VISPRING 500 micrograms/ml EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINERS

2. What you need to know before using Vispring in single-dose containers.

Do not use Vispring in single-dose containers if

• You are allergic to tetrizoline or any of the other components of this medicine (listed in section 6).
• You have increased intraocular pressure (narrow-angle glaucoma).
• You have heart disease or high blood pressure (hypertension).
• You have a tumor in the adrenal glands (pheochromocytoma).
• You have an overactive thyroid gland (hyperthyroidism).
• You have controlled diabetes with insulin.
• You are being treated with monoamine oxidase inhibitor antidepressants or other blood pressure-raising medications.
• You have dry rhinitis.
• You have inflamed cornea and conjunctiva (keratoconjunctivitis).
• In children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine, especially:

• If you have eye pain, headache, changes in vision, rapid appearance of floaters, redness or persistent irritation of the eye, pain after exposure to light or double vision. If this happens to you or if the conditions worsen or persist or if new symptoms appear, you should stop using the medicine and consult a doctor.
• If you are over 65 years old.

When using this product, the pupils may temporarily dilate.

If you wear contact lenses, they should be removed before administering the medicine

Excessive or continuous use of this product can cause increased redness of the eye.

To avoid contamination of the product, do not touch any surface with the tip of the container. Do not use the product if the solution changes color or becomes cloudy.

Children and adolescents

Do not use in children under 2 years of age.

Using Vispring in single-dose containers with other medicines

Vispring cannot be used if you are being treated with:

• Monoamine oxidase inhibitor antidepressants or
• Blood pressure-raising medications.

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, and in particular if you are using the following medicine, as it may be necessary to modify the dose of one of them:

• Tricyclic antidepressants.

Consult your doctor before administering any other medicine via the ocular route; it is recommended to wait at least 5 minutes between both administrations.

Pregnancy, breastfeeding, and fertility

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.

Driving and using machines

Vispring in single-dose containers has little or no influence on the ability to drive and use machines. In rare cases, the ability to drive and use machines may be altered due to blurred vision or glare.

3. How to use Vispring in single-dose containers

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

This medicine is administered via the ocular route.

The recommended dose is:

Adults and children over 6 years old: 1 or 2 drops in the affected eyes 2 or 3 times a day as needed, up to a maximum of 4 times a day.

Children from 2 to 6 years old: Use only under strict medical control

The amount of Vispring in single-dose containers is sufficient for a single use in both eyes. Once a single-dose container is separated from the strip and the closure device is removed, apply the drops to the eye by gently pressing the container. After application, it is convenient to blink gently for a few seconds to facilitate uniform distribution of the drops.

Discard the container after each use.

It should only be used for minor eye irritations. If you do not get relief within 48 hours or if the redness increases or persists, discontinue use and consult your doctor.

It should only be used until the symptoms disappear and never for more than a week.

If you use more Vispring in single-dose containers than you should

Excessive use or oral ingestion can lead to cardiovascular instability, central nervous system depression including somnolence and coma, and respiratory depression including apnea.

There is a risk, especially in neonates and children, due to absorption of the product, for example, due to ingestion.

The symptoms associated with overdose are dilation of the pupil of the eye, bluish discoloration of skin and mucous membranes, vomiting, sedation, somnolence, stupor, drooling, nausea, fever, cramps, alteration of heart rhythm, cardiac arrest, increased blood pressure, pulmonary edema, respiratory and mental alterations.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91.562.04.20 (indicating the medicine and the amount ingested).

If you forget to use Vispring in single-dose containers

Do not use a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vispring can cause side effects, although not everybody gets them.

Frequent (may affect up to 1 in 10 patients): Ocular irritation (pain, itching, burning), visual disturbances.

Uncommon (may affect up to 1 in 100 people): Burning of the ocular mucosa, dry eye, rebound hyperemia, palpitations, headache, tremor, weakness, sweating, and increased blood pressure.

Rare (may affect up to 1 in 1,000 patients): Blurred vision, irritation of the ocular conjunctiva, and dilation of the pupil (mydriasis).

Very rare (may affect up to 1 in 10,000 people): Reactions at the application site (including ocular or periocular burning, erythema, irritation, edema, pain, and itching).

Unknown (frequency cannot be estimated from available data): Increased lacrimation.

Prolonged and frequent use can cause dry eye syndrome.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vispring in single-dose containers.

Do not store above 25°C.

Keep out of sight and reach of children.

Do not use this medicine after the expiration date stated on the carton after EXP.

The expiration date is the last day of the month indicated.

Discard the container after each use

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and additional information.

Composition of Vispring in single-dose containers

• The active ingredient is tetrizoline hydrochloride. Each ml contains 500 micrograms of tetrizoline hydrochloride as the active ingredient. Each single-dose container of 0.5 ml contains 250 micrograms of tetrizoline hydrochloride

• The other components (excipients) are: Boric acid (E-284), sodium borate, sodium chloride, and purified water.

Vispring in single-dose containers is a clear and colorless eye drop solution presented in 0.5 ml single-dose containers. Each box contains 10 single-dose containers.

Marketing authorization holder and manufacturer

Marketing authorization holder

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

ManufacturerLABORATOIRE UNITHER

Rue De L Arquerie

Coutances, 50200

France

Date of the last revision of this leaflet: November 2017

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es