Viscofresh 10 mg/ml eye drops solution in single-dose container
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Viscofresh 10 mg/ml eye drops solution in single-dose container
sodium carmellose
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Viscofresh is and what it is used for
- What you need to know before using Viscofresh
- How to use Viscofresh
- Possible side effects
- How to store Viscofresh
- Contents of the pack and other information
1. What Viscofresh is and what it is used for
Viscofresh is a tear substitute containing the lubricant sodium carmellose. It is used to treat symptoms of dry eye (such as pain, burning, irritation, or dryness) caused by insufficient tear production to keep the eye moist.
2. What you need to know before using Viscofresh
Do not use Viscofresh:
- If you are allergic to sodium carmellose or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- If you wear contact lenses, they must be removed before using Viscofresh. Lenses may be reinserted 15 minutes after application.
- If irritation, pain, redness, or changes in vision occur, or if your condition worsens, stop using this medicine and consult your doctor or pharmacist.
- To avoid contamination or possible eye injury, do not let the open end of the single-dose container come into contact with the eye or any other surface.
Other medicines and Viscofresh
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are using other eye drops, wait at least 15 minutes between administering the other drops and Viscofresh.
Pregnancy and breastfeeding
Viscofresh may be used during pregnancy and breastfeeding.
Driving and using machines
Viscofresh may cause short-term blurred vision, usually lasting from 1 to 15 minutes. If you experience temporary blurred vision, do not drive or operate machinery until your vision is clear.
3. How to use Viscofresh
Viscofresh is for ophthalmic use (applied to the eye).
Follow exactly the instructions for administration provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.
The recommended dose is 1-2 drops of Viscofresh in the affected eye(s), as needed.
Ensure the single-dose container is intact before use. The solution should be used immediately after opening. Wash your hands before use.
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Separate one single-dose container from the strip containing several containers.
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Hold the single-dose container in an upright position (with the cap facing up) and twist the cap.
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Gently pull down the lower eyelid to form a pouch. Turn the single-dose container upside down and squeeze it to administer one drop into the eye. Blink a few times.
Do not reuse the single-dose container even if there is solution remaining. It is very important that you discard it and do not keep it.
If you use more Viscofresh than you should
This is unlikely to cause you any harm. If you are concerned, consult your doctor or pharmacist.
If you forget to use Viscofresh
Apply the next dose as needed or according to the usual schedule advised by your doctor or pharmacist. Do not take a double dose to make up for forgotten doses.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following medically relevant adverse reactions or adverse effects have been identified in clinical trials:
Frequent (may affect up to 1 in 10 people):
- eye irritation (including stinging and discomfort)
- eye pain
- eye itching
- visual disturbances
Post-marketing experience
The following medically relevant adverse reactions or adverse effects have been reported during post-marketing experience:
Uncommon (may affect up to 1 in 100 people):
- allergic reaction (including ocular or eyelid swelling)
- blurred vision
- increased tear production (also known as lacrimation)
- sticky eyes
- crusting of the eyelid and/or medication residue
- sensation of a foreign body in the eye
- eye/eyelid redness
- worsening of vision
- injury to the eye surface due to contact between the dropper tip and the eye during instillation of the eye drops.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Viscofresh
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the single-dose container, on the aluminium pouch, and on the carton after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
Store the single-dose containers in the pouch and return the pouch to the carton. The pouch is necessary to prevent loss of moisture.
Do not use if the packaging shows signs of tampering. Do not use this medicine if you notice any change in colour or cloudiness of the solution.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Sigre Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Viscofresh
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The active substance is sodium carmellose, 10 mg/ml.
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The other components are: sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, and purified water.
The components used in Viscofresh 10 mg/ml have been selected to match those present in tears naturally produced by the eye.
Appearance of the product and contents of the container
Viscofresh is presented as a transparent, colourless to slightly yellowish eye drop solution in a small transparent container (blister type), known as a single-dose container. The single-dose container has a twist-off cap. Each single-dose container holds 0.4 ml of solution.
Each box contains 10, 20, 30, 40, 60 or 90 single-dose containers in an aluminium pouch.
Each aluminium pouch contains 10 single-dose containers.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder:
AbbVie Spain, S.L.U.
Avenida de Burgos 91,
28050 Madrid
Spain
Manufacturer:
Allergan Pharmaceuticals Ireland.
Westport, Co. Mayo,
Ireland
Date of the most recent revision of this leaflet: March 2025
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es