Leaflet: information for the user

Viscofresh 5mg/ml eye drops in single-dose solution

Sodium carmelose

Read this 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Viscofresh is and what it is used for

2.What you need to know before you start using Viscofresh

3.How to use Viscofresh

4.Possible side effects

1. Storage of Viscofresh

6.Contents of the pack and additional information

Viscofreshis an artificial tear substitute and contains the lubricant called sodium carboxymethylcellulose. It is used for the treatment of symptoms of dry eye (such as pain, burning, irritation or dryness).

Do not use Viscofresh

If you are allergic to sodium carboxymethylcellulose orany of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Viscofresh.

• If irritation, pain, and changes in vision appear or if symptoms worsen,or if you consider your situation to be worsening, stop using this medication and consult your doctor or pharmacist.

Other medications and Viscofresh

Inform your doctor or pharmacist if you are using or have recently used any other medication.

If you are using any other eye drops, you must administer them 5 minutes before applying Viscofresh.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consultyour doctor or pharmacist before using this medication.

Viscofreshcan be used during pregnancy and breastfeeding.

Driving and operating machinery

Viscofresh may cause temporary blurred vision, do not drive or operate hazardous machinery until your vision is clear.

Follow exactly the medication administration instructions indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Viscofresh is used topically in the eye.

The recommended dose is one or two drops in the affected eye or eyes as needed or as directed by your specialist.

No need to remove contact lenses before using Viscofresh.

To use the product properly:

-Separate one of the single-dose vials from the strip formed by several.

-Before applying the solution to the eye, check that the single-dose vial is not damaged.

-Open the vial by applying pressure to the top.

-Apply one or two drops in the affected eye or eyes immediately after opening the vial and discard the rest.

Make sure the single-dose vial is intact before use. The solution must be used immediately after opening.To avoid contamination or injury, do not allow the dropper to come into contact with the eye or any other surface.Wash your hands before use.

1. Separate one of the single-dose vials from the strip formed by several vials.
2. Hold the single-dose vial in a vertical position (with the cap facing up) and turn the cap.
3. Pull your lower eyelid down to form a pouch. Turn the single-dose vial downwards and press it to apply one drop to each eye. Blink a few times.

Do not use the single-dose vial again even if there is solution left.

If you use more Viscofresh than you should

If you accidentally use an excessive amount of Viscofresh or in case of accidental ingestion, contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

2. If you forgot to use Viscofresh
3. Apply one drop to the eye(s) that need treatment as soon as you remember, and then return to your regular schedule. Do not use a double dose to compensate for the missed doses.
5. If you have any further doubts about the use of this product, consult your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent adverse reactions (occurring in 1 to 10 patients out of 100): Eye irritation (including burning and stinging), eye pain, eye/eyelid itching), visual disturbances.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Adverse effects observed after marketing (whose frequency cannot be determined) are:allergic reactions (including ocular), blurred vision and increased tearing,sensation of sticky eye, eye redness, ocular surface injury due to the dropper coming into contact during application of the eye drops.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist or nurse, even if it is apossibleadverse effect not appearing in this prospectus.You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medicationout of the sight and reach of children. Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not use Viscofresh if the packaging shows signs of manipulation.

Viscofreshis an colorless or slightly yellowish solution. Do not use the packaging if a change in color is observed or if the contents become turbid.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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