Viscofresh 5 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 5 mg/ml eye drops solution in single-dose container
Sodium carmellose
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
Contents of the leaflet
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What Viscofresh is and what it is used for
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What you need to know before using Viscofresh
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How to use Viscofresh
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Possible side effects
- Storage of Viscofresh
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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).
2. What you need to know before starting to use 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
Consult your doctor or pharmacist before starting to use Viscofresh.
- If irritation, pain, or changes in vision occur, or if symptoms worsen, or if you think your condition is getting worse, stop using this medicine and consult your doctor or pharmacist.
Other medicines and Viscofresh
Tell your doctor or pharmacist if you are using or have recently used any other medicines.
If you are using any other eye product, you should administer it 5 minutes before applying Viscofresh.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Viscofresh may be used during pregnancy and breastfeeding.
Driving and use of machines
Viscofresh may cause temporary blurred vision; do not drive or operate dangerous machinery until your vision is clear.
3. How to use Viscofresh
Follow exactly the instructions for administering the medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Viscofresh is administered by the ophthalmic route.
The recommended dose is one or two drops in the affected eye(s) as often as necessary or as directed by your specialist.
It is not necessary to remove contact lenses before using Viscofresh.
To use the product correctly:
- Separate one single-dose vial from the strip containing multiple vials.
- Before applying the solution to the eye, check that the single-dose container is not damaged or broken.
- Open the container by pressing on the top part.
- Immediately after opening the container, apply one or two drops to the affected eye(s) and discard any remaining solution.
Ensure that the single-dose container is intact before use. The solution must be used immediately after opening. To avoid contamination or possible injury, do not allow the dropper tip to touch the eye or any other surface. Wash your hands before use.
- Separate one single-dose container from the strip of multiple containers.
- Hold the single-dose container vertically (with the cap facing upwards) and twist the cap.
- Gently pull down the lower eyelid to form a pouch. Turn the single-dose container upside down and squeeze it to apply one drop into each eye. Blink a few times.
Do not reuse the single-dose container even if some solution remains.
If you use more Viscofresh than you should
If you accidentally use too much Viscofresh or if the product is accidentally ingested, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the name of the medicine and the amount ingested.
- If you forget to use Viscofresh
- Apply one drop to the eye(s) requiring treatment as soon as you remember, then return to your usual dosing schedule. Do not use a double dose to make up for a missed dose.
- If you have further questions about the use of this product, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Frequent adverse reactions (occur in 1 to 10 out of 100 patients): Eye irritation (including burning and stinging), eye pain, eye/eyelid itching, visual disturbances.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects observed after marketing (frequency cannot be estimated from the available data): Allergic reactions (including ocular allergies), blurred vision and increased tearing, sensation of sticky eyes, eye redness, injury to the ocular surface due to contact of the dropper tip with the eye during instillation of the eye drops.
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 can 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 store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.
Do not use Viscofresh if the packaging shows signs of tampering.
Viscofresh is a colourless or slightly yellowish solution. Do not use the container if a change in colour is observed or if the solution becomes cloudy.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Viscofresh
- The active substance is sodium carmellose.
- The other components are: sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, hydrochloric acid or sodium hydroxide (for pH adjustment), and purified water.
Appearance of the medicinal product and contents of the pack
Viscofresh is presented as a sterile eye drop solution in single-dose containers. Each single-dose container contains 0.4 ml of solution.
The single-dose container has a cap opened by twisting the tab.
It is available in packs of 10 single-dose vials or 30 single-dose vials within a sealed aluminum pouch. One aluminum pouch contains 10 single-dose vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
AbbVie Spain, S.L.U.
Avenida de Burgos 91,
28050 Madrid,
Spain
Manufacturer:
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland
Date of the most recent revision of this summary of product characteristics:
11/2017
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/