor.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What SICCAFLUID is and what it is used for
2. Before you use SICCAFLUID
3. How to use SICCAFLUID
4. Possible side effects
5. How to store SICCAFLUID
6. Further information

1. WHAT SICCAFLUID IS AND WHAT IT IS USED FOR

SICCAFLUID is a tear substitute containing a lubricant called Carbomer 974P.
It is an ophthalmic gel used to relieve symptoms of dry eye (such as pain,
burning, irritation, or dryness) caused by eyes that do not produce enough tears.

2. BEFORE USING SICCAFLUID

Do not use SICCAFLUID
If you are allergic (hypersensitive) to Carbomer or to any of the other ingredients of SICCAFLUID,
listed in Section 6, “What SICCAFLUID contains”.

Take special care with SICCAFLUID:

• If you wear soft contact lenses: You must remove them before using SICCAFLUID ophthalmic gel. After using SICCAFLUID, wait at least 30 minutes before reinserting your lenses. See also section 2, "SICCAFLUID contains benzalkonium chloride".
• If your condition worsens or does not improve after starting treatment with SICCAFLUID: Consult 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 dosage recommended for adults have been established based on clinical experience; however, data from clinical studies are not available.

Use with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
If you are using any other eye medication during treatment with SICCAFLUID: First apply the other ophthalmic medicine, wait 15 minutes, then apply SICCAFLUID.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, consult your doctor before starting to use SICCAFLUID. Your doctor will decide whether you can use SICCAFLUID.

Driving and operating machinery
You may experience transient blurred vision after using SICCAFLUID. Wait until your vision returns to normal before driving or operating machinery.

SICCAFLUID contains benzalkonium chloride
This medicine contains 0.0015 mg of benzalkonium chloride per drop, equivalent to 0.06 mg/g.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove your contact lenses before using this medicine and wait 30 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience any unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. HOW TO USE SICCAFLUID

If SICCAFLUID has been prescribed for you, always use it exactly as directed by your
physician. If you have any doubts, consult your doctor or pharmacist.
The usual dose of SICCAFLUID is 1 drop in each eye requiring treatment, up to 4 times daily.
Children and adolescents up to 18 years of age:
The safety and efficacy of SICCAFLUID in children and adolescents at the adult-recommended
dosage have been established based on clinical experience; however, data from clinical
trials are not available.

Instructions for use
Do not use the bottle if the seal around the cap is broken before first opening.
Wash your hands thoroughly before opening the bottle. Tilt your head backward and look at
the ceiling.

1. Gently pull down the lower eyelid of the eye requiring treatment until a small "pocket" is formed.
2. Turn the bottle upside down. Squeeze it to release 1 drop into the "pocket".
3. Release the lower eyelid and blink a few times.
4. Repeat steps 1–3 for the other eye, if treatment is needed.

To help prevent infection, do not let the tip of the bottle touch the eye, surrounding tissue,
or any other surface. Immediately after use, close the bottle with the screw cap.
Store the bottle upside down; this helps droplet formation for the next use of SICCAFLUID.
After opening, the bottle must not be used for more than 28 days; please also see Section 5
“How to store SICCAFLUID”.

If you use more SICCAFLUID than you should
Using more drops than recommended is not known to cause harm.
If you forget to use SICCAFLUID
If you miss a dose of SICCAFLUID, continue with the next dose as scheduled.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, SICCAFLUID may cause side effects, although not everybody gets them.
Contact your doctor if:

• your condition worsens or has not improved after starting treatment with SICCAFLUID.

If you experience any of the following side effects shortly after using the eye gel,
contact your doctor if they concern you:

• short-term blurred vision;
• mild, short-term burning or stinging sensation in the eyes.

The above-mentioned side effects are known to occur, but the number of people affected may vary.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse.
This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at the website
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SICCAFLUID

Keep out of the reach and sight of children.
Do not use SICCAFLUID after the expiry date stated on the label of the bottle and on the carton after 'EXP.'. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep the bottle in the outer packaging to protect it from light.
Store the bottle in an inverted position, as this helps droplet formation for the next time SICCAFLUID is used.
The bottle must be discarded 28 days after first opening, even if there are still some drops remaining.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. OTHER INFORMATION

What SICCAFLUID contains

• The active substance is Carbomer 974P 2.5 mg/g.
• The excipients are benzalkonium chloride, sorbitol, monohydrate lysine, trihydrate sodium acetate, polyvinyl alcohol, water for injections.

Description of the appearance of SICCAFLUID and package contents
SICCAFLUID is a slightly yellowish, opalescent gel contained in a plastic bottle with a screw cap.
Each bottle contains 10 g of ophthalmic gel.
Each carton contains 1 bottle.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
THEA FARMA S.p.A.
Via Tiziano, 32
20145 MILAN
ITALY

Manufacturer
URSAPHARM, ARZNEIMITTEL GMBH
INDUSTRIESTRASSE
66129 SAARBRÜCKEN
GERMANY
OR
FARMILA-THEA Farmaceutici S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese
ITALY

This leaflet was last approved in June 2025
Detailed information on this medicinal product is available on the AIFA website.

PACKAGE LEAFLET: INFORMATION FOR THE USER

SICCAFLUID 2.5 mg/g, ophthalmic gel in single-dose container

Carbomer 974P
Please read this leaflet carefully as it contains important information for you.
This medicine is available without a prescription. However, it is important to use SICCAFLUID carefully to achieve the best results.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, please consult your pharmacist.
• If your symptoms worsen or do not improve, you should contact your doctor.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

7. WHAT SICCAFLUID IS AND WHAT IT IS USED FOR

SICCAFLUID is a tear substitute and contains a lubricant called
Carbomer 974P.
It is an ophthalmic gel used to relieve symptoms of dry eye
(such as pain, burning, irritation or dryness) caused by insufficient tear production.

8. BEFORE USING SICCAFLUID

Do not use SICCAFLUID

• If you are allergic (hypersensitive) to Carbomer or to any of the other ingredients of SICCAFLUID listed in Section 6, “What SICCAFLUID contains”.

Take special care with SICCAFLUID:

• If your condition worsens or does not improve after starting treatment with SICCAFLUID: consult 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 dosage recommended for adults have been established based on clinical experience, but data from clinical studies are not available.

Use with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
If you are using any other eye medication during treatment with SICCAFLUID: first apply the other ophthalmic drug, wait 15 minutes, then apply SICCAFLUID.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, ask your doctor for advice before starting to use SICCAFLUID. Your doctor will decide whether you can use SICCAFLUID.

Driving and using machines
You may experience transient blurred vision after using SICCAFLUID. Wait until your vision returns to normal before driving or operating machinery.

9. HOW TO USE SICCAFLUID

If SICCAFLUID has been prescribed for you, always use it exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual dose of SICCAFLUID is 1 drop in each eye requiring treatment, 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 dosage recommended for adults have been established based on clinical experience; however, data from clinical studies are not available.

Instructions for use
Wash your hands thoroughly before opening the single-dose container.
Make sure the gel is at the tip of the container. To open the container, twist off the tab. Tilt your head backward and look at the ceiling.

5. Gently pull down the lower eyelid of the eye requiring treatment until a small "pocket" is formed.
6. Turn the vial upside down. Squeeze it to release 1 drop into the "pocket".
7. Release the lower eyelid and blink a few times.
8. Repeat steps 1–3 for the other eye, if treatment is needed. One single-dose container is sufficient for treating both eyes, if required.

To help prevent infection, do not let the tip of the vial touch the eye, surrounding tissue, or any other surface.
Dispose of the single-dose container after use. Do not store it for later use.

If you use more SICCAFLUID than you should
Using more drops than prescribed of SICCAFLUID is not expected to cause harm.

If you forget to use SICCAFLUID
If you miss a dose of SICCAFLUID, continue with the next dose as scheduled.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

10. POSSIBLE ADVERSE REACTIONS

Like all medicines, SICCAFLUID may cause adverse reactions, although not everyone experiences them.
Contact your doctor if:

• your condition worsens or does not improve after starting treatment with SICCAFLUID.

If you experience any of the following adverse reactions immediately after using the eye gel, contact your doctor, especially if they concern you:

• short-term blurred vision;
• mild, short-term burning or stinging sensation in the eyes.

The above-mentioned side effects are known to occur, but the number of people affected may vary.
Reporting of adverse reactions
If you experience any adverse reaction, consult your doctor, pharmacist, or nurse. This includes possible adverse reactions not listed in this leaflet. You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide further information on the safety of this medicine.

11. HOW TO STORE SICCAFLUID

Keep out of the reach and sight of children.
Do not use SICCAFLUID after the expiry date stated on the label of the single-dose container, on the pouch, and on the outer carton after 'EXP.'. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep the single-dose containers in the original packaging to protect them from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

12. OTHER INFORMATION

What SICCAFLUID contains

• The active substance is Carbomer 974P 2.5 mg/g.
• The excipients are sorbitol, lysine monohydrate, sodium acetate trihydrate, polyvinyl alcohol, and water for injections.

Description of the appearance of SICCAFLUID and contents of the pack
SICCAFLUID is a slightly yellowish, opalescent gel contained in a single-dose container.
Each single-dose container holds 0.5 g of ophthalmic gel.
A carton contains 10, 20, 30 or 60 single-dose containers.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
THEA FARMA S.p.A. – Via Tiziano, 32 – 20145 MILAN, ITALY

Manufacturer
Laboratoire UNITHER,
ZI Longpré
10 rue André Durouchez
80084 Amiens Cedex 2
FRANCE
Or
Laboratoire UNITHER
1 rue de l’Arquerie
50200 Coutances
FRANCE

This medicinal product is authorized in the European Economic Area (EEA) countries
under the following names:
France, Spain, Italy and Portugal…………………………………SICCAFLUID
Netherlands……………………………………………….SICCAFLUID UNIDOSE
Iceland and Norway………………………………………………………OFTAGEL

This leaflet was last approved in October 2021
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA).