Vispring belongs to the group of medicines called decongestants for ophthalmological use that work by producing ocular decongestion.

Vispring is indicated for the temporary symptomatic relief of mild conjunctival congestion in adults and children over 6 years of age due to: smoke, wind, chlorinated water, light, and other irritating agents.

Do not use Vispring in single-dose containers if

• You are allergic to tetrizolin or any of the other ingredients of this medicine (listed in section 6).
• You have increased pressure in the eye (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 insulin-controlled diabetes.
• You are taking antidepressants in the class of amino oxidase inhibitors or other blood pressure-raising drugs.
• You have dry rhinitis.
• The cornea and conjunctival membrane of the eye are inflamed (keratoconjunctivitis).
• In children under 2 years of age.

Warnings and cautions

Consult your doctor or pharmacist before using this medicine and especially:

• If you have eye pain, headache, vision changes, rapid appearance of floating spots, ongoing redness or 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 your doctor.
• If you are over 65 years of age.

When using this product, the pupils may temporarily dilate.

If you wear contact lenses, these must be removed before the drug is administered.

Excessive or continuous use of this product may 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:

• Amino oxidase inhibitor antidepressant medications or
• Blood pressure raising drugs.

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

• Tricyclic antidepressant medications.

Consult your doctor before administering any other ophthalmic medication, it is recommended to allow at least 5 minutes between both administrations.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you might be pregnant or are planning 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 impaired due to blurred vision or glare.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medicine is for ophthalmic use.

The recommended dose is:

Adults and children over 6 years: 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 2 to 6 years: 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 has been separated from the strip, and the closure device removed, apply the drops to the eye by lightly pressing the container. After application, it is advisable 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 be used only until symptoms disappear and never for more than a week.

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

Overuse or oral ingestion can lead to cardiovascular instability, central nervous system depression including drowsiness and coma, and respiratory depression including apnea.

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

Symptoms associated with overdose are dilation of the eye pupil, bluish discoloration of the skin and mucous membranes, vomiting, sedation, drowsiness, stupor, drooling, nausea, fever, cramps, altered heart rhythm, cardiac arrest, increased blood pressure. , pulmonary edema, respiratory and mental disorders.

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicology Information Service, telephone 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 a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Common (may affect up to 1 in 10 people): Eye irritation (pain, stinging, burning), visual disturbances.

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

Rare (may affect up to 1 in 1,000 people): blurred vision, irritation of the eye conjunctiva and dilation of the pupil (mydriasis).

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

Not known (frequency cannot be estimated from the available data): Lacrimation increased.

Prolonged and frequent use can cause dry eye syndrome.

Communication of adverse effects

If you experience any kind of side effect, consult your doctor or pharmacist, even if it is about possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for medicines for Human Use: https://www.notificaram.es . By reporting side effects you can help provide more information on the safety of this medicine.

Do not store above 25ºC.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

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

Discard the container after each use.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines you do not need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

Composition of Vispring in single-dose containers

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

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

Vispring in single-dose containers is a clear, colorless eye drops solution that comes in 0.5 ml single-dose containers. Each box contains 10 packages.

Holder of the marketing authorization and responsible for manufacturing

Marketing authorization holder

JOHNSON & JOHNSON SA

Walk of the Twelve Stars, 5-7

28042-Madrid

Responsible for manufacturing

LABORATOIRE UNITHER

Zi de la Guérie

Coutances Cedex

France

Date of the last revision of this leaflet: November 2017

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