Siccafluid 2.5 mg/g ophthalmic gel in single-dose units
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
SICCAFLUID 2.5 mg/g OPHTHALMIC GEL IN SINGLE-DOSE UNITS
Carbomer 974 P
Read the entire leaflet carefully as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If symptoms worsen or persist, you should consult your doctor.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents
- What Siccafluid is and what it is used for
- Before you use Siccafluid
- How to use Siccafluid
- Possible side effects
- How to store Siccafluid
- 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 soreness, burning, irritation, or dryness) caused by insufficient tear production.
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 your condition worsens or does not improve after 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 dosage recommended for adults has been established based on clinical experience; however, clinical studies on this subject are not available.
Use of other medicines
Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
If you need to use any other ophthalmic medicine during treatment with Siccafluid: first use the other ophthalmic medicine 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 discuss with him or her before starting treatment with Siccafluid.
He or she will decide whether you can use Siccafluid.
Driving and using machines
Your vision may become blurred for a short time after using Siccafluid.
You should not drive or operate machinery until your vision returns to normal.
3. How to use Siccafluid
If Siccafluid has been recommended for your use, follow exactly the administration instructions provided by your doctor. Consult your doctor or pharmacist if you have any doubts.
The usual dose is 1 drop administered into the affected eye(s) 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 clinical studies in this population are not 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, twist until the break-off tab on the top breaks.
Tilt your head backward and look upward.
- Gently pull down the eyelid of the affected eye until a small "pocket" is formed.
- Turn the container upside down. Squeeze until one drop falls into the "pocket".
- Release the lower eyelid and blink several times.
- Repeat steps 1 to 3 in the other eye if it also requires treatment.
To help prevent infection, do not touch the eye, surrounding areas, or anything else with the tip of the container.
Discard the single-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 recommended does not cause any harm.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 your regular schedule.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Siccafluid may cause adverse effects, although not everyone experiences 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 ophthalmic gel to the eye, speak with your doctor if you are concerned:
• Temporary 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 of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
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 expiry date stated on the container and the carton after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C. Store single-dose containers in the original packaging to protect from light.
Immediately discard the single-dose container with any remaining solution after use.
Do not keep for later use.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.
6. Additional information
Composition of Siccafluid
- The active substance is Carbomer 974 P 2.5 mg/g.
- The other components are sorbitol, lysine monohydrate, sodium acetate trihydrate, polyvinyl alcohol, and water for injections.
Appearance of the product and content of the container
Siccafluid is a slightly yellowish, opalescent gel in single-dose containers.
Each single-dose container contains 0.5 g of gel.
Each carton contains 10, 20, 30 or 60 single-dose containers (not all pack sizes may be marketed).
Marketing Authorization Holder
LABORATORIOS THEA S.A.
C/ Enric Granados, nº 86-88, 2ª planta, 08008 Barcelona, Spain
Manufacturer
LABORATOIRES UNITHER
1 RUE DE L’ARQUERIE 50200 COUTANCES
FRANCE
OR
LABORATOIRES UNITHER ESPACE INDUSTRIEL NORD
151, RUE ANDRÉ DUROUCHEZ – BP 28028
80084 AMIENS CEDEX-2
FRANCE
This medicinal product 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 summary was approved in March 2015
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/