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Relief dry eye symptoms (such as swelling, burning, irritation or dryness) caused when the eyes do not produce enough tears
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1. WHAT SICCAFLUID UNIDOSE AND WHAT IT IS USED
Siccafluid is a substitute for tears and contains a lubricant called Carbomer 974P.
It is an ophthalmic gel used for the relief of symptoms of dry eye (such as swelling, burning, irritation or dryness) caused when the eyes not produce enough tears.
2. BEFORE YOU USE SICCAFLUID UNIDOSE
Do not use Siccafluid if you are allergic (hypersensitive) to carbomer or any of the other ingredients of Siccafluid listed in section 6, "What's in Siccafluid".
Take special care with Siccafluid
· If your condition worsens or does not improve after initiating treatment with Siccafluid, contact your doctor.
· DO NOT INJECT, DO NOT SWALLOW.
Children and adolescents up to 18 years old
The safety and efficacy in children and adolescents SICCAFLUID the recommended adult dosage has been established based on clinical experience, but there are no clinical studies on the subject.
Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you have to use any other eye medication during treatment with Siccafluid:
first use the other eye medication and wait 15 minutes before using Siccafluid.
Pregnancy and lactation
Consult your doctor or pharmacist before taking any medicine.
If you are pregnant or breastfeeding, contact your doctor before starting to consult using Siccafluid.
He or she will decide whether you can use Siccafluid.
Driving and using machines
Your eyesight 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 UNIDOSE
If you Siccafluid has been recommended for use, follow the dosing instructions given by your doctor exactly. Ask your doctor or pharmacist if you have doubts.
The usual dose is administered 1 drop in the affected eye up to 4 times a day.
Children and adolescents up to 18 years old: there are no clinical studies.
How to use:
Wash hands before opening the dose container.
Check that the gel is at the tip of the container. To open the package turn to break the tab on the top.
Tilt your head back and look up.
1. Gently pull down the eyelid of the affected eye until a small "pocket" is formed.
2. Turn the bottle upside down unidosis. Press until one drop into the "pocket".
3. Release the lower eyelid and blink several times.
4. Repeat steps 1 through 3 in the other eye if you also need treated. A dose container is sufficient to treat both eyes, if necessary.
To help prevent infection not touch the eye, surrounding areas or other with the tip of the container.
Discard the dose container after use. Do not store it for later use.
If you use more than you should Siccafluid
Using more drops Siccafluid of which should not cause any harm.
In case of overdose or accidental ingestion immediately consult your doctor or pharmacist or call poison control center telephone +34 91 562 04 20
If you forget to Siccafluid
Do not use a double dose to make up the missed dose. Apply the next dose at intervals to be established.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Siccafluid can cause side effects, although not everybody gets them.
Contact your doctor if:
· Symptoms worsen or do not improve having started treatment with Siccafluid.
If any of the following side effects after applying the eye gel in the eye, talk to your doctor if it is concerned:
· Blurred vision passing
· Mild itching or burning sensation in the eye.
The aforementioned side effects may occur, but the number of people likely to be affected may vary.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. HOW TO STORE SICCAFLUID
Keep out of reach and sight of children.
Do not use Siccafluid 2.5 mg / g ophthalmic gel after the expiry date stated on the label and carton after EXP. The expiry date is the last day of that month.
Do not store above 25 ° C. Retain dose containers in the original packaging to protect from light.
Immediately discard the dose container with any remaining solution after use. Do not save for later use.
6. FURTHER INFORMATION
Composition of Siccafluid Unidose
- The active substance is Carbomer 974 P 2.5mg / g.
- The other ingredients are sorbitol, lysine monohydrate, sodium acetate trihydrate, polyvinyl alcohol and water for injections.
Looks like and contents of the pack
Siccafluid is a slightly yellowish opalescent gel in single-dose containers. Each dose container contains 0.5 g of gel.
Holder of the marketing authorization
LABORATORIES THEA S.A.
Pg. St. Joan 91, 08009 Barcelona
LABORATOIRES responsible for manufacturing
UNITHER ZI OF GUERIE
COUTANCES 50211 CEDEX
LABORATOIRES UNITHER ZI Longpre
10 RUE ANDRÉ DUROUCHEZ
80084 AMIENS CEDEX-2
This medicine is authorized in UE with the following names:
France, Spain, Italy and Portugal: ............... SICCAFLUID
Netherlands ................................... SICCAFLUID UNIDOSE
Iceland and Norway ................................ OFTAGEL
Source: Spanish Agency for Medicines and Health Products